Journal Article

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

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

2020

Overview

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.

• Publisher: BioMed Central,BioMed Central Ltd,Springer Nature B.V,BMC
• Subject: Biomedicine / Care and treatment / Comparative analysis / Cost analysis / Cost-Benefit Analysis / Economic evaluation / Female / Health Sciences / Health services / Hospitals / Humans / Medicine / Medicine & Public Health / Multicenter Studies as Topic / Pelvic organ prolapse / Pelvic Organ Prolapse - diagnosis / Pelvic Organ Prolapse - therapy / Pessaries / Pessary / Prolapse / Prostheses and implants / Quality of Life / Randomised controlled trial (RCT) / Randomized Controlled Trials as Topic / Self care (Health) / Self-Management / Statistics for Life Sciences / Study Protocol / Surgery / Testing / Treatment Outcome / Uterine prolapse / Vagina / Women / Women's health services