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
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
Affiliations
Suzanne Hagen
Research Unit, Glasgow Caledonian University
Rohna Kearney
The Warrell Unit, St. Mary’s Hospital, Manchester University Hospitals NHS Foundation Trust, Manchester Academic Health Science Centre
Kirsteen Goodman
Research Unit, Glasgow Caledonian University
Lynn Melone
Research Unit, Glasgow Caledonian University
Andrew Elders
Research Unit, Glasgow Caledonian University
Sarkis Manoukian
Yunus Centre for Social Business and Health, Glasgow Caledonian University
Wael Agur
NHS Ayrshire & Arran, Crosshouse Hospital
Catherine Best
NMAHP Research Unit, unit 13 Scion House, University of Stirling Innovation Park
Suzanne Breeman
Health Services Research Unit (HSRU), University of Aberdeen
Melanie Dembinsky
Health Sciences & Sport, University of Stirling
Lucy Dwyer
The Warrell Unit, St. Mary’s Hospital, Manchester University Hospitals NHS Foundation Trust, Manchester Academic Health Science Centre
Mark Forrest
Health Services Research Unit (HSRU), University of Aberdeen
Margaret Graham
Patient and Public Involvement (PPI) representative
Karen Guerrero
Department of Urogynaecology, NHS Greater Glasgow & Clyde
Christine Hemming
Aberdeen Maternity Hospital & Aberdeen Royal Infirmary, Grampian University Hospitals NHS Trust
Aethele Khunda
South Tees Hospitals NHS Foundation Trust, James Cook University Hospital
Helen Mason
Yunus Centre for Social Business and Health, Glasgow Caledonian University
Doreen McClurg
Research Unit, Glasgow Caledonian University
John Norrie
Usher Institute of Population Health Sciences and Informatics, College of Medicine and Veterinary Medicine, The University of Edinburgh
Anastasia Karachalia-Sandri
Research Unit, Glasgow Caledonian University
Ranee Thakar
Croydon Health Services NHS Trust, Croydon University Hospital
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.
