Treatment of prolapse with self-care pessary: the TOPSY trial
- Conditions
- Pelvic organ prolapseUrological and Genital Diseases
- Registration Number
- ISRCTN62510577
- Lead Sponsor
- Glasgow Caledonian University
- Brief Summary
2020 Protocol article in https://pubmed.ncbi.nlm.nih.gov/33032651/ process evaluation protocol (added 14/10/2020) 2020 Protocol article in https://pubmed.ncbi.nlm.nih.gov/33032644/ protocol (added 14/10/2020) 2022 Other publications in https://pubmed.ncbi.nlm.nih.gov/36064727/ Theoretical and practical development of the TOPSY self-management intervention for women who use a vaginal pessary for pelvic organ prolapse (added 06/09/2022) 2023 Results article in https://pubmed.ncbi.nlm.nih.gov/38078194/ (added 19/12/2023) 2024 Results article in https://pubmed.ncbi.nlm.nih.gov/38767959/ Clinical and cost-effectiveness (added 22/05/2024)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 340
1. Women with pelvic organ prolapse of any type or stage
2. Aged =18 years
3. Women treated with a vaginal pessary
4. Pessary retained for 2 weeks or more
1. Women with a shelf or Gellhorn pessary as these are difficult for women to remove and replace themselves
2. Women lacking in manual dexterity, e.g. those with arthritis, as women would not be able to remove and replace her own pessary
3. Women judged by the treating clinician to have a cognitive deficit such that she would be unable to give informed consent or understand self-management instruction
4. Pregnant women
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Current primary outcome measure as of 31/08/2022:<br>Prolapse-specific quality of life, measured using PFIQ-7 at baseline, 6, 12 and 18 months and 4 years<br><br>_____<br><br>Previous primary outcome measure:<br>Prolapse-specific quality of life, measured using PFIQ-7 at baseline, 6, 12 and 18 months
- Secondary Outcome Measures
Name Time Method