{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,18]],"date-time":"2026-08-18T04:06:43Z","timestamp":1787026003187,"version":"build-2736575974"},"reference-count":94,"publisher":"National Institute for Health and Care Research","license":[{"start":{"date-parts":[[2024,5,1]],"date-time":"2024-05-01T00:00:00Z","timestamp":1714521600000},"content-version":"unspecified","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100000664","name":"Health Technology Assessment programme","doi-asserted-by":"publisher","award":["16\/82\/01"],"award-info":[{"award-number":["16\/82\/01"]}],"id":[{"id":"10.13039\/501100000664","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["journalslibrary.nihr.ac.uk"],"crossmark-restriction":false},"short-container-title":["Health Technol Assess"],"abstract":"\n Background<\/jats:title>\n Pelvic organ prolapse is common, causes unpleasant symptoms and negatively affects women\u2019s quality of life. In the UK, most women with pelvic organ prolapse attend clinics for pessary care.<\/jats:p>\n <\/jats:sec>\n \n Objectives<\/jats:title>\n To determine the clinical effectiveness and cost-effectiveness of vaginal pessary self-management 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.<\/jats:p>\n <\/jats:sec>\n \n Design<\/jats:title>\n A multicentre, parallel-group, superiority randomised controlled trial with a mixed-methods process evaluation.<\/jats:p>\n <\/jats:sec>\n \n Participants<\/jats:title>\n Women attending UK NHS outpatient pessary services, aged \u2265 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.<\/jats:p>\n <\/jats:sec>\n \n Intervention<\/jats:title>\n 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\u2019 usual practice.<\/jats:p>\n <\/jats:sec>\n \n Allocation<\/jats:title>\n Remote web-based application; minimisation was by age, pessary user type and centre.<\/jats:p>\n <\/jats:sec>\n \n Blinding<\/jats:title>\n Participants, those delivering the intervention and researchers were not blinded to group allocation.<\/jats:p>\n <\/jats:sec>\n \n Outcomes<\/jats:title>\n 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.<\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n \n Three hundred and forty women were randomised (self-management,\n n<\/jats:italic>\n = 169; clinic-based care,\n n<\/jats:italic>\n = 171). At 18 months post randomisation, 291 questionnaires with valid primary outcome data were available (self-management,\n n<\/jats:italic>\n = 139; clinic-based care,\n n<\/jats:italic>\n = 152). Baseline economic analysis was based on 264 participants (self-management,\n n<\/jats:italic>\n = 125; clinic-based care,\n n<\/jats:italic>\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 \u22120.03, 95% confidence interval \u22129.32 to 9.25). There was fidelity to intervention delivery. Self-management was cost-effective at a willingness-to-pay threshold of \u00a320,000 per quality-adjusted life-year gained, with an estimated incremental net benefit of \u00a3564.32 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 self-managing 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 n<\/jats:italic>\n = 17; clinic-based care,\n n<\/jats:italic>\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.\n <\/jats:p>\n <\/jats:sec>\n \n Conclusions<\/jats:title>\n 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 from treatment.<\/jats:p>\n <\/jats:sec>\n \n Study registration<\/jats:title>\n This study is registered as ISRCTN62510577.<\/jats:p>\n <\/jats:sec>\n \n Funding<\/jats:title>\n \n This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 16\/82\/01) and is published in full in\n Health Technology Assessment<\/jats:italic>\n ; Vol. 28, No. 23. See the NIHR Funding and Awards website for further award information.\n <\/jats:p>\n <\/jats:sec>","DOI":"10.3310\/nwtb5403","type":"journal-article","created":{"date-parts":[[2023,3,17]],"date-time":"2023-03-17T05:50:10Z","timestamp":1679032210000},"page":"1-121","update-policy":"https:\/\/doi.org\/10.3310\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":6,"title":["Clinical and cost\u2010effectiveness of pessary self\u2010management versus clinic-based care for pelvic organ prolapse in women: the TOPSY RCT with process evaluation"],"prefix":"10.3310","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-4071-0803","authenticated-orcid":true,"given":"Carol","family":"Bugge","sequence":"first","affiliation":[{"name":"School of Health and Life Sciences, Glasgow Caledonian University, Glasgow, 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