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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

Authors
  • Hagen, Suzanne1
  • Kearney, Rohna2, 3
  • Goodman, Kirsteen1
  • Melone, Lynn1
  • Elders, Andrew1
  • Manoukian, Sarkis4
  • Agur, Wael5, 6
  • Best, Catherine7
  • Breeman, Suzanne8
  • Dembinsky, Melanie9
  • Dwyer, Lucy2, 3
  • Forrest, Mark8
  • Graham, Margaret10
  • Guerrero, Karen11
  • Hemming, Christine12
  • Khunda, Aethele13
  • Mason, Helen4
  • McClurg, Doreen1
  • Norrie, John14
  • Karachalia-Sandri, Anastasia1
  • And 2 more
  • 1 Research Unit, Glasgow Caledonian University, Glasgow, UK , Glasgow (United Kingdom)
  • 2 Manchester University Hospitals NHS Foundation Trust, Manchester Academic Health Science Centre, Manchester, UK , Manchester (United Kingdom)
  • 3 Faculty of Medical Human Sciences, University of Manchester, Manchester, UK , Manchester (United Kingdom)
  • 4 Glasgow Caledonian University, Glasgow, UK , Glasgow (United Kingdom)
  • 5 NHS Ayrshire & Arran, Crosshouse Hospital, Kilmarnock, UK , Kilmarnock (United Kingdom)
  • 6 University of Glasgow, Glasgow, UK , Glasgow (United Kingdom)
  • 7 University of Stirling Innovation Park, Stirling, UK , Stirling (United Kingdom)
  • 8 University of Aberdeen, Aberdeen, UK , Aberdeen (United Kingdom)
  • 9 University of Stirling, Stirling, UK , Stirling (United Kingdom)
  • 10 Patient and Public Involvement (PPI) representative, Dunlop, UK , Dunlop (United Kingdom)
  • 11 NHS Greater Glasgow & Clyde, Glasgow, UK , Glasgow (United Kingdom)
  • 12 Grampian University Hospitals NHS Trust, Aberdeen, UK , Aberdeen (United Kingdom)
  • 13 James Cook University Hospital, Middlesbrough, UK , Middlesbrough (United Kingdom)
  • 14 College of Medicine and Veterinary Medicine, The University of Edinburgh, Edinburgh, UK , Edinburgh (United Kingdom)
  • 15 Croydon University Hospital, Croydon, UK , Croydon (United Kingdom)
Type
Published Article
Journal
Trials
Publisher
Springer (Biomed Central Ltd.)
Publication Date
Oct 08, 2020
Volume
21
Issue
1
Identifiers
DOI: 10.1186/s13063-020-04738-9
Source
Springer Nature
Keywords
License
Green

Abstract

BackgroundPelvic 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.MethodsThis 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.DiscussionThe 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 registrationISRCTN Registry ISRCTN62510577. Registered on June 10, 2017.

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