|Appears in Collections:||Faculty of Health Sciences and Sport Journal Articles|
|Peer Review Status:||Refereed|
|Title:||Clinical and cost-effectiveness of vaginal pessary self-management compared to clinic-based care for pelvic organ prolapse: protocol for the TOPSY randomised controlled trial|
Quality of life
Randomised controlled trial (RCT)
|Citation:||Hagen S, Kearney R, Goodman K, Melone L, Elders A, Manoukian S, Agur W, Best C, Breeman S, Dembinsky M, Dwyer L, Forrest M, Graham M, Guerrero K & Bugge C (2020) Clinical and cost-effectiveness of vaginal pessary self-management compared to clinic-based care for pelvic organ prolapse: protocol for the TOPSY randomised controlled trial. Trials, 21 (1), Art. No.: 837. https://doi.org/10.1186/s13063-020-04738-9|
|Abstract:||Background 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. Many women will use a vaginal pessary to treat their prolapse symptoms. Clinic based care usually consists of having a pessary fitted in a primary or secondary care setting, and returning approximately every six months for healthcare professional review and pessary change. However, it is possible that women could remove, clean and re‐insert their pessary themselves; this is called self‐management. This trial aims to assess if self‐management of a vaginal pessary is associated with better quality of life for women with prolapse when compared to clinic based care. Methods This is a multicentre randomised controlled trial in at least 17 UK centres. The intervention group will receive pessary self-management teaching, a self-management information leaflet, a follow up phone call and access to a local telephone number for clinical support. The control group will receive the clinic based pessary care which is standard at their centre. Demographic and medical history data will be collected from both groups at baseline. The primary outcome is condition‐specific quality of life at 18 months’ post-randomisation. Several secondary outcomes will also be assessed using participant-completed questionnaires. Questionnaires will be administered at baseline, 6, 12 and 18 months’ post-randomisation. An economic evaluation will be carried out alongside the trial to evaluate cost-effectiveness. A process evaluation will run parallel to the trial, the protocol for which is reported in a companion paper. Discussion The results of the trial will provide robust evidence of the effectiveness of pessary self-management compared to clinic based care in terms of improving women's quality of life, and of its cost-effectiveness.|
|Rights:||This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.|
|Notes:||Additional co-authors: Christine Hemming, Aethele Khunda, Helen Mason, Doreen McClurg, John Norrie, Anastasia Karachalia-Sandri, Ranee Thakar|
|s13063-020-04738-9.pdf||Fulltext - Published Version||958.46 kB||Adobe PDF||View/Open|
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