Variation in availability and use of surgical care for female urinary incontinence: a mixed-methods study

Article history

The research reported in this issue of the journal was funded by the HS&DR programme or one of its preceding programmes as project number 14/70/162. The contractual start date was in June 2016. The final report began editorial review in April 2019 and was accepted for publication in December 2019. The authors have been wholly responsible for all data collection, analysis and interpretation, and for writing up their work. The HS&DR editors and production house have tried to ensure the accuracy of the authors’ report and would like to thank the reviewers for their constructive comments on the final report document. However, they do not accept liability for damages or losses arising from material published in this report.

Copyright statement

© Queen’s Printer and Controller of HMSO 2021. This work was produced by Geary et al. under the terms of a commissioning contract issued by the Secretary of State for Health and Social Care. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be addressed to: NIHR Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UK.

2021 Queen’s Printer and Controller of HMSO

Types of urinary incontinence

Female urinary incontinence can be classified into subtypes. Stress urinary incontinence (SUI) is the involuntary loss of urine with increases in abdominal pressure, such as when exercising or coughing. Urgency urinary incontinence (UUI) is characterised by a sudden and compelling desire to pass urine that is difficult to defer. Overactive bladder syndrome, which can include UUI, is usually accompanied by frequency and nocturia. Many women experience coexisting stress and urgency UI symptoms, a subtype often called mixed urinary incontinence (MUI). However, women do not require extensive preliminary evaluation of the subtype of urinary incontinence before beginning initial non-invasive treatments as symptoms may commence without clear differentiation between the two most common subtypes: stress and urgency UI. Stress UI appears to be the most common subtype of UI. Epidemiological evidence suggests that about 50% of women with UI indicate that they have solely SUI symptoms and about 40% indicate symptoms suggesting that they have MUI. 16,17

Treatment

Overall aims

The aim of the project was to improve the delivery and organisation of surgical services for women with UI in England. We assessed the availability and use of surgical services for UI across NHS England and identified factors that explain observed variation in use, including the impact of administrative data issues, patients’ experiences and expectations, clinicians’ judgement, and organisational and contextual factors. During the first 2 years of the project, an additional objective was added to this project (i.e. WP 6) to explore the long-term removal and reoperation rates after MUT insertion for SUI.

Objectives

The objectives were captured in five WPs. We analysed existing primary and secondary care data sets and collected data from patients (using in-depth interviews) and clinicians (using case vignettes or ‘paper patients’).

• Objective 1: methods development –

  • assesses the consistency, completeness and accuracy of diagnostic and procedure coding for UI in existing electronic data sets (WP 1)

  • develops a coding framework for UI allowing for divergent coding practices among providers (WP 1).

• Objective 2: availability and delivery of services –

  • assesses variation between NHS Clinical Commissioning Groups (CCGs), Local Area Teams and Clinical Senates (or other relevant regional units) in rate of surgery for UI (WP 2)

  • examines the impact of supply-side factors (e.g. primary care characteristics and availability and delivery of secondary care services) on local surgical rates (WP 2).

• Objective 3: understanding patients’ experiences and expectations –

  • explores the impact of UI on women’s lives and if and when it is perceived to be a medical problem (WP 3)

  • collects women’s own accounts of experiences and expectations of surgical and non-surgical treatments and outcomes, including the many different values that women draw on (WP 3).

• Objective 4: understanding the determinants of referral and surgical treatment –

  • identifies determinants of outpatient referrals and surgery, using a linked primary–secondary care data set (WP 4)

  • explores the relative importance of specific patient characteristics for clinicians in their treatment decisions, using case vignettes (WP 5).

An additional objective was to explore the long-term removal and reoperation rates after MUT insertion for SUI (WP 6).

Within most WPs, further work was carried out to evaluate how findings vary according to age, economic deprivation, ethnicity and type of procedure.

Data sources

The Hospital Episode Statistics (HES) database contains information on each episode of admitted patient care (APC) in English NHS hospital trusts. These data are extracted from local patient administration systems as part of the Commissioning Data Set. This data set is submitted to NHS Digital for processing and made available for audit and research as the HES data set. 42 Each record contains data on patient demographics (e.g. age, sex, ethnicity and area of residence), the episode of care (e.g. hospital name, date of admission and discharge) and clinical information. Diagnoses are recorded using the International Classification of Diseases, Tenth Revision (ICD-10),43 and procedures using the Office of Population, Censuses and Surveys Classification of Interventions and Procedures, version 4 (OPCS-4). 44 Each patient is assigned a unique identifier, making it possible to study longitudinal patterns of care, including tracking any future admission or procedure in the same or a different NHS hospital.

The Clinical Practice Research Datalink (CPRD) (formerly the General Practice Research Database) collates routinely collected anonymised patient data from general practices that have agreed at a practice level to provide data. All patients registered with participating practices are included in the data set, unless they have individually requested to opt out of data sharing at their GP practice. CPRD uses Read codes (used to record symptoms, diagnoses, processes of care) and British National Formulary codes to record information on prescriptions. More than 600 GP practices contribute data to CPRD, covering 9% of the population. CPRD linkage data include patients from 411 practices, covering approximately 75% of contributing CPRD practices in England. 45 Compared with the 2011 UK census, CPRD patients are broadly representative of the UK population in terms of age, sex and ethnicity, and comparable for body mass index (BMI) distribution to the Health Survey for England. 46 CPRD is deemed ‘up to standard’ (UTS) for research purposes and widely used in epidemiological and health services research. CPRD data have been linked to HES APC and HES Outpatient data by the trusted third party, NHS Digital. Three distinct administrative health-care data sets were used in this project: HES APC, CPRD and CPRD-linked to HES APC and HES Outpatient. We indicate throughout this report which data were used by each WP.

In addition to using the administrative health-care databases HES and CPRD, we conducted primary data collection. This data collection comprised interviews with women who had been referred to secondary care and were considering surgical treatment, and an online survey of gynaecologists using clinical case vignettes (i.e. hypothetical patients). The primary data collection is described in detail in the sections below for WPs 3 and 5.

Methods for work package 1

Work package 1 aimed to assess the consistency, completeness and accuracy of diagnostic and procedure coding for UI in the HES and the CPRD databases, and to develop a coding framework for UI allowing for divergent coding practices among providers.

In the HES database, we first used a ‘forward and backward’ searching strategy. The forward searching step began with a list of ICD-10 and OPCS-4 codes that were compiled iteratively by the clinical and methodological members of the research team. The backwards strategy then explored whether or not records found on the basis of the prespecified ICD-10 codes contain additional relevant OPCS-4 codes that were not prespecified. A similar exercise considers additional ICD-10 codes in records found on the basis of the prespecified OPCS-4 codes. Second, we assessed the frequency with which all of these potentially relevant codes have been used and explore the consistency of diagnosis and procedure codes within the records of individual patients. Third, the variation in consistency of diagnosis and procedure codes among providers was explored to identify providers that have divergent coding practices. We have previously demonstrated that this strategy for using HES data has the potential to produce a coding framework creating groups of patients who are homogeneous with respect to diagnosis, prognosis and treatment. 47

In the CPRD database, we started with a previously published code list. 48 We tested this existing code list by evaluating the consistency between diagnostic and treatment codes and the temporal consistency of coding within records of the same patient. Next, additional relevant keywords, synonyms and possible codes were identified by searching additional published literature and code list repositories. Finally, the clinicians on the research team manually reviewed the code list (individually and collectively). Recommendations made by each clinician were collated and collectively discussed with the aim of reaching a consensus on the codes that would be regarded as UI diagnosis or treatment codes. The coding work conducted for WP 1 fed directly into the analyses conducted for WPs 2, 4 and 6.

Methods for work package 2

Work package 2 aimed to assess variation in rates of surgery for SUI using HES APC (inpatient) data. We examined variation in rates of SUI surgery between NHS CCGs and other relevant regional units, and the impact of supply-side factors (e.g. primary care characteristics and availability and organisation of secondary care services) on local rates. WP 2 focused on variation in surgery for SUI specifically because SUI symptoms are the most common subtype of UI symptoms; 50% of women with UI indicate solely SUI symptoms and approximately 40% indicate MUI symptoms, where SUI and UUI symptoms coexist. 16,17

The cohort comprised women aged ≥ 20 years who had received surgical treatment for SUI between 1 April 2013 and 31 March 2016 and had a SUI diagnosis recorded at the time of the procedure. SUI surgery was defined using UK OPCS-4 codes (Table 1) based on coding work conducted for WP 1. 44 SUI diagnosis was defined using the ICD-10 code N39.3 Stress urinary incontinence. 43

The outcome measure was rate of surgery for SUI per 100,000 women per year at two geographic levels: 209 CCGs and 44 Sustainability and Transformation Partnership (STP) areas. CCGs are statutory NHS bodies responsible for the planning and commissioning of health care services in a local area (with an average population size of about 104,000 adult females). CCG areas are grouped into 44 STP areas (with an average population size of about 493,000 adult females), which were set up to co-ordinate improvements in the delivery of NHS services. 49 Reference denominator populations were derived by aggregating the 2011 census population counts for women aged ≥ 20 years in lower-layer super output areas (LSOAs) that are within the respective boundaries of the CCG and STP areas. There are 32,844 LSOAs (postcode-based geographic units) in England (with an average population of approximately 1700 people). 50 Women may have had repeat procedures in the study period, but only the first procedure was counted in calculating the surgery rate.

Sociodemographic factors may explain variations in the rates of surgery for SUI. We adjusted for age, socioeconomic deprivation, ethnicity and limiting long-term illness in our regression models. We handled age as a patient-level characteristic grouped into five categories (i.e. 20–39, 40–49, 50–59, 60–69 and ≥ 70 years). Socioeconomic deprivation, ethnicity and limiting long-term illness were CCG-level characteristics derived from 2011 census data. 50 For socioeconomic deprivation, we used the averages of the national ranking of the Index of Multiple Deprivation (IMD) of LSOAs within each CCG, and grouped the CCG averages into national quintiles ranging from 1 (most deprived CCGs) to 5 (least deprived CCGs). 51 For ethnicity, we used the percentage of the population reporting a black, Asian and minority ethnic (BAME) background, and for long-term illness we used the percentage of the population who reported that their day-to-day activities were limited because of a health problem or disability that had lasted, or was expected to last, at least 12 months. For each CCG, we took the averages of these percentages for LSOAs and grouped these CCG averages into national quintiles (range: 1 corresponds to CCGs with average percentages in the lowest quintile to 5 the highest quintile).

We calculated the number and the unadjusted and adjusted rates per 100,000 women per year of SUI procedures overall, and according to patient and regional characteristics. Incidence rate ratios (IRRs) were used to represent associations between the procedure rate and regional characteristics. Multilevel Poisson regression models were used to produce empirical Bayes’ estimates of the unadjusted and adjusted incidence rates for each CCG and STP area. In addition, risk-adjusted regression models were used to assess geographic variation in the rates of surgery by year. The empirical Bayes’ estimator produces more precise results by ‘pulling’ estimates for small outlier regions towards the mean. 52 For each geographic area level (CCG/STP), we illustrated the amount of variation in adjusted surgery rates using maps and range plots with 99.8% credibility intervals. CCGs and STPs were marked as ‘outliers’ where the national average rate of surgery was not within the 99.8% credibility interval of their rates. All statistical analyses were performed using Stata, version 15 (StataCorp LP, College Station, TX, USA).

Methods for work package 3

Work package 3 aimed to explore the impact of UI on women’s lives and if and when surgery is perceived to be a treatment option, collecting women’s own accounts of expectations of surgical and non-surgical treatments, experiences and outcomes through semistructured interviews. WP 3 used primary data collected from interviews with women. All women considering surgery for their UI could participate in the interviews. We did not restrict the interviews to women with a specific subtype of UI (e.g. SUI or UUI).

A broad narrative review of the patient experience social sciences literature was conducted to map out the issues female UI raises that are in common with other conditions, including those related to shame; embarrassment and stigma; gender, identity and sexuality; social relationships, work and mobility; experiences of care; and medicalisation of the female body. These higher-order topics informed the development of the semistructured interview topic guide and generated the analytical themes that were later used to complement the more descriptive codes derived from the content analysis of the interviews. The topic guide (see Appendix 6) was also informed by discussion with the research team, especially drawing on the input from the public and patient representatives. The topic guide was designed so that interviews would be sufficiently open and flexible to ensure that participants are able to talk at length about issues that most concern them.

Women were recruited from four urogynaecology outpatient clinics in different parts of England: Birmingham, Gillingham (in Kent), Leicester and Southampton. Recruitment was limited to women being treated in England for practical reasons. Between May and December 2017, women who had been referred to these clinics, were aged ≥ 18 years, had not previously had urology surgery (for UI or a related condition) and were now considering surgery for their UI were approached about the project by members of the clinic teams (which included physiotherapists, nurses, surgical consultants and specialist registrars) as part of the patient’s routine appointments. Women who were potentially interested in participating were given an information sheet and form to complete and return directly to the qualitative members of the research team at the London School of Hygiene & Tropical Medicine if they wished to participate. Those women who completed the form were contacted by telephone or e-mail (depending on their preference) and given further information about the study and what the interview would involve. Interviews were then scheduled and conducted either face to face or by telephone (also according to the women’s preferences). Women were given the opportunity to ask further questions about the research before agreeing to participate. Written consent was obtained from all interviewees and women were also informed that they could withdraw their consent at any time, during or after the interviews. Women were reassured that the interviewer was not part of the clinic staff and that their decision to participate or not would have no influence on their care. Ethics approval for the study was granted by the NHS Health Research Authority (Research Ethics Committee reference number 16/IEC08/0044).

Interviewees were initially purposively sampled by region (clinic) and age. The geographical location of those women interviewed did not appear to influence their responses, whereas ageing emerged as a strong theme through the interviews. Interviewees were therefore then sampled by age alone, to ensure that women of a wide range of ages were included. Interviews lasted between 40 and 130 minutes, were audio-recorded and transcribed verbatim. Transcription was undertaken by an external company experienced in dealing with confidential data. Transcripts were imported and coded in NVivo 10 (QSR International, Warrington, UK). Initial coding was undertaken by the interviewer while recruitment and interviews were under way. Following a constant comparative method53,54 emerging themes from the interviews were followed up in more depth in subsequent interviews such that the topic guide became more refined and focused on areas that were most important to the participants themselves.

The codes, drawn both deductively from the interview topic guide and literature review and inductively through early analysis, were augmented and refined through the process of analysis and through discussion with the WP 3 lead. Codes were then ordered into higher-level themes and hierarchies, with codes that were similar collapsed together. These codes were then discussed with the rest of the research team, which included clinicians, leading to further refinement.

Methods for work package 4

Work package 4 aimed to identify determinants of gynaecology outpatient referrals and surgery for women with UI.

Methods for work package 5

Work package 5 used primary data collected from an online survey. The survey used hypothetical simulated patients described by clinical case vignettes to measure variation in clinicians’ approaches to recommending surgical treatment for female SUI. This method has been used to measure variation in clinicians’ approaches to the diagnosis and treatment of patients with a range of similar health problems and is considered to be a cost-effective way of studying how clinicians respond to specific characteristics of their patients when making decisions rather than using medical records or standardised patients. 58–62

Methods for additional work package: work package 6

With growing concerns about the long-term outcomes of MUT procedures (of a subset of SUI procedures) changing the context of surgery for SUI, we also conducted additional research. The objective of this additional WP (WP 6) was to estimate the long-term rates of mesh tape removal and reoperation in women who had a MUT inserted for SUI.

Patient and public involvement

All WPs benefited from the input from two patient and public involvement (PPI) representatives who were members of the Project Advisory Group. They shared their experience of the NHS as patients, which guided the project’s overall design as well as the specific design of the qualitative and quantitative WPs. They also commented on all results and contributed to their interpretation.

Further PPI input was provided by the co-vice chairperson of the RCOG’s Women’s Network who was a member of the Project Steering Committee. In this capacity, she was able to comment on the results of the project from the perspective of the wider and diverse group of women represented by this network.

Key findings

• The rate of surgery for SUI was 40 procedures per 100,000 women per year.

• Risk-adjusted rates ranged from 20 to 106 procedures per 100,000 women per year across CCGs and from 24 to 69 procedures per 100,000 women per year across the STP areas.

• These regional differences were only partially explained by demographic characteristics, as adjustment reduced variance of surgery rates by 16% among the CCGs and 35% among the STPs.

Table 4 describes the distribution of regional characteristics and the association between these factors and SUI procedure rates.

Referrals

Parts of this text have been reproduced with permission from Gurol-Urganci et al. 68 This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data. The text includes minor additions and formatting changes to the original text.

Between April 2004 and March 2014, 104,466 women had at least one UI diagnosis code and met the cohort criteria. The median age of women in the cohort was 58 years [interquartile range (IQR) 45–73 years]. Almost one-third of women (32%) were overweight (i.e. with a BMI of 25–29 kg/m²) and 29% were obese (i.e. with a BMI of 30–39 kg/m²). Ethnicity data were missing for over half (55%) of the referrals cohort; 92% were white, 4% were Asian/Asian British and 2% were black/black British. Of the comorbidities considered, CVD and anxiety or depression were the most common, each recorded for approximately 12% of women (Table 5).

Of the 104,466 women with UI, 47,838 (45.8%) had a referral to a UI specialist (Figure 3). Of these, 28,476 women (27.3% of the 104,466 women with UI, 59.5% of the 47,838 women referred) were referred within 30 days of their index UI diagnosis. The cumulative incidence of referral (with death as a competing risk) at 30 days, 1 year and 9 years was 25.5% (95% CI 25.3% to 25.8%), 34.0% (95% CI 33.7% to 34.3%) and 54.5% (95% CI 53.9% to 55.2%), respectively (Figure 4).

FIGURE 3.

Referrals analysis cohort. Parts of this figure have been reproduced with permission from Gurol-Urganci et al. 68 This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (https://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data. The figure includes minor additions and formatting changes to the original figure.

Parts of this figure have been reproduced with permission from Gurol-Urganci et al. 68 This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (https://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data. The figure includes minor additions and formatting changes to the original figure. © Queen’s Printer and Controller of HMSO 2021. This work was produced by Geary et al. under the terms of a commissioning contract issued by the Secretary of State for Health and Social Care. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be addressed to: NIHR Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UK.

FIGURE 4.

Cumulative incidence of any referral within the study period.

Surgical treatment

A total of 30,312 women in the linked CPRD–HES data set were identified as having been referred for UI between 1 April 2004 and 31 March 2014 (see Box 1). The median follow-up time was 4.6 years for women alive at the end of follow-up (IQR 2.4–6.9 years). The median age of women in the ‘determinants of surgery’ cohort was 53.6 years (IQR 43.4–67.6 years) and > 90% had a white ethnicity recorded. As in the referrals cohort, two-thirds of women (66.4%) were overweight, obese or severely obese and less than one-fifth (17%) were current smokers. Of the comorbidities considered, anxiety or depression and CVD were the most common, recorded for approximately 8.4% and 6.8% of women, respectively (Table 6).

Of the 30,312 women in the CPRD–HES ‘determinants of surgery’ cohort, 4307 (14.2%) underwent a UI procedure (Figure 5), of which 4050 (94.5%) were SUI procedures and 257 (5.5%) were UUI procedures. Of the SUI procedures, 89% (n = 3606) were MUT insertions.

FIGURE 5.

Surgery analysis cohort.

The rate of UI surgery was 7.3% (95% CI 7.0% to 7.6%) at 1 year, 13.4% (95% CI 13.0% to 13.8%) at 3 years, 15.5% (95% CI 15.0% to 15.9%) at 5 years, and 18.1% of the women (95% CI 17.5% to 18.7%) at 9 years after the initial referral (with death as a competing risk; Figure 6, see Table 6).

FIGURE 6.

Cumulative incidence of any UI operation after referral within the study period.

Patient/practice characteristics associated with surgery

As in the findings with respect to referrals, age and ethnicity were associated with being less likely to have received surgical treatment. The rate of surgery was lower among older women (aged ≥ 50 years) than among those aged 40–49 years. The rate of surgery was lowest among those women aged 70–79 years [11.7% at 9 years after referral compared with 26.7% among women aged 40–49 years (sdHR 0.42, 95% CI 0.37 to 0.48); see Table 6] and ≥ 80 years [3.4% at 9 years after referral compared with 26.7% among women aged 40–49 years (sdHR 0.12, 95% CI 0.10 to 0.16); see Table 6]. Asian/Asian British and black/black British women had a lower rate of surgery than white women [Asian/Asian British women: 9.4% at 9 years after referral compared with 19.2% for white women (sdHR 0.50, 95% CI 0.38 to 0.67); black/black British women: 11.5% at 9 years compared with 17.8% for white women (sdHR 0.57, 95% CI 0.43 to 0.76)].

Similar associations between BMI and surgery were observed as between BMI and referral. Women whose BMI placed them in the severely obese group had a lower rate of surgical treatment than women with a BMI in the normal range [12.4% for severely obese women 9 years after referral compared with 18.5% for women with a normal BMI (sdHR 0.64, 95% CI 0.53 to 0.77)]. Women whose BMI indicated that they were underweight also had a lower rate of surgery than women with a normal range BMI [11.1% for underweight women at 9 years compared with 18.5% for women with a normal BMI (sdHR 0.63, 95% CI 0.51 to 0.78)]. Three comorbidities were associated with the rate of surgical treatment. Women with a diagnosis of POP had a higher rate of surgery than women without a POP diagnosis (sdHR 1.30, 95% CI 1.11 to 1.52). Women with T2DM or anxiety/depression had a lower rate of surgery than women without a diagnosis of these conditions (sdHR 0.62, 95% CI 0.50 to 0.79 and sdHR 0.84, 95% CI 0.76 to 0.94, respectively). There was substantial variation in the rate of surgery by region of referring general practice, ranging from 14.4% in London at 9 years after referral to 21.7% in the South East Coast region (Figure 7).

FIGURE 7.

Geographical variation in rate of referral and UI surgery in England. (a) Referral after a new diagnosis; and (b) UI surgery after referral.

Figure 7 illustrates geographical variation in the rate of referral and SUI surgery in England. For this figure, we have restricted the referrals cohort to England only for comparability with the surgery cohort, which is England only as a result of the linkage of CPRD data (UK wide) with HES (English hospital data). Figure 7 demonstrates that two regions, the South East and Yorkshire and The Humber, have high rates of both referrals and surgical treatment, whereas, in the North East, both referral and surgery rates are relatively low. Figure 7 suggests that geographical variation in the overall rate of surgery (as demonstrated in WP 2, Chapter 4) is likely to arise from differences in both primary care (in terms of referrals) and secondary care.

Key findings

• Almost half of women newly diagnosed with UI in primary care in the UK between April 2004 and March 2014 were referred to secondary care within 9 years. Of those women, 59.5% were referred within 30 days.

• Referral rates were lower for older women, women from a minority ethnic background, women who were underweight (BMI of < 20 kg/m²) and women who were severely obese (BMI of ≥ 40 kg/m²).

• Of the women who had been referred for UI, 7.3% underwent a UI procedure within 1 year of referral, 15.5% within 5 years and 18.1% within 9 years.

• Surgery rates were lower in older women, women from a minority ethnic background and women who were underweight or severely obese.

Mid-urethral mesh tape insertions

A total of 95,057 women resident in England had a first MUT insertion between 1 April 2006 and 31 December 2015 and a diagnosis of SUI. Of these, 60,194 women (63.3%) had a retropubic and 34,863 (36.7%) had a transobturator insertion. The median follow-up time was 5.5 years for women who were alive at the end of follow-up (IQR 3.2–7.5 years). The women’s median age was 51 years (IQR 44–61 years) and 19.8% had one or more comorbidity. A total of 18.1% had a concurrent prolapse operation in the same episode as their MUT insertion (Table 7).

Mid-urethral mesh tape removal

Mid-urethral mesh tape was removed in 1.4% (95% CI 1.3% to 1.4%) of the women at 1 year, in 2.7% (95% CI 2.6% to 2.8%) at 5 years and in 3.3% (95% CI 3.2% to 3.4%) at 9 years after the initial insertion, accounting for the competing risk of death (see Table 7 and Figure 8). The risk of removal was higher (at all time points) in women who had a retropubic insertion than in those who had a transobturator insertion (3.6% compared with 2.7% at 9 years after insertion; see Table 7). This difference remained after adjusting for other risk factors (sdHR for transobturator insertion: 0.72, 95% CI 0.62 to 0.84). The risk of MUT removal decreased with age (4.4% for women aged 18–39 years compared with 2.1% for women aged ≥ 70 years at 9 years after insertion; sdHR 0.46, 95% CI 0.38 to 0.56; see Table 7).

FIGURE 8.

Mid-urethral mesh tape removal, reoperation for SUI and any reoperation by time from insertion. Reproduced with permission from Gurol-Urganci et al. 70 JAMA 2018;320(16):1659–69. Copyright © 2018, American Medical Association. All rights reserved.

Reproduced with permission from Gurol-Urganci et al. 70 JAMA 2018;320(16):1659–69. Copyright © 2018, American Medical Association. All rights reserved.

Reoperation for stress urinary incontinence

Risk of reoperation for SUI was 1.3% (95% CI 1.3% to 1.4%) of the women at 1 year, 3.5% (95% CI 3.4% to 3.6%) at 5 years and 4.5% (95% CI 4.3% to 4.7%) at 9 years after the initial insertion, accounting for the competing risk of death (Table 8 and Figure 8). The risk of reoperation for SUI was higher (at all time points) in women who had a transobturator insertion than in those who had a retropubic insertion (5.3% compared with 4.1% at 9 years after insertion; see Table 8), which remained after adjusting for other risk factors (sdHR for transobturator insertion, 1.31, 95% CI 1.14 to 1.51). A higher risk of reoperation for SUI was associated with having undergone a non-mesh continence procedure prior to the initial MUT insertion in this study [8.1% for women who had a bulking injection and 4.5% for women who did not (sdHR 1.74, 95% CI 1.32 to 2.29); 11.1% for women who had another non-mesh SUI continence procedure and 4.5% for women who did not (sdHR 2.60, 95% CI 1.85 to 3.65); see Table 8].

Any reoperation

The risk of any reoperation (i.e. mesh tape removal and/or reoperation for SUI) following the initial MUT insertion was 2.6% (95% CI 2.5% to 2.7%) at 1 year, 5.5% (95% CI 5.4% to 5.7%) at 5 years and 6.9% (95% CI 6.7% to 7.1%) at 9 years (Table 9). The risk of any reoperation was not statistically significantly different between initial retropubic or transobturator insertions (see Table 9).

Key findings

• The rate of MUT removal was 1.4% at 1 year, 2.7% at 5 years and 3.3% at 9 years.

• The 9-year removal risk after transobturator insertion (2.7%) was lower than the risk after retropubic insertion (3.6%).

• The rate of any reoperation, including mesh tape removal, was 2.6% at 1 year, 5.5% at 5 years and 6.9% at 9 years.

• The 9-year risk of any reoperation was not statistically significantly different after transobturator insertion (7.2%) or retropubic insertion (6.8%).

How serious is my condition?

Women placed their management of UI symptoms and their contemplation of having surgery in relation to the competing demands on their time as mothers, daughters, partners, siblings and/or employees. To continue these roles and responsibilities as far as possible, all of the women interviewed had made substantial changes to their lives such as taking (and hiding) incontinence pads as they went about their day (sometimes having supplies at the houses of other family members); keeping changes of clothes at work or in their car; wearing loose, dark trousers or flowing skirts to hide any leaking; and avoiding activities that might trigger urine loss (e.g. running or going on the trampoline with their children). As the circumstances of daily life changed, UI symptoms could also become more or less obvious:

I feel like it’s got worse, I feel like my bladder has got weaker, that I haven’t been able to retain it as much. But I don’t know whether that’s because I’m more aware of it now because [name of daughter]’s that much older . . . Whereas when they’re younger you’re at home, you can go to the toilet that much easier.

Interviewee 26, 32 years old

The management of UI in relation to everyday life also had an impact on how women regarded the pragmatics of having a potential operation. Timing both the surgery and the recovery time around childcare, caring for others and work (along with their sick leave options) were key concerns. Although taking time out of these roles might be seen as an investment in their future bodies, this was often hard to negotiate:

I don’t really want it [the operation]. But if I delay it, I’m getting older, whereas obviously, 40, almost 41, my youngest is 13 [years old], my oldest is 17 [years old], so at some point they’re going to leave. I might as well enjoy the time now and be able to do more. Because we like to put the badminton net up in the garden. I can’t play badminton, or go running, you know . . .

Interviewee 23, 40 years old

Changes in life circumstances for some older women meant that they experienced reduced demands on their time and could now consider having surgery, which in the past they could not have done. One woman in her 60s talked about how, now that her husband’s ill health had got better, she could attend to her own issues, whereas another said:

. . . I did give up work, so it wasn’t an issue to think, oh, crikey, I’ve got to get back to work. So, I felt that, all in all, I could cope with the operation.

Interviewee 5, 62 years old

Finding time for surgery in relation to competing demands also depended on the extent to which women prioritised their UI and saw it as something that should be dealt with. For many women whose symptoms were very pronounced and had an impact on their lives in a dramatic way, it was easy to decide that something more intrusive than conservative treatments should be undertaken. However, for others, this step was less clear:

. . . my problem doesn’t feel bad enough to go for surgery . . . I really wanted to keep going with the physio[therapy] and try and sort it out that way. And I’ve been signed off physio[therapy] now because it just wasn’t getting any better . . . they gave me this sheet explaining the surgery and the risks involved and things, and it feels like quite a hard decision to make, because I think if I had a really bad problem the risks would be worth taking . . . I feel the problem I’ve got, I’ve made some improvement but it’s only going to get worse as I get older, and why not sort it out now rather than wait for another 10 years where it’s really bad. It feels quite a difficult decision . . .

Interviewee 7, 51 years old

Women across the age groups compared themselves with others they knew with similar symptoms, to try and contextualise the severity of their own condition. Although some women were not aware of others with similar problems, others talked about particular discussions and comparisons. Many women put their symptoms worsening as down to ageing, and comparisons were often drawn with others of a similar age:

I’ve had the same peer group since I was a young girl, and my friends will go out and they don’t have to take spare knickers in their bag in case they laugh on the dance floor or they trip over, or a sudden movement happens that they have an issue with incontinence. I run with my friends, and they don’t have a problem, they can run for ages and ages.

Interviewee 11, 38 years old

The cost of such surgery, not only in terms of their own bodies and time but also in terms of NHS resources, was also a concern expressed spontaneously, particularly by some older women. This led these women to question whether or not their current symptoms were worth such a major intervention, especially when this might just be part of ‘normal’ ageing:

I suppose one of my issues around do I take any action around this is, is this a normal part of ageing, do I accept it, do other people accept it, is the problem I’ve got worse, or not as bad as other people? You don’t know how to compare yourself with other people because it’s not really talked about . . . I mentioned it to two people and they’ve both said, well they implied, that it’s something you just accept with age.

Interviewee 6, 66 years old

Drawing on the lives and experiences of others to find out what was a ‘normal’ amount and frequency of urine loss allowed women of different ages to make a judgement about how severe their symptoms were and, therefore, whether or not they should consider surgical interventions. However, combining this with the other demands on their time, and the extent to which they were able to deal with their symptoms in everyday life, made different types of surgery more or less possible.

How serious is surgery?

In addition to drawing on the experiences of others and their own life circumstances to evaluate the seriousness of their UI condition, women’s considerations about surgery were also shaped by hearing about other people’s experiences of having the procedure for the same symptoms:

My sister and one of my best friends who I worked with, they’ve both had their bladders done . . . my sister now, she’s back out there and doing things. And I go, I want to be like my sister . . . My mate, she paid private rather than wait. ’Cause we didn’t know about this. We were all just taking tablets, didn’t know you could have an operation for it.

Interviewee 16, 50 years old

Without having experienced UI surgery themselves, women across the age groups drew on a range of different sources of information to try to anticipate the impact that such surgery would have on their bodies, on their time and in relation to their other roles and responsibilities. Mentioning the stigma associated with UI, a number of women of all ages referred to the fact that the symptoms of, and surgery for, UI were not often talked about and so because they did not know other women with the same issue directly, it was difficult to understand what was ‘normal’ and what surgery might be like. A few women had researched online for reports of what UI surgery might be like, or looked for news articles or radio or TV programmes that might mention this, although others made a conscious decision not to do this:

I don’t want to fill my head with what might happen . . . I don’t want to be like, oh, so, if mine is different, what have I got then? I try not to, I just get the leaflets from the physio lady or from my doctors and I really try not to go on Google or research it myself.

Interviewee 10, 26 years old

In relation to the procedure itself, it was more common for women to draw on their own previous experiences of surgery for other conditions to guess what surgery for UI might be like; some were concerned about repeating negative experiences, whereas for others recalling past surgical experiences was reassuring:

. . . it doesn’t bother me at all because I know what I’m going in to . . . it’s just like when I came out of my hysterectomy they said, right, okay, you can’t do anything for 6 weeks, and I’m like, what does that mean, you know? . . . from that point of view I feel more prepared almost, so, not that you ever are for surgery, but I do feel more prepared.

Interviewee 15, 36 years old

Embedded in many of these accounts was the idea that the surgery was always a significant intervention that not only required time to recover from, but also might put the body under great strain. A number of women talked about how their body found it hard to recover from general anaesthetic or being sutured. Such thinking focused on the fact that an operation always puts the body at risk, rather than the possible longer-term outcomes or chances of success. Nonetheless, the specifics of how this particular surgery would be performed on an intimate area of their anatomy was a particular concern for some women, as one woman explained:

I thought they will [use] keyhole [surgery] or [go] through the stomach or something. I didn’t think they would actually be doing it through the vagina. So, obviously anything to do with your private area you’re going to be a bit nervous about. It’s something completely different that, the only person that’s ever been there is when I’ve had children.

Interviewee 10, 26 years old

The overall point is that risks and fears around surgery, and particularly surgery around such intimate areas, were already present for women outside any discussion around the use of mesh. As the study progressed, issues around the mesh controversy were sometimes spontaneously raised, but they never dominated the interviews. In some of the later interviews, women talked about how they, or others in their family, had heard about the mesh controversy. However, the women were rarely clear whether or not this might relate to the surgery that they were considering, and there were always many other factors to take into account:

. . . I’ve got an 8-year-old, I’m busy, and I didn’t want, and also I had read a bit about the controversy about the sling that’s been in the papers and stuff in the last year or so, so I opted just to get the injections.

Interviewee 21, 46 years old

Another woman balanced if she might have problems with the mesh with the necessity of the operation, and had decided not to proceed:

. . . after reading all that in the Daily Mail [a British tabloid newspaper, London], I’m not sure how much of it is true, and whether they don’t know until you have the operation if you’re going to be allergic to that mesh . . . it’s not life-threatening this. If it was life-threatening I wouldn’t have a choice, but I have got a choice.

Interviewee 12, 74 years old

The perception of surgery as a serious and dramatic intervention led a number of women to describe trying to find ways to avoid surgery; despite surgery being raised as a possibility, one woman wondered:

Perhaps if I carry on with my exercises I might . . . you know, I might be OK.

Interviewee 8, 71 years old

Given the nature of our interview cohort of women, conservative treatments, by definition, had largely not been successful. Some women were nevertheless hopeful that continuing with these approaches might eventually prove effective. This subgroup of women, therefore, found it particularly difficult to decide whether or not to have surgery, because the decision had to be made not merely on the clinical information they were given, but also the hope that they held on to that a non-surgical intervention might work in the future. Some women talked about the need to encourage younger women to start pelvic floor exercises earlier and a couple of women had mentioned this to their daughters. The idea behind this was both that muscle strength might be maintained and that early issues could be stopped from developing, particularly if they came after childbirth:

I think I’d let it go too far . . . I think perhaps the pelvic floor exercises would have worked but I’d left it too long.

Interviewee 19, 54 years old

Ageing, and the changes to the body and everyday life that this might bring, was a key aspect that crossed different themes from the interviews. This related not only to the ideas of the ageing body across women’s accounts and where the body should be at particular ages, but also to different experiences that women of different ages had and how UI symptoms and surgery fitted into their daily lives. This resulted in greater clarity about whether or not to have surgery and what type to have for some women. However, many of the women interviewed were as yet undecided about surgery.

Key findings

• Women have two key concerns when they make decisions about whether or not to have surgical treatment for their incontinence: perceptions of the severity of their condition and perceptions of the seriousness, or risk, of surgery.

• Women assessed the severity of their UI according to their individual circumstances rather than criteria such as frequency or quantity of leakage. Women moved the concept of ‘severity’ beyond a medical definition of UI to include what is important to them as individuals.

• For women with UI, decision-making about surgical treatment is a distributed process based on multivariate criteria, which often shift in priority over time. As a consequence, decisions are rarely made conclusively.

Recommendations for surgery

Figure 9 shows the variation in the recommendation scores of all clinicians for the 18 case profiles. The IQR was between 2 and 4 on the 5-point scale for 11 of the 18 vignettes. The scores were most strongly in favour of recommending surgery for case 5 (a 68-year-old woman with a BMI of 30 kg/m², pure SUI and no previous SUI surgery, with leakage several times a day, for whom her incontinence is quite a problem, and ASA grade 2) and most strongly against recommending surgery for case 6 (a 68-year-old woman with a BMI of 23 kg/m², with MUI, previous SUI surgery, leakage once a day, for whom her incontinence is a bit of a problem, and ASA grade 3).

FIGURE 9.

Surgical treatment recommendations of the clinicians for the 18 clinical case profiles. The recommendations are scored on a five-point Likert scale ranging from ‘certainly not’ to ‘certainly yes’. The range plots (horizontal bars) represent the 25th and the 75th percentile of the mean recommendation score. BNI, bladder neck injection. Reproduced with permission from Mamza et al. 72 This is an Open Access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY 4.0) license, which permits others to distribute, remix, adapt and build upon this work, for commercial use, provided the original work is properly cited. See: http://creativecommons.org/licenses/by/4.0/.

Reproduced with permission from Mamza et al. 72 This is an Open Access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY 4.0) license, which permits others to distribute, remix, adapt and build upon this work, for commercial use, provided the original work is properly cited. See: http://creativecommons.org/licenses/by/4.0/.

Impact of women’s characteristics on gynaecologists’ recommendations

Figure 10 demonstrates the impact that the patient characteristics have on the clinicians’ recommendations. Overall, the impact that the patient characteristics have was relatively small. UI type had the greatest impact (i.e. a mean difference in recommendation score for women with SUI and MUI of 0.8, weight = 23%; see Chapter 3), closely followed by the impact of previous SUI surgery (weight = 21%) and, to a lesser extent, the frequency of leakage (weight = 15%) and BMI (weight = 15%). Extent of bother (weight = 13%), physical status (as assessed via the ASA grade) (weight = 8%) and age (weight = 6%) had the least influence on the clinicians’ recommendations. The mixed-effects analysis of variance indicated that all patient characteristics captured in the vignettes significantly influenced the recommendation score (i.e. the p-value was always < 0.001).

FIGURE 10.

Influence of patient characteristics on clinicians’ recommendation for surgical treatment. The recommendations are scored on a five-point Likert scale ranging from ‘certainly not’ to ‘certainly yes’. Average score based on responses to a 5-point scale ranging from 1 ‘certainly not’ to 5 ‘certainly yes’. Reproduced with permission from Mamza et al. 72 This is an Open Access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY 4.0) license, which permits others to distribute, remix, adapt and build upon this work, for commercial use, provided the original work is properly cited. See: http://creativecommons.org/licenses/by/4.0/.

Reproduced with permission from Mamza et al. 72 This is an Open Access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY 4.0) license, which permits others to distribute, remix, adapt and build upon this work, for commercial use, provided the original work is properly cited. See: http://creativecommons.org/licenses/by/4.0/.

Impact of clinicians’ characteristics on their recommendations

The average recommendation scores did not differ significantly by clinicians’ gender, age, specialty or trainee status (Table 12). In addition, there were no statistically significant differences between the scores of clinicians in England, Scotland, Wales and Northern Ireland. Using the mixed-effects model, we did not find any evidence that the relative influence of the patient characteristics on the recommendation scores varied according to the clinician’s characteristics (i.e. the p-value of the interaction test for specialty, gender and age was always > 0.05).

Additional analyses found that six clinicians gave a recommendation score of 1 (‘certainly not’) to all 18 vignettes. However, excluding the responses of these six clinicians had only a slight impact on the mean recommendation scores and weights associated with the patient characteristics.

Gynaecologists’ practice styles

The latent class analysis identified five mutually exclusive groups of clinicians with a different practice style. The AIC and BIC decreased as more latent classes were added, but levelled off after five latent classes. In total, 244 of the 245 respondents could be assigned to a practice style group (see Chapter 3). The mean recommendation scores for the five practice style groups ranged from 1.25 to 4.04 (p < 0.001), illustrating wide variation in clinicians’ inclination to recommend surgical treatment (see Table 12). There were no statistically significant differences in clinicians’ characteristics between the five groups.

Compared with the differences in overall inclination to recommend surgical treatment between the practice style groups, the impact of the women’s characteristics on clinicians’ recommendation scores is small (Figure 11). The largest differences are observed for practice style groups 2 and 3, which appeared to give a greater weight to BMI, type of SUI and previous SUI surgery than the clinicians in the other practice style groups.

FIGURE 11.

Influence of patient characteristics on clinicians’ recommendations for surgical treatment according to practice style group. The recommendations are scored on a five-point Likert scale ranging from ‘certainly not’ to ‘certainly yes’. Reproduced with permission from Mamza et al. 72 This is an Open Access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY 4.0) license, which permits others to distribute, remix, adapt and build upon this work, for commercial use, provided the original work is properly cited. See: http://creativecommons.org/licenses/by/4.0/.

Reproduced with permission from Mamza et al. 72 This is an Open Access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY 4.0) license, which permits others to distribute, remix, adapt and build upon this work, for commercial use, provided the original work is properly cited. See: http://creativecommons.org/licenses/by/4.0/.

Key findings

• The type of UI (SUI, stress-predominant MUI or mixed UI) was the most important determinant of gynaecologists’ decisions to recommend surgical treatment, followed by previous SUI surgery (none, bladder neck injection, MUT).

• Five groups of gynaecologists whose practice style differed mainly with respect to their mean recommendation score could be distinguished.

Changing context

The data used in this project capture a period of substantial change in surgical treatment for UI. MUTs were introduced in 1998 as a new, minimally invasive surgical treatment for SUI. 23 The use of MUTs rose precipitously and reached a maximum of 11,365 procedures in 2009 in England, becoming almost the sole surgical treatment conducted for SUI. At the same time, the use of the previous standard treatment for SUI, colposuspension (a major abdominal surgery), declined from > 3500 procedures per year to just 200. 20 However, the use of MUTs for SUI has since rapidly declined in the England (and elsewhere), with a 50% reduction between 2008 and 2017 (to just 6227 procedures in 2016–17). 21 This highlights a change in surgical practice that is likely to reflect growing public concerns about longer-term complications, outcomes and risk of further surgery after these MUT procedures. 21–26 In 2018, the use of MUTs as a treatment for female SUI was ‘paused’ in the NHS in England, following an interim recommendation of the Independent Medicines and Medical Devices Safety Review. 73,74

Project overview

This project used five different approaches:

1. We analysed existing NHS data sets from primary care (CPRD) and secondary care (HES) to understand the determinants of referral of women with UI to secondary care as well as the determinants of the use of surgical treatment in women with UI, which were mainly SUI procedures (predominantly MUT insertions) (WPs 1 and 4).

2. We analysed an existing NHS data set from secondary care (HES) to understand geographical variation in the use of surgical treatment in women with SUI (WP 2).

3. We collected accounts from women who had been referred to an outpatient clinic in secondary care about the impact of UI on their lives and their expectations of surgical and non-surgical treatments (WP 3).

4. We carried out a national survey of gynaecologists in the UK with a special interest in urogynaecology to understand better how their decisions to recommend surgical treatment are influenced by the characteristics of women with UI (WP 5).

5. In response to the discussions about the safety of MUT insertions, we conducted supplementary work to assess long-term removal and reoperation rates after MUT insertion for SUI using the HES data set (additional WP – WP 6).

Brief overview of findings

There were a number of key findings.

With respect to WPs 2 and 4, which aimed to assess the determinants of referral to a UI specialist and surgery for women with UI (WP 4) and variation in the rate of surgery for SUI and determinants of this variation between NHS CCGs and other regional units (WP 2):

• Our analyses of primary care data demonstrated that almost 50% of women who were diagnosed with UI by their GP between 2004 and 2014 were referred to a UI specialist in the 9 years after the UI was first recorded. Almost 60% of those women who were referred were referred within the first 30 days. The referral rate was lower in older women, in women from a minority ethnic background and in women who were either underweight or severely obese. We also found considerable geographical variation.

• In addition, using primary care data linked to secondary care data we found that 7.3% of women who were referred to a UI specialist between 2004 and 2014 had surgical treatment for UI within 1 year and 18.1% within 9 years. Of the 4307 UI procedures conducted, 4050 (94.5%) were SUI procedures and 257 (5.5%) were UUI procedures. Of the SUI procedures, 89% (n = 3606) were MUT insertions. Again, we found that UI surgery rates were lower in older women, in women from a minority ethnic background, and in women who were either underweight or severely obese. There was also considerable regional variation in the use of surgery.

• Between 2013 and 2016, the overall rate of SUI surgery was 40 per 100,000 women per year in the NHS England (WP 2). There was substantial variation in rates between geographic regions with adjusted surgical rates ranging from 20 to 106 procedures per 100,000 women per year between CCGs and from 24 to 69 procedures per 100,000 women per year between STPs. Annual SUI surgery rates per 100,000 women per year declined over the study period from 52 in 2013 to 36 in 2015. Regional age and ethnicity distributions were associated with surgery rates.

With respect to WP 3, which aimed to explore women’s experiences of UI and their expectations of surgical and non-surgical treatments and outcomes:

• The interviews demonstrated that women’s decision-making centred on perceptions of the severity of their UI and the seriousness, or risk, of surgery.

• Women judged the severity of their UI according to their individual circumstances rather than criteria such as quantity and frequency of leakage, which are often used clinically. The women’s accounts moved the concept of ‘severity’ beyond the commonly used medical definitions of UI severity to include what is important to women themselves.

• Decisions about surgery were rarely made conclusively. Decision-making about surgery is a distributed process based on multivariate criteria, which often change in priority over time.

With respect to WP 5, which aimed to explore the relative importance of specific patient characteristics for clinicians in their treatment recommendations:

• The survey of gynaecologists in the UK, asking them whether or not they would recommend surgery for women with UI described in a series of clinical case vignettes, demonstrated that the decisions of the 245 gynaecologists were most strongly determined by the subtype of UI (stress, stress-predominant or mixed UI) and whether or not a patient had undergone previous SUI surgery (none, bladder neck injection or MUT).

• Five distinct groups of gynaecologists could be distinguished whose practice style differed mainly with respect to their average inclination to recommend surgery.

With respect to the additional WP on long-term removal and reoperation rates after MUT insertion:

• The overall 9-year mesh tape removal rate was 3.3% and the reoperation rate, including mesh tape removal, was 6.9%.

• The 9-year removal rates were 3.6% after a retropubic insertion and 2.7% after a transobturator insertion.

• The 9-year reoperation rates were 6.8% after a retropubic insertion and 7.2% after a transobturator insertion.

Discussion

Women’s own accounts

Our results demonstrate that women’s decision-making in relation to surgery centred on their individual perceptions of the severity of their UI and the risk of surgery. This reflects findings of previous research; for example, it has been suggested that only around half of older people seek help for UI, commonly because of the belief that it is a ‘normal’ part of ageing. 40,79 Some women questioned whether or not their symptoms justified the cost of surgical treatment to the NHS.

In addition, differences in the treatment of UI received by older women and women from minority ethnic backgrounds may reflect differences their incontinence-related health beliefs, preferences and care-seeking behaviour. 33,41,80–82 It has also been reported that women from Asian backgrounds in particular are less likely to seek care because of sociocultural norms and related embarrassment, particularly in relation to discussing sensitive problems with male health-care providers. 83,84

Clinical recommendations about treatments for UI frequently involve considering severity in terms of the quantity and frequency of leakage. However, we found that women judge the severity and impact of their UI from a much broader set of criteria, ranging from personal bodily experiences to how extensively the condition disrupts their social roles and daily lives, as well as the ideas, opinions, and experiences of others. Two different women with the same quantity and frequency of leakage can experience UI as having very different levels of severity and impact on their daily lives. Acknowledging this in the process of shared decision-making around treatment, including surgery, provides an important opportunity to ensure that discussions and treatment decisions reflect women’s own lives and experiences in personalising medicine.

Women’s perceptions and decisions were open to new information and changing circumstances. The ideas, opinions and experiences of others were important to women’s treatment decision-making process. The ‘unfinished’, flexible nature of this decision-making and the growing publicity of safety concerns relating to MUT procedures had the potential to increase uncertainty in women’s decisions regarding surgery.

Recommendations of gynaecologists on surgical treatment

The study using clinical case vignettes showed that five groups of clinicians could be distinguished who differed in ‘practice style’, especially in their average inclination to recommend surgical treatment. These results reflect that some gynaecologists recommend surgery to many of their patients, whereas others would hardly recommend it to anyone. The recommendations for surgical treatment were only minimally influenced by patient characteristics.

In our clinical case vignettes, we included patient characteristics that can be derived only from patient-reported information (frequency of leakage and bother) and those that are derived from information determined by the clinicians (type and severity of UI, previous surgery). We found that the weights assigned to the clinician-derived characteristics had a stronger combined influence on the gynaecologists’ recommendations than the patient-reported characteristics. It is important to note that the clinician-derived characteristics describe the severity and type of the UI that have a recognised impact on the effectiveness of specific surgical treatments. 85

We found that a woman’s age and BMI had relatively little impact on clinicians’ recommendations for surgical treatment, which is in line with evidence that surgical treatments are effective in obese and elderly patients. 76,86–89 This finding contrasts with that from our linked primary and secondary care data study, where we observed that older women and those who were obese were less likely to have received surgical treatment. However, it is also generally accepted that clinical decision-making is more complex for these groups given that their overall health and functional status may be poorer. 89

Removal and reoperation rates after mid-urethral mesh tape insertions

More than 95,000 women had a MUT insertion for SUI between 2006 and 2016. Within 9 years of MUT insertion, 1 in 30 women had undergone a removal procedure and 1 in 14 had undergone a reoperation, including mesh tape removal.

Risks of removal and any reoperation (mesh tape removal and/or reoperation for SUI) were lower among older women and among women from a minority ethnic background. This suggests that removal and reoperation risks may be associated with women’s background. However, it is not possible to disentangle potential explanations for these differences, which could include higher morbidity, differences in the severity of the underlying UI that led to the initial surgery and women’s choices about seeking further clinical advice and treatment.

The risk of a removal was about 30% lower following transobturator MUT insertions than following retropubic MUT insertions, which is in line with earlier findings from Scotland and England. 90,91 This may be explained by the removal of transobturator sling being a more complicated procedure. 19 Recently issued NICE guidelines on the management of urinary incontinence in women19 therefore recommend that the transobturator approach should no longer be offered:

unless there are specific clinical circumstances (for example, previous pelvic procedures) in which the retropubic approach should be avoided.

© NICE 2019 Urinary Incontinence and Pelvic Organ Prolapse in Women: Management. Available from www.nice.org.uk/guidance/ng123. All rights reserved. Subject to notice of rights NICE guidance is prepared for the National Health Service in England. All NICE guidance is subject to regular review and may be updated or withdrawn. NICE accepts no responsibility for the use of its content in this publication

It is important to note that the risk of any reoperation, also including mesh tape removal, was not associated with the route of insertion, which confirms that the lower rate of removal after a transobturator MUT insertion is not the result of a lower complication rate.

Study strengths and limitations

A first strength of this project was the availability of comprehensive national data sets with records of referral from primary to secondary care and of the use of surgery for female UI. Second, we complemented analyses of these existing national data sets with primary data collected from women and clinicians themselves. Our interviews with women added considerably to our quantitative findings, indicating the importance of the broader values and understandings women drew on in making treatment decisions and the importance of the wider context of their lives. Our survey of gynaecologists provided an efficient and explicit approach to study the differences in the gynaecologists’ practice style in terms of their average inclination to recommend surgery and the impact that patient characteristics have on their recommendations.

The main limitations of this project concern the primary and secondary care data, particularly the quality and scope of some of their data fields. Although primary diagnosis and primary procedure fields are established as highly accurate in many routinely collected data sets, the recording of comorbidities is known to be more variable, potentially introducing an unknown amount of bias. 92 Despite this, studies comparing administrative data with case note reviews have shown that administrative data are sufficiently robust to support their use for research. 93 Routinely collected administrative data, primarily collected for management and reimbursement purposes, such as HES, lack information on relevant case mix factors, in particular those relating to symptom severity. This is likely to have contributed to some of the observed variation in the referral and surgery rates between geographical regions and between specific groups of women. However, other studies81–84,94 have also demonstrated variation in other aspects of continence care geographically and by age and ethnicity, so residual confounding is unlikely to fully explain the variation in referral and surgery rates observed in our study.

In the context of growing safety concerns about some of the surgical treatments for SUI, it is also likely that at least some of the variation observed in our project was related to this debate leading to differences in professional opinion about the appropriateness of these surgical treatments. However, although rates of SUI surgery dropped substantially over the study period, the extent of geographic variation remained stable. This, and the level of variation remaining after adjusting for regional and patient-level characteristics, suggests that residual confounding is unlikely to explain all of the geographical variation and that women in some areas and from some groups were less likely to be referred or treated surgically than women with the same condition in other areas or in other groups.

An additional complexity of using routinely collected administrative or health-care data for research is that the absence of a code for a condition in the records relating to a particular patient must be interpreted as absence of that condition in that patient. Potential misclassification may arise from patients not presenting to the health-care provider with the condition and from variation in coding practice among health-care providers. It is also likely that the extent of such misclassification varies between conditions. 46

Furthermore, there are often no standardised definitions for diagnoses, so we developed code lists to identify key exposures and outcomes. To avoid the use of inconsistent definitions between studies, we used published code lists as far as possible.

A further limitation inherent to studies using routinely collected data is that reasons for clinical decisions are often not available or are unspecific. For example, the reasons why MUT removals or reoperations were conducted were not available. The most common diagnostic code recorded in HES for removals was ‘complications of genitourinary prosthetic devices, implants, and grafts’, which cannot capture common specific problems following MUT insertion, such as mesh exposure, pain, dyspareunia and voiding difficulties. One approach to obtain better data for the reasons for removal surgery would be to collect information reported by women themselves. Patient-reported outcome measures could be included in the registry that will be established to monitor surgical procedures for UI in England, especially if these patient-reported outcome measures are collected before and after mesh and non-mesh treatments.

Where routinely collected clinical and administrative data sets are well-established, as in England, they allow consideration of outcomes in the longer term that would be prohibitively expensive and subject to loss to follow-up in prospective studies. However, those using these data to look at longer-term outcomes must consider changes in coding practices over time. For example, in our project, new OPCS-4 codes (used in the HES database) for retropubic and transobturator MUT insertions were introduced in April 2006. Before April 2006, these procedures were recorded with other non-classified procedures. We ensured that our procedure classifications took these coding standard changes into account. In addition, for the ‘removals’ analyses, which explicitly distinguished between route of MUT insertion, we conducted sensitivity analyses to examine the potential impact that some hospitals continuing to use the old coding standards had beyond April 2006. Our findings were robust to sensitivity analyses starting the study period 1 year later and to including the previous coding standards.

Routinely collected data provide large sample sizes of nationally representative data. In this project, this enabled us to capture the care that women received in primary and secondary care. For example, CPRD, although it covers only 7% of the UK population, has been shown to be a representative sample of primary care patients in the UK. Furthermore, HES has nearly 100% coverage of patients treated by NHS England. Therefore, our findings from these data sets can be considered generalisable to the national population of women with UI who seek care. 46,95 However, previous research has indicated that as many as 75% of women with UI do not seek care and some of those who experience complications after surgery may not seek further care. We were unable to capture the experiences of these women using these data sources.

The focus of this project was on surgical treatments for women with UI, which the routinely collected administrative data are well placed to capture. The interviews were also designed to capture women’s decision-making processes around surgical treatment, recruiting women who had been referred to secondary care and were considering surgery. However, because of this we do not capture those women whose experiences of UI, and perhaps thoughts around surgery, meant that they were not referred to secondary care or were not using NHS services at all. There is also the possibility that women who were approached but did not consent to be interviewed may share characteristics that were not captured in the interviews. This may be particularly relevant given that we were unable to purposively sample for the interviews according to ethnicity.

A further limitation of administrative health-care data is that they do not capture care provided in the private sector. Although precise figures are lacking, it is likely that at least 90% of all UI procedures in England are provided by the NHS, as the total annual spending on private health care in England is about 5% of the total annual NHS spend. 96 Primary data collection also has some limitations. For example, for the case vignettes survey we invited all members of two professional bodies practising in the UK with a specialist interest in UI. However, urologists were not included, and their practice and views may be different. As a result, our case vignette findings are applicable only to gynaecological practice.

Moreover, we could include only gynaecologists in our study, using case vignettes to explore the impact of patient characteristics on recommendations about surgery. The contact details of urologists involved in treatment of female UI were simply not available. We can only speculate to what extent the results observed in gynaecologists reflect those that would have been obtained in urologists. In addition, the response of only 245 gynaecologists could be included, out of the 1139 members of the RCOG with special interest in urogynaecology. We could not explore the differences between responders and non-responders because we did not have access to the characteristics of the non-responders.

Interpretation of findings

Information on variation in practice is important for examining relationships between policy decisions and clinical decisions, and this information raises questions concerning the efficiency and effectiveness of health care. 35 In evaluating practice variation, surgical care can be considered to be ‘preference sensitive’ where more than one generally accepted treatment option is available. In this situation, the ‘correct’ rate of treatment should depend on informed patient choice, but rates may vary substantially because of the differences in the professional opinion of clinicians. International data illustrate extensive variation in elective surgery rates in many areas of practice that is much greater than can reasonably be explained by differences in condition severity. 92,97,98 Our findings suggest that this is also the case for surgery for female UI.

It is important to remember that patients in geographical areas with low rates of elective surgery, such as for UI, are not necessarily untreated; they may be treated differently. Patients’ decisions regarding their treatment are understandably strongly influenced by the opinions of their clinicians. Treating patients according to their preferences requires shared decision-making and the active engagement of patients in their choice of treatment. In the context of UI surgery, it is likely that at least some of the observed variation in the use of surgery will have been related to the debate about the safety of MUTs for SUI, which would have led to differences in professional opinion about the appropriateness of these treatments for female SUI. Surgical care for UI may also be considered ‘supply sensitive’, with the frequency of use relating to capacity in the local health-care system. The geographic areas used in the analyses of geographical variation in SUI surgery rates (CCGs and STPs) are defined by NHS bodies that commission local hospital services. For this reason, differences in capacity of the local health-care system may have contributed to the observed variation.

The data used in this project (from the routinely collected clinical and administrative data sets and obtained from primary data collection in women and clinicians) were collected before the national ‘pause’ in the use of MUTs for SUI. However, the growing controversy over the use of MUTs for UI over the course of the period from which our data are drawn is likely to have played a role in our findings. Growing safety concerns around these most common surgical treatments for SUI over the study period,99–101 with some women experiencing pain, painful sex and mesh exposure,99,102 are likely to have introduced more uncertainty to women’s and clinician’s decision-making in relation to treatment and referral for female UI. This is reflected in our findings of substantial variation in rates of referrals, surgery and mesh tape removals both geographically and between groups (i.e. older women and those from minority ethnic backgrounds), which persisted after adjustment for individual-level factors likely to affect women’s preferences.

Implications and recommendations for future research

Summary of the research agenda

In summary, the proposed research agenda includes:

• a stronger emphasis on using data based on experiences and outcomes reported by women themselves

• ongoing refinement of procedure codes in HES data to ensure that partial and total removal of mesh tape can be distinguished

• initiation of studies that specifically aim to get a better understanding of the characteristics of patients for whom the benefits of surgical treatment outweigh the risks

• the development of approaches, including patient decision aids, which support women in making decisions about surgical treatment for SUI.

Project team and roles

Project Advisory Group and roles

Jonathan Duckett (BSUG and Medway NHS Foundation Trust; clinical input), Philip Toozs-Hobson (BSUG and Birmingham Women’s NHS Foundation Trust; clinical input), Ash Monga (BSUG and University Hospitals Southampton; clinical input), Tahir Mahmood (RCOG and Victoria Hospital; clinical input), Margaret Buchanan-Geddes (RCOG Women’s Voices; lay member), Jacqueline Emkes (independent; lay member), David Cromwell [London School of Hygiene & Tropical Medicine (LSHTM); methodological input] and Mylene Lagarde (LSHTM and London School of Economics; methodological input).

Project Steering Committee

Simon de Lusignan (Professor of Primary Care and Clinical Informatics, University of Surrey), Jenni Burt (Senior Research Associate, University of Cambridge), Lucia Dolan (Consultant Urogynaecologist, Belfast City Hospital), Marcus Drake (Consultant Urologist, Senior Lecturer in Urology, North Bristol NHS Trust, University of Bristol), Pallavi Latthe (Consultant Obstetrician and Gynaecologist, Birmingham Women’s NHS Foundation Trust), Karen Ward (Consultant Urogynaecologist, Manchester University Hospital NHS Trust) and Catherine Nestor (lay representative, co-vice chairperson, RCOG Women’s Network).

Contributions of authors

Rebecca S Geary (https://orcid.org/0000-0003-1417-1057) (Assistant Professor, Health Services Research) was the co-lead for WPs 1, 2 and 4, she contributed to writing up WP 6, wrote the first draft of the report and managed all processes in preparation for the final report.

Ipek Gurol-Urganci (https://orcid.org/0000-0002-6517-3485) (Assistant Professor, Health Services Research) was co-principal investigator, the co-lead for WPs 1, 2, 4 and 6, she conducted all quantitative analyses, prepared the results for the report and contributed to writing up the report.

Jil B Mamza (https://orcid.org/0000-0001-6240-7525) (Research Fellow, Epidemiology) was the co-lead for WP 5 and supported data management and analyses for WPs 2, 4 and 6.

Rebecca Lynch (https://orcid.org/0000-0002-6890-698X) (Assistant Professor, Medical Anthropology) was the co-lead for WP 3, conducted all qualitative data collection and analyses, and prepared the qualitative results for the report.

Dina El-Hamamsy (https://orcid.org/0000-0002-0257-533X) (Clinical Research Fellow, Urogynaecology) provided clinical input for the interpretation of results for all WPs and commented on the draft report, focusing on key findings, discussion and recommendations.

Andrew Wilson (https://orcid.org/0000-0002-9814-5966) (Professor, Primary Care) provided clinical input for the design and conduct of all WPs and interpretation of the results, and commented on the draft report, focusing on key findings, discussion and recommendations.

Simon Cohn (https://orcid.org/0000-0003-4660-2800) (Professor, Medical Anthropology) was the co-lead for WP 3, advised on the design and conduct of WP 3 and commented on the results and key findings for WP 3.

Douglas Tincello (https://orcid.org/0000-0002-6385-851X) (Professor, Urogynaecology) was co-principal investigator, provided clinical input for the design and conduct of all WPs and interpretation of the results. He also commented on the draft report, focusing on key findings, discussion and recommendations.

Jan van der Meulen (https://orcid.org/0000-0002-9451-2335) (Professor, Clinical Epidemiology) was the principal investigator for the project. He advised on the design, conduct and analyses for all WPs, was the co-lead for WPs 5 and 6, provided key input for interpretation of the results and revised all sections of the report critically.

Publications

Gurol-Urganci I, Geary RS, Mamza JB, Duckett J, El-Hamamsy D, Dolan L, et al. Long-term rate of mesh sling removal following midurethral mesh sling insertion among women with stress urinary incontinence. JAMA 2018;320:1659–69.

Lynch R. Of Flesh and Mesh: Time, Materiality, and Health in Surgical Recovery. In Parkhurst A, Carroll T, editors. Medical Materialities Towards a Material Culture of Medical Anthropology. London: Routledge; 2019. pp. 23–35.

Mamza JB, Geary RS, El-Hamamsy D, Cromwell DA, Duckett J, Monga A, et al. Geographical variation in rates of surgical treatment for female stress urinary incontinence in England: a national cohort study. BMJ Open 2019;9:e029878.

Gurol-Urganci I, Geary RS, Mamza JB, Iwagami M, El-Hamamsy D, Duckett J, et al. Determinants of referral of women with urinary incontinence to specialist services: a national cohort study using primary care data from the UK. BMC Fam Pract 2020;21:211.

Lynch R, Toozs-Hobson P, Duckett J, Tincello D, Cohn S. Making a decision about surgery for female urinary incontinence: a qualitative study of women’s views. Int Urogynecol J 2021;32:127–33.

Mamza JB, Geary R, El-Hamamsy D, Gurol I, Duckett J, Mahmood T, et al. Variation in surgical treatment advice for women with stress urinary incontinence: a study using clinical case vignettes. Int Urogynecol J 2020;31:1153–61.

Data-sharing statement

The HES data were made available by NHS Digital and reused with the permission of NHS Digital. The CPRD data (including HES-linked data) were made available by the Medicines and Healthcare products Regulatory Agency and reused with the permission of the Medicines and Healthcare products Regulatory Agency. The HES and CPRD data are available on application to NHS Digital and the Medicines and Healthcare products Regulatory Agency. The data generated from the interviews with women and the survey of gynaecologists are not suitable for sharing beyond those contained within the report. Further information can be obtained from the corresponding author.

Patient data

This work uses data provided by patients and collected by the NHS as part of their care and support. Using patient data is vital to improve health and care for everyone. There is huge potential to make better use of information from people’s patient records, to understand more about disease, develop new treatments, monitor safety, and plan NHS services. Patient data should be kept safe and secure, to protect everyone’s privacy, and it’s important that there are safeguards to make sure that it is stored and used responsibly. Everyone should be able to find out about how patient data are used. #datasaveslives You can find out more about the background to this citation here: https://understandingpatientdata.org.uk/data-citation.

Disclaimers

This report presents independent research funded by the National Institute for Health Research (NIHR). The views and opinions expressed by authors in this publication are those of the authors and do not necessarily reflect those of the NHS, the NIHR, NETSCC, the HS&DR programme or the Department of Health and Social Care. If there are verbatim quotations included in this publication the views and opinions expressed by the interviewees are those of the interviewees and do not necessarily reflect those of the authors, those of the NHS, the NIHR, NETSCC, the HS&DR programme or the Department of Health and Social Care.

Ethnicity

Ethnicity information was captured based on Read codes reported in Wright et al. 104

Smoking status

Information on smoking was captured based on Read codes reported in Stocks et al. 105 and Joseph et al. 106

Comorbidities

All comorbidities were captured using Read code repositories reported at https://clinicalcodes.rss.mhs.man.ac.uk/medcodes/articles/ (accessed 9 May 2020), with the exception of those listed below.

Preamble to interview

My name is Rebecca Lynch and I’m a researcher based at the London School of Hygiene and Tropical Medicine (a university based in London). I’m interviewing women in different parts of the country about their experiences of urinary incontinence and incontinence care for a project that looks to improve the services that women are offered.

I am not directly connected to the clinic where you are a patient. This study is separate to the services offered at the hospital. What we talk about will not affect your treatment and care at the clinic and our conversation won’t be disclosed to people working there.

If you’re happy for me to do so, I’d like to record our conversation so that it can be written up for analysis. All recordings and access to what we’ve talked about will be kept confidential, including from those working at the clinic, unless you tell me something that indicates that you or someone else is at risk of harm. I would discuss this with you before telling anyone else. When I write about what patients have told me, this will be anonymised and I will be careful that you cannot be identified in anything I write up or present.

We are planning to write and present our findings in academic journals and at academic conferences, links to papers will be available through our project website. We are also planning to write a summary of our findings that might be easier for people to look through, this will also be available for you to read from our project website.

You have already had a chance to look at the participant information sheet and consent form – do you have any questions about either of these?

Can I talk you through the statements on the consent form to check that these are clear?

Are you happy to participate? If you are happy to be involved, can I remind you again that you are able to leave at any time during the interview if you do not wish to continue, and if you would like to withdraw from the study afterwards, you can ask me to withdraw your data any time up to when we publish, without giving a reason for doing this.

If you are happy to do so, can I then ask you to complete the consent form, including whether you would be happy for me to record the interview?