Extension - June '24: Exploring the feasibility and acceptability of conducting a study comparing the effectiveness of colpocleisis with sacrospinous fixation in women with pelvic organ prolapse (the C-POP study)

Background: Pelvic organ prolapse (POP) is a condition affecting 1 in 2 women[1]. Apical prolapse (AP) is where the uterus, cervix or vaginal vault bulge or hang down into the vagina. Incidence peaks at 70-79 years and can negatively impact a woman’s quality of life[2]. Surgical management options for older, sexually inactive women with AP, include sacrospinous fixation (SSF) and colpocleisis. Although colpocleisis is known to have lower complication and recurrence rates than SSF, it is an obliterative surgery which takes away the ability to have vaginal intercourse[3]. A combination of the prevalence of the condition, the older age of the women (an NIHR identified underserved group within research), the significant annual treatment costs to the NHS (£45 million), and the potentially life changing consequences of the surgery contribute to the importance of establishing the best evidence for treatment. Key uncertainties for women and healthcare professionals (HCPs) remain regarding both surgeries. It is therefore important to explore the feasibility and acceptability of undertaking a future effectiveness trial comparing colpocleisis with SSF.
Aim: To explore the feasibility and acceptability of conducting a study comparing the effectiveness of colpocleisis with sacrospinous fixation in women with pelvic organ prolapse. This overarching aim will be addressed via five objectives linked to the MRC/NIHR framework and delivered via four work packages (WP1-4).
PPIE: The C-POP study has been designed with strong PPI engagement aligned with the NIHR’s six standards for Public Involvement. We have two PPI co-applicants who support and co-chair our patient advisory group (PAG). Our PAG includes a diverse group of women with direct experience of colpocleisis and/or SSF. Our PAG have informed for example: (1) the design of the study, (2) what PPI engagement should look like, (3) how we can appropriately identify and recruit women, (3) what questions are appropriate to ask around sexual function and how, and (5) dissemination activities.
Methods: C-POP is a multi-method feasibility study aligned with the 2021 MRC/NIHR Framework for Developing and Evaluating Complex Interventions[4]. A programme theory and list of recommendations for a future effectiveness trial will be produced via four work packages (WP) (see Attachment X Flow Chart). WP1: qualitative interview study exploring insight from women with AP (n=50-60). WP2: qualitative interview study exploring insight from HCPs involved in the care of women with AP (n=20-30). WP3: a quantitative study exploring the number of eligible women for a future effectiveness trial. WP4: national stakeholder event to gather feedback on the findings of WPs1-3(n=30-40). Qualitative data will be analysed using reflexive thematic analysis. Quantitative data will be analysed descriptively.
Anticipated impact: The findings from this study will provide clear guidance, which is based on insight from women, HCPs, and key stakeholders, on the feasibility of and key considerations for a future effectiveness trial. Data will include specific insight on: (i) the issue of coital status for women of various ages and different cultural backgrounds; (ii) other sensitivities, uncertainties and preferences of women and HCPs regarding treatment options for AP; (iii) the number of eligible women for a future trial; and (iv) potential mechanisms for feasibility and acceptability of a future trial. If findings from C-POP demonstrate a future trial is feasible and acceptable, the resulting programme theory and recommendations will form the basis for a robust trial that is well-developed and delivered, and provides compelling trial data to inform future clinical practice and guidelines.
Dissemination: We intend to proactively disseminate and engage with our key audiences from the outset of the project. Our audience includes women with AP, people who care for women with AP, the general public, commissioning organisations (e.g., clinical commissioning groups, NHS England), HCPs involved in care provision, external statutory organisations (e.g., Department for Health and Social Care, NICE, NHS Information Centres, and third sector condition specific organisations (e.g. Bladder Health UK). We will use a range of tailored dissemination strategies to target our audience, including: (i) early-stage methods such as blogs, social media outputs and ongoing networking with stakeholders; and (ii) end of study methods such as published articles, NIHR report, conference presentations, press release of study findings, and an end of study video summary.
Timelines for Delivery: 21 months. Months 1-3 study set up. Months 3-19 qualitative work with women (WP1), HCPs (WP2) and quantitative eligibility screening study (WP3). Months 19-21 stakeholder workshop (WP4), report writing and dissemination.