To investigate acceptability, adherence to treatment and pathways to effectiveness (quality of life) of a self-management intervention when compared to clinic-based care for women who use a vaginal pessary for pelvic organ prolapse.

The study design was a qualitative case study (1) carried out in parallel to a randomised controlled trial. The intervention tested was self-management of a vaginal pessary for women with pelvic organ prolapse. The self-management intervention included a 30 minute teaching session, an information leaflet, a two-week follow up telephone call and a contact telephone number for the local centre. Following ethical approval, purposive maximum variation sampling (based on trial group [self-management or clinic-based care], variance in treating centre, user status [new/ existing pessary users], and age) was used to invite a subsample of women, who had consented to a randomised controlled trial, to take part in the case study. Interested women were sent written information about, and asked to consent to, the case study specifically. The data from each recruited woman formed one case. Women were interviewed at baseline and 18 months after randomisation. Interviews were semi-structured, digitally recorded and transcribed. Where possible, interviews were face to face and either at the participant’s home or in the clinic. COVID-19 affected data collection in that no face-to-face interviews could be conducted after March 2020, and all remaining interviews were by telephone. Interviews explored women’s experiences of: prolapse symptoms and pessary use, the intervention they received, adherence and outcome. Data analysis followed case study analytic traditions (1) whereby all data from a case were analysed and findings collected together to form a case summary with a focus on understanding a woman’s experience of prolapse and pessary use, intervention, adherence and outcome and how these factors interacted. Case summaries were collated by group (self-management and clinic-based care), the groups were then qualitatively compared.

Sample: Thirty-six women, 18 per group, were recruited as planned; 23 women had data at both time points (12 self-management and 11 clinic-based care) and these cases formed the basis of the analysis, with 1392 minutes of interview data recorded. The age range of the recruited women was 49 to 72 years. Twelve women were new pessary users and 11 were existing users. Women were recruited across the 21 UK centres involved in the study.
Acceptability: Self-management was reported to be an acceptable intervention to women whether they received self-management or not.  Women reported benefits of pessary self-management for women and health services, and valued the possibilities provided to women who could self-manage their pessary such as flexibility and independence in using the pessary as needed.  Acceptability of self-management was supported by provision of a local telephone number for contact in case of concerns. 
“I think everything is fine and as I say, if I have a problem, I know there’s a number I can call which is…that gives you confidence as well, that you’re not totally abandoned.” (Case 22, self-management)
Adherence: Adherence varied considerably between individual women.  There were examples of women who adhered completely to their self-management or clinic-based intervention throughout the 18 month follow up.  There were those who adhered to some extent, and those who did not adhere at all (Table 1). Patterns of adherence to trial group were similar between self-management and clinic-based care. 
Intervention adherence varied over time because of multiple contextual factors. Key facilitators of adherence for both trial groups were good general health and a supportive network. For the clinic-based care group a need for reassurance from a trained healthcare professional was a factor positively contributing to adherence. For women in the self-management group the desire to be in control and able to manage the pessary themselves was a positive factor. For example: 
“So I was quite happy to go to the hospital because they just had a look to make sure everything was all right and I found that really quite reassuring.” (Case 17, clinic-based care)
“It’s just been feeling more empowered myself to take care of myself and to not have to go to the hospital as regularly, so every six months.  Now, I can go annually.  For me, that’s just so much easier in terms of my lifestyle.” (Case 21, self-management)
A key barrier to adherence was developing bothersome pessary complications. 
Table 1: Case study examples of variation in adherence by treatment group
 
Pathways to Effectiveness (Quality of Life): As with adherence there was considerable variation in prolapse symptoms and quality of life at 18-month follow-up (Table 2). The pessary itself influenced women’s quality of life, regardless of trial group. There were women who experienced good quality of life in both groups, with some women in the self-management group stating that their quality of life has improved beyond the symptom control of the pessary; and those with no improvement or / worsening symptoms. 
Table 2: Case study examples of variance in quality of life at 18 months
 


The presence of pessary complications greatly affected quality of life of women using a vaginal pessary for their prolapse. For instance: 
“… taking the pessary out in case that was causing or some cause of the urinary infections.  So I actually had the pessary removed in March this year and certainly been no worse and I think probably better.” (Case 03, clinic-based care)
Self-efficacy (confidence) influenced both adherence and quality of life. Women in the self-management group had different self-efficacy to those in the clinic-based group. For example, women in the self-management group felt more confident in addressing common problems with their pessary, such as discharge or slippage, on their own without the need for additional for appointments.

The acceptability of self-management makes it an intervention that is appropriate to offer in prolapse health services. A local support telephone number is an important part of the provision of those self-management services. There is an interaction between the context within which women live their lives, her confidence and ability to self-manage her pessary, her adherence and her quality of life outcomes. Recognition of, and understanding about, that interaction forms an integral part of the treatment counselling women need to self-manage their pessary.

Women find self-management of a vaginal pessary for prolapse an acceptable intervention. Adherence to vaginal pessary self-management and women’s prolapse related quality of life are influenced by contextual factors in women’s lives, the absence of pessary complications and a woman’s self-efficacy to self-manage a pessary.

Yin KR. Case Study Research: Design and Methods. 2009 4th ed. Thousand Oaks: SAGE Publications

Continence 2S2 (2022) 100208
DOI: 10.1016/j.cont.2022.100208