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Published in: Trials 1/2020

Open Access 01-12-2020 | Care | Study protocol

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

Authors: Suzanne Hagen, Rohna Kearney, Kirsteen Goodman, Lynn Melone, Andrew Elders, Sarkis Manoukian, Wael Agur, Catherine Best, Suzanne Breeman, Melanie Dembinsky, Lucy Dwyer, Mark Forrest, Margaret Graham, Karen Guerrero, Christine Hemming, Aethele Khunda, Helen Mason, Doreen McClurg, John Norrie, Anastasia Karachalia-Sandri, Ranee Thakar, Carol Bugge

Published in: Trials | Issue 1/2020

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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 6 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.

Trial registration

ISRCTN Registry ISRCTN62510577. Registered on June 10, 2017.
Appendix
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Metadata
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
Authors
Suzanne Hagen
Rohna Kearney
Kirsteen Goodman
Lynn Melone
Andrew Elders
Sarkis Manoukian
Wael Agur
Catherine Best
Suzanne Breeman
Melanie Dembinsky
Lucy Dwyer
Mark Forrest
Margaret Graham
Karen Guerrero
Christine Hemming
Aethele Khunda
Helen Mason
Doreen McClurg
John Norrie
Anastasia Karachalia-Sandri
Ranee Thakar
Carol Bugge
Publication date
01-12-2020
Publisher
BioMed Central
Keyword
Care
Published in
Trials / Issue 1/2020
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-020-04738-9

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