Qualitative study

Qualitative studies have been widely used in healthcare research to explore patient and provider perspectives of services and evaluate various healthcare experiences.88 The FUTURE RCT included an embedded qualitative component to provide an in-depth exploration to complement the quantitative data and aid the interpretation of trial findings.89

The principal research questions for the qualitative exploration were:

1. What are clinician’s perspectives of urodynamics in the investigation of refractory OAB and how does this influence decision-making?
2. What are the experiences of participants leading to their decision to pursue treatment and what are their perspectives on investigations, potential treatment options and outcomes?
3. What are the reflections of patient participants following their investigations and treatment?

Methodology

Participants and recruitment

Clinicians

Clinicians from the FUTURE recruitment sites received e-mail invitations and a PIL outlining the purpose and aim of the qualitative study (see www.fundingawards.nihr.ac.uk/award/15/150/05). Those willing to participate provided written or electronically signed consent (see www.fundingawards.nihr.ac.uk/award/15/150/05) and semistructured interviews were conducted either at the start of the trial or within 6 to 12 months of recruitment starting.

Patients

Participants from the FUTURE trial who had consented to take part in the qualitative study were purposively sampled to promote diversity within the population.

A dedicated qualitative study PIL was provided and, following written, digital or verbal consent, a telephone interview was scheduled at the participants’ convenience. Participant recruitment and interviews were conducted with the aim of achieving data saturation, the point at which there are no new emerging themes.90

Data collection

A uniform approach to interviews in all participant groups was incorporated, tailoring the focus of the interviews according to the group. The semistructured interview guide was designed based on the study aim, discussion between study researchers and review of the literature.91 All the interviews were conducted remotely via telephone in line with the social distancing rules in place during the time of the study and were audio-recorded.

Data analysis

Interview recordings were transcribed verbatim and uploaded onto the QSR Nvivo 10 (QSR International, Warrington, UK) software package to facilitate data analysis using a thematic analysis process: familiarisation of the data collected, initial coding followed by generation and re-examination of themes.92–94

Qualitative study participants

The study comprised three groups of participants as detailed in Table 23.

Study 1: clinicians’ perception of urodynamics and its influence on decision-making

Aim

To evaluate the attitudes of surgeons on the influence of urodynamics on decision-making (at the start of the trial or 6–12 months after starting recruitment at their site). The interview primarily involved questions to understand clinicians’ perception of urodynamics and its role in their patient’s treatment pathway (see www.fundingawards.nihr.ac.uk/award/15/150/05).

Themes

A summary of the themes observed during study 1 (clinicians’ perception of urodynamics and its influence on decision-making) is shown in Table 24. Also see Appendix 5 for additional interview findings.

Conventional or current care pathway

Investigation offered

In line with NICE guidelines³ the majority of clinicians confirmed that until they started the FUTURE trial it was standard practice in their hospital for patients to receive urodynamics if their conservative treatment, such as lifestyle changes, bladder training and medications, had failed to produce the desired results. Additionally, clinician responses revealed that urodynamics was used as a standard investigation procedure before subjecting patients to invasive treatment such as BoNT-A or sacral nerve stimulation (SNS).

Usually if they’ve been seen and tried on medication and failed and still have symptoms then conventionally, they’ll just get urodynamics.

For refractory overactive bladder we currently obviously do urodynamics before invasive treatments and when I say invasive that’s Botox and SNS.

Treatments offered

Botulinum toxin injection A as first-line treatment

Most clinicians mentioned recommending BoNT-A as the first treatment to patients when conservative treatment had failed. This was because BoNT-A was perceived as a simple procedure that would either succeed or fail and would not have any long-lasting effects for the patient once it had worn off. Additionally, various other factors including local availability of the treatment influenced the clinicians’ choice of treatment.

We would then go on to perform urodynamics, with a view to considering Botox injection as our next line of treatment.

Usually, Botox would be the first line of treatment […]. Botox tends to be a lot more black and white, that it’s either going to work or it’s not so it’s a lot easier to know fairly quickly.

Other treatment options

Some clinicians stated that they offered other treatments such as PTNS or SNS along with BoNT-A. In some cases, however, these choices were influenced by patient-centric factors such as their history, or preference. It was also influenced by treatment availability or guided by investigation results.

I know that the NICE guidelines tell you to offer Botox first and we do that but also I feel that patient choice is important, so I do offer them, I tell them about the other treatment options.

Factors influencing clinicians’ decision and treatment recommendations

Investigation information

Bladder diary

A bladder diary was revealed as one of the key instruments that facilitated clinicians with their decision-making, diagnosis and treatment assignment.

A well completed bladder diary, is by far the best guide really.

However, they acknowledge that the quality of the bladder diary varies among patients, thus resulting in a varying degree of reliability. As a result, some suggested that they felt urodynamics would give a better picture in addition to the bladder diary.

I think it depends on the patient to be honest with you, it always depends on the patient yes and how accurate is the bladder diary.

Early history and test reports

In addition to information gathered from the patient’s bladder diary, clinicians emphasised the importance of patient history and test reports in guiding their decisions.

Well, patient history and bladder diaries are usually the two things that I look at basically.

I mean some of them come straight and say I leak only when I cough and sneeze. Others leak for example and then on detailed history you would find that it’s urge incontinence rather than stress incontinence. So, history examination is good in guiding that there is nothing else.

Urodynamics

While clinicians expressed their reliance on the bladder diary and early test reports in deciding what treatment to recommend, some explicitly said that urodynamics provided some of the most useful information that strongly influenced their decision. Furthermore, some stated that urodynamics served as a confirmatory investigation and provided them with confidence to proceed with their treatment recommendation. On the other hand, there were clinicians whose responses revealed that the results generated through urodynamics did not influence their choice of treatment.

We usually proceed with urodynamics, just to be accurate.

I suppose it’s confirmatory, that you are doing it to try and confirm what you think is going on and probably as much to rule out other things.

Even though the urodynamics might not have shown any overactivity then it wouldn’t stop me from following the patients symptoms and offering them something like Botox. It’s informative but it’s not a deal breaker for me.

A clinician associated one of the key benefits of urodynamics with the quality time it gave them with their patient, adequate time to communicate and imbibe the patients’ problems in depth.

It gives you an hour with the patient, I think that gives you the opportunity to talk things through in much more detail.

It also helps you establish rapport with the patient that you might be meeting for many years to come.

It gives you a much better feel for the patient, so I think it gives you an additional level of empathy for them for sure.

Guidelines

Existing guidelines such as NICE95 strongly influenced clinician’s choice of treatment pathway for their patients. There were, however, a few clinicians whose responses revealed that their decisions were not completely driven by guidelines; instead they prioritised patient preference.

We follow the guidelines so if it affects your overactive bladder then we do urodynamics.

I give them the option of PTNS, SNS and Botox and I know that the NICE guidelines tell you to offer Botox first and we do that but also I feel that patient choice is important.

Although the NICE guidelines states that we should always offer people Botox injections first, once we mention the requirement for self-catheterisation many people refuse to accept opting for Botox injection. Therefore, it is quite common for us to put the SNS and PTNS down as the other options.

Treatment availability

Another factor that influenced treatment recommendation was the local availability of the respective treatment. This was also tied to abiding with patient preference, as clinicians revealed that patient’s willingness to travel to different locations to receive a treatment also influenced their ultimate treatment pathway.

I think we offer more SNS because we have it locally.

Well, we are not able to offer sacral nerve modulation here any more so we offer the sacral neuromodulation to go to [City D], or they’re offered Botox injections.

Influence of patient characteristics

Patient characteristics and medical history

Clinicians acknowledged that a blanket approach to treatment pathway may not be suitable, as each patient may have unique clinical characteristics that may influence their treatment and outcome.

I think it’s not one size fits all, I believe in tailor made management, guidelines are guidelines, quite often we see people who have scenarios which deviates from the normal pathway, it’s always tailor made, I can’t really say one test is superior to the other.

Additionally, clinicians expressed consideration of the patient’s age, ability to self-catheterise or other concomitant health conditions that may potentially influence their treatment experience or outcome.

Patients with lack of ability to self-catheterise, again we consider they are a better candidate for nerve stimulation.

If I think they’re not going to be able to self-catheterise then I will direct them away from Botox.

Patient preference

There were clinicians who stated that despite the NICE guidelines, patient preference would influence their decision and treatment. They identified abiding with patient preference was key to treatment satisfaction.

I feel that patient choice is important, so I do tell them about the other treatment options.

We offer the option to the patient and the patient chooses for herself.

Clinicians’ observation of patient experience of urodynamics

From the clinicians’ years of experience and witnessing their patients undergo urodynamics, they reported that their patients may be anxious when they come to have urodynamics, perhaps even describing fear, due to the invasive nature of the investigation and the use of catheters.

I think most are anxious because they’re not quite sure exactly what it’s going to be like.

Most of them are scared so they are expecting the worst.

Not many people in general like urodynamics, patient-wise. When I say ‘don’t like it’, it’s the apprehension, what is this test, its invasive catheters, tubes, things like this.

However, after having urodynamics many clinicians found that patients felt it had not been as bad as they had expected.

The majority of the people, actually we hear this from patients a lot, ‘oh it’s not that bad, not as bad as I expected’.

On the whole they find it’s not as bad as they thought.

Future practice

Comprehensive clinical assessment – avoiding urodynamic investigation

Several advantages were described for CCA, with some clinicians reporting that undertaking clinical assessment without urodynamics increased the efficiency and speed of the pathway, avoided the risk of a UTI associated with urodynamics, and saved the patient from the stress and embarrassment of the urodynamics investigation, particularly related to the use of a rectal catheter. Cost reductions were also identified.

It makes the pathway quicker, it avoids the risk of UTI from urodynamics, and it saves money, no need for the machine, no need for the time, the personnel.

For the patient I don’t think there is any other advantage apart from the stress of the test [Urodynamics] … so there are health advantages by avoiding the risks related to the test.

Some patients don’t like the idea of a catheter especially a rectal catheter.

Do we need urodynamics?

Some clinicians did not like the idea of urodynamics being eliminated from the patient’s investigation pathway altogether; instead, they suggested relying on urodynamics on a case-by-case basis.

With the current knowledge I would say keep the urodynamics after failed conservative treatment.

I suppose we can then say well ok for cases who do not respond to temporary stimulation then you can do urodynamics at that stage, rather than everybody.

Contrarily, some clinicians were open to discontinuing the urodynamic investigation as they felt it did not yield any added benefits to the care pathway and only viewed it as an inconvenience or hurdle.

My impression is that the results are going to be exactly the same in that I can’t see that there’s any advantage to having had urodynamics … it’s not going to make any difference to the outcome whether they’ve had it or not.

As long as you do the diary and the bladder scan and a good history there’s not a lot of advantage doing urodynamics.

Discussion

Among the clinicians participating in FUTURE, assigning patients to undergo urodynamics was the most conventional investigation practice followed. This was primarily as a result of abiding by NICE guidelines.95 However, despite its widespread use, clinicians’ perception of the usefulness of urodynamics as an investigation tool and perception of its benefits varied widely.

Most of the clinician responses revealed that bladder diary and patient history were viewed as key instruments that aided clinicians in understanding patient symptoms and assigning them appropriate treatment. Some, however, acknowledged the limitations of these instruments, highlighting the varying degree of quality obtained from the bladder diary. They stated that this is where urodynamics plays a crucial role. Despite its limitations, urodynamics was highlighted by clinicians as an investigation procedure that enabled them to confirm patient symptoms and provide them with the confidence to assign specific treatments to their patient. In addition, our study identified other factors which influenced clinicians’ decision and treatment recommendations; these include clinical guidelines, local availability of treatment and patient preference.

The most recommended treatment was BoNT-A. The relatively simple nature of the procedure was a factor in its popularity. There were also some clinicians who recommended treatment options alternative to BoNT-A, such as PTNS or SNS, and relied on patient characteristics and preference such as their ability to self-catheterise.

The role of urodynamics in this pathway received varying views among clinicians. Some demonstrated high reliance on this investigation due to the additional information it generated, the confirmation it provided, and the additional patient–practitioner communication it enabled. Based on these benefits, some clinicians did not comply with the idea of urodynamics being removed from the care pathway. Instead, they recommended that the use of urodynamics may be limited to patients who absolutely require it. Contrary to these views, other clinicians were happy with the idea of not including urodynamics in their care pathway as they did not identify any beneficial contribution of urodynamics and mostly viewed it as a stage delaying patient treatment, increasing use of healthcare resources, and causing inconvenience to patients. They also expressed their observation of patient experience of urodynamics, with the majority describing patient anxiety associated with the procedure. However, they also stated that despite patients being apprehensive of the procedure, their post-investigation experience revealed that the procedure was manageable and better than their initial expectations.

Study 2: participants’ experience and attitudes pre randomisation

Aims

1. To explore FUTURE trial participant experiences of symptoms and their impact prior to randomisation.
2. To explore participant attitudes to potential treatment options, invasive testing, and outcomes.

Themes

A summary of the themes emerging from study 2 (participants’ experience and attitudes pre-randomisation) is shown in Table 25. Also see Appendix 5 for additional interview findings.

Early symptoms and their impact

Symptoms

Many patients stated that they had been experiencing bladder symptoms such as urgency and leakage for several years.

I put up with it I suppose the last 5–6 years I suppose.

My eldest child is coming up 7 … the issue started from when I had him and that was in 2015.

They stated that the severity of their symptoms varied and experienced some good days and some problematic days. Many also highlighted that their symptoms had worsened over the years either with age, pregnancy or childbirth.

I’ve had bladder problems for many, many years and I’ve had times when it’s been alright and then other times when it’s become quite a problem. So, I get very uncomfortable.

So that got worse with age and it got worse after I had my daughter so 6 years, 7 years ago now.

Impact

Patients’ experiences with bladder symptoms revealed that it had severely impacted their life and had an influence on their day-to-day activities.

Day-to-day activities

Many individuals shared occurrences of accidental leakage and embarrassing instances caused by their bladder problems. They expressed how it had restricted their participation in social events and physical and leisure activities. Their lack of involvement was also driven by the excessive planning required to manage bladder problems. This included ensuring proximity of toilets during a day out, packing extra clothes and pads, and planning journey breaks.

So, it is a bit restrictive, and I can’t go swimming because I have to wear a pad because I don’t want to be leaking in the swimming pool. So, things like that it does affect you.

When you go anywhere you’ve got to look round and find a toilet before you can go do whatever you wanted to do. I don’t go in town anymore because what if I didn’t get a bus in time. It’s just worrying all the time, you can’t go for a walk, can’t take the dog for a walk. It just stops you doing everything.

It was also noted from the interviews that the bladder problems significantly impacted other key factors of an individual’s life such as sleep, diet, work and relationships.

Sleep

An urge to urinate several times at night was common among most patients, with many reporting waking two to three times during the night. These individuals considered this one of the worst impacts of bladder problems and expressed how it was taking a toll on their sleep cycle and ultimately affecting their activities during the day.

Yes, it does, I’m up and down, up and down and I’m one of these that can’t sleep once I’m awake so if it’s 2 o’clock in the morning I’m wide awake then, then I’m absolutely shattered the next day.

When your sleep’s broken two or three times during the night … it does make you feel a bit groggy sometimes in the morning.

Meanwhile, a participant also mentioned that the symptoms were more severe during the night compared to the daytime.

The night-time is the issue at the moment really … when I’m out I never really get to that desperate stage because I’m aware of where I am often where the toilets are, anyway but at night because I am getting I think personally run down, I’m very tired and a bit wimpy.

Furthermore, some patients mentioned that they had avoided drinking more fluids before bed in order to avoid multiple trips to the toilet during the night, therefore highlighting the impact of their symptoms on their diet or fluid consumption.

I try not to drink before I go to bed.

At night if I don’t drink a lot before I go to bed I’m fine, I can sleep all night.

Fluid intake

Patient experiences revealed that their symptoms and urge to urinate had affected their fluid intake, that is, they had either reduced or avoided drinking water or their favourite beverage. Irrespective of knowing the harmful impact of drinking less water, these individuals expressed that they minimised their water intake in order to avoid any potential accidents, leakage and sudden urgency of urination at unexpected times.

I think it varies on what I drink as well. I have cut down on my tea, fizzy drinks, any alcohol, I wasn’t a big alcohol drinker anyway.

But I try not to drink as much when I’m out and that in itself is not good either. I feel like if I have a drink I’m going to want to go to the toilet.

Work

Bladder symptoms had a negative influence on most of the individuals work, due to their frequent need to use the toilet. Moreover, the severity of the symptoms prevented some from taking up a full-time job.

Well actually part of the reason I’m not working is this because I couldn’t work, like I mean I’d spend half my day in the toilet, you know.

I work part time from home because of everything that’s been going on yes.

In addition to these issues, some expressed the challenges associated with keeping their bladder problem a secret and mentioned they were in constant fear of being in an embarrassing accident or of being questioned about their frequent toilet visits.

I don’t wear jeans unless they’re black because I feel like, especially if I’m wearing blue jeans if I had an accident, you could tell and that would be even more embarrassing.

Every work that I’ve had I’ve like, no you seem to be going to the toilet a lot, and … it’s affecting life all in all.

Contrarily, some participants revealed having little or no trouble at work and indicated to have managed their symptoms well. This lack of issues was mainly due to the individual’s job type or post at work.

I suppose so because you see I only work in the afternoons and it’s certainly not an issue at work.

It wasn’t too bad, because I worked in an office so I was sat down most of the time so it didn’t really have a lot of impact, I could go to the toilet when needed.

Relationships

Some patient responses revealed that the symptoms associated with OAB had impacted various relationships, including marital relationships, relationship with potential sexual partners, and friends.

It impacted on my marriage because I was constantly in and out of bed all night and my husband wasn’t able to sleep, I started to wet myself occasionally.

If I’ve met somebody it puts me off even wanting to sleep with anybody, to be in the same bed with somebody because sometimes I wake up in the night and there’s a wet patch on the bed.

My friends were getting so mad at me because we didn’t do half of the stuff that we wanted to do in the time that we were there because it affected me really, really badly.

Impact on mental health

The restrictions and planning requirements imposed due to the individual’s bladder problems have instilled what participants described as ‘a sense of panic’ which has reportedly impacted their mental health. Patients also stated being in a state of constant fear of potential accidents, increased stress due to excessive planning prior to events, and a growing sense of isolation, loneliness and deterioration of confidence.

I think it impacted on my mental health as well because I constantly thought about it so as I’m constantly thinking about it, I’m constantly wanting to go to the toilet.

And I felt very down and kind of depressed thinking gosh, at the time I was only 32 so then I realised that it’s really bad.

If we were going anywhere, I’d get this anxiety because I needed to know where the toilets was and that I could access them. It just actually controls all your everyday life.

On the other hand, some stated that the symptoms got worse due to their stress and anxiety.

So, it is like a vicious cycle to be honest because obviously you get quite anxious about doing these things and it [bladder symptoms] gets worse, so you get more anxious and then it [bladder symptoms] gets worse.

It gets to a point where I’m really stressed and I get very, very stressed so I just have to go.

Prior treatment, outcome and impact

Treatment options and its outcomes

All participants had tried one or more treatments, including medication, physiotherapy and surgery. Individual experiences and satisfaction with medications and tablets varied. Some stated that the medication initially had a positive impact, but its effect wore off with time, while others stated that the tablets or side effects worsened their symptoms. Patients’ experiences with physiotherapy and surgeries were similar – none of them were satisfied with the treatment outcomes and continued to suffer with bladder difficulties.

They gave me the tablets, some of them helped for a short while and then it just seemed to wear off. The second lot of tablets that I had they were really, really bad, if anything I thought they were making me worse than what I was.

I had physio, an amazing lady … and then at some point, she said to me I can’t help you any more I’ve done everything that I could.

Influence of early treatment outcome on future treatment

Participants expressed dissatisfaction regarding their current treatment results (prior to joining the trial) and were unhappy with its overall outcome. Their experiences reveal that they had tried various treatment options and had perhaps run out of medications to try or were reluctant to continue experimenting with new medications due to potential side effects, need for long-term consumption or minimal effectiveness. This has therefore resulted in their seeking further treatment and enrolling in FUTURE in the hope of finding an ultimate solution to their ongoing bladder problem.

I have, I’ve tried medication and things which haven’t worked so they stopped them. And really to me this is like the last option.

So, it’s got to a point now where I’m just trying to see if there’s anything else I can either do to help myself or someone else can help me.

Factors influencing participants’ perception and choice of treatment

Treatment options – perception

Most participants were willing to try any treatment that was offered to them. This response was mainly triggered as they had reached a tolerance threshold and could not manage their bladder symptoms. Many were hoping to receive a treatment that would enable them to live a normal and stress-free life.

I’d be happy, no matter what I have to go through because like I said it’s such a bane in my life.

I want a solution and keep thinking I’ll try anything not to be like this and to just get a good night’s sleep.

I wouldn’t care, I’d try anything as long as I thought I was getting somewhere.

Although most of the participants were open to any available treatment options, some had certain preferences. For instance, a few expressed their wish to avoid surgical options.

I would be very reluctant to have to go in for another very invasive operation. Like the ones that I’ve had, especially as they haven’t worked.

I don’t know, I don’t want any kind of surgery where you have to cut through and then do something complicated … just something simple that will resolve the issue. I don’t like surgery.

Some patients expressed relying on the information given by the medical team to guide their treatment pathway and, therefore, reported having done minimal research on their own, resulting in their lack of awareness of various potential treatment options.

I sometimes think it’s better to not do that [own research] and just take the information you’re giving me, and my nurse is giving me.

They gave me leaflets and I read all the leaflets so there’s no point sitting researching things online when I know the basics, you know what I mean.

Treatment options – choice

Some participants highlighted various factors that could influence their choice of treatment and impact their willingness to accept the recommended treatment. The most mentioned factors included the following.

Travelling

While some participants demonstrated reluctance to travel far distances due to lack of their own transport, or inability to travel long distances while managing their existing health issues, others were willing to travel and did not identify it as a barrier.

So, if I had to travel somewhere for the day … that would be fine if it meant that I got better treatment.

Yes, the location, if it’s too far I wouldn’t do it because as I say if I get out the car, I’ve got to go to the toilet so if I’m stuck anywhere that would be it, it would have to be local.

The one that would bother me is getting to somewhere that’s a distance away because I can’t drive any more, and the transportation would be the issue. That would be my only problem.

Time frame

There were mixed views among participants regarding their willingness to wait to receive a treatment. While a few were not concerned with the long waiting times, a few displayed worries, stating long waiting time may impact their day-to-day schedule. Some were also reluctant to undergo procedures that would require multiple hospital visits or involve a long recovery period.

I don’t think I would have too long a wait. I’ve had this condition as I said over 20 years … so waiting a little while longer is neither here nor there really.

But obviously I’ve got to factor all this in with working full time, you know so for me, I need something that’s not going to drag on for months and months and months either.

Side effects or impact on existing treatment or health issues

Some participants expressed displeasure at the prospect of proceeding with a treatment that would lead to severe side effects for fear of negatively impacting their existing health conditions and medications. A willingness to compromise and accept minimal side effects was described if the benefits outweigh the negative effects.

I’m willing to put up with some side effects as long as they’re not too severe, I think there’s a risk with everything isn’t there so you’ve just got to, you’d be saying no to everything wouldn’t you, if you looked at it that way.

Something temporary that’s ok. But not a side effect that will change my life completely.

Expectations of treatment outcome

While exploring participants’ expectations from future treatment, a few common goals were noted. These included the following.

Normality

Participants emphasised the desire to live a normal life. The meaning of a normal life varied for everyone, but in general it reflected the life they had before their bladder symptoms were aggravated.

Just being normal, I’m not looking for something out of this world it’s just that you’re normal again and you can do things, go out and not worry about where’s the next toilet.

I’m hoping that every bad symptom I have is gone, as obvious as that sounds.

I would be hoping that this would stop, and I’d have a normal life like before.

Increased bladder control

One of the common expectations of treatment outcome among the participants was to have more control over their bladder. Many hoped that the treatment would reduce the number of toilet visits. They expressed their desire to stop leaking and hence stop wearing pads.

Ideally I’d like to have some more control over my bladder.

Well, I would like the leakage to stop, that would be amazing.

To stop wearing pads for a start, and hopefully I can get some more control over my bladder so that when I want to go, I’ve got time to go and not have that urgency to get there quickly.

I’m hoping to be able to go out without having to consider a toilet at all times.

Engaging in activities of preference

Participants hoped to restart socialising and taking part in activities of their liking such as going for a run, keeping physically fit, and travelling.

I mean it would be amazing if I can do basic stuff with my kids, if I can just go to the park, if I can even run after.

I want to be able to go on a night out without constantly thinking oh my God is there going to be a queue in the toilets and stuff and being able to hold it in at least a couple of minutes instead of it like flooding out.

I’d go out a bit more and enjoy my life a bit more because at the moment I’m not enjoying anything really.

Reduced anxiety

Participants further voiced their wish to minimise worrying and stop being in a state of constant stress caused by thinking about how to manage their bladder symptoms.

Well, the most satisfactory outcome would be that this would all stop and that I could just get on with my life without this being a constant anxiety.

I think that’s what I’m hoping for so I’m not anxious every time I go out anywhere, even on a drive. Going any distance.

Improved sleep

Getting a good night’s sleep was another commonly hoped-for outcome. Since nocturia was one of the main symptoms of the participant’s bladder problem, resolving this was one of their key goals. They expressed how better sleep could improve their quality of life and bring the ‘normality’ factor back.

To go to bed at night and once I’m in my bed to sleep all night, get up the next morning, how it used to be, need the toilet and that would be it. Feel normal again I suppose.

Getting a decent night’s sleep, I’m very sleep decremented at the moment because I just can’t, as soon as I move, I’m finding that my water’s coming away.

Managing expectations

Although participants had various expectations, they seemed to demonstrate a level of understanding that all their hopes for their post-treatment life may not be met. They, therefore, expressed that they would be satisfied even if they received minimal relief from their current bladder problems and their symptoms became more manageable post investigations and treatment.

To be honest with you I don’t expect being 100%.

70% that’s fine. I’m not hoping 100% as if you don’t leak at all or something. I don’t mind a little bit of leaking here and there but not like what I’m having now.

Early perception of investigation arm – urodynamics or comprehensive clinical assessment only

Participants had mixed perceptions and reactions towards receiving urodynamics or being assigned to the CCA only arm. There were participants keen to undergo urodynamics in hope of finding a solution, or because all other treatments had failed, and they therefore felt more hopeful and validated to have a choice or an investigation option still available. On the other hand, a similar proportion of participants were put off by the thought of urodynamics either because of the invasiveness of the procedure or due to the perception that the procedure would only delay their treatment. Among those who were not keen to undergo urodynamics, some were willing to put up with it if it meant finding a solution to their bladder problems.

There were a few participants who had a previous invasive urodynamics experience and were more confident to undergo the investigation. However, there were some with previous urodynamics experience who were unhappy with the procedure or considered it pointless to repeat it.

Positive perceptions

Keen or happy to undergo urodynamics

I’m actually not bothered about it to be honest. If me taking part in the study means that they can try and get to the bottom of what’s going on with me and it does help other people going forwards.

This makes sense[having urodynamics] rather than to be dished out some treatment and then do it and then it might not be right and so give out some more treatment.

More prepared due to previous urodynamics experience:

That was what I had in 2015 it established I had an overactive bladder … I don’t actually have a problem with procedures at all.

Well, I’ve had no bad recollections of it. I mean I had it done and that’s it, it’s only a bit embarrassing when you sort of think you’re weeing yourself, that’s it.

Negative perceptions

Unhappy with the idea of urodynamics:

Obviously I’d rather not have it …. So, my reason is because I do get quite nervous …. So, I’d rather not have it because I don’t want to be in pain. I don’t want to be uncomfortable.

I hope I don’t have to have it; I’m dreading it.

Unhappy but open to undergoing urodynamics:

Well, I don’t really know, it’s hard because I’m not really fancying catheters but if it has to be, it has to be.

If I have to have urodynamics I have to have them, I mean I’d prefer not to but if I have to, I’ll just do it. As long as it gets things moving, I will just go with the flow really.

Unhappy with previous urodynamics experience and hence not looking forward to another:

To be quite honest with you I’ve already had the dynamics test, which to have to go back through that again would seem silly because of us already having it done and you already sort of know what the outcomes have been of that.

I’ve had the urodynamics twice before, they’re not something to relish.

Treatment perceptions – initial perception of botulinum toxin injection-A

While discussing treatment options, all participants in this study discussed BoNT-A as their potential future treatment; therefore, BoNT-A and its perception has emerged as one of the key themes in this study.

Positive perceptions

Some patients were happy to undergo BoNT-A as they identified it as a quick procedure and were willing to try it in the hope it improved their symptoms.

I’m quite happy to go ahead with the Botox treatment, it seems as if it’s a fairly easy procedure. I’m quite happy to go along with that.

Well, it’s brilliant that it’s a 5-minute procedure, I’m really happy that it’s so quick. I’m happy that I’ll be awake because I’m terrified of general anaesthetics.

Negative perceptions

A few individuals were apprehensive of the procedure due to its invasive nature. They expressed their fear and some highlighted that although they would undergo the treatment, if recommended, it was not something they were looking forward to.

Terrified but I think it’s got to be given a go.

I was offered this Botox treatment, which I was a bit wary of to start with because they said that about 15% could go wrong, out of 100 and that would involve me putting a catheter in myself which I was a bit unsure of what to do with that.

I’m very anxious about that [Botox] as well because I can’t imagine what that’s going to be like.

Concerns of treatment failure

Quite a few patients were nervous due to potential failure of the treatment or were worried that the BoNT-A procedure would hinder their urination and ultimately force them to self-catheterise.

I’m worried that I will be this unlucky person because I could end up with an infection and obviously I have to do it [catheterise] myself which is scary as well. But I think this is one of the risks

I know you might have problem then passing urine and things, you might not, but you might. But that is a bit of a worry obviously because I don’t really want to have more problem.

Discussion

Participant experiences reveal they have put up with their bladder problems and associated symptoms for many years. Information extracted through the interviews provides clear indication of the negative impact that bladder symptoms have on their day-to-day lives. It has caused severe restrictions on their activities and has ultimately taken a toll on their mental health. Additionally, failure or poor efficacy of past treatments has added to their existing disappointment and frustration. This scenario, therefore, has driven these individuals to seek further treatment.

Although the majority of the participants were keen to undergo further investigations and seek treatment for a cure, some revealed several personal and external factors that potentially influence their perceptions of available investigation and treatment options. Similarly, their perceptions of urodynamics were influenced by a few factors, where positive perceptions were influenced by their strong drive to find a successful treatment, or confidence from previous invasive medical experience. On the other hand, negative perceptions were triggered by fear of the procedure or lack of confidence associated with the benefit of the procedure or negative experience with previous urodynamic procedures. A similar pattern was noted for participants’ perception of BoNT-A as a treatment: while some were optimistic to undergo BoNT-A, there were some who were reluctant due to the invasiveness and stages involved with the procedure. Ultimately, however, every participant’s goal was to get through their treatment pathway in order to achieve a successful outcome.

Furthermore, participants’ eagerness to move forward in their treatment pathway was driven by several hopeful scenarios associated with post-treatment outcomes. The shared expectation among all participants was to get back to living a life without their bladder symptoms taking control of their choices and actions. However, their previous experiences of failed or ineffective treatments have resulted in their being more cautious of what they could expect as a result of their upcoming treatment.

Additionally, participant responses revealed their limited knowledge of various treatment options, as all participants in this study were aware of only BoNT-A as a therapy, thus highlighting the need for increasing patient knowledge and awareness of various treatment pathways in order to enable them to make a more informed choice.

Study 3: participants’ experience of urodynamics and opinions regarding treatment outcome to include evaluation of treatment satisfaction or desire for further treatment (3–6 months post treatment)

Aims

1. To explore participants’ perception of their randomised arm, their treatment experience and outcome.

1. To understand participants urodynamics experience and its potential impact on their treatment and outcome.

Themes

A summary of the themes emerging from study 3 (participants’ experience of urodynamics and opinions regarding treatment outcome) are shown in Table 26. Also see Appendix 5 for additional interview findings.

Urodynamics as an investigation pathway

Participants who had undergone either urodynamics or CCA only shared their views on being randomised to receive urodynamics or not, respectively. Based on their experiences and perceptions the following themes were derived.

Individuals who were randomised to undergo urodynamics displayed varying responses.

Perception of the urodynamics arm

Hopeful

Having to undergo an additional clinical investigation made some participants feel more validated. They expressed feeling more optimistic of finding a solution and nearing their goal of rectifying their bladder problems. Furthermore, for a few, this stage was deemed to be hopeful as all their previous treatments or investigations had failed.

But knowing that it’s like an actual problem I’d be having tests for just makes me feel more validated.

And I thought well this is going to help, if I do this it’s going to help people further down the line hopefully, so that was my thinking.

Nervous

There were participants apprehensive about undergoing urodynamics. This was mainly due to the invasiveness of the procedure or due to the fear of the unknown.

As I thought about the information, I’d been given I thought I don’t really want to go ahead with the urodynamics.

I was nervous because I was told pretty much what to expect at the urodynamics.

A bit nervous because it’s something I hadn’t had before, but It was fine.

Unhappy

Some expressed complete displeasure about being randomised to receive urodynamics. This response was mainly due to the discomfort associated with the procedure. Furthermore, one participant declined urodynamics.

I didn’t like it and I’m quite a private person, so it was a big thing for me to go through that. I didn’t think it was very nice to be honest.

I wasn’t looking forward to it at all because I knew that it was obviously going to be a bit uncomfortable.

I was actually really disappointed, and I actually cancelled my appointment for the urodynamics because of all the information I’d been given, I just felt that it wasn’t really the way forward for me.

Confident from previous invasive procedure or diagnosis

Most of those who had previously undergone urodynamics or an invasive diagnosis experience were more confident to undergo the procedure. Additionally, some demonstrated greater acceptance due to their experience with pregnancy and childbirth. Therefore, these individuals were not reluctant or unhappy, instead they were less bothered on being assigned to the urodynamics arm.

Before the urodynamics went ahead I had my bladder examined, you know so with the camera put up to make sure obviously to exclude anything going on so that, I suppose, helped prepare me for the urodynamics.

It’s quite invasive but having had children and had various operations no it didn’t bother me at all.

Open to any procedure to stop the problem

Many participants were willing to undergo urodynamics by putting aside their fears and discomfort, as they were keen to find a solution to their problem, and therefore had a positive outlook on being randomised to the urodynamics arm.

Usually, I just jump through the hoops they ask me to do to get things done. Each time I’m just hoping something will work, you know?

I needed to find out why this is happening and if there was a way that it could be either minimised or stopped so having something like that done was just a help, I didn’t find that a problem at all.

My thoughts were positive because if the medication wasn’t working, I was keen to try anything that might work or at least investigate what was going on, so I had no negative thoughts about it at all.

Perception of the CCA only arm

Only two participants from the comprehensive clinical assessment only arm were interviewed due to issues within the trial design making it difficult to identify participants at the correct time point in the clinical treatment pathway. Perceptions of both these participants were different, with one expressing delight for having avoided urodynamics, mainly because she was relieved to have avoided a procedure which was deemed uncomfortable and invasive: ‘Oh yes, I was thrilled’ (P08), whereas the other participant expressed unawareness regarding the urodynamics procedure, thus having no opinion either way.

Urodynamics experience and perception of usefulness

Experience

Embarrassing

Some participants considered the urodynamics procedure humiliating and were uncomfortable as the investigation required them to be quite exposed and urinate while being watched.

It’s still demeaning, and I didn’t like it.

It wasn’t at all a pleasant experience.

Non-embarrassing

There were individuals who were not affected by it and did not consider the procedure difficult or demeaning.

No, no. you can’t feel embarrassed because you’re asking for treatment, so yeah, giving you treatment, what’s the point in being embarrassed about?

I did not feel any embarrassment at all, even when the fluid was pushed into my bladder, and I obviously couldn’t hold it. So, which was what the test was all about.

Painful and uncomfortable

There were participants who found the procedure to be painful and therefore categorised it as an awful experience to go through. Reports of physical discomfort or uneasiness felt due to the presence of the medical team around them were noted.

But my experience with it no, overall is it wasn’t as if I’d like put myself forward to do it again. Just because of the pain, simply because of the pain.

When they were sort of filling up my bladder, it then became very uncomfortable.

There was about four people in the room, and I was very uncomfortable with it. And to me, you should maybe be left on your own.

Reassuring

Undergoing urodynamics was deemed to be reassuring for some participants, as they felt some action was taken in order to resolve their problem. They considered the process beneficial and believed it yielded results that had potential to drive success of their future treatment.

Yes, I would, I would rather have had it definitely because it did actually show up that I still have interstitial cystitis and frequency and whatever so yes, I was glad to get it.

I found it a very reassuring experience. The staff there, the consultant and a nurse …. The urodynamics actually confirmed what the problem was and therefore a course of treatment could then be planned.

Perception of usefulness

Most of the participants regarded the urodynamics as a useful procedure. They believed it provided the medical team with information, hence enabling them to get a clear picture of their bladder problems and further aid in deciding the most suitable treatment. These individuals were also willing to repeat the procedure if required. However, a few were convinced that urodynamics did not make any valuable contribution to their treatment journey and considered it an unnecessary hurdle in their pathway to cure.

Positive perception

So, I kind of thought, well, at least it’s showing them what I need doing and, you know, confirming what I need doing.

Urodynamics actually confirmed what the problem was and therefore a course of treatment could then be planned. So yes, if I had to go back in time, no hesitation at all in going for the urodynamics.

Negative perception

The negative perceptions were associated with a rather inconclusive urodynamics investigation.

So, I have done urodynamics, but I think it was fairly inconclusive.

[The care team] couldn’t make sure that was accurate because one of the connections of the pipe had come loose but I thought to myself I’m not going to have that again, I thought I personally wouldn’t have that again.

Botulinum toxin injection-A early perception and experience

All participants in this qualitative component of the FUTURE study received BoNT-A as their treatment. Therefore, BoNT-A and its experience have emerged as one of the key themes in this study.

Awareness

Many were familiar with the term BoNT-A, but they were extremely surprised after learning it was a treatment for their bladder problem since they identified it as something only used in the cosmetic industry. Some expressed having vague knowledge of this treatment for OAB as they knew someone who had the treatment or had heard it from the medical team at an early stage of their diagnosis or treatment pathway.

Unaware

I was quite surprised it was an option to be honest, I didn’t think Botox worked for anything like that.

I think I laughed because people normally get it on their faces. I had never ever heard of it and a lot of people I’d spoken to had never heard of it.

Aware

I’ve known about Botox for a while.

Well, I didn’t really understand it, but I knew somebody that had had it for the same reason and that it had helped her.

Procedure experience

Among the participants who had undergone urodynamics, most shared a positive BoNT-A experience. Some of these pleasant experiences could be attributed to the either the general or local anaesthetic the participants received. A few categorised BoNT-A as a better experience compared to urodynamics, whereas there were individuals who identified the procedure as fascinating as they were allowed to view the procedure on screen while they were undergoing it.

On the other hand, two of those who did not undergo urodynamics and some from the urodynamics arm described BoNT-A as a moderately painful and uncomfortable procedure. One stated that they were not well aware of the procedure, which resulted in their being less prepared for the treatment, and hence the discomfort. In addition to this, there were two individuals, one from each arm, who declined BoNT-A after learning the details of the procedure as they feared potential pain, infection or need to self-catheterise.

Urodynamics arm

I had anaesthetic, so I didn’t feel anything.

So I knew that it was going to be a catheter but they used some kind of anaesthetic, numbing thing and honestly I didn’t expect it to work but it did, I actually didn’t really feel much of the catheter going in …. So yes, it was as comfortable as it could be really.

Quite fascinating. I watched it on the screen. It’s not so painful or anything.

It’s very difficult, I mean you read about Botox and oh it’s fantastic … it was intensely painful, it was really, and I’m not a wimp, it was really painful, and it did nothing.

Comprehensive clinical assessment only arm

Well, it was a little uncomfortable at times, like to almost being painful, briefly, very briefly but yes I was glad when it was over.

Perception of repetition

The potential need to repeat BoNT-A received mixed reaction among participants. None of the participants were looking forward to repeat BoNT-A. They were, nevertheless, willing to make a compromise and endure the procedure in return for greater control over their bladder. Some, however, displayed complete displeasure as their initial BoNT-A had failed to produce the desired result.

I thought I don’t really want it. If there was something else, they could do that would be great, but if it stops me from keep piddling, as often as I do.

I’d rather have the procedure than what I had before. Yeah, rather because I can go out. I can live a normal life now.

Catheterisation

Initial thoughts

None of the participants were happy with the idea of self-catheterisation. However, many were open to do it if it was a requirement. Some expressed their concerns regarding the potential difficulties they would face if they had to self-catheterise. This included managing to self-catheterise if they considered themselves to be overweight, or fear of infection. Some deemed it an inconvenience if they had to continue doing it in the long term. Furthermore, one declined BoNT-A due to the potential need to self-catheterise.

Well, at first I said there’s no way I can self-catheterise I am a big woman.

I wouldn’t mind for a short period of time, and because I work from home, it would be easier. If I was back in the workplace, or if I was, you know, out a lot of the time I think I would become quite self-conscious if I had to do it.

I mean, it’s just if I had to do it, it’s an inconvenience, but it’s a necessary inconvenience as far as I’m concerned.

Experience

Inevitably several participants were required to self-catheterise following their BoNT-A treatment. There were positive and negative experiences of participants who had to self-catheterise. Positive experiences involved participants expressing their satisfaction with their being able to completely empty their bladder. Most of these individuals were willing to continue self-catheterisation for as long as required. Negative experiences that participants shared included pain, discomfort and numbness due to continual need to self-catheterise.

In the beginning it was quite uncomfortable, and I did get a nasty infection for which I had to have antibiotics but apart from that it’s not caused me any issues …. It’s a really weird sensation to be honest because my whole body feels empty whereas before it didn’t …. So, it’s absolutely amazing and it would not bother me if I had to catheterise for the rest of my life.

I’ve been trying to self-catheterise and I am really struggling with that.

Post-treatment outcome and impact

Patient satisfaction

Patients from the urodynamics arm and one from the CCA only arm expressed their pleasure following BoNT-A treatment. Some clearly described their satisfaction with the outcome and were thrilled to have more control over their bladder.

I’m OK. Yes, yes, I’m OK. The last time I was in seeing Doctor x, he was quite happy, and I was quite happy.

Yes, very satisfied …. No. I mean I rather the whole thing hadn’t happened, but it did. So no, I I’m entirely satisfied with the service that I got once I had been referred to the urology clinic. They were fantastic.

Treatment outcome

Many patients shared positive stories of their treatment outcome. For some the positive impact was immediate, while some had to wait a few days to a week to spot differences and improvements in their symptoms.

Positive outcome

But to be honest great, really great. I felt, I was watching the urgency just in case it came on me, but it’s been smashing.

Absolutely brilliant because some days I can go 4–5 hours without having to go to the toilet, whereas before in that time I probably would have gone about 20 times.

Those who were unhappy with the treatment outcome, that is the BoNT-A had failed, and their bladder symptoms continued to prevail, expressed tremendous disappointment as they were hoping and relying on this treatment to work.

Negative outcome

I’m sure I am leaking when I’m sat there, I am not really aware of it. you know?

I was really hoping for the Botox to work, and it hasn’t. I can probably run slightly longer but I still leak … it didn’t help. It hasn’t worked as well as I hoped.

And they kept saying it takes 2–3 weeks to work oh it takes 3–4 weeks to work. And then they said we’ve never known anybody where it hasn’t worked at all before. Well, I don’t believe that. I can’t be unique in that respect, and they just don’t have any answers.

Treatment impact

Day-to-day

Participants said they were able to go out and socialise more. They expressed their pleasure at being able to get back doing activities such as shopping, driving, travelling, working or even enjoying an extra drink without having to worry about their bladder. Some expressed extreme satisfaction and stated all their symptoms had disappeared and they were able to live a normal life like a healthy person. They were thrilled with the reduced frequency of their toilet visits. Additionally, the outcome seems to have reduced the burden on the participant’s mental health, with them being more carefree and confident.

Yes, just like not having to think ahead all the time, where we’ll be sitting, where we’ll be going, who am I with, am I comfortable…. It’s took that bit of pressure away.

I have a few more fizzy drinks than I normally would which is like, it sounds silly to say because it’s such a normal thing for people.

I mean I could go with my friends … on day trips on the coach. I wouldn’t be able to do that before.

Yes, it’s removed all the symptoms completely.

Patients also mentioned spending less money on pads and stated they had either stopped or continued to wear pads only as a precautionary measure.

I am not spending so much money on the pants as I used to. I was spending a fortune before but now I’ve only got to get them for the night-time.

I’m still using pads, but not as many. it’s more a precautionary measure because I still leak from time to time. But not as much as I used to.

Among the few who reported negative treatment outcomes, some stated that their treatment had made no difference to their condition, with one even mentioning that their symptoms got worse after the investigation and treatment.

No difference whatsoever …. Well initially for about 2 weeks I was going more, it was awful, it was exhausting …. It was really bad over a three-day period so in the end the nurses there fitted me with a catheter because I just couldn’t do anything … they took the catheter out and it was just exactly as it had been before, couldn’t go more than an hour and a half in the night, well was just a total prisoner to it, couldn’t do anything.

Sometimes I feel I got worse, you know? It’s like a vicious cycle.

Sleep

Some highlighted that their sleep had improved post treatment, to the point that their friends and family had noticed improvement. A few credited this improvement to self-catheterisation. One also noted that although their symptoms during the day had diminished, nocturia continued and hence they had a disturbed sleep even post treatment.

I sleep better, my friends tell me I don’t look so haggard.

I’ve had the odd night where I’m sleeping right through and getting up comfortably so that’s good.

I’m OK at night now yeah because I self-catheterise. When I go to bed most nights.

Well, the thing is the only thing that hasn’t really changed is not sleeping. I try to stay awake as long as possible but eventually I nod off. I am asleep for about 3–4 hours and then I’m awaken.

Comprehensive clinical assessment only arm

Only two participants from the CCA only arm were interviewed. Experiences of their treatment pathway and outcomes differed, with minimal overlapping of emerging themes. Therefore, these experiences have been described in terms of case studies to articulate reflections on this course of investigation. Participants’ experiences have been summarised to highlight distinctive stages in their treatment pathway comparable to the descriptive analysis provided for those who underwent urodynamic investigation.

Case study 1

The first participant was assigned to the CCA only arm and expressed being thrilled to have avoided urodynamics. A key reason for this response as stated by the participant was that keeping track of urine output or maintaining a bladder diary was a burden in itself and thus undergoing urodynamics would only add to this. This participant was assigned to receive BoNT-A and described the procedure as uncomfortable. However, the participant expressed satisfaction with the treatment outcome and stated that, although it took a while before their symptoms began to improve, the ultimate response to the treatment has been satisfactory. The participant further emphasised that, considering the positive outcome of BoNT-A, she was willing to repeat the procedure irrespective of the slight discomfort associated with it. A positive reflection of the investigation and treatment pathway was therefore articulated for this individual.

Case study 2

The second participant assigned to the CCA only arm demonstrated unawareness of the urodynamics procedure, thereby hindering the possibility of exploring their perception of not undergoing the urodynamic investigation. This participant was assigned to receive BoNT-A but was unhappy with the outcome and stated that the treatment had made no difference and did not result in any improvement of her bladder symptoms. This participant has, therefore, moved on to receive treatment outside the recommendations of the NHS and mentioned relying on acupuncture. She stated that this has resulted in some improvements and was in turn happy to continue in this pathway for as long as it enables her to manage her symptoms. A negative reflection of the investigation and treatment pathway was therefore articulated for this individual.

These cases highlight the different experiences of the two participants interviewed in the CCA only arm. While we are unable to draw conclusions from these individual accounts, they demonstrate the different experiences that women can encounter when undergoing similar investigation and treatment pathways.

Discussion

The perspectives of clinicians and participants in FUTURE have provided valuable insights into the investigation and treatment pathways for women with refractory OAB symptoms. In combination with the trial findings, these data can inform practice in this area informed by the accounts of the individuals involved in these encounters.

From a clinician perspective, we identified that urodynamics is commonly practised for women with these symptoms and used to inform treatment decision-making. The reason for including urodynamics is described as being multifactorial. The main reasons for its inclusion is to conform with NICE guidance, clinical judgement indicating it is warranted, and where there is a quest for additional information to explain symptom presentation.

The bladder diary and clinical history-taking were identified as key assessments for decision-making in this clinical population. Recognition of the impact of variable quality in the completion of diaries was highlighted, as accuracy is critical to its value.

Botulinum toxin injection A was described as the most common treatment choice, liked for the simplicity of its provision and general accessibility. It is viewed as a valuable first option to see if it will be effective and continue with other treatment considerations if unsuccessful. Variability is evident in the scope of other available treatments that are offered, largely due to service provision in the setting.

Preference for the use of urodynamics varied, with some describing it as an important component to the investigation of women with these symptoms and others felt it was not essential and a waste of resources and questioned its value in informing treatment pathways.

From the participant perspective, a clear story of enduring and impactful symptoms was described, caused by their urinary symptoms. These symptoms affected all participants to varying degrees in every facet of their daily lives and an exasperated desire to return to normality was articulated.

Decision-making was explored, prior to knowledge of the investigation or treatment that would ensue, highlighting that this is a complex area that has many influences that must be considered. Previous experience of investigation and treatment, potential side effects, time frames and geographical location are all important factors that influence a decision to be able to undertake the proposed clinical pathway. While many participants expressed the feeling that they would do whatever it takes to resolve their symptoms, these factors alongside personal circumstances are critical in ensuring patients are at the centre of the decision-making process.

More specifically, considering urodynamic investigation, an equal distribution of participants were willing to undergo urodynamics or were reluctant to undergo urodynamics. From our findings, it appears that those most likely to be willing to undergo urodynamics were those who perceived the investigation to be useful and value-adding in their treatment pathway. Furthermore, confidence to undergo urodynamics was mostly noted among those who previously discussed their problem with peers or had previous experience of urodynamics, or an invasive investigation. Among those who were unhappy to undergo urodynamics, this response stemmed mainly due to their perception of the discomfort and pain associated with the procedure. Additionally, a few individuals were apprehensive of the urodynamics process. However, despite feeling nervous they were willing to go through the procedure with a positive outlook if it would better inform the treatment decision-making, because their previous treatments had failed, and they considered this pathway as their last resort to arrive at a treatment plan.

The two participants who were interviewed who underwent CCA only had differing accounts, with one pleased to not have urodynamics, having dreaded the procedure, and for the other a complete unawareness of urodynamics, making it difficult to explore her perception of this investigation. This highlights the need for clear information and guidance regarding the options to ensure patients are fully informed.

The experience of participants undergoing urodynamics varied. For some it aligned with their initial perceptions either negatively or positively. For others, there was an altered perception following the investigation, usually from a negative to positive perspective, with it often being described as ‘not as bad as expected’. This suggests that counselling patients regarding the procedure and its expectations may help in improving the outcome and experience of the investigation.

Having had urodynamics, participants seemed more at ease with the BoNT-A procedure, except a small minority who voiced displeasure and found the treatment procedure uncomfortable. Irrespective of their initial perception and experience of BoNT-A, a few participants were concerned at the idea of having to repeat BoNT-A and carry out self-catheterisation for a prolonged period. Nevertheless, despite these worries, most of the participants noted that the benefits of the procedure outweighed the drawbacks and inconveniences associated with it.

A clear improvement of symptoms was described among the majority of the participants. Although the treatment failed to produce the desired outcome for a few, a considerable majority of participants stated that the treatment had a positive impact and had tremendously enhanced their quality of life.

Conclusions

It is clear from the results that both advising and undertaking a clinical investigation and treatment pathway for refractory OAB involves complex decision-making. Clinicians identify the necessity of clinical assessment/investigations for the effective treatment of women with these symptoms. The value of important tools such as bladder diaries, clinical history-taking and urodynamics is recognised. Patient participants have clearly articulated the desire to resolve bladder symptoms that impact their everyday lives. Opinions are mixed regarding the appetite for urodynamics, varying from those who are reluctant to undergo this investigation, to those who are prepared to undergo it if it serves a purpose in guiding treatment decision-making, and those who are happy to go along with whatever is advised. Understanding that this diversity exists provides an opportunity to appropriately counsel women regarding their investigation and treatment pathway choices.

Clarity regarding the indications and value of urodynamic investigation that are clearly articulated to women with refractory OAB is key. Understanding if and why urodynamics will add value to the treatment pathway would be a critical component to providing more comprehensive counselling to enable women to make informed choices. Empowering patients to understand their options and why certain pathways are advocated is necessary to ensure shared decision-making where possible and particularly applies to this area of clinical care, given the sensitive nature of urodynamics and the experiences articulated.

The rich data and descriptions provided by both clinicians and participants will inform patient counselling regarding this investigation and treatment pathway, as lived-experience accounts are extremely valuable.

Comparison with evidence base

Our findings confirm previous findings in this area related to women undergoing urodynamics, not only for investigation of OAB96–98 Some studies have found that women report urodynamics to be uncomfortable or even painful, particularly during the insertion of the catheter into the bladder. However, other research has suggested that the level of discomfort varies widely among women, and some may not experience any discomfort at all.

Additionally, some women have reported feeling embarrassed or anxious during the test, particularly if it is their first time undergoing urodynamics. External influences include the type of catheter used, positioning during the test, skill of the clinicians, age, medical history and previous experiences of medical investigations. Crucially, counselling is vital and the voices of women with lived experience included in this report will be extremely valuable in fully informing women about their assessment/investigation to enable them to prepare appropriately.

Limitations

Our key limitation is that participants in the CCA only arm were substantially fewer than the urodynamics arm. Despite the smaller sample size, we were still able to obtain valuable insights from the interviews conducted with these two participants, which are presented in the form of case studies. While the limited number of participants in the CCA only arm may have some impact on the generalisability of our findings, we believe that the insights gained from these interviews are still valuable for informing potential future research and clinical practice.