Title: 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
Funder: Chief Scientist Office, Scotland

Abstract: 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.

Lay abstract: Pelvic organ prolapse (or prolapse) is a common condition in women where the pelvic organs (bladder, bowel or womb) descend into the vagina and cause distressing symptoms that adversely affect quality of life. Two thirds of women initially choose a vaginal pessary to treat their prolapse symptoms. The pessary is placed in the vagina to support the pelvic organs. It is usually fitted at a gynaecological or general practice clinic and the woman returns approximately every 6 months to have it removed and changed (this is called standard care). However, it is possible that women could remove, clean and reinsert their pessary themselves at home, thus offering them more confidence in their ability to maintain and improve their own health; this is called self-management. This study will assess if self-management of a vaginal pessary is more effective at improving women’s quality of life than standard follow up care (visiting the clinic approximately 6-monthly). Women with any severity or kind of prolapse would be invited to take part in the study as long as they had successfully used a pessary for at least 2 weeks. They will receive written information about the study and if willing to take part they will sign a consent form and then be assigned at random to either self-management or standard care. We aim to recruit 330 women to the study. Women in the standard care group (165 women) would be seen regularly in a hospital, community or GP clinic to have the pessary removed and a new one inserted. Research suggests that self-management is effective because people become more confident in their ability to look after their own health. To gain that confidence women in the study would need support to gain knowledge and skills. We would therefore offer each woman in the self-management group (165 women) a 30 minute self-management teaching appointment with a specialist health professional to ensure women know how to change and clean their pessary and to allow time to practise. We would ask women to change their pessary at least once within 2 weeks of the appointment and telephone them to ask if they have done so. Self-managing women would be given a local phone number to call if they have any problems with their pessary. To find out if self-management does improve women’s quality of life we would ask all women to fill out questionnaires at the start of the study and 6,12 and 18 months later. We would gather information that allows us to find out if self-management is more or less expensive for the NHS and for women. To help us understand how and why aspects of self-management may or may not work we will record some self-management teaching appointments and interview some women and health professionals. Our team has considerable expertise in studies with women who have prolapse and who use pessaries. In combination we have all the clinical and research skills required to deliver the project in a way that keeps women as the focus. This includes, within our core team, one woman who has experience of using a pessary for prolapse and who is going to remain part of the team for the duration of the study. She and one other woman who uses a pessary for prolapse have discussed the application. We also have Patient and Public Involvement support from: - Women's Voices within the Royal College of Obstetrics and Gynaecology; and, - other women who use a pessary for prolapse (on the Project Management Group and within the Trial Steering Committee). To maximise study impact we will use social media, patient-focused media outlets, professional publications, and academic publications to share findings. We will send findings to participants, relevant charities, Royal Colleges, special interest groups and Directors of Health Authorities.

Research activity codes: 7.1 INDIVIDUAL CARE NEEDS
Health categories: RENAL AND UROGENITAL