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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

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  • Suzanne Hagen
  • Rohna Kearney
  • 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
  • Anastasia Karachalia-sandri
  • Ranee Thakar
  • Carol Bugge

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https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-020-04738-9
Original languageEnglish
JournalTrials
Volume21
Issue number1
DOIs
Publication statusPublished - 8 Oct 2020

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.

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