Clinical and Cost‐effectiveness of Pessary Self‐management Versus Clinic-Based Care for Pelvic Organ Prolapse in Women: the TOPSY RCT with Process Evaluation

Background: Pelvic organ prolapse is common, causes unpleasant symptoms and negatively affects women's quality of life. In the UK, most women with pelvic organ prolapse attend clinics for pessary care. Objectives: To determine the clinical effectiveness and cost-effectiveness of vaginal pessary selfmanagement on prolapse -specific quality of life for women with prolapse compared with clinic -based care; and to assess intervention acceptability and contextual influences on effectiveness, adherence and fidelity. Design: A multicentre, parallel -group, superiority randomised controlled trial with a mixed -methods process evaluation. vParticipants: Women attending UK NHS outpatient pessary services, aged >= 18 years, using a pessary of any type/material (except shelf, Gellhorn or Cube) for at least 2 weeks. Exclusions: women with limited manual dexterity, with cognitive deficit (prohibiting consent or self -management), pregnant or non -English-speaking. Intervention: The self -management intervention involved a 30 -minute teaching appointment, an information leaflet, a 2 -week follow-up telephone call and a local clinic telephone helpline number. Clinic -based care involved routine appointments determined by centres' usual practice. Allocation: Remote web -based application; minimisation was by age, pessary user type and centre. Blinding: Participants, those delivering the intervention and researchers were not blinded to group allocation. Outcomes: The patient -reported primary outcome (measured using the Pelvic Floor Impact Questionnaire -7) was prolapse -specific quality of life, and the cost-effectiveness outcome was incremental cost per quality -adjusted life -year (a specifically developed health Resource Use Questionnaire was used) at 18 months post randomisation. Secondary outcome measures included self -efficacy and complications. Process evaluation data were collected by interview, audio -recording and checklist. Analysis was by intention to treat. Results: Three hundred and forty women were randomised (self -management, n = 169; clinic -based care, n = 171). At 18 months post randomisation, 291 questionnaires with valid primary outcome data were available (self -management, n = 139; clinic -based care, n = 152). Baseline economic analysis was based on 264 participants (self -management, n = 125; clinic -based care, n = 139) with valid quality of life and resource use data. Self -management was an acceptable intervention. There was no group difference in prolapse -specific quality of life at 18 months (adjusted mean difference -0.03, 95% confidence interval -9.32 to 9.25). There was fidelity to intervention delivery. Self -management was cost-effective at a willingness -to -pay threshold of 20,000 pound per quality -adjusted life -year gained, with an estimated incremental net benefit of 564.32 pound and an 80.81% probability of cost-effectiveness. At 18 months, more pessary complications were reported in the clinic -based care group (adjusted mean difference 3.83, 95% confidence interval 0.81 to 6.86). There was no group difference in general self -efficacy, but selfmanaging women were more confident in pessary self -management activities. In both groups, contextual factors impacted on adherence and effectiveness. There were no reported serious unexpected serious adverse reactions. There were 32 serious adverse events (self -management, n = 17; clinic -based care, n = 14), all unrelated to the intervention. Skew in the baseline data for the Pelvic Floor Impact Questionnaire -7, the influence of the global COVID-19 pandemic, the potential effects of crossover and the lack of ethnic diversity in the recruited sample were possible limitations. Conclusions: Self -management was acceptable and cost-effective, led to fewer complications and did not improve or worsen quality of life for women with prolapse compared with clinic -based care. Future research is needed to develop a quality -of -life measure that is sensitive to the changes women desire