A qualitative study of women’s preferences for treatment of pelvic floor disorders

Authors


M Basu, Specialty Trainee in Obstetrics and Gynaecology, Medway Maritime Hospital, Windmill Road, Gillingham, Kent ME7 5NY, UK. Email mayabasu@aol.com

Abstract

Please cite this paper as: Basu M, Wise B, Duckett J. A qualitative study of women’s preferences for treatment of pelvic floor disorders. BJOG 2011;118:338–344.

Objective  To explore women’s perceptions of new and established treatments for stress urinary incontinence (SUI) and prolapse, and to identify factors important to women in decision-making about treatments.

Design  Qualitative interview study.

Setting  Urogynaecology unit in a large UK district general hospital.

Population  Women referred from their general practitioner with SUI and/or prolapse symptoms.

Methods  Each woman was given a questionnaire detailing nonsurgical and surgical treatments for SUI and/or prolapse. This briefly detailed the treatment, together with published success and complication rates. Participants were taken through a semi-structured interview based on their perceptions of each treatment, and the factors that lead them to find treatments acceptable or not acceptable. Interviews were conducted by a member of the research team before the initial appointment with the clinical team. Interviews were transcribed and subjected to thematic analysis using constant comparison derived from grounded theory.

Main outcome measure  Themes identified from analysis of interview transcripts.

Results  A total of 16 women were interviewed. Their median age was 54 years (range 48–70 years). Women with SUI were keen to have the treatment with the highest chance of long-term success, even if this was more invasive. Women with prolapse were more unsure about this, and less willing to risk potential complications for a higher chance of long-term success.

Conclusions  Many factors affect women’s decision-making with regards to treatment choices. This analysis highlights the need for careful exploration of women’s hopes and expectations before embarking on treatment.

Introduction

Pelvic floor disorders such as pelvic organ prolapse and stress incontinence are chronic conditions that affect millions of women worldwide, leading to significant impairment of quality of life.1,2 There are now an increasing variety of treatments available for these conditions; a search of a clinical trial registry using the terms ‘incontinence’ and ‘pelvic organ prolapse’ revealed over 400 active clinical trials.

Much of the focus has been on the dual goals of either rendering treatments more minimally invasive or increasing patient satisfaction. Until the late 1990s, the commonest treatment for stress incontinence was the Burch colposuspension. This procedure, although having proven efficacy, is associated with significant morbidity.3 The introduction of retropubic mid-urethral slings such as the Tension-Free Vaginal Tape (Ethicon, Somerville, NJ, USA) offered clinicians and the women they were treating a less invasive alternative with comparable success rates and a lower incidence of complications.4 Further development in devices and treatments for stress incontinence has been driven by the wish to further reduce the morbidity associated with surgical interventions and a move towards more ‘office-based’ procedures. Similarly, surgical management of pelvic organ prolapse has been changed by the introduction of synthetic and biological meshes for pelvic floor reconstruction. Although a recent systematic review has confirmed that mesh-augmented repairs are associated with a lower anatomical recurrence rate,5 there is evidence that this increased efficacy is accompanied by a higher complication rate.6

Women with pelvic floor disorders therefore have more treatment options now than at any time. There has been relatively little work assessing what women want from treatment, and we know very little about what is acceptable to women in terms of success rates and complications. Alternative treatment modalities for pelvic floor disorders are being introduced at a rapid rate; women may now be faced with a potentially confusing array of treatments for their symptoms. Insight into how women perceive the acceptability of these treatments and their associated complications would be an important addition to our knowledge. The advantage of a qualitative approach in this situation is that subtle factors affecting women’s perceptions of different surgical and nonsurgical treatments can be explored in some depth, leading to more insight into reasoning and decision-making.

The aim of this study was to assess how acceptable various treatments for stress incontinence and prolapse are to women, to explore their perceptions of the treatments themselves, including success and complication rates and to assess what factors matter most to women when making choices about treatments.

Methods

Women were recruited prospectively from a urogynaecology clinic in a large UK district general hospital. This was an analysis of a subgroup from a larger quantitative study that aimed to assess the acceptability of available treatments for stress urinary incontinence (SUI) and prolapse. This study used a deliberate purposive sampling approach to recruit newly referred women with SUI and/or prolapse. Each was asked to fill in a questionnaire (see Questionnaires S1 and S2), which detailed various established and novel treatments for SUI and prolapse, including published success and complication rates. Women were asked to indicate (using a closed format approach) whether they would accept each treatment if offered it. All women who were new to the urogynaecology clinic were given written information and invited to fill in the questionnaire upon arrival, before any interaction with the clinical team. No counselling was given before this to avoid influencing their opinions. Women were selected for recruitment into the qualitative arm of the study from the overall cohort using a randomisation sequence. All had a history of either troublesome SUI or symptomatic pelvic organ prolapse, and had requested treatment leading to a referral from their general practitioner. Women who had previously had treatment for SUI or prolapse were excluded because of the possibility that their previous experiences could influence the results and render comparisons with treatment-naive women unfeasible. The results of the quantitative study will be reported separately.

Selected women were invited to take part in a qualitative interview in which their perceptions and opinions of different treatment modalities would be explored in more depth. We aimed to recruit 15–20 women for the qualitative study, with the objective being to reach data saturation in the thematic analysis (i.e. for comparison of data sets to reveal no new themes or sub-themes), using a purposive sampling approach. Subjects were given written information and were asked to give consent to take part in the study. Interviews took place before any counselling from clinicians.

Each woman was given the questionnaire (see Questionnaires S1 and S2) with a series of statements briefly describing common nonsurgical and surgical treatments for SUI and prolapse, including success and complication rates. These were taken from published meta-analyses or systematic review data if available. This was devised specifically for this study by the research team. It was reviewed for content by the senior authors and reviewed by women not participating in the study for ease of reading. Participants had been asked to consider whether they would accept each treatment if offered it. Using their thoughts on this as a starting point, each participant was taken through a semi-structured interview regarding their thoughts on different treatment options and the underlying issues that lead them to find each treatment acceptable or unacceptable. Apart from the women’s initial responses to the treatment descriptions, which formed the starting point, the interviews were unstructured with the content varying according to responses from the participant. In this way, the scope and details covered in the interview were very much patient defined, with minimal guidance from the interviewer. All interviews were conducted by the same researcher, who had no previous contact with the women. Participants were made aware that this researcher was not part of the clinical team and so would have no part in their on-going care and that identifiable content of the interview would not be seen by the clinical team during their care episode. Each interview was recorded on an audio tape and transcribed verbatim afterwards. Interviews were conducted in an office away from the main clinic area. No explicit time constraints were applied, but each interview typically lasted between 30 and 40 minutes.

The transcripts of the interviews were analysed thematically using constant comparison derived from Grounded Theory, as described by Glaser and Strauss.7 This involved comparing the transcripts systematically with each other to identify themes and sub-themes that emerged as being relevant to the experiences of each woman. The themes were modified and updated sequentially as the analysis progressed and new concepts were identified. A list of themes was compiled and the transcripts re-read, coded and checked by the senior author.

Participants were given written information and asked to provide written consent. This study was approved by the West Kent Research Ethics Committee.

Results

A total of 16 women were interviewed for this study, with saturation being reached well within this number. The median age of these women was 54 years (range 48–70 years). Of these 16 women, nine had SUI, five had prolapse and two had both SUI and prolapse.

The dominant themes which emerged from analysis of the interview transcripts are outlined below.

Effect of symptoms on quality of life

The effect of symptoms on quality of life underpinned the opinions of all the women with incontinence with regards to the treatments they found acceptable. This theme emerged from the beginning of all the interviews and was raised by the women themselves with no prompting from the interviewer. All the women described major disruption to all areas of their lives; they were especially focused however on the effect of incontinence on their relationships and social interactions.

He’s (her partner) starting to lose patience now ‘cause it’s caused a few occasions where I’ve said to him I’ve got to go home, even though I’ve got a pad on. It’s like wearing a nappy. (Woman with SUI, aged 51)

you’re actually talking to someone and you cough and you actually wee, and sometimes if I’ve got a skirt on it’s down my legs and it is embarrassing. It is very embarrassing. (Woman with SUI, aged 57)

The women with SUI perceived their symptoms to be embarrassing and extremely bothersome, and ascribed their opinions regarding the acceptability of the different treatment options to this. It seemed to be this issue that drove all of their subsequent decision-making. The ultimate goal that these women wished to achieve was for their quality of life to be as it was before they developed incontinence symptoms.

That’s what I want to feel, normal. So that I can sit and laugh my head off when I’ve had a few drinks and not think, ‘oh crumbs, I’ve got to go to the toilet.’ I just want a normal life basically. (Woman with SUI, aged 61)

Women with prolapse tended to be more focused on the pros and cons of the treatments themselves, rather than the effect the outcome of treatment may have on their quality of life.

Wish for a permanent solution

Both the women with SUI and the women with prolapse expressed a wish for a treatment that did not require continued input, either in the form of clinic visits (e.g. for vaginal pessary changes) or self-administered treatment (e.g. medical treatment of SUI or continued pelvic floor exercises). They found surgical solutions more acceptable because they were perceived as a ‘one-off’ treatment after which they could forget about their symptoms and carry on as before. The wish to ‘not have to think about this all the time’ was a frequent one. Going together with this was the perception that having to continue with pessary changes, pelvic floor exercises or medications meant that they were not cured, and so were not ‘normal’, and it seemed to be this perception that dominated the discussion around this issue. The women also expressed dissatisfaction that having to remember to come for repeated clinic visits, do exercises or take medications was an inconvenience that could be overcome by opting for surgery instead.

It’s months more embarrassment, waiting to see if it works. And I just want to forget about it. It’s a waste of time anyway, my pelvic floor isn’t any good, so it’s like trying to build Mr Puny up (laughing). (Woman with SUI and prolapse, aged 48, discussing pelvic floor physiotherapy)

I’ve had babies and done the pelvic floor exercises after delivery, and you do forget to do them. So for me personally, yes it might work for a little while, but I think I would revert back to being a bit loose. (Woman with SUI, aged 53, discussing pelvic floor physiotherapy)

My friend who has a pessary goes through quite a lot you know…every few months it has to be taken out and put back in…so I want something long term. (Woman with prolapse, aged 70, discussing vaginal pessaries)

Success rates of treatment

The women with incontinence wanted the treatment with the highest success rate and persistence of cure into the long term. They found the persistence of any incontinence whatsoever undesirable and found the outpatient procedures less acceptable because of the lower quoted success rates, despite the fact that they might be more convenient. This theme overlapped with the quality of life theme, with the women citing the effect of incontinence on their quality of life as the reason for their pursuit of the treatment with the highest success rate possible.

I just want to come in and they say, that’s that, you’re sorted. If I’m going to get something done, I want to have something that is most likely to work—even if it’s a bit more inconvenient. (Woman with SUI and prolapse, aged 60)

I just want to feel like I used to feel…I don’t want to feel like some of these smelly old women that you see in supermarkets. That smell of urine, that frightens the hell out of me. That’s why I want the thing that will almost definitely work. (Woman with SUI, aged 51)

Women with prolapse were less assertive in their wishes for a successful treatment. They expressed the wish to feel better than they currently did, but were less certain of the merits of reducing the risk of recurrent prolapse by using mesh. This theme was linked to the theme of complications (see next section), with women being worried about the potential complications of mesh and being less willing to risk these for a potentially lower recurrence rate.

I don’t expect to feel the way I did when I was 25—if only! It’d just be nice to get rid of this bulge and not feel like an old lady, ‘cause I’m only 49. (Woman with prolapse, aged 49)

I know it can drop again, my sister had that…but I’m a bit worried about putting bits and pieces down there. That would worry me…I know it could come back, but I just wouldn’t be interested in that at all. (Woman with prolapse, aged 67)

Complications of surgery

Women with prolapse were focused on the complications of the surgical treatments. Although they talked at some length about potential risks, few completely disregarded mesh-augmented repairs. They were generally uncertain about the acceptability of the mesh augmented repairs and wished to know more details about complications. There was much discussion about the fine balance between a decreased chance of recurrence versus complications—and the nature of the complications. It seemed to be the nature of the complications themselves that rendered this a factor in decision-making.

I’m not sure I would want something down there that shouldn’t be there. It’s different if it’s somewhere else but putting plastic bits down there…I’m not sure…But is it any better to have it all fall down again? (Woman with prolapse, aged 53)

Well that’s difficult, I mean everything has complications. But I don’t know about that one…I am 70. (Woman with prolapse, aged 70)

Not sure, I mean it’s possible if you’ve got that plastic in there that my husband could feel it, isn’t it? And how do you get it out if there is something wrong with it? (Woman with prolapse, aged 53)

Women with incontinence did not talk at length about complications, being more focused on issues of success as discussed above.

Confusion about surgical options for prolapse

Leading on from the last theme, there was a general confusion about surgical treatments for prolapse, and actually making a decision regarding this was something that most of the women found difficult to do. Although women found the idea of a lower recurrence rate with mesh repairs attractive, none were sure of how to rationalise this with the potential complications. Many spent time trying to weigh up the pros and cons of the risk of needing another operation for prolapse in the future with the risk of mesh-related complications. One woman of the seven with prolapse stated that she would be keen to have a repair with mesh, with the remaining women unable to give a firm positive or negative answer. There was a perception among all seven women that the ‘best’ operation for prolapse should involve a hysterectomy. Going together with this was the perception that undergoing a hysterectomy was preferable because the uterus no longer serves any purpose after child-bearing; those who were premenopausal were also attracted by the idea of their periods stopping.

So on the one hand you’re telling me that it could come back, and on the other hand you’re telling me that I might have to have another operation because it could all go wrong…but on average most people are fine! It’s not a very easy decision really; I’m not sure I’d be able to say either way. (Woman with prolapse, aged 59)

Well it’s difficult isn’t it? I’d leave it up to the doctors I think. If you don’t know what’s best for me, how am I meant to? (Woman with prolapse, aged 67)

I would prefer a hysterectomy and get it all over with, rather than risk it coming back. (Woman with SUI and prolapse, aged 60)

To me, a womb serves its purpose when you’re 20, you want children. The idea of falling (pregnant)…I know they say it can’t happen, but in the menopause it can, there’s menopausal babies walking around…Basically I just want it gone. I want it all, my periods taken away. (Woman with SUI and prolapse, aged 48)

Discussion

There are many studies in the literature examining the efficacy of well-established and more novel treatments for incontinence and prolapse, however there are very few data on how women perceive these treatments and the factors involved in their reasoning and decision-making when offered both nonsurgical and surgical treatments. This study has shown that women with incontinence perceived success rates to be dominant in their decision-making regarding treatments. This seemed to be closely connected to the impact that incontinence has on their quality of life, and the wish that they had to be completely cured of their incontinence, rather than merely improved. Women with prolapse tended to be more uncertain about procedures with higher success rates which go hand in hand with a higher risk of complications. Both groups of women tended towards a preference for one-off treatments that aimed to be curative, rather than nonsurgical treatments requiring continued input.

Studies have in the past attempted to address what women hope to achieve from treatment, which may provide a context for our results. A questionnaire study of 100 women with incontinence in a tertiary centre found that the majority of women want to never leak in any situation, with large leaks and leaking during intercourse being the most unacceptable scenarios.8 In contrast to our results however, the women in this study found less invasive treatments to be more attractive, even if this meant a trade off in terms of success rates. This may reflect the fact that this population was from a tertiary centre and included women who had undergone failed treatments in the past, and so may have been more willing to accept an improvement rather than a cure. A questionnaire study of women’s expectations of treatment for SUI found that most women expected a good improvement in symptoms, with only a minority expecting a complete cure.9 It has also been found that women with more severe symptoms and those with higher degrees of quality of life impairment have higher expectations of treatment.9,10

These studies all adopted a quantitative approach, which may render the results difficult to generalise to the individual. Questionnaire-based studies, by their nature, require women to categorise their responses. Other authors have attempted to explore women’s desired outcomes for surgical treatment of SUI and prolapse. A qualitative study of the experiences and expectations of women with prolapse suggested that women are most affected by the physical symptoms of prolapse and the effect that these have on their daily activities, with their expectations of treatment being to return to normal in terms of their family, social and professional roles, physical activities and sexual function.11 The same authors also examined women’s expectations of continence surgery, and found that women wish to restore overall well-being, to overcome the social stigma caused by their incontinence and again, to return to normal in terms of physical and social activities, sexual function and body image.12 These studies have examined women’s general aspirations and goals when undergoing surgical treatment, but have not explored the factors that matter most to women when contemplating different treatment options.

The differences in attitude between women with SUI and those with prolapse are a somewhat unexpected finding. Both SUI and prolapse are known to have significant effects on quality of life. One might therefore postulate that women in both groups would have similar attitudes towards success rates and complications, which was not the case in this study. There are several possible explanations for this. It may be that the women with SUI do experience higher quality of life impairment than those with prolapse, and so are unwilling to trade off a lower success rate for a lower risk of complications. It would have been valuable to have formally scored quality of life impairment in each woman and correlated this with their willingness to accept each treatment to investigate this, although other authors have reported no significant correlation.8 The women with prolapse also spoke of concerns of having a ‘foreign’ material in the vagina, and were worried about the possibility of altered sensation or orientation secondary to this. This highlights the fact that although mesh may have a higher success rate in terms of long-term restoration of anatomy, this may not be perceived by women as a cure if they then develop new symptoms, particularly related to sexual function or vaginal discomfort. This is also of some importance when one considers the well-documented fact that symptoms of prolapse are only weakly correlated with anatomical severity,13 meaning that the pursuit of anatomical correction as a primary goal may not equate to any better subjective outcome for the woman. The women being interviewed were generally unsure about the pros and cons of mesh-augmented repair, and this is certainly in keeping with the diverse and conflicting opinions held by health professionals.14

There was a clear finding that women found treatments requiring continuing input less acceptable than ‘one-off’ treatments. The need for ongoing management was perceived as keeping them in a patient role, making it difficult to achieve their wish to forget about their symptoms. These more conservative treatments may also require appointments with healthcare professionals, or necessitate remembering to take tablets or perform an exercise regimen, which could be perceived as an inconvenience when compared with the ‘quick fix’ of surgery. This may also have been a reflection of the population being studied. All were women who had been referred from primary care, which implies that they had either declined or failed to improve with conservative treatment such as pelvic floor physiotherapy or vaginal pessaries.

This study is the first published attempt to define how women’s expectations of treatment and perceptions of actual treatment modalities interact in decision-making, in exploring where the balance between what a woman wants to achieve from treatment versus any perceived potentially negative factors associated with a particular treatment lies. The same issues were consistently discussed by the participants, which facilitated a meaningful thematic analysis and indicated good internal coherence. Thematic saturation was reached well within the number of interviews conducted. The information given to the women regarding each treatment modality (see Questionnaires S1 and S2) was taken where possible from high evidence level sources such as the Cochrane Database or systematic reviews. Where this was not possible, example for novel treatments such as mini-slings, the available data from the literature were used, and women were informed that long-term outcome data were not yet available. We believe that the information given was an accurate representation of what women would be told regarding treatments in a clinical situation. It is possible that women’s responses may have been influenced by the fact that the interviewer was a clinician. Efforts were made to negate this by assuring participants that the interviewer was primarily a researcher and not involved in direct clinical care, and by conducting the interviews away from the clinic setting in as relaxed a manner as possible.

The findings of this study are of importance in the context of political pressures to promote patient choice. Studies of treatment decision-making in people with other healthcare problems have also shown that this is a complex process driven by the severity of symptoms, available resources, efficacy of treatments and the influence of physicians.15,16 In the treatment of SUI, there is a move towards community and outpatient-based procedures, which is being promoted both by government and by medical device companies. The results of this study seem to indicate however that women want one–off treatments with proven efficacy. In the treatment of prolapse, there is uncertainty among women about whether the potential complications of mesh-augmented repair are acceptable to reduce the risk of recurrence; this mirrors the lack of consensus among clinicians. Patient and public involvement is encouraged in new research projects by the National Institute for Health Research. This qualitative study gives useful information for anyone setting up a study involving incontinent women or women with prolapse. The results of this study complement the body of literature examining what women hope to achieve from treatment by exploring in depth what is acceptable and unacceptable in terms of success rates and complications and how this ties in with their own personal experiences. These results may therefore be of help in counselling women with regards to treatment, and possibly also in planning care pathways in urogynaecology.

Disclosure of interest

No conflicts of interest.

Contribution to authorship

MB contributed to the conception of study and wrote the protocol, conducted the interviews, analysed the interview transcripts and drafted the manuscript. BW and JD contributed to the conception and supervision of the study and to revision of the manuscript.

Details of ethics approval

The study was approved by West Kent Research Ethics Committee, letter dated 25 March 2009, REC reference 09/H1101/1.

Funding

No external funding was received.

Acknowledgements

The authors wish to thank Maria Eaton and Sian Beale (Urogynaecology Nurse Practitioners) and all the staff in the Urogynaecology outpatients clinic.

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