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

• Published in: Current controlled trials in cardiovascular medicine Vol. 21; no. 1; p. 837
• Main Authors: Hagen, Suzanne, Kearney, Rohna, Goodman, Kirsteen, Melone, Lynn, Elders, Andrew, Manoukian, Sarkis, Agur, Wael, Best, Catherine, Breeman, Suzanne, Dembinsky, Melanie, Dwyer, Lucy, Forrest, Mark, Graham, Margaret, Guerrero, Karen, Hemming, Christine, Khunda, Aethele, Mason, Helen, McClurg, Doreen, Norrie, John, Karachalia-Sandri, Anastasia, Thakar, Ranee, Bugge, Carol
• Format: Journal Article
• Language: English
• Published: London BioMed Central Ltd 08.10.2020; BioMed Central; BMC
• Subjects: Care and treatment; Comparative analysis; Cost analysis; Economic evaluation; Health sciences; Health services; Hospitals; Pelvic organ prolapse; Pessary; Prolapse; Prostheses and implants; Quality of life; Randomised controlled trial (RCT); Self care (Health); Self-management; Study Protocol; Surgery; Testing; Uterine prolapse; Vagina; Women; Women's health services; United Kingdom; United Kingdom > UK
• ISSN: 1745-6215; 1745-6215
• DOI: 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 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.