临床试验/ISRCTN62510577

ISRCTN62510577已完成未知

A multi-centre 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

Glasgow Caledonian University0 个研究点目标入组 340 人开始时间: 2017年10月6日最近更新: 2024年6月3日

试验速览

阶段: 未知
状态: 已完成
发起方: Glasgow Caledonian University
入组人数: 340

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

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)

研究设计

研究类型: Interventional

入排标准

性别: Female

入选标准

•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

排除标准

•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

研究者

发起方

Glasgow Caledonian University

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