Introduction
Stress urinary incontinence (SUI) is a very common condition. Procedures to treat SUI include urethral bulking, mid-urethral slings (MUS), autologous fascial slings and colposuspension. Over the last decade, continence surgery has been the subject of controversy in the UK, and there have been several government inquiries and reviews of safety, primarily in relation to mesh. The most recent inquiry in England, the Independent Medicines and Medical Devices Safety Review, was commissioned by the Government in February 2018 and has yet to report its conclusion. Until the 2018 pause on MUS in England, MUS were by far the most common procedure performed, with 84 tapes for every one non-tape procedure [
1].
One of the recurring themes in these inquiries was the poor counselling provided by clinicians to women undergoing surgery for SUI. This has led clinicians to consider ways to improve the information they provide. The recently published NICE guideline on incontinence and prolapse [
2] contains patient decision aids (PDA). However, it contains very little on how women can make a choice among three operations, with fairly similar outcomes. It also treats bulking as a separate category of treatment. Other PDAs for SUI have been published [
3,
4]; however, these are based on expert opinion rather than a systematic meta-analysis of the evidence which NICE undertook. Furthermore, none of the PDAs were informed by how women chose an operation for SUI. It is important clinicians understand what matters to women considering treatment. Therefore, this study endeavoured to gain greater insight into the process of women‘s decision-making when choosing an SUI procedure. This knowledge may lead to patient-focused PDAs and may help to identify gaps in current evidence which require further research.
Results
Two hundred sixteen women completed the questionnaire. Four questionnaires were excluded from analysis because two women decided not to go ahead with their SUI treatment and another two were identified to be ineligible as this was not their first continence procedure.
The analysis of 212 women found 64% opted for urethral bulking (
n = 135), 23% a mid-urethral sling (
n = 48), 12% colposuspension (
n = 25) and 2% a fascial sling (
n = 4). Characteristics of the sample population are detailed within Table
2. There was no significant difference in age, BMI, smoking status or previous laparotomies and the procedure chosen for SUI (Table
3). Hospital type was a significant factor in determining the procedure chosen (
P < 0.001) with mid-urethral sling and colposuspension or fascial sling all most likely to be chosen by women attending a tertiary hospital compared with those attending a secondary-care hospital (Table
3). However, at both hospital types urethral bulking was the most frequently chosen procedure (75% in secondary-care hospitals and 51% in tertiary hospitals).
Table 2
Characteristics of the sample population
Age | Media n = 50 |
IQR = 44,58 |
Range = 27–84 |
BMI | Media n = 28 |
IQR = 25,32 |
Range = 17–58 |
Smoking status | Yes n = 27 (13%) |
No n = 185 (87%) |
Site type | Secondary n = 111 (52%) |
Tertiary n = 101 (48%) |
Laparotomy | None n = 130 (62%) |
One n = 63 (30%) |
Two or more n = 19 (9%) |
Missing data n = 1 |
Table 3
Procedures chosen and participant demographics and lifestyle factors
Age | Median | 48 | 50 | 54 | P < 0.73 |
Range | 31–81 | 27–84 | 30–71 |
BMI | Median | 27 | 28 | 27 | P < 0.59 |
Range | 21–58 | 17–50 | 21–41 |
Smoker | Yes | 7 (15%) | 18 (13%) | 2 (7%) | P < 0.58 |
Hospital | Secondary | 20 (42%) | 83 (61%) | 8 (28%) | P < 0.001 |
Tertiary | 28 (58%) | 52 (39%) | 21 (72%) |
Laparotomy | 0 | 29 (60%) | 84 (62%) | 17 (59%) | P < 0.96 |
1 | 15 (31%) | 38 (28%) | 10 (34%) |
2 or more | 4 (8%) | 13 (9%) | 2 (7%) |
Thematic analysis found the major themes associated with patient decision-making were as follows.
Invasiveness of the procedure
Women’s concerns about the “invasiveness” of the procedure were expressed by 53 women (25%). While invasiveness was frequently cited as a factor which affected decision-making, only a small number of women defined what made them consider a procedure more or less invasive:
‘Less cuts.’
(Chose urethral bulking)
It was apparent from the analysis some women did not consider injection of a urethral bulking agent to be surgery:
‘(I) feel that my condition isn’t severe enough for an operation.’
(Chose urethral bulking)
‘I was very relieved when…the bulking agent was offered, I have lived with symptoms for years thinking surgery was (the) only option.’
(Chose urethral bulking)
Of the 53 women who reported invasiveness was an important factor in decision-making, 83% opted for urethral bulking (n = 44), 9% a colposuspension (n = 5) and 8% a mid-urethral sling (n = 4).
Chance of success
Success rate and “invasiveness” of the procedure were jointly the most frequently mentioned factors in women’s decision-making. Fifty-three women, 25% of the total cohort, reported the success rates of different procedures influenced their choice. Reassuring statistics about likelihood of cure were of overriding importance as illustrated in the following quotes:
‘Percentage of how many women it has worked for.’
(Chose MUS)
‘It was 90% it worked.’
(Chose MUS)
‘Better percentage for success’
(Chose colposuspension)
However, 5 of the 53 women stated success rate was not the most important factor in their decision-making and, whilst a consideration, avoiding mesh or having the least invasive procedure was their primary concern.
The 53 women who cited efficacy as important to their decision were most likely to opt for a mid-urethral sling (42%) followed by urethral bulking (36%) and colposuspension (23%).
Duration of recovery
Forty-four women (21%) cited recovery as an important consideration for them when deciding upon a procedure. For many (
n = 11) this was due to concerns about needing to take time off work. For others, it was due to their responsibilities as a carer within their family (
n = 6).
‘I have two toddlers to look after so having an operation was not an option for me at this time. I am a working mum running my own business. My husband works full time. The treatment I have picked is best as I would only be off work for a day.’
(Chose urethral bulking)
Of the women who expressed recovery as a factor which influenced their choice, the majority opted for urethral bulking (n = 31, 67%). However, ten chose a mid-urethral sling (22%), two a colposuspension (4%) and one a fascial sling (2%).
Risk of complications
The risk of post-operative complications was a factor in the decision-making process for 26 women (12%). Most did not specify the post-operative risks they had considered; instead they used generic terms such as: ‘complications’, ‘side-effects’, ‘risks’ and ‘safety’. However, three women from two different sites had concerns regarding post-operative voiding dysfunction and the possibility of self-catheterisation. One woman expressed concerns about pain.
Risk analysis
Forty women (19%) cited risk as a factor which influenced their decision-making regarding SUI procedures. However, some expressed desire for the procedure they perceived had the lowest risk whilst others described a process of balancing risk with efficacy.
Sixteen women within this group (40%) opted for the procedure they perceived to have the lowest risk as demonstrated in the following quotations:
‘The safest way.’
(Chose urethral bulking)
‘I was going to choose the TVT but I work in a solicitors and we have had a lot of cases of women having problems with TVT. This made me change my mind and choose the Bulkamid even though the success rate is not as good. I didn’t want to take the risk at having problems.’
(Chose urethral bulking)
However, a separate subgroup of 18 women (45%) made statements which suggested they had understood and weighed up the risks associated with a procedure but balanced this against other factors in their decision-making:
‘Low risk with reasonable outcome.’
(Chose urethral bulking)
‘Success rate, recovery time and after operation complications (this changed my opinion).’
(Chose MUS)
‘What has the best results and no/minimal side effects.’
(Chose colposuspension)
A further six women (15%) stated they had considered risk; however, they did not clarify whether this influenced them to opt for their perceived lowest risk procedure or whether the risk could be outweighed by other factors such as efficacy.
Use of mesh
Twenty-four women (11%) stated the use of mesh impacted upon their decision-making. For all but two of these women (
n = 22, 92%), avoidance of mesh influenced the procedure they opted for. Two women (9%) specified they did not want a foreign body inside them and one woman (4%) had concerns about rejection of mesh.
‘Colposuspension is using natural own body tissues which hopefully will be less likely to be rejected and there are no tapes so less likely tearing or infected.’
(Chose colposuspension)
Despite acknowledging the risks of mesh procedures, two women (8%) decided to proceed with a mid-urethral sling. Both weighed up the risk of mesh compared with the anticipated effectiveness of the procedure. One woman conducted her own research to enable her to make her decision:
‘Efficacy/outcome balanced with acceptable risks. Lots of media scare stories about mesh/tape but on reading NICE guidance and the few research documents I could Google, I felt on balance it was a better option long term.’
(Chose MUS)
Another woman had prior history of a mesh procedure and based upon this positive experience wanted mesh again:
‘Works the most percentage, already had the mesh used in a bowel prolapse, its worked 100% for me.’
(Chose MUS)
Influence of the clinician
The clinician was cited as a factor which affected decision-making for 20 women (9%). Most of these (
n = 15) felt they had been advised or guided by the clinician to choose a particular procedure as demonstrated by the following quotes:
‘The one which the consultant thought would be best for me.’
(Chose urethral bulking)
‘Done right, trusting the doctors decisions.’
(Chose urethral bulking)
There was evidence some clinicians modified counselling regarding SUI procedures based upon patients’ co-morbidities. Women recognized they had been guided towards a particular procedure by their clinician:
‘I wasn’t offered any other treatment other than Bulkamid, as I was told I was too overweight for other options.’
(Chose urethral bulking BMI-40)
‘Advice from doctor (I), listened to the options as I have other medical conditions that affect my treatment options.’
(Chose urethral bulking)
Another four women decided upon their SUI procedure based upon the reputation or expertise of the clinician or hospital they were receiving care from:
‘The hospital’s reputation and the surgeon, I trusted both on my first meeting.’
(Chose urethral bulking)
‘(The) Reputation and experience of surgeon in this area carrying out this type of procedure.’
(Chose MUS)
The procedures chosen by women who reported a clinician had influenced their choice were in similar proportions to the overall study population. However, upon comparison of participants depending on their hospital type, those who cited clinician influence at a secondary-care hospital (n = 11) were most likely to choose urethral bulking (73% n = 8) over a mid-urethral sling (27% n = 3). No patients seen at a secondary-care hospital who reported their decision-making was influenced by a clinician chose a colposuspension or fascial sling. At tertiary hospitals, patients who cited that clinicians influenced their choice (n = 9) were more evenly spread across all four procedures: urethral bulking (33% n = 3), mid-urethral sling (33% n = 3), colposuspension (22% n = 2) and fascial sling (11% n = 1).
Thirteen women (6%) stated stories in the media had influenced their decision-making:
‘I was concerned about the safety of the tape being used due to reading about problems in Scotland and watching TV programme highlighting concerns. I opted for colposuspension but after discussing complications…I was persuaded by the consultant to go for the TVT.’
(Chose MUS)
‘I didn’t want the mesh (TVT) due to press.’
(Chose urethral bulking)
‘Had opportunity to have the TVT but declined due to negative publicity.’
(Chose urethral bulking)
Hierarchy of treatments
A novel theme identified amongst women who opted for urethral bulking was the concept of a hierarchical approach to SUI treatments, starting with the perceived least invasive procedure and having alternative procedures if bulking was ineffective. Twelve women (6%) recorded this influenced their decision-making as illustrated in the quotes below:
‘That I started at the lower end of operations. This would give me future options if needed.’
(Chose urethral bulking)
‘I prefer to try least invasive method before I would even consider any other. I was told other alternative would not be affected by having the least invasive treatment.’
(Chose urethral bulking)
Type of anaesthetic
The type of anaesthetic required factored in the decision-making of nine women (4%). All preferred a treatment option which did not require a general anaesthetic:
‘Don’t like being put to sleep as I am scared.’
(Chose urethral bulking)
‘I wasn’t very keen on anaesthetic.’
(Chose urethral bulking)
Other themes
In addition to the themes previously discussed, a small number of women cited different factors which influenced their choice. These included knowing someone who had previously had the procedure (n = 6), perceiving the procedure to be definitive treatment (n = 5), their plans for further pregnancies (n = 5), pain (n = 5) and advice from family or friends (n = 2).
Despite the questionnaire asking women “What was the most important issue to you when making your treatment decision?” 46 (22%) recorded comments which did not relate to their decision-making or choice of procedure, mentioning only the impact of the condition.
Discussion
Main findings
This study was conducted before the pause on the use of tapes was introduced in England. It found when women, in a real clinical situation, across 12 hospitals were offered a choice of four treatments for primary SUI, urethral bulking was the most popular choice (64%). This was despite there being fewer published data on the outcome of bulking compared with the other procedures. There was no association between operation chosen and patient factors such as age, BMI or co-morbidities. There was however a suggestion of a narrow field of choice of procedure in secondary care.
This is the first study to investigate, in real life, the factors women consider important when choosing an operation for primary SUI. The study found that although success was important this was balanced against the perceived “invasiveness” and “risk” of the procedure.
Interpretation
A recent qualitative study by Casteleijn et al. in which women were asked to choose between two operations, either urethral bulking or a MUS, reported patients would consider urethral bulking as their primary option if it has a cure rate of 70% after 1 year [
7]. (However, our study found several women expressed a hierarchical framework in their approach to treatment for SUI. These women first wished to try urethral bulking, which they perceived to be a low-risk simple procedure with short recovery. They accepted treatment may fail and they may need further treatment at a later date. Such hierarchical approaches to treatment are common in other areas of medicine. Before a modern hierarchical treatment approach is promoted for treatment of SUI there is a need for further research to determine not only the overall economic cost and the risk of treatment fatigue but importantly the impact on efficacy of further treatments if the first treatment in the hierarchy fails.
Our study shows the large range of factors influencing women’s decision-making and the highly individual nature of choice. Women balanced the severity of SUI against competing risks of complications and differing success rates, all of which were couched in poorly defined terms such as “invasiveness” and “success”. Understanding the importance of these factors and their meaning to each individual enables clinicians to provide information to women which meets their needs.
Concerns about polypropylene mesh and the media’s representation of mesh procedures were found to have influenced women’s decision-making. It is important to provide women with accurate evidence-based information about mesh complications and complications of other treatment options to ensure they are not required to seek it from unverified sources.
This study has highlighted the complexity of information about SUI procedures being presented to women. Different methods of presenting information, in written and audio visual formats should be explored to ensure we meet patient’s information needs. Factors identified as important to women within this study should be used to develop decision-making tools. The meaning of terms such as risk, success, natural, minor, simple and invasiveness should be explored, qualified and ultimately standardized. The recently published NICE PDA tool [
2] demonstrates how little objective evidence is available for each of these complex competing factors. Furthermore, there is no evidence to help women decide on a treatment based on their physical characteristics such as age or BMI. Most women considered a number of factors and tried to weigh these against each other before making their decision. An electronic decision-making tool could help woman to weigh various factors and facilitate their decision-making.
Limitations
One limitation of the study is that the number of women opting for each procedure was not equal; therefore, there may be a bias in the views expressed. However, the study was designed to ensure it captured a real-life cohort of women undergoing a primary stress incontinence procedure to determine the frequency of their choice.
This research followed a pragmatic design exploring patient choice at a number of different sites; therefore, verbal counselling and written information provided was not standardized. There is therefore the potential that participants were unduly biased towards certain treatments depending on the conscious or unconscious bias of clinicians. Nonetheless, this reflects the real-world nature of the possibility of clinician influence during the process of shared decision-making.
There was a compromise in the study design between capturing information on a large number of women to determine the frequency of choice and the level of detail in the reasons behind their choice. The research team used an open free-text question and thematic analysis technique. This question may not have been sufficiently clear as 25% of responses related to a desire for SUI treatment rather than specifying why they had chosen one procedure over another. Alternatively, this may accurately reflect that for some women the type of treatment is less of a concern than the pressing need for amelioration of their urinary symptoms.
Study eligibility required that all participants be suitable for and offered at least two SUI procedures. Despite this, some participants reported they had only been offered the procedure chosen. Upon retrospective review of these patient’s medical records, it was identified that the clinician had documented discussion of a number of procedures. This demonstrates that a patient’s interpretation of choice may be different from clinicians.
While the study was funded by Contura, who produce Bulkamid, the research was designed and coordinated by the research team with no involvement from the company. There was no financial incentive for clinicians to use Bulkamid nor was Bulkamid provided at a reduced rate for participating centres. Therefore, the authors do not believe the research funding limits the validity of these findings.
Open Access 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/.
Publisher’s note
Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.