Urodynamics tests for the diagnosis and management of bladder outlet obstruction in men: the UPSTREAM non-inferiority RCT

Key secondary (surgery)

The number of men having surgery within 18 months was recorded in each arm and the proportion of men having surgery was calculated using the number of men with a completed 18-month case report form (CRF) as the denominator. Men who withdrew consent for a notes review to be carried out at 18 months, or who died, were removed for this outcome. As a pragmatic trial, standard practice for the centres were followed, relating to the type of surgery, LUTS medications or other treatments.

Adverse events

The number of AEs were recorded in each arm, as well as the severity, expectedness and relationship to testing and treatment. Box 2 provides the definition of a serious adverse event (SAE) and lists expected and related AEs. When events were related to surgery, they were given a Clavien–Dindo classification,23 of which there are five grades (plus two subgroups for grades 3 and 4); see Dindo et al. 23 for further details.

All AEs (serious and non-serious) were reviewed by an independent clinician, including the relatedness to testing and treatment and Clavien–Dindo scoring for surgery-related events, to ensure uniformity in the classifications across the centres and check for bias in the classifications. Any disagreements with the assignment or classification were revised when appropriate.

Per-protocol analysis

The primary and key secondary analyses were repeated, analysing men who received UDS, having been allocated to it, against those who did not receive it, having been allocated to routine care. Therefore, any men who had not complied with their randomised pathway were excluded from the analyses.

Complier-average causal effect analysis

The complier-average causal effect (CACE) analysis used the data from those men who did receive their randomised treatment but, unlike the primary analysis, incorporated the treatment-received variable as the independent variable and randomisation as an instrumental variable, using the ‘iv regress sls’ command in Stata.

Mixed-effects model

This analysis allowed us to look at the total 18-month impact of the intervention and whether or not there was a difference between the two arms. The mixed-effects repeated measures approach was adopted to assess the total 18-month impact, while accounting for missing data at each 6-month time point.

Imputation using 6- and 12-month data

When baseline IPSSs were missing, the 6-month scores were utilised if no intervention procedures had taken place (e.g. surgery). When 18-month scores were missing, the 12-months scores were utilised if all intervention procedures had taken place by this time point, if they were scheduled to take place.

Imputation for missing data

Men included in the analysis were compared with those men who were not followed up at 18 months. The missingness mechanism was assessed and multiple imputation methods were adopted. The randomisation seed was prespecified (648) to allow reproducible results and reduce any tampering.

Adjustment for clinically important confounders

When the trial was designed, the clinicians produced a list of clinically important confounders that should be considered in the analysis of the primary outcome. These were centre, age, comorbidities and symptom severity. Therefore, these were adjusted for in a sensitivity analysis.

Adjustment for imbalance at baseline

A prespecified measure of imbalance was used to compare the arms and any continuous measures that were at least 0.5 SDs apart, or had an absolute difference of 10% (for binary and categorical outcomes), were adjusted for.

Adjustment for time from surgery

When UPSTREAM was designed, the team envisaged that the 18-month follow-up would incorporate a 6-month post-surgery gap that would allow any side effects of treatment to subside. It became apparent that assessment and treatment pathways across the 26 hospitals varied, and waiting lists for surgery were longer than anticipated, potentially influencing the 18-month symptom scores. Therefore, the time between surgery and the 18-month questionnaire was calculated, imputing a time of 1000 days when no surgery occurred.

When the 18-month time points were scrutinised during follow-up, the team chose to conduct a post hoc sensitivity analysis that excluded follow-up outside a certain trial window (16–20 months). This was done to ensure that the results we achieved were truly reflective of an 18-month follow-up.

Use of routine hospital data

Informatics or similar departments in all centres were approached and independent information analysts were asked to provide electronic information from routinely collected hospital data. Routine hospital data were obtained for those men who had granted ongoing consent for the trial team to access their medical notes. We requested diagnostic codes (International Statistical Classification of Diseases, Tenth Edition), procedural codes (International Classification of Interventions and Procedures), currency codes [Healthcare Resource Group (HRG)], and admission and discharge dates at finished consultant episode (FCE)-level data, for all for inpatient stays (including day cases). For outpatient attendances and outpatient diagnostic imaging tests, we requested, as applicable, procedure, HRG/currency codes, diagnostic codes and attendance dates (although we requested diagnostic codes, these were widely unavailable). We requested attendance date and HRG code data for emergency admissions.

For all centres, a Microsoft Excel^® spreadsheet (Microsoft Corporation, Redmond, WA, USA), containing a list of trial (participant) identifiers and individualised dates of randomisation and 18-month follow-up, was sent to the onsite trial research nurses; they then added date of birth and NHS and hospital numbers to the trial identifiers, and securely forwarded the information to the information analyst. Data on all inpatient stays, outpatient and emergency department attendances, and diagnostic imaging outpatient appointments between the two given dates were added to this spreadsheet, which was then returned to the research nurse. All data were anonymised by the research nurses prior to the secure transfer of data to the trial team.

For 58 participants completing follow-up close to the trial end date, it was necessary to request their data before their 18-month follow-up date. We accepted a minimum of 15 months’ follow-up data for these patients, effectively administratively censoring these patients at 15 months.

Two clinicians devised a list of all specialties that may conceivably be involved in treating conditions that may present with LUTS (Box 3). All events recorded against specialties that, according to clinician opinion, would be unlikely to be related to the treatment of LUTS were deleted.

All inpatient data were processed using the 2016/17 NHS reference costs grouper. 32 This ensured that all HRGs generated from the diagnostic and procedure codes provided by hospitals could be subsequently valued using the published 2016/17 NHS Reference Costs. 33 The relevant diagnostic or procedure codes were used to assign a treatment specialty if this information was missing. If necessary, main specialty codes were derived from treating specialty codes (e.g. colorectal surgery treating specialty was assigned the general surgery main specialty). Urology is both a treating and a main specialty.

When the grouper generated HRG codes that matched with a zero cost in the reference costs, these were checked for errors and, when appropriate, were assigned an alternative HRG code based on clinical opinion. Unbundled diagnostic imaging, nuclear medicine and chemotherapy services produced by the grouper were costed separately and added to the secondary care costs.

Finished consultant episodes were amalgamated into spells. A spell consists of a continuous stay in a single NHS hospital trust. The NHS treats any two inpatient spells that occur in a short duration as a single spell. Any patients with spells that occurred within 48 hours of each other were costed as a single spell. If any FCE within a spell was recorded against a LUTS-related specialty, the spell was included in the inpatient resource use costing.

All day-case and inpatient admissions were assumed to be elective and costed as such, unless the patient had an emergency attendance recorded at the treating hospital in the 24 hours prior to an inpatient admission. If an inpatient stay was greater than the grouper-provided trim point, then an additional cost was applied to the number of excess bed-days. Any spells in which the patient was admitted and discharged on the same day were costed using day-case reference costs.

All outpatient attendances not assigned a HRG code were valued as consultant-led, follow-up, face-to-face appointments, unless the hospital indicated otherwise in writing. Any International Classification of Interventions and Procedures codes suggestive of an outpatient procedure appointment, such as UDS or uroflowmetry, rather than a clinic appointment, were recorded and valued as such. Outpatient procedures and clinic appointments occurring on the same day were costed separately.

Two centres were unable to provide HRG information of emergency department attendances. The date of attendance was provided and the most commonly used HRG from the rest of the data set was attributed to these attendances for costing purposes.

Trial design

In-depth semistructured interviews were conducted with patients enrolled in UPSTREAM,19 at 26 secondary care urology centres across England. Interviews allow for the exploration of complex and sensitive issues, allowing participants to engage in a dialogue in their own language and drawing on their life experiences to cover the issues that are important to them.

Recruitment and sampling

All trial participants had consented at baseline to being approached by a qualitative researcher. Purposive sampling was used to select a maximum variation sample in relation to (1) trial arm; (2) trial centre; (3) sociodemographic and clinical variables, age, ethnicity and socioeconomic status; and (4) baseline total IPSS. 51 Socioeconomic status was estimated using the Index of Multiple Deprivation decile,52 which ranks areas in England from most deprived (score of 1) to least deprived (score of 10); we sampled across three categories (high, 1–4; medium, 5–7; low, 8–10). The IPSS assesses seven symptoms: incomplete emptying, frequency, intermittency, urgency, weak stream, straining and nocturia; each is scored 0 (best) to 5 (worst). Total IPSS at baseline was categorised as high or low using the American Urological Association Symptom Index classification: ≥ 20 indicates high symptom burden (severe symptoms) and ≤ 19 indicates low symptom burden (mild or moderate symptoms). 51 For the post-surgery patients, their most recent post-surgery IPSS was also considered during sampling when available.

Patients were recruited for interview at two time points: either 1–8 weeks after the consultation in which their treatment had been decided and recorded, or 6 weeks to 4 months after receiving surgery for LUTS. This was to capture variation along the treatment pathway and in treatment types (surgery vs. non-invasive treatment).

Interviews

Participants in the local Bristol area were interviewed either face to face or by telephone, depending on their preference. Participants in other geographical areas were interviewed by telephone. All interviews were conducted by Cynthia A Ochieng or Lucy E Selman, both experienced and trained qualitative researchers with a background in health services research. Neither researcher works clinically in urology, nor was previously known to participants.

Interviews followed topic guides developed at the start of the trial based on the literature, the qualitative trial aims and input from the TMG, including patient representatives (see Appendix 5). The topic guides were devised to ensure that the primary issues were covered across all interviews, but did not dictate data collection. The topic guide incorporated considerable flexibility to enable participants to introduce new issues unanticipated by the researchers. Each topic guide was piloted with two men with LUTS (data not included in analysis), and refined prior to use. The topic guides were further refined as data collection progressed, in response to emerging findings.

In telephone interviews, consent was taken verbally prior to the interview. In face-to-face interviews, participants gave written consent. Field notes were taken during and after the interviews and integrated into the analysis. All interviews were digitally audio-recorded, professionally transcribed verbatim, anonymised and checked for accuracy prior to analysis. Transcripts and field notes were imported into NVivo V10 software (QSR International, Warrington, UK) for analysis.

Analysis of the interviews

Analysis was conducted in parallel with data collection, with findings from early analysis informing later data collection in an iterative process, and sampling continued until no new themes emerged from the analysis by the end of data collection. 53 Thematic analysis54 was used to analyse the data, following six steps:

1. Familiarisation with the data through detailed reading.

2. Two different members of the qualitative research team independently constructed draft coding frames using line-by-line coding of a sample of the data. A combination of deductive coding, based on the aims of the trial and the topic guide, and inductive coding, identifying themes in the data, was used.

3. The qualitative research team met to compare the coding frames and decide on the final draft of coding frame to be used.

4. Themes were defined (in NVivo) and the coding frame applied to the data by one researcher.

5. The researcher met with the rest of the qualitative team as coding progressed, to review and discuss emerging findings.

6. A narrative was drafted based on the analysis, paying attention to patterns and deviant cases, with input from the qualitative team (LES, CAO, JH, CC). Emerging findings were also discussed at TMG meetings to refine the topic guide and qualitative analysis and to inform trial conduct.

Separate coding frames in the same NVivo project were created for pre-treatment and post-surgery patient data sets. Clinician interviews were analysed in a separate NVivo project. Analysis initially focused on each data set separately, and then considered and integrated findings from the patient and clinician qualitative data sets.

Trial participants

In total, 50 interviews were conducted, comprising nine patients who declined to participate in the trial and 41 trial participants. The trial participants interviewed were from diverse locations in England (25 pre treatment, 16 post surgery) and ranged in age from 52 to 89 years (Table 32). Fifteen participants had a high symptom burden at baseline. Twenty-five participants had experienced UDS testing.

Among pre-treatment trial participants, seven agreed to surgery after receiving UDS during UPSTREAM, five agreed to surgery after non-invasive testing (i.e. routine care), six agreed to conservative treatment after UDS during UPSTREAM (although one man was undecided) and seven agreed to conservative treatment after non-invasive testing.

Verbatim quotes are used below to illustrate emerging themes from the analysis, with PT denoting pre-treatment trial participants and PS post-surgery trial participants.

Views and acceptability of UPSTREAM among decliners

Seven interviews were conducted with patients who declined to take part in the trial. Reasons given for not taking part in UPSTREAM included patients wanting to be allocated to UDS (or not), because of their own opinion or that of their consultant, and not wanting to leave the choice of assessment to randomisation. Reasons for not wanting to be randomised to receive UDS included not wanting UDS unnecessarily, fear that having UDS might delay or lead to surgery and not liking the idea of having an invasive UDS test. One decliner had a bad previous experience with UDS and did not want to have it again. Others reported not having the time owing to work constraints or other commitments.

I thought, well [–] I actually – I would rather either have or not have a UDS test based on what the consultant, in discussion with me, thinks is necessary or advisable. I didn’t just to [–] want to randomly either have it or not have it because I’d just randomly been selected for one group or another.

Decliner 1

I’ve already – I feel that this is, um, a step too far. If I can go in and have the operation without all this nonsense, um, and I’m sorry, I used that word [laughs] but, um, I – I just felt that the sooner I get it over and done with the better.

Decliner 4

I felt that, although he [consultant] explained it [surgery] well, he explained it very lightly but, oh yes, I had to go in overnight, er, and, alright, I – I had a pipe up me, my pipe, pipe, er, and I would be alright. But when I read the [–] er [–] booklet that he gave me, I realised that it was a lot more complicated than that, and that I would be out of action for anything up to a month . . . And I could be bleeding, I could have catheters again, so I decided at my age of 85 that it wasn’t worth doing. I’ll get up, er, more frequently at night, thank you.

Decliner 3

Participants’ initial impressions of UPSTREAM and reasons for taking part

All trial participants interviewed were happy to be approached and take part in UPSTREAM. Participants’ main motivations to take part were the altruistic belief that taking part would benefit others or the view that they would benefit directly from participating. Some participants were favourably disposed towards research that aimed to improve practice and wanted to help for this reason. Others believed that they would receive quicker and better care and treatment if they were part of the trial, or wanted to know more about their condition and felt that taking part would help with treatment decision-making. One participant wanted to avoid surgery and felt that the trial may provide alternative options:

Like treatment for cancers and all sorts of things, someone has to try the drugs at some stage and whatever else you know surgery, it’s all in the early days you know done without anaesthetic and that, I wouldn’t have wanted that, but um if nobody does it, we’ll not move forward.

PS8, routine care

I want to help other guys in this situation, and if the information I pass over together with other people’s helps to improve um, quality of life for people, then yeah I’m more than happy to get involved.

PS9, UDS

I thought maybe it would speed things up and people would be more aware of it, you know. And not only that, you know, if someone else is watching what’s going through the process, through the back door, then maybe I’ll get a better service . . . I think if I wasn’t on the UPSTREAM programme I’d be just, you know, a Joe Bloggs and a number.

PT17, UDS

Participant understanding of randomisation

Trial participants reported different levels of understanding of the trial aims, the randomisation of participants into two arms, why this was done and what was involved in each arm. Most participants had a clear understanding of what randomisation meant and what the two arms entailed. However, some understood only that they would be randomised and not what being in one of the two arms entailed:

Well as far as I understood it was to see, err, whether actually doing the UDS extra part of it actually improved the diagnosis of the problem . . . I think that’s what I understood by it.

PS1, routine care

Well, as I said, it was random anyway. You couldn’t opt to go in one group or the other. It was a random selection. Erm, for the second test to prove straightaway that you needed surgery, to me is a better idea.

PT4, UDS

I didn’t know what to make of it because I don’t know if I . . . if I err . . . I didn’t know whether . . . what was going to be done to the other group was, was something good, you know. I never . . . I don’t think from the start I had a clear understanding of what the difference was, and when I was told that, you know, I would be in the passive group or whatever the proper term would be.

PS4, routine care

The acceptability of randomisation and equipoise/arm preference

Participants were happy to be randomised and accepted that it was part of the trial design. Although some participants from the routine care arm said that they would have been happy to have been allocated to either group, most participants (from both arms) did express a preference for one arm or the other. Reasons for wanting to be allocated to the invasive UDS testing arm included believing that the UDS arm would be more effective, in that it would provide more complete and accurate information to inform treatment decision-making:

Well, I understand that that’s the way trials work. You know, it’s got to be randomised, and you have to accept whatever arm of the trial you are on . . . And, and I don’t have, you know, I had no feelings one way or another. I think, you know, I understand how clinical trials are done, so, so I think, you know, if you wanna take part, you have to accept whatever happens, whatever group you get assigned to is absolutely fine.

PT5, routine care

I was bitterly disappointed actually that I wasn’t in the [UDS arm] . . . It would have been more helpful . . . I think it would have been more interesting for me as well . . . just finding out about how your body works to a certain extent. It’s more you know. The more tests the better, I say – to a certain extent, because you know exactly what’s going on then.

PS5, routine care

[You] would only get more definitive answers from the UDS test . . . I must admit if I hadn’t been selected for that, I think I might have been a bit disappointed . . . clearer set of information on how to make the right decision to operating or not . . . much more accurate assessment of what the effect of surgery would be.

PT10, UDS

What improvements could be made to UPSTREAM?

Although most participants were happy participating in the trial, reported good experiences and did not have any recommendations for improvements, a minority of participants did raise issues. A few participants felt that the questionnaires were restrictive, not allowing a true reflection of their experience. Participants welcomed the interviews as an opportunity to explain, in more depth, their experiences:

Sometimes they’re looking for, are perhaps looking for black and white answers, whereas, er, not really an opportunity to explain what exactly what has happened.

PS12, UDS

I’ve had the opportunity to take part in a conversation like this which is important, not just for you, but for me.

PT25, routine care

Lack of contact at the start of the trial and having to wait to see a consultant or have tests was a problem for some participants. An accurate timeline for what to expect when consenting to the trial would have been appreciated:

I probably haven’t treated it [the trial] quite with the respect it deserves, ‘cause I got a little bit anti when I was rolling about here and seemed to be waiting an awfully long time for somebody to do something about it rather than ask me questions about it . . . the only thing annoys me at times is I’d rather somebody said to me you, you know . . . you could be waiting 12 or 18 months rather than 12 weeks, because you get quite excited about, it’s gonna happen, and then it doesn’t. And also when you leave the hospital, they tell you, you know ‘Oh, you’ll see the consultant in 2 weeks’ . . . and it turns out to be nearly 3 months. I’d rather be told up front what it’s likely to be than, um, wildly inaccurate figures.

PS12, routine care

Acceptability and experiences of urodynamics

All 25 men who had undergone UDS testing (either during UPSTREAM or earlier in their illness journey) reported that it was acceptable, despite any discomfort or other issues they might have experienced. Of the 16 men who had not had UDS previously, 10 said they would have been happy to have it if needed:

I’m used to being prodded and god knows what else. I don’t take any notice of that . . . The more tests the better I always say . . . you know exactly what’s going on then.

PS5, routine care

Of the remaining six men, four said that they would have had it if needed, but would have been apprehensive because of its invasive nature and were glad it had not been required. Two men said that they would want more information about the test and its purpose. One man had declined to have UDS because a prior cystoscopy had found a narrow constriction and he did not want to risk any damage that might delay his planned surgery.

The main reason for wanting UDS was the perceived accuracy of the test and the desire to have maximum information to inform the treatment decision:

I like answers . . . and we got the answers. So if I hadn’t had the test done, then we’re just left with a load of symptoms which could be caused by this or that. Erm, so I mean, in terms of, erm, the invasion of the test, it’s . . . not a problem . . . totally acceptable.

PT20, UDS

We did not find any evidence of associations between age or symptom severity and the acceptability of UDS.

Experience of urodynamics: pain, discomfort and infection

In general, UDS was well tolerated by the 25 participants who had experienced it. However, there was variation in how uncomfortable men found the procedure. Seven men reported that it was at least a little painful, with some experiencing severe pain, but they, nevertheless, thought UDS was acceptable:

Having a tube stuck inside me and afterwards was 10 out of 10 pain . . . It was awful. But the people I dealt with were very good . . . Yes [acceptable], no problem. Obviously embarrassing, uncomfortable, not very pleasant. Erm – well, I mean, I had the choice of having the test done or not, so, you know, I read about it, it sounded horrible, but, erm – I am quite a positive person. I want to live the best. I’ve got a family to look after.

PT6, UDS

Five men reported that the procedure was pain free:

I was quite surprised, actually. Especially at the, at the rear end, I thought, ‘Oh, there might be a pain involved here’. But there wasn’t. I had no pain at all. I just – it was, it was better than what I thought it was going to be.

PT11, UDS

Urodynamics was sometimes perceived as easier and less uncomfortable than uroflowmetry, because UDS does not involve having to wait with a full bladder:

When they put liquids into you, [it] was more uncomfortable . . . easier . . . It’s able to fill your bladder through your penis, so that they can measure the flow . . . That was a bit embarrassing, but like I said, I found it better because I didn’t have to retain anything. So to me . . . although embarrassing, [UDS] is a better system [than flowmetry].

PT4, UDS

Eight participants reported short-lived negative after-effects of UDS: stinging when urinating, a small amount of bleeding, a UTI or disrupted flow/urgency. However, despite these issues, the men said they would willingly have the test again if needed.

Experience of urodynamics: embarrassment

A minority of participants (7/25) reported that having UDS was embarrassing, because of either its intimate nature or not being prepared for its effects:

The final pee that I was having was with a catheter up my urethra. Now, how you’re supposed to pee into a jug when you’ve got a catheter up you, I do not know. But it went all over the wall and the floor, which embarrassed me. If they’d said, ‘Look, this is what’s going to happen, don’t worry about it’ . . . one of the nurses had to clean it all up when she came back in.

PT10, UDS

One patient reported that he found UDS less embarrassing than a rectal examination:

. . . it’s not very nice for them anyway, and certainly not nice for you either.

PT4, UDS

The degree to which UDS assessments (and other tests for LUTS) were perceived as embarrassing, depended in part on the level of privacy available, including the number of people in the room during the test, room location and size (a larger room near a corridor was more socially awkward). Patients preferred as few people present in the examination room as possible during the test, that staff were introduced to them and that they knew their roles:

It was all right. Embarrassing [laughs]! Stood there in front of all the people! . . . There were a couple of students! [Laughs] A couple of nurses! [Laughs].

Were you asked about whether you minded them being there, or . . . ?

Yeah, yeah, [the doctor] asked me if I minded if they’d be there . . . I didn’t mind. Yeah, a little bit embarrassing.

Who performed the UDS test could also be a concern and a cause of embarrassment. Two men mentioned the sex of the person performing the test in relation to their embarrassment. One would have preferred a woman to have carried out the test:

Well, it’s not very nice for another man to play with your . . . Well, not play with you but actually touch you, they’re doing things. Then to stand in front of women as well . . .

Oh, there were women in the room?

Yeah, well, I was asked about . . . One was a trainee nurse and one was a senior nurse. So to be quite honest, [–] to me, it’s easier for me to be naked in front of a woman than what it is a man.

Another said that his test had been performed by a female nurse and initially he thought he would have preferred a man. However, by the end of the test he thought it was better to have it performed by a woman. Despite any embarrassment, men still found UDS acceptable.

Participants’ perceptions of the value of urodynamics

As previous results suggest, UDS was primarily valued by participants for the additional insight it gave them and their clinicians into their LUTS:

I was glad that it was clear result in itself . . . it was effective in actually showing, illustrating the problem and the extent of the problem . . . it was effective in actually getting something sorted.

PT22, UDS

Urodynamics was often the last in a series of assessments participants had received for their LUTS. Many patients felt satisfaction that having UDS meant that they had received all the investigative tests available and, therefore, had all possible facts regarding their condition:

You’re having a test that was different from what erm, you’d experienced before . . . there was a sort of finality about that, you know. You felt that, you know, OK [–] there’s nowhere else to go, you know.

PT11, UDS

Three patients reported that they found invasive UDS testing interesting or engaging as they learnt about the cause of their LUTS. UDS was perceived as more informative than other tests, providing a more accurate account of the cause of LUTS:

I done the flow rate thing, the UDS was I think far more accurate . . . I thought it was a very clever test . . . You know, I think it showed a lot more . . . that other test was probably one of my bad days, because the growth of a prostate outside the bladder acts like a ball-valve so it shuts my flow off . . . Yeah, I think it was a good test.

PT15, UDS

For some patients, the results of UDS played an important role in their treatment decision-making [see Participant perspectives on the role of assessments (including urodynamics) in lower urinary tract symptoms treatment decision-making]:

. . . although they weren’t pleasant, you feel as though at least everybody’s had a go, and they’ve done as much as they can. And I think when [consultant] sort of turned round and sort of said, ‘Well, that confirms everything’ . . . and he’s not made any secrets of what he thought, so you knew what he was talking about.

PT13, UDS

Information provision for urodynamics

Although, overall, men’s experiences of care were positive, there were instances along the diagnostic pathway when participants reported that they had been inadequately informed. Four patients felt that they had not been fully informed on the process of UDS in advance, such as what it would involve, the need to urinate and possibly spray, or the risk of developing a UTI afterwards:

They put a catheter in, and I told them, the nurse who was doing it . . . ‘When you put that catheter in’, I said, ‘I know for a fact, by at least tomorrow, I’m going to have an infection’. – ‘No, everything’s sterilised. You won’t have an infection’. True enough, I had an infection, and it was a Saturday the next day. My doctor was closed.

PT11, UDS

Although most participants reported being given leaflets about the test prior to having it, one patient did not know he was having UDS until he arrived at the hospital on the day of the test. Another participant described the importance of patients feeling fully informed while awaiting their tests:

Very clear information is very important. ‘You’ll be sitting here; you’ll be sitting here for an hour. It’ll be that length of time before we will call you, or this will take, given the number of people we’ve got, I expect it’ll be this.’ If it’s wrong, it’s wrong, it doesn’t matter, but actually giving clear and confident messages allows people to feel that they’re not completely out of control . . . they haven’t been forgotten in the corner.

PT22, UDS

There was variability in participants’ reports of how and when their test results were explained to them and the adequacies of the explanations they received. Men had the results of UDS explained to them during the test by the technician or nurse undertaking it, from a doctor straight after receiving the test, or at a separate appointment with a doctor a short time later. When test results were available and discussed with a clinician immediately after the test, this was appreciated:

I had an instant diagnosis, saying that I needed an operation . . . I weren’t expecting that. I was expecting to have a letter a week later saying, ‘We think this, that and the other’.

PT4, UDS

[Getting] the information on the day, obviously that’s better for everybody, you know. I think it takes the angst out of it really.

PT1, routine care

Most men were satisfied with the explanation of test results, reporting that the explanations received were excellent or adequate:

So, I could understand, you know, what results they were looking for and they actually showed me the graph results. So erm, that was quite interesting. That was explained.

PT13, UDS

Having done the different tests, how were the results explained to you?

Yes, very well . . . The nurse explained it to me as well, and then I came back to the doctor and he went through it with me.

Two men reported poor explanations of UDS results. One reported a problem with the results of the UDS being explained in a rushed manner and immediately after the test:

The consultant was in a hurry, so he started trying to explain the readings off the test on the computer to me while I was still standing there in a gown with a catheter in. And I said, ‘I’m sorry. I can’t take this in now. Can you wait until I’ve got dressed?’ . . . The only thing he [doctor] said to me was this thing about, ‘There’s an awful lot of pressure going in, and not a lot of urine coming out.’ Erm, so I saw, you know, the computer monitor and one or two printouts, but I didn’t ask. I wasn’t shown those.

PT10, UDS

Participant perspectives on the role of assessments (including urodynamics) in lower urinary tract symptoms treatment decision-making

Participants valued assessments for their information and reassurance: assessments answered questions they had, helped clarify the cause of their LUTS, validated what they and their clinicians had already suspected, and provided reassurance. For some participants, assessments provided new information, confirming either that they had a problem that needed to and could be treated, or that they would not benefit from surgery:

I didn’t realise that I had a flow rate problem until I had this flow test done.

PT13, UDS

The results meant that I didn’t have a problem that I thought, you know, we originally thought we had, because they wondered if I had a narrowing of the tube through the, through the prostate because of the enlargement. But there was no narrowing, and it was perfectly all right.

PT7, routine care

Urodynamics, in particular, was valued for its perceived accuracy, for example in showing whether or not the bladder outlet was obstructed and therefore whether or not the patient would benefit from BOO surgery:

It [UDS test] decided me . . . it determined if I’m having the operation or not. They said, ‘You have got a blockage. I would suggest having this operation’. Well, that more or less made my mind up to go through with it, when I’d had that UDS . . . that was the final straw, yes. When I had that done, I decided then I was going to have it done.

PS11, UDS

It meant, meant that there’s nothing else wrong with me, or any concerns . . . and that I just have to live with it really.

PT6, UDS

[UDS] gave them immediate information on exactly what the problem was.

PT10, UDS

Assessment results influenced treatment decision-making to varying extents. For some men, the assessments were essential to both their clinicians’ and their own decision-making process (e.g. validating what was already suspected and/or providing a rationale for a treatment pathway):

Do you think the results of the assessments that you did helped make the decision for which treatment you’d get?

Oh, yes, yes, yes . . . For both [clinician and patient], I think, because, I mean, although they weren’t pleasant, you feel as though at least everybody’s had a go, and they’ve done as much as they can. And I think when [consultant] sort of turned round and sort of said, ‘Well, that confirms everything’ . . . and he’s not made any secrets of what he thought, so you knew what he was talking about.

I didn’t realise that I had a flow rate problem until I had this flow test done.

PT13, UDS

[The assessments] answered questions for the nurse and the consultant and then they could explain to me the implication of the results . . . if I hadn’t been producing the flow that I was, you know, they said that would warrant a lot more investigation than the results that we have, which were quite satisfactory.

PT20, UDS

Others reported that, although assessments were helpful to clinicians, they had not personally found them helpful. Either because the participant was happy to defer interpretation of assessments and treatment decision-making, or because the participant already wanted surgery, but felt his consultant needed convincing evidence:

I guess it proved what I already knew. So I suppose it was for the doctor, I guess they needed more evidence than me saying my flow is not as strong as it used to be.

PT14, routine care

I probably had the idea that [surgery] was the correct way to go before [UDS], basically from what was happening to me, but then [UDS] validated it and therefore, you know, both the consultant and myself were on the same path then.

PT22, UDS

Of the 41 patients interviewed, five said that the assessments had not helped with the treatment decision. The most common reasons for this were the patient already knowing that he wanted surgery to alleviate his LUTS, the consultant being perceived as already decided on surgery, and the test results being inconclusive or not presenting any new information:

Do you think the results of your test, the test that you did, do you think those helped make the decision for surgery?

No. The results, not really. My symptoms, as I know them, convinced me that something needed to be done. Erm, the fact that we want to get on with our lives and get it sorted, hopefully. And, erm, we realised there was no other way, really, because the fact that it has gone on for 5 months, now, every day, the smell, and we’re going to carry on like the rest of our days, might as well have something done to try and remove that.

I mean nothing else was gonna work anyway, so it was a question of, did I put up with this, or do I have the operation. It was either have it or put up with the problems which would increase, and I wasn’t prepared to do that.

PS9, UDS

A further three participants said they were unsure if assessment results had assisted with treatment decision-making, because either the consultant led the decision-making or their medication had not been changed:

Did you think that the results of the assessments helped you make the decision to take medication instead of surgery?

Well, I not make the decision myself the doctor, it’s up to the doctor. If the doctor say ‘You stay on the medicine’, I stay on the medicine.

And do you think that the results of the assessment then made the doctor decide that medication was better than surgery in this case?

Well, he had to make a decision and he said, ‘Yes, you should take medicine’.

Types of treatment decision-making

The type of treatment decision-making after LUTS assessment fell into one of three categories: (1) shared, (2) clinician led or (3) patient led. Overall, 20 out of 41 patients described the decision as shared with their consultant or clinical team, 14 patients described the decision as clinician led and seven patients described it as patient led (Table 33). Descriptions of clinician-led decision-making were more common among patients receiving conservative, non-surgical treatment for their LUTS, whereas patient-led decision-making was more common in patients who opted for surgery.

Shared decision-making was characterised by the patient and consultant or clinical team discussing assessment results and treatment options and together agreeing a course of treatment. Participants describing shared decision-making felt that clinicians were open and shared information and that they were involved in the decision:

No, I felt that, you know everything was, the information was well-shared, and I understand what I was doing, and yes, it was absolutely fine, and I didn’t feel, you know, I felt well understood and that I was listened to and yes, I think they, they were very, very kind of open about whether I wanted to do the tests or whatever.

PT5, routine care

Clinician-led decision-making was characterised by the clinician primarily making decisions about assessments and how to proceed with a patient’s treatment and the patient abiding by this decision. Participants who described the decision as clinician led described not feeling involved in the decision-making, but most were happy to defer the decision to the clinician as the person best placed to make such decisions. In these cases, participants often did not feel that there was a decision to be made from their perspective, they deferred to the clinician’s expertise and saw the treatment decision as wholly the clinician’s decision:

The doctor is the expert . . . It depends on doctor, if doctor say I [should have] surgery, I have to go . . . it is the doctors, they had to make a decision, not me. If they said, ‘well you need operation’ then I have to make a decision, yes or no.

PT2, UDS

Some participants receiving conservative treatment and describing clinician-led decision-making did feel that they would have wanted more involvement and information if surgery had been recommended:

I mean, they decided that I didn’t need an operation, whatever the operation was. He did explain it to me before, but because I didn’t need it, I didn’t take much notice after that . . . I wouldn’t have surgery done, anyway. If they recommended it, I don’t think I would have gone down that road. Don’t fancy the idea of going into hospital and having, having an operation in, in that particular area.

PT7, routine care

Patient-led decision-making was evident when patients stressed that the treatment decision was theirs and that they had led and directed the process of reaching the decision, sometimes consulting family members. Some clinicians encouraged this approach:

The young – he were a young doctor – he explained what had happened, and then after he explained what I’d been doing, or how it had worked. And then he said to me, ‘Go away, discuss it with your wife . . . You’ve got a 96% chance it does work, but you do get the odd 1 in a 100 that might, you know, it might not work, and you might have this problem, you might have that problem. Go away with your wife, discuss it, and then it’s up to you whether you want it doing or not’. Which I did.

PS11, UDS

One patient described why directing the treatment decision was crucial for him:

The issue is in all of this, do you have enough information? Are you happy that the information is contextually correct and appropriate? Are you then happy that you’ve got the opportunity to make an informed decision? Yes. And there’s no imposition by anybody . . . Well informed and then regardless of what happens, I am at ease with that situation . . . Being at ease with the decision is very important. ‘Cause the alternative is to be uncertain: Have I made the right decision? What if this? What if that? And that sort of stuff is stressful.

PT25, routine care

Expectations and experiences of bladder outlet obstruction surgery

Participants’ expectations of their surgery varied across the 16 post-surgery participants and were influenced by the information they received from the urology team in advance. Some participants described not knowing what to expect in terms of the surgery and recovery, and felt that information provision had been poor:

Beforehand I wasn’t really sure . . . wasn’t really sure if it would work or quite what recovery would be like.

PS1, routine care

Well, I didn’t know what it [surgery] were gonna be like.

PS16, routine care

Although some participants wanted more information, others felt that they didn’t need a great deal and trusted that the doctors knew what they were doing:

Well I wasn’t quite sure [what surgery would be like] . . . I tried to get out of him [the doctor] how on earth you go down through a tube and bore outside, but didn’t get any answer to that I’m afraid . . . really just explained what was going to happen and it was the anaesthetic where the lower part of my body was completely dead for 6 hours . . . Didn’t have a general, no. Spinal anaesthetic . . . It wasn’t my choice, it’s what they wanted to do. No [information], not really, no. You know, you hope people know what they’re doing, they got on with the job, and it’s all done and dusted.

PS14, UDS

Other participants felt that they had been given ample information and that their concerns or queries had been addressed, so that their experiences of surgery had met their expectations:

[My expectations for surgery and recovery were] exactly as it’s going . . . we got a chance to do that [discuss queries] before, you know I saw [the surgeon] the morning of the surgery . . . as I say, the pamphlet that I was given detailed everything, and so, consequently, no real surprises.

PS9, UDS

Another way in which participants formed expectations of surgery was by talking to friends and family members who had the same or similar procedures in the past:

I thought it would be . . . I know a few people who have [had it] done, including a brother-in-law of mine, and I expected a lot of pain in the immediate aftermath and then a rapid . . . a rapid return to better . . . better urinary practice, you know, more regular, no leakage, that sort of thing.

PS4, routine care

A few participants reported that they had to wait longer than expected to have the surgery, which was difficult for them as they had to manage their symptoms in the meantime:

There was a fair waiting list. Initially I was down to be for surgery at the end of last year, would have been about this sort of time last year they said that, it was that but, I get the feeling when I sort of rang up and asked if there was any idea of sort of general type thing they said ‘well no we don’t really know’, ‘cause they had a lot of cancer type patients first, which obviously had priority, so ours, mine, obviously wasn’t a priority one, as far as they were concerned. It was getting inconvenient for me . . . after that, it was just that, I think it was fairly . . . the sooner the better type of thing . . . You’d be in a queue which could be anything up to a year. So, thought oh no . . . That was a, I suppose that was a bit disheartening in that respect, having to wait more and more, because it was, it didn’t give me confidence at all about sort of going out or that, [I] was forever, as I said, generally having to look for, trees and toilets and things.

PS13, UDS

Some participants described their expectations for the surgery being met or even surpassed by the experience of surgery itself:

I mean, really I thought it went much better than I was expecting, because I suppose it all went quite easily, and I knew, I sort of knew what to expect, so I wasn’t too worried.

PS1, routine care

Did your expectations of what was going to happen, of the surgery, match what actually happened? Was there anything that surprised you or . . . ?

It was greater, it was brilliant, it was, no the whole thing was er, was a very good experience, very good experience . . . I actually . . . genuinely, thoroughly enjoyed the day . . . everybody, whether they were, you know the consultant or whether they were the anaesthetist or whether it was the cleaner on the floor, they were all brilliant and er, I totally enjoyed the whole experience.

Participants typically stayed in hospital for 2 or 3 days when they had surgery, with some only staying one night. All expected to stay in for approximately 2 or 3 days, but those who were discharged earlier were happy to go home and did not feel concerned about this. Some participants had to return to hospital following complications, mainly on an outpatient basis, but a few were readmitted:

I was supposed to come out the Friday . . . but what happened, they took off the catheter – I had a bad time. They took off the catheter and then when I came home I couldn’t pass water and so I had to go back [that night] . . . when I went home again I was having so [the next morning] I have to end up in – back in the hospital and spend a couple of days there.

PS7, UDS

Expectations and experiences of post-surgery recovery

Most participants reported feeling prepared for what to expect in recovery and having been given good information about recovery by the health-care team. Leaflets, the internet and other people who had been through similar procedures were the other main sources of information:

I don’t remember exactly what I was told, but mostly, you know, I read it on the internet, erm, how long it takes and, erm, what sort of stay one should expect in hospital and most of the information, I get it from the internet.

PS15, routine care

Well, there were various booklets or papers that were given to me . . . And I realised that there was going to be problems over the first 6 weeks.

PS10, UDS

Many participants reported experiencing pain, discomfort and bleeding after surgery, and were expecting this. They knew that they would have to drink plenty of water and could develop an infection or need to have a catheter fitted:

If you’re going to have surgery, you’re going to have pain afterwards. That’s probably a given to a certain extent.

PS5, routine care

However, some participants who reported these outcomes felt that they had not been prepared enough and would have liked more information:

When they sent me home that night, I went home equipped with a catheter which I had to use for the next 2 weeks. I hadn’t expected that, but you know, I didn’t feel betrayed or anything.

PS4, routine care

I suppose it does say in the pamphlet that you may get a urinary infection, but so maybe you know I should have been told more about that really, because I did suffer with it for a good week or so, thinking it was just normal rather than an infection.

PS2, routine care

I was bleeding quite a lot and it did carry on bleeding for about 2 weeks . . . That was a bit unexpected.

PS1, routine care

Some participants reported recovery being better than they expected and were surprised as to how little pain they experienced and how quickly their pre-surgery symptoms had subsided:

It was a lot better than I thought it was going to be, to be quite honest. Yeah. I recovered very quickly, which I found amazing, to be quite honest, but . . . Because you expect, when you have surgery you expect there to be pain for at least a week or so, don’t you, a couple of weeks on and off. It comes and . . . It gets better day by day, like, anyway, but there was nothing particularly. You know, there was no pain or anything.

PS5, routine care

Recovery was instant. As soon as I went to the toilet, it was flowing fast. I could have a full bladder and it was empty within 20 seconds instead of 2 and a half minutes like it used to do. And it was brilliant.

PS11, UDS

For a few participants, recovery took longer than they thought it would; in some cases, this was due to complications following surgery:

After coming out of hospital, I started getting problems with my urine. Obviously, there was blood and you know that sort of thing, but, erm, I think after [2 weeks] I started getting a feeling of urine retention. And, erm, that night at about 10.30 p.m. it sort of completely stopped my urine, then I had to go to [hospital X’s] A&E [accident and emergency] and I had a catheter put in. At the A&E I was given a rectal examination by the duty doctor – erm, I have written it down so I am reading it – who reported enlarged prostate, no hard stool and he prescribed an antibiotic called Nitrofurantoin.

PS15, routine care

Negative recovery experiences were made worse by a lack of consistency in health-care professionals, having to wait a long time to see a doctor after surgery and a lack of medical attention after being discharged, particularly out of hours. Some participants would have liked more opportunity to access specialist follow-up care. Having a telephone number for the hospital that patients could ring during recovery was valued:

The one thing I would say though is that I never saw the same doctor twice . . . So I saw the consultant, like I say, I saw the surgeon when I had the urine test, the flow test, then I saw him just before the operation, that same one, but after that, the one I saw was different, when they come round for like a bed check there’s always a different doctor every time . . . Then when I did [see], you know, the urologist, the last one, that was a different urologist from the one who done the operation . . . so everyone was different and there was no continuity . . . It would be nice to have more continuity.

PS2, routine care

I think it [would] be much better if you could [contact] somebody for a bit of advice or even another backflush out of hours . . . I think a little bit more medical attention rather than trying to sort something out on your own [would] be better just for those initial 2 or 3 days when you have issues.

PS12, UDS

When they gave me that phone number when I went home and said I should call any time of night or day if I have any concerns at all, I think that had been pretty well covered and I didn’t have to do that, but it was good to know that I could do that.

PS4, routine care

Some participants also reported being given advice regarding recovery, but feeling well and so not adhering to the advice. In some cases, this was fine, but other participants experienced negative reactions:

I think about 3 weeks and I was back to doing everything I, maybe not supposed to have done but I was doing it and it’s never had any effect on me and, you know everything is working all right.

PS14, UDS

I went on holiday 6 weeks later, in fact after the operation . . . I climbed a big hill, which is 3800 steps and I came back down again and I found I bled the next day . . . I probably overdid it.

PS2, routine care

Symptoms post surgery

In general, participants were happy they had the surgery and would recommend it to others with similar symptoms. Some participants recognised the risk of symptoms returning and some were still experiencing negative symptoms at the time of the interview, but, overall, participants reported that they had improved and that the pros of surgery outweighed the cons:

If I knew someone who had the same problem as me, I’d definitely advise them to get it done, because as I say, it has made a vast improvement so and there is that I’d need to do it again because it, the prostate can grow back . . . so I may have to have it again which wouldn’t really bother me too much now.

PS2, routine care

Across the sample, the success of the surgery was categorised as high, moderate or low, based on participants’ descriptions of their current symptoms and feelings. There was no apparent pattern between the success of surgery and whether or not participants had received UDS. For eight participants, the surgery had been highly successful, with a marked improvement in LUTS (e.g. improved flow, less urgency and complete emptying of the bladder), and high levels of satisfaction:

It’s gone really. I don’t have the flow problem. I don’t have the leakage problem. I don’t have to worry about whether I’m going to be caught out somewhere when I feel desperate need to urinate and I’m unable to do so in a civilised fashion. So, all of those concerns, I think have been addressed by the surgery.

PS4, routine care

For five participants, surgery had been moderately successful. These participants had seen their LUTS improve and were satisfied with the results, but still experienced some problems (e.g. urgency, retrograde ejaculation or slow flow rate).

It’s better than it was. As I say, I can go to the toilet now and empty it out. Before I could go and probably, what, 10 minutes, quarter of an hour later – and same days it’d be back again. But it’s improved.

PS16, routine care

Because I get retrograde ejaculations now . . . they said it was one of the side effects. So, I knew it would happen, so it didn’t really matter . . . Although the medication I was taking was stopping ejaculations anyhow so . . . [it] didn’t really make much difference really.

PS2, routine care

Three participants had seen no real improvement in their LUTS, or had seen improvements in some (e.g. nocturia, flow) but worsening in others (e.g. pain, incontinence). These three participants felt that their current symptoms were a direct result of the surgery or a side effect or indicated that the surgery had not been successful. Participants were told that their symptoms would ease over time and wondered if they were still recovering between 48 and 63 days after surgery. Participants were aware of the risk of side effects, but did not fully understand the symptoms they continued to have and would have liked more information:

The symptoms haven’t really changed. I’m still getting the same feeling of pressure and um frequency um, still getting those, but again I’m to expect that . . . Because I’ve got to get the muscles in that area back to how – they’ve been messed around for 2 years and I’m not going to get them back in 2 months.

PS9, UDS

I may have ongoing infection, poor bladder emptying, or renal obstruction, all of which need to be assessed. [The consultant] recommended urgent urology review . . . After that, I have met [surgeon] and he has assured me that, erm, the operation went very well and the symptoms which I have . . . like tummy swelling or [pain in] my right side waist, they are not connected with the surgery. They may be something else, you know, which is resulting in this.

PS15, routine care

Participants discussed having to adjust to their new situation, whether this was not having symptoms they had got used to, or having new ones because of the surgery. They used medication, self-catheterisation or incontinence pads to manage any ongoing symptoms:

Basically, if it gets bad I might take sort of ibuprofen or paracetamol but basically you soon get used to it and you just adapt to it, well I’ve adapted to it.

PS6, routine care

The only drawback is having a self-catheter. But I’ve got used to it now.

PS8, routine care

Trial design

In-depth semistructured interviews were conducted with clinicians involved in UPSTREAM. 19

Recruitment and sampling

Clinicians were purposefully sampled in relation to (1) trial centre and (2) professional role. Urology consultants were recruited via an e-mail invitation from the trial chief investigator. Research nurses were recruited via an e-mail from the UPSTREAM lead research nurse. E-mail invitations included the participant information sheet and the researcher’s contact details. Consultants and research nurses who expressed interest in participating were contacted by a researcher to arrange a convenient time for an interview.

Interviews

All the clinician interviews were conducted by telephone. Interviews followed topic guides developed at the start of the trial based on the literature, the qualitative trial aims and input from the TMG (see Appendix 6). They were also piloted and refined prior to data collection. The topic guides were further refined as data collection progressed, in response to emerging findings. Consent was taken verbally before the interviews began. All interviews were digitally audio-recorded, professionally transcribed verbatim, anonymised and checked for accuracy prior to analysis.

Analysis of the interviews

Analysis followed the same process as for the patient interviews (see UPSTREAM participants’ views and experiences, Analysis of the interviews).

Participants

A total of 21 interviews were conducted [15 consultant urologists, five nurses (four urology nurses and one research nurse) and one UDS technician], with staff from 18 different trial centres. Number of years’ experience in their role ranged from 3 to 37 years (mean 16 years). Fourteen of the 21 clinicians had previous experience of using UDS (67%). Interviews were conducted between July 2016 and March 2017 and had been involved in the trial between 12 and 34 months after trial initiation (mean 23.4 months, SD 5.53 months).

Clinicians’ views and experiences of UPSTREAM

The consultants interviewed were responsible for championing the trial in their centres, with some being trial co-applicants. Most were involved in identification of patients and trial recruitment. Some were involved in the UDS testing procedures and all were involved in the interpretation and discussion of the results with patients, as well as decision-making concerning surgery. The nurses interviewed were mainly involved with inviting patients to have the test and performing the test. A few of the nurses were involved in the interpretation of test results, but none were involved in treatment decision-making.

Clinicians expressed mostly positive views of the trial and enjoyed being part of it. They felt that it was an important and timely trial. They also welcomed answers that would standardise pathways and decision-making in current inconsistent systems:

Those practised by different consultants in different departments are so diverse . . . so it’s hard to know how consistent it is.

Clinician 11

Clinicians reported having good support from the trial team that helped facilitate the trial at their centres. Updates on recruitment and the progress of the trial and reminders were welcomed by clinicians, and they liked the proactive nature of the trial team:

Support from [trial team] has been very good. I think chasing up reminders has been very good. I think the meetings organised to give updates, I think that’s been very good.

Clinician 15

Some clinicians voiced concerns over the inclusion criteria, leading to heterogeneity of trial participants, and felt that this may lead to difficulty in interpreting and translating the trial results to inform practice:

You know, it’s an interesting question because it’s a test which is not very pleasant, so I will see what it will tell us. I think we’ll end up being told a group being defined in which it’s helpful. I don’t know that there’ll be many surprises and I wonder if it’ll be very useful clinically, ‘cause I suspect you’ll have to remember quite a few features about that group and you may not knowingly meet that particular group. It might be difficult to define the group that apparently UDS is helpful in.

Clinician 4

Although clinicians had varied views on the usefulness of the trial outcomes, all believed themselves to be in equipoise for whether UDS or no UDS would be more effective:

On the whole them seemed . . . I think relatively balanced with equipoise and make the call as saying that we don’t really know exactly who should or should not have tests.

Clinician 2

Identification and recruitment of trial participants

Most clinicians felt that their centre had done well with recruitment, but some issues were reported when identifying and recruiting patients, including clinician engagement with the trial strain on clinicians’ time in already busy clinics, some patients’ reluctance to take part and variance in care across clinics.

Some clinicians reported resistance to recruiting to UPSTREAM from hospital management and colleagues who had concerns around the pressures on existing waiting lists and patient numbers. They did not want to add more patients to already busy clinic lists as a result of the trial. It was also difficult to identify and recruit patients when other clinicians were not pro-research:

To try and push in study which would involve doing UDS in half the patients that we recruit, it was a bit tricky when it came to management, when it came to other clinicians who were, who were a little bit concerned about what would happen to the waiting list and the numbers. So if there was a way by which we could have expressed or had additional sessions to do the UDS of those patients who, who were selected in the intervention group then maybe, I don’t know, maybe it would have made a difference because then the other clinicians would have probably tried to come on board by offering, offering their patients for the study. But I think that was probably something that played, well, not made terribly obvious but it was there going around in the background that, that there might be an additional workload on the UDS list.

Clinician 10

It’s getting others who see patients . . . but don’t have the same level of interest that I or one or two others do. In other words, I think patients are quite interested and pro-active in the trial. I think it becomes a lot harder selling it to colleagues continuously when they don’t have a direct interest in the trial.

Clinician 15

Diversity and consistency of care across centres were reported to be challenging when recruiting patients into the trial. Owing to having several consultants and clinics spread out across centres, research nurses could not always access all patients in all clinics. This was further complicated by patients not always continually seeing the same health-care professional:

Just identifying the patients, once we knew about the patient we could recruit, but the patients present at different consultants’ different clinics, different community clinics so trying to find out, identification is a difficulty.

Clinician 11

Some clinicians reported patients being reluctant to take part in the trial for a range of reasons. Clinicians reported some busy, younger patients not wanting to attend additional hospital appointments; patients wanting to progress with the most effective treatment available and not wanting to risk being randomised to another assessment; and the invasive nature of UDS potentially putting patients off:

We still struggle with recruiting. We screened a lot of patients, but we haven’t recruited that many and I think it’s mainly because patients are reluctant to undergo these procedures. In fact, there is certainly reluctance to undergo UDS, that arm.

Clinician 7

So it was difficult to enrol young patients because it’s an extra test and they need to come once more to the hospital and I can understand it’s not very pleasant.

Clinician 5

A key facilitator to trial recruitment and success at centres was having a research nurse who had dedicated time to identify patients, explain the trial and recruit them to the trial. Dedication and available time was important to clinicians, but the presence of a research nurse was particularly helpful and clinicians felt that they could not have recruited sufficiently without them:

I think the most important thing is dedication and time, dedication from our point of view as a clinician to identify and initially explain the trial, remember you’re identifying these patients in a busy clinic and you then can’t afford to get them back to another clinic to go through it again . . . so again it’s having the nurse with the time because I effectively patient identify and then I’ll introduce them to the trial to see whether they are interested, once I’ve got their interest I then get the research nurse to sit down with them half an hour, giving them all the information . . . So I think the time spent by the research nurse, that is crucial.

Clinician 15

I think, as I say, we’re lucky because we have a research nurse who has basically has taken on all the administrative side of it, all the contact with the patient. So our involvement has been to carry on and do the procedures.

Nurse 4

Impact of trial participation on usual practice

There were mixed views on if and how participating in the trial had affected usual practice and interviewee workload. Some clinicians believed that the trial created an artificial decision process: if the trial was not in place, patients would not perceive a choice in whether or not to have UDS, but rather take it as the next step in investigative tests as advised by the clinician. This, therefore, changed the way that they perceived the test from a needed test to an optional one:

I think if we, outside the research, if you were to say to patients ‘you need another test and this is what it would involve’, I, we used to sort of put it across in a way that this is the next step, but in the research model when we were recruiting them and giving them the details of what could happen, that they may or may not have UDS, it’s a slightly, slightly different, different scenario because what, they knew that this is probably an optional test rather than when you really see a patient and you think like, ‘OK, I need urodynamics here’, you tell the patient that you need UDS so the patient gets the impression ‘OK, if I don’t have this test we don’t know what needs to be done next’. So that difference was there.

Clinician 10

Well the trial has changed us because we don’t have to make that judgement whether we, yes because we have to, we look at someone at say you know, we enrol them for the trial and then you see them with their UDS at a part where you might not have already have done them or you have made a decision to do surgery in the absence . . . So it has changed our usual practice.

Clinician 4

In some centres, the trial created extra steps in the patient pathway. There was extra diagnostic testing in some patients who would not otherwise have had UDS, which was perceived to delay the clinical decision-making. Also, an additional follow-up consultation was necessary at some centres to discuss treatment and management post assessment:

It’s got an impact in as much as it’s another step in the diagnostic pathway, so the patient that was going to have surgery has [had to have UDS] in the study but wouldn’t have had it clinically, then it takes longer to get that clinical decision.

Clinician 11

After the UDS I would normally discharge a patient if there was nothing to be done. But with the trial there is a further follow-up consultation and that has added to the outpatient activity.

Clinician 14

Some clinicians interviewed found it difficult to fit the additional work created by the trial into the time they currently had available in practice. One clinician reported using their allocated administration time to run additional clinics:

The challenge was, if you’re going to recruit a person, it takes that additional bit of time and generally most of the clinics that we do are overbooked, so the situation is such that a clinician who’s trying to do their clinic, his main aim is to try and finish doing what he needs to do or what she needs to do within that, within that space of time. Generally, it’s not always efficient because the clinics always finish off late and going through the extra bits there is no help, can be, can be difficult who is not doing it on a regular basis . . . I don’t think we were able to overcome it.

Clinician 10

Well, a lot of extra work . . . overbooking my clinic in order to fit these [trial] patients in, I have to open an extra clinic . . . I have to either book the list or I have to create an extra list in my time which is designated for my admin[istration].

Clinician 12

Some clinicians struggled for space in the hospital to perform UDS as part of the trial:

It hasn’t particularly added to the workload where we were going to see someone anyway . . . we’re just short of capacity in a proper area to put them in, which made life a little difficult.

Clinician 2

Not all clinicians reported adverse impact on their current practice, with clinicians who already performed UDS routinely easily able to absorb UPSTREAM patients into their usual practice:

It’s slotted into our standard practice quite well in the sense that the UDS clinics that I already do, I’ve included the men in those without too much trouble, so it’s not put undue pressure on our service. The other specialist clinics that I do, the non-UDS patients have been fitted in to that, and, again, there hasn’t been a particular problem with service impact.

Clinician 13

It’s no different to what we used to do when we weren’t sure if someone should have a TURP, we did UDS. They came back for the results and we tell them we think they need an operation or that it wouldn’t help them. So no change.

Clinician 4

Some centres completed all tests and discussed the results in one session, a ‘one-stop shop’ (Clinician 5), whereas, in usual practice, patients would have to wait for a follow-up appointment, which would have resulted in a longer process:

But if you look at it, that process [usual practice] takes longer . . . Because you’re talking about two, three times of clinic. One, the patient comes in, two, they refer the patient to the UDS, so he or she, well, we’re talking about ‘he’s now, will receive an appointment letter . . . They come in . . . have to review the results and contact the patient, or get another appointment for this patient to come and discuss the results. Whilst within UPSTREAM, we do all these things on the same day, within the same appointment.

Nurse 1

Some clinicians reported increasing the use of UDS outside the trial in their usual practice as a result of seeing the benefits of UDS in the trial:

Yes, it has [affected practice,] it has and I, I have found that I tend to offer urodynamics more to the group of patients that probably go through me now.

Clinician 10

Clinician views of urodynamics

Views on UDS varied across clinicians, as did the extent of UDS use in usual practice before the trial. Most clinicians spoke positively about UDS, with some saying that it was underused, but a few expressed more negative views and believed that UDS was overused as a result of a lack of evidence on when to use it:

I think it’s [UDS] important to investigating people with complex urinary tract symptoms and I think it’s something which is really necessary in a large number of people. I also think it’s underused.

Clinician 7

It’s [UDS] requested for reasons that aren’t clearly thought out, so potentially it could be being overused.

Clinician 3

Some clinicians who expressed more positive views used UDS more routinely before surgery, with one clinician reporting using it before any invasive therapy:

I love it, it’s like lifting the bonnet on the bladder, so I always like seeing the outcomes, but have some colleagues who would always do UDS before a TURP and I wouldn’t.

Clinician 4

I think it’s very useful . . . I think essentially that at the end of the day, if you’re going to perform an invasive procedure, i.e. an operation, then you’ve got to be sure that’s the right operation, then you should definitely do it . . . personally I think it has a big role.

Clinician 9

My personal view is that the vast majority, if not all those should undergo UDS before TURP to confirm BOO.

Clinician 13

Some felt that the usefulness of UDS was limited and the test was not always accurate because of the artificial nature of UDS:

I like it. I don’t do it. I like it. It gives a slight objectivity, but that’s all.

Clinician 14

Occasionally, you don’t get an answer to your question . . . you’re not always able to reproduce the symptoms that you’re trying to reproduce in an artificial clinical setting, so it’s not always diagnostic.

Clinician 3

Clinicians who did not routinely use UDS before surgery usually performed UDS after all other tests had been done and when results had not produced a clear answer as to whether or not surgery should be performed or when the diagnosis was unclear:

If the patient has a history of enlarged prostate, poor flow, I tend to carry straight on with surgery without UDS.

Clinician 11

It’s the last test that’s being requested . . . just to confirm their findings . . . to formulate a correct, the best management for the patients.

Nurse 5

There was consistency across clinicians when describing patient symptoms that would warrant UDS. These included the patient being considered young (aged < 60 years) or old (aged > 80 years), having chronic retention, bladder underactivity or complicating factors such as neurological conditions. UDS would usually be used in patients for whom medication or conservative treatment had failed or who had previously had surgery:

Large residuals, so chronic retention. If the flow rate is variable or borderline . . . there was a mixture of storage and voiding symptoms . . . but typically after they have tried medical therapy, and usually failed or not had sufficient benefit.

Clinician 2

The typical indication would be extremes of age, i.e. young patients and older patients and also those who specifically failed after previous intervention or surgery.

Clinician 8

Clinicians reported different practices when it came to who performed the UDS test and interpretation of test results. Most UDS clinics were nurse led, with some mixed nurse and consultant led, and a minority being consultant only. In most centres, consultants interpreted the results and discussed the findings with patients, but some had nurses deliver the results and if needed, scheduled a later discussion about treatment with the clinician:

So the specialist nurse who is doing the dynamic test and is talking to the consultant and then he’s [nurse] delivering the result as in verbal and some written information. And the exacting of that results, so if the patient needs something to be done accordingly. But then we have another proper discussion and the clinical discussion with the patient and the consultant.

Clinician 5

I usually do it [explain UDS results] at the time of the test. We are there and we explain what we found during the urodynamic test ourselves.

Clinician 7

Clinician perspectives on the role of urodynamics in lower urinary tract symptoms treatment decision-making

Clinicians reported using the results of UDS testing to make the best decision possible for patients. The results helped clinicians to decide when not to go ahead with surgery and, if it was appropriate to perform surgery, the risks and benefits of surgery based on patient characteristics. In addition, UDS testing allowed clinicians to assess the potential success of surgery and if there would be any foreseeable issues or complications if surgery was performed. Clinicians also believed that the test helped the patients with improved understanding of their symptoms and treatment options, including surgery:

If properly indicated it really does affect our decision and help make the better decisions for the patient.

Clinician 8

I think yes, it has a positive, positive impact for the patients and the doctor and it can help inform subsequent management and also help the patient understand in a bit more detail about why they’ve got this urinary symptom.

Clinician 1

Clinicians reported that the UDS results provided clear-cut information about what was happening with the bladder and prostate (e.g. if there was a blockage). This helped them decide whether or not surgery would be suitable and provided a rationale for their decision to explain to patients:

I think the advantage is that is gives good or accurate information about what exactly is happening with the bladder or the prostate. And it helps surgeons make decisions on whether to operate on someone or not.

Nurse 1

You’re going in with the strength of knowing the results, i.e. you are definitely obstructed you’re definitely not obstructed, you’re definitely stable, no you’re unstable. So you have the strength of the test behind you.

Clinician 15

Urodynamics provided a way of assessing the risks against the benefits of performing surgery, in order to make a final treatment decision. This was particularly important in those patients who may be unfit for surgery or for whom surgery might present additional risks:

So if I’ve got particular concern about the risks of the procedure, and I want to be sure that the potential benefit or it’s so that they might not necessarily benefit but in order to make that kind of judgement, if I want to be able to tell them [the patient] ‘you know I think you’ve got a much more better chance of success based on your UDS and therefore we might go ahead’.

Clinician 4

I think UDS is beneficial in some cases where the picture is not clear cut so you cannot definitely say that OK, surgery is going make an improvement.

Clinician 10

Potentially avoiding an unnecessary operation, exposing them to the risk without the benefits.

Clinician 13

Urodynamics also helped clinicians understand what the outcomes of the surgery may be and whether or not any complications may ensue. Clinicians believed that the UDS results helped to facilitate a more informed conversation with patients about their symptoms and treatment options. The results could help patients understand the need to go ahead with surgery or have pharmacological treatment, and what the complications may be:

It might show that a very overactive bladder or small capacity bladder and that might make you a bit suspicious about any urgency experience after surgery.

Clinician 1

I think patients should have it [UDS] done because we have had patients . . . who had prostate surgery and actually they have been wetter after surgery than beforehand, because they hadn’t had UDS studies in the first place . . . I think it helps for the patient, because to be worse after a procedure is not a good idea.

Nurse 3

So the situations where the bladder is underactive, they’re not able to empty their bladders completely. I mean, even in those cases where if we were to offer them outflow obstructive surgery we would be able to explain to them, ‘see your bladder is underactive, you may not always be able to empty your bladder completely’, because some of them feel that it is surgery that is going to correct all the symptoms and it helps to explain to them some of the things which has less likelihood of getting corrected.

Clinician 10

Although all clinicians reported that they used UDS to inform treatment decision-making and facilitate their conversations with patients about these decisions, clinicians described various ways they did so. Some described informing the patient of the test results and providing their view on whether or not surgery should be performed. Some provided the test results and let the patient decide whether or not to have surgery, and others discussed results and options in a shared decision-making process. Some clinicians felt that the tests were more for the benefit of the clinical team and its decision-making rather than for the patients:

I tailor the information that I give according to what they want, what they understand, but, in general, they are making an informed decision . . . I don’t usually recommend [surgery] unless they specifically ask me to. I just tell them it’s their decision and I give them the information.

Clinician 3

They [patients] rely on my summation of all the tests they’ve had done. They are generally influenced by your decision, probably the odd one or two patients that will ask very critically every bit, the majority won’t.

Clinician 15

The patients share that information and they have a say in the decision-making process. If we can give a bit more information to the patient about the probability of success based on UDS, they can make a more informed decision.

Clinician 1

I don’t think the patient is that bothered. It’s the symptoms that are important. What the test shows is not that important to the patient. I think the assessments play a role for the clinician [in decision-making] but whether they play a role for the patients . . . I’m not sure.

Clinician 7

Views on potential urodynamics roll-out

Clinicians agreed that UDS should be implemented more widely if the trial showed a strong indication for patient benefit. They stressed that a good evidence base would be needed to convince clinicians to use UDS more widely. Clinicians would want clear indication, protocols or instructions for who to target and which patients would benefit most from UDS (e.g. age, existing conditions):

I think the question is not just that studies show it’s better, it’s quantifying that benefit and how much benefit that it can have in patients. Had they had surgery when they shouldn’t have done or were appropriately denied surgery. So, you know, it’s not just the benefit, it’s more the degree of benefit needed . . . maybe that would be an important parameter to know.

Clinician 1

I think you’d have to have fairly convincing data as it is required.

Clinician 14

I mean, if the trial comes up with something that provides good evidence of benefit and it’s cost-effective, then I would hope that people would take it up . . . it’s an invasive test which has got side effects and it’s not particularly pleasant test for people to have. And it costs money and takes time . . . there’s a risk associated with it so there has to be benefit.

Clinician 3

Clinicians discussed what would be needed to get wider UDS use into practice, should it be found to be effective. Clinicians believed that the impact of rolling out UDS more widely across the NHS would depend on whether or not centres were currently using UDS, the extent of resources available and the interest and engagement of clinicians:

It depends on your centre, I imagine somewhere . . . who uses them [UDS] a lot, it might not impact on the resource because they already have a [team] that’s keen on the UDS. It’s centres like our own, we’re probably somewhere in the middle and then there may be centres that don’t use UDS very much at all who may be having to create a whole new service to support that, or a centre that doesn’t have urodynamics on site that’s going to have to refer their patients to another organisation, so it will be dependent on the organisation and on what the additional resource will be.

Clinician 11

I think the major problem is that if people aren’t doing UDS, then obviously you have to set up the service, which is always going to be a problem.

Clinician 6

I think we have the capacity. We have the staff, we have the kit . . . suppose you would need an extra UDS list . . . I think you’d need an extra list . . . that’s an extra one a week.

Clinician 4

Some clinicians stressed the need for consultants to be involved in interpretation of the more complicated UDS test results. However, they recognised that not all clinicians have an interest in UDS and some may prefer to pass the tests to nurses to conduct and interpret. Therefore, if UDS were to be introduced as standard practice, clinicians would need encouragement to use UDS. National guidelines may help facilitate this engagement:

I think what is happening at the present time is that UDS is not something that any clinician willingly wants to take on, so it’s not a topic which excites most clinicians . . . so I think encouraging more clinicians to be involved would be the next challenge because it’s . . . very easy to say, ‘OK, I’ve got a couple of nurses that I’m going to train and ask them to do UDS’. I mean some of the straight forward UDS results that do get produced by this test are straightforward but, then you do get certain tests which won’t ultimately answer your question and having a clinician is necessary to make sense out of it.

Clinician 10

A lot of it would come down to whether or not the surgeons bought into the fact that it was, erm required . . . I think it comes down to if there was some kind of . . . some sort of NICE guidelines that all patients coming in for TURP must have UDS as part of their pathway, then it becomes something that we have to work out how to do, as opposed to that we have to decide whether we want to do it.

Nurse 4

Clinicians felt that additional staff training would be required, which would be difficult owing to current problems with the availability of training courses and where the courses were run:

Staffing, because you need technicians who can operate the machine. You need to be trained how to do it . . . the training of urology staff on how to perform UDS and, you know, how to capture all the relevant information should be advocated for, especially in hospitals where it is being performed . . . but if they have a machine, and it’s being performed, then I’ll recommend that staff are trained on it. The only problem is different hospitals who have different machines, which, you know, operate differently. But wherever you are, wherever you find yourself, get yourself trained.

Nurse 1

Staff training would be a concern. Like when there’s only two of us was doing it, and not all hospitals, I think, have got their own UDS unit . . . it’s not a regular, the course itself is not a rolling throughout the year, it’s a specific day, a date I think, it’s in a year and that . . . the venue is really far. In [place] we were lucky that when we were to have the UDS, you have attend the UDS course, it’s [local] and that’s accessible to us, otherwise you have to go all the way to [place].

Nurse 5

Clinicians also anticipated logistical issues with space availability; at some centres, clinicians reported that there would be no rooms available to conduct UDS:

Well, you need to find first of all the right resources . . . particularly in our hospital, we’re very short of available rooms, so even though we would like to do more UDS, we can’t because there’s no other times when we can actually have a room available.

Clinician 12

Clinicians highlighted the strains that some current services were already under and voiced concerns that routinely introducing UDS would have a detrimental effect on services:

The main thing is the increased capacity you would have to have . . . I think there would be a big challenge in the NHS . . . a lot of units do have problems trying to provide UDS support for the team.

Clinician 9

We know our nurses are struggling to cope with the workload we’ve got and the space we’ve got which is very little for 10 consultants and others. So I think trying to routinely [conduct UDS] . . . would just break the service currently, or we’d have to give something else up.

Clinician 2

Clinicians were also aware of the cost implications of additional testing and said that they would need a clear indication of the NHS tariff for the test and how it would be paid for:

The other thing is . . . where do UDS fit in to the NHS tariffs, you know, with the funding stream and how UDS is funded within the NHS. Are you expecting the costs [to be accommodated], or do you get extra funding to carry out UDS?

Clinician 1

Even though additional resources would be required, clinicians felt that, if the evidence indicated that UDS should be used and would benefit patients, then it would be worth it:

There’s implications, but if high-quality research suggests that the use of UDS guides us towards the right patients who are likely to benefit the most . . . high-quality health care that’s cost-effective as well, it would reduce the risk of operating on people who will get no or minimal benefit and, hopefully, those that have surgery will be satisfied with the treatment and will be the right group to operate on; so yeah, it would be worth the additional resource if it was needed.

Clinician 11

I think we’ll do that [increase capacity] because if it brings benefit to the patients, we will be happy to do that.

Clinician 5

Summary of findings and implications

UPSTREAM was viewed positively by both trial participants and clinicians, with participants valuing the research for ensuring best practice and clinicians reporting being well supported by the trial team. Most patients who declined trial participation reported a preference for either receiving or not receiving UDS, or a treatment preference. Future studies can overcome this issue by encouraging recruitment staff to explore arm or treatment preferences during recruitment and, by doing so, help potential trial participants to express their concerns, discuss equipoise and randomisation, and reach an informed decision about trial participation. 55 Trial arm preference was also expressed by some of the trial participants interviewed, particularly those men in the UDS arm, who felt that they may receive quicker and better care and treatments, would know more about their condition as a result of UDS, or that it would help with decision-making, which overcame concerns about the procedure.

Most participants reported that UDS testing was acceptable, despite a minority of participants experiencing pain, a UTI or embarrassment. 48 Participants valued UDS for its perceived accuracy and the information it provided about symptom aetiology, and thought that it gave more insight into LUTS than other tests. Reflecting clinical guidelines,4 UDS was carried out after other assessments, such as uroflowmetry and completion of bladder diaries, and was therefore perceived as completing the possible assessments comprehensively. For some men, the results of UDS played an important role in treatment decision-making.

Levels of discomfort and embarrassment experienced during the test varied, but all the men were prepared to have the test again, if needed, despite any negative experiences. Embarrassment was related to the intimate nature of the test and a lack of awareness or preparation for its effects. The keys to minimising embarrassment were good communication and privacy; ensuring men knew what to expect; limiting the number of staff present; and introducing staff and explaining their role. For some men, the sex of the person performing the test was important. Information deficits were reported before, during and after the test, and there was variability in how and when results were explained, and the adequacy of explanations.

These findings have clear clinical implications. It is essential that clinicians inform patients in advance about what to expect during and after the test, including the risk and treatment of UTIs. Patients should be informed that passing urine during the test can be associated with spraying and that this will easily be dealt with afterwards. During UDS practice, efforts should be made to limit the number of staff present in the assessment room and ensure that maximum possible privacy is maintained. Patients should be introduced to the clinicians present and informed of their role, with agreement sought for the involvement of trainees in the procedure. After the test, patients should be allowed to get dressed in their normal clothes before the concluding discussions. Clinicians should discuss side effects with patients and what to do if they experience any problems. Clinicians and patients would ideally discuss the results of UDS testing on the same day as the test or shortly after, with the detail and depth of the explanation in line with patients’ preference.

Our finding of variability in the degree of privacy, dignity, discomfort and information provision experienced by patients undergoing UDS testing indicate that staff require training and guidance in these areas. 48 Current UDS guidelines4 omit guidance on how to ensure that urological assessment is patient centred, yet this is crucial to ensure positive experiences among patients. Inadequacies in UK training in the conduct of UDS investigations have been reported previously;56 our findings suggest that such training needs to include the sensitive conduct of UDS testing and associated information provision. Our recommendations for best practice provide48 support for the ICS statement that patients must receive proper information in advance of testing,57 and our findings inform the medical community about the appropriate content.

Most trial participants who received UDS felt that it was useful in treatment decision-making: UDS could help clarify why they were experiencing symptoms, validate what they and the clinician had suspected, provide reassurance, demonstrate that they had a problem that needed treatment, help them understand what treatment was required and provide a conclusive answer that there was an indication to undergo surgery. Shared decision-making was the most common approach to treatment decision-making described by participants, followed by doctor- and then patient-led decision-making. Although some patients felt that they had the final choice over treatment decisions, others felt that they were not involved in treatment decision-making and UDS results were for the clinician to use in making a decision. Shared or patient-led decision-making was reported more among men who had received, or were scheduled to have, surgery.

The main motivation for surgery reported by trial participants was the desire to reduce or eliminate their LUTS and the impact of LUTS. Expectations for surgery and whether or not these were met varied between participants, and ranged from not knowing what to expect to expectations being surpassed in some cases. Information provision regarding surgery was also reported as varied in terms of what was provided, but also what participants wanted. Some participants reported having enough information but others not enough, some patients preferred not to have extremely detailed information whereas others wanted more detail. An unexpected lengthy waiting time for surgery was problematic, as participants had to continue to live with unwanted symptoms indefinitely and more clarity about what to expect in terms of accurate waiting times would have been valued.

Most trial participants reported being prepared for what to expect with post-surgery recovery and these expectations were mostly met. Again, there was a range of reported experiences of recovery and some participants experienced unexpected side effects or complications. A few participants did report negative experiences that might have been avoided with continuity of care and facilitated specialist aftercare. Participants felt that information about adhering to recovery activity could have been clearer, particularly in those who felt well and who engaged in work or other activities, which resulted in negative consequences. Overall, participants felt that the decision to go ahead with surgery was the right one: 13 out of 16 post-surgery participants described highly or moderately successful outcomes and almost all patients reported the pros of surgery to outweigh the cons. However, several participants described having to adjust to their new situation, whether this was improved symptoms or negative side effects.

Clinician views on the acceptability and usefulness of UDS were varied, as was their use in routine practice. Most clinicians viewed UDS positively and believed it to be underused. These clinicians were more likely to use UDS routinely before surgery. Some clinicians viewed UDS more negatively, felt that it was currently unclear when UDS should be used and therefore felt that it was sometimes overused in usual practice. Some felt that the test’s usefulness was limited, as it was conducted in an artificial setting. Variability in practice across centres resulted in heterogeneity and inconsistency in who performed the test and how and when test results were discussed with patients.

Clinicians valued UDS when making decisions about treatment and condition management, particularly in judging the appropriateness, probable benefit and potential risks of surgery. UDS provided additional information to supplement other urological tests, which helped clarify the patient’s situation and helped when discussing possible treatment options with patients. Clinicians used UDS results in different ways, with different types of decision-making being reported. Some clinicians felt that the test results were primarily for them to make a decision, which they then advised the patient of, whereas others used this information to facilitate a shared decision-making discussion with the patient as to how to proceed.

Clinicians agreed that UDS should be implemented more widely in routine practice if there was a sound evidence base to do so. They recommended clear guidelines to enable clinicians to implement UDS appropriately. The impact of implementing UDS more widely would depend on existing practice, resources and clinician interest. Levels and availability of training in UDS would need to be considered and addressed, as would staff capacity and logistical issues, such as having appropriate space to conduct the test.

Main findings in the context of the wider literature

Previous studies have utilised qualitative methods to investigate patients’ views, experiences and health beliefs about LUTS,58–61 triggers for and barriers to help-seeking,62 and perspectives on treatment outcomes. 63

Existing evidence regarding the acceptability of UDS is largely from questionnaire-based studies and suggests that UDS is well tolerated,64,65 but can also be uncomfortable66 and might cause complications,67 although the extent of these is unclear. 68 To our knowledge, UPSTREAM is the first in-depth study of men’s attitudes to and experiences of UDS for LUTS, using formal qualitative research methodology. 48

Our findings support those of Scarpero et al. ,69 who found that UDS was well tolerated, with patients experiencing minimal to moderate discomfort and embarrassment. As in Shaw et al. ’s 70 mixed-sex (female-predominant) qualitative study, embarrassment was related to the intimacy of the procedure and privacy was therefore important. Previous research has suggested that UDS might be less acceptable to younger patients. 71 This was not evidenced among our participants, but this could be due to the older age group of men with LUTS in our trial sample (age range 52–89 years). Yiou et al. 71 found that being aged < 54 years was sometimes associated with experiencing painful sensation during UDS in a cohort of 68 men and 103 women.

Little has been published about clinician views on UDS, with existing literature focusing on female urinary incontinence and the use of UDS before surgery. 72 Our findings are consistent with results reported from a survey and interviews,72 which indicate polarised views in clinicians on the usefulness and current use of UDS. Hilton et al. 72 found that the majority of clinicians used UDS before surgery, with some reporting UDS as essential in adding to the overall picture, to help inform the best course of action and to provide a safety net for reducing the risk of inappropriate surgery. Some clinicians, however, reported limited use due to a lack of clarity in existing guidelines on how and when to use UDS.

Strengths and limitations

The strengths of the current study include our focus on an in-depth understanding of patients’ and clinicians’ perspectives on, and experiences of, the trial, UDS and surgery; the recruitment of a large and diverse sample of trial participants in terms of age, symptom burden and treatment decision; our understanding of clinicians in terms of centre and professional role; and the attainment of data saturation. Not all the trial participants included underwent UDS, as the views and attitudes of those who have not had the test are also important in considering acceptability in the target population. Analysis demonstrated a high degree of similarity between pre-treatment and post-surgery interviews, with both containing positive and negative views and experiences of UDS testing, not dependent on treatment decisions or surgery outcome. However, most patients interviewed had consented to a trial in which there was a 50% chance of randomisation to receive UDS, so those totally opposed to it might not have consented to the trial; this should be taken into account in interpreting the findings.