CompletedPregnancy, Children & Inherited ConditionsDigestion, Kidneys & Other Organs
A multicentre randomised controlled trial, with process evaluation,to test the clinical and cost-effectiveness of self-management of vaginal pessaries to treat pelvic organ prolapse,compared to standard care to improve women's quality of life. TOPSY trial:Treatment Of Prolapse with Self-care pessarY
Women with pelvic organ prolapse who currently must return to a hospital clinic every six months for pessary cleaning and reinsertion will instead learn to do it themselves. The TOPSY trial tests whether teaching women to insert, remove, and manage their own vaginal pessary improves their quality of life compared to standard clinic-based care. Pelvic organ prolapse—where pelvic organs bulge into the vagina—affects many women, especially after childbirth or menopause. Standard care requires regular clinic visits for pessary maintenance, which is inconvenient, costly for the NHS, and can discourage long-term use. No large trial has tested whether self-management is as effective or more effective than this routine follow-up. If self-management proves superior or equivalent, women could avoid frequent hospital appointments, gaining greater control over their condition. The NHS could reduce clinic workload and costs. The trial also includes an economic evaluation to determine whether self-management saves money for both the health service and patients. A four-year follow-up will assess whether benefits persist long-term.
View original technical description
DESIGN: A parallel group multi-centre individual randomised controlled trial to test for superiority of pessary self-management compared to standard pessary care to improve women’s condition-specific quality of life. The research will include an internal pilot study, nested process evaluation, and economic evaluation. SETTING: Recruitment will take place in 17 UK centres (hospital gynaecology outpatient clinics, community gynaecology clinics, and general practices), where women receive a pessary as treatment for prolapse. TARGET POPULATION: Women >=18 years with prolapse and a vaginal pessary that has been retained for at least 2 weeks, of any type/material (except Shelf and Gellhorn) and who have the manual and cognitive dexterity to fit a pessary will be included. HEALTH TECHNOLOGIES: Standard care will follow local centre protocol (usually 6 monthly follow-up at hospital/community/GP clinic).Data will be gathered to describe standard care. Self-management women will receive: 1) a 30 minute teaching appointment with a specialist health professional where they will be shown and observed inserting and removing their pessary, and will be given self-management leaflets including information on complications; 2) a follow-up phone call after 2 weeks to offer support and validate adherence to self-management; 3) local telephone support and 4) an 18 month follow up clinic appointment. OUTCOME MEASUREMENT: Our primary outcome is condition-specific quality of life at 18 months (PFIQ-7). Secondary outcomes include: generic quality of life (EQ-5D-5L); treatment acceptability; patterns of pessary use; pessary complications; pessary discontinuation; adherence to self-management/standard care; crossover to other group; prolapse symptoms (PFDI-21); sexual dysfunction (PISQ-12); need for other prolapse treatment; and women's self-efficacy. All measures will be taken at baseline and 18 months and a subset of outcomes at 6 and 12 months’ post-randomisation. The process evaluation will use audio-recordings, interviews and secondary outcomes to assess: recruitment, experiences, acceptability, adherence, fidelity and contextual factors. ECONOMIC EVALUATION: We will gather cost information to determine if self-management is more or less expensive for the NHS and women using routinely-collected health data and participant-completed questionnaires. Cost data will be combined with the primary outcome data in a cost effectiveness analysis. A SAMPLE SIZE of 262 is required. Allowing for 20% attrition, 330 women will be randomised (165 per group) over 15 months. DIFFERENCE BETWEEN CURRENT & PLANNED CARE: Women in the standard care group will return to clinic approximately every six months (as dictated by local protocol). Self-managing women will not return for these regular pessary review appointments. PROJECT TIMELINES/RECRUITMENT RATE: Duration 45 months. 1-6: preparation of documentation ready to commence recruitment, start of approval, centre recruitment and training processes; 7-12 internal pilot; 7-21 participant recruitment, 7-39 process evaluation data collection; 13-39 RCT follow-up; 7-45 process evaluation data analysis; 40-45 RCT analysis. Centres on average see 35 women a month. Aim to recruit 2-3 women per month per established centre. STOP/GO PILOT CRITERIA. The primary stop/go criteria in the pilot study focusses on randomisation of sufficient numbers of eligible women. EXPERTISE: The team has expertise in women’s perspectives of pessary use, urogynaecology, nursing, physiotherapy, clinical pessary management, pessary research, self-management, clinical trials, health economics, statistics, process evaluation. 4 YEAR FOLLOW-UP: There is a funded and approved extension to the TOPSY study. Women who OPT-in will be sent one additional questionnaire 4 years after randomisation. All outcomes measured at the 4 years remain the same, with addition of the IPAQ-E questionnaire as a measure of physical activity. APPLE (TOPSY Su
Plain English summaries and category classifications on this site are generated by AI and may not perfectly reflect the original research.
Is something wrong? Let us know