C-POP Study findings: exploring trial feasibility comparing vaginal surgeries for prolapse

Objective: The surgical management of apical pelvic organ prolapse in older women often involves vaginal procedures such as colpocleisis or sacrospinous fixation, yet the comparative effectiveness of these interventions remains unclear. The C-POP study aimed to assess the feasibility and acceptability of a future randomised controlled trial comparing these two vaginal surgical options.

Design: Multi method feasibility study aligned with the 2021 MRC/NIHR Framework for Developing and Evaluating Complex Interventions.

Method: Participants were recruited via 15 NHS sites, and via non-NHS pathways (e.g., social media). Audio-recorded interviews were conducted with a diverse sample (based on geography, sociodemographic and ethnicity) of 54 women with apical pelvic organ prolapse and 28 clinicians. Data were analysed using a hybrid deductive-inductive thematic approach. Clinical records from 14 NHS sites were reviewed and analysed descriptively to estimate potential numbers of patients eligible for a future trial. Findings from the interviews and clinical records were further discussed and future actions identified during a national stakeholder workshop involving 17 participants including patients (n = 5), clinicians (n = 8) and triallists (n = 4).

Results: Both women and clinicians found the concept of randomisation unacceptable. Women strongly preferred retaining decision-making autonomy, expressed firm surgical preferences, and trusted clinician recommendations. Clinicians reported that their surgical decisions were influenced by patient factors including age, frailty, comorbidities, and perceptions about preserving sexual function. A review of clinical records identified 157 women as potentially eligible for a future trial across 14 NHS sites over a total of 61 months of data collection. Stakeholder workshop discussions corroborated findings from interviews and the review of clinical data. Collectively, these insights highlighted significant barriers to the acceptability and feasibility of a future randomised control trial in this context.

Conclusions: A future randomised controlled trial comparing colpocleisis and sacrospinous fixation for apical pelvic organ prolapse is neither acceptable nor feasible. Alternative study designs, such as observational studies or patient-preference trials, should be considered to provide a framework that better aligns with the preferences and expectations of stakeholders while addressing this important clinical question.