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

Trials

Christine Hemming¹  Ranee Thakar²  Karen Guerrero³  Melanie Dembinsky⁴  Carol Bugge⁴  Mark Forrest⁵  Suzanne Breeman⁵  Wael Agur⁶  Catherine Best⁷  Margaret Graham⁸  Kirsteen Goodman⁹  Lynn Melone⁹  Anastasia Karachalia-Sandri⁹  Andrew Elders⁹  Doreen McClurg⁹  Suzanne Hagen⁹  Aethele Khunda^1,10  Lucy Dwyer^1,11  Rohna Kearney^1,11  John Norrie^1,12  Helen Mason^1,13  Sarkis Manoukian^1,13 

[1] Aberdeen Maternity Hospital & Aberdeen Royal Infirmary, Grampian University Hospitals NHS Trust, Aberdeen, UK;Croydon Health Services NHS Trust, Croydon University Hospital, Croydon, UK;Department of Urogynaecology, NHS Greater Glasgow & Clyde, Glasgow, UK;Health Sciences & Sport, University of Stirling, Stirling, UK;Health Services Research Unit (HSRU), University of Aberdeen, Aberdeen, UK;NHS Ayrshire & Arran, Crosshouse Hospital, Kilmarnock, UK;School of Medicine, Dentistry & Nursing, University of Glasgow, Glasgow, UK;NMAHP Research Unit, unit 13 Scion House, University of Stirling Innovation Park, Stirling, UK;Patient and Public Involvement (PPI) representative, Dunlop, UK;Research Unit, Glasgow Caledonian University, Glasgow, UK;South Tees Hospitals NHS Foundation Trust, James Cook University Hospital, Middlesbrough, UK;The Warrell Unit, St. Mary’s Hospital, Manchester University Hospitals NHS Foundation Trust, Manchester Academic Health Science Centre, Manchester, UK;University Institute of Human Development, Faculty of Medical Human Sciences, University of Manchester, Manchester, UK;Usher Institute of Population Health Sciences and Informatics, College of Medicine and Veterinary Medicine, The University of Edinburgh, Edinburgh, UK;Yunus Centre for Social Business and Health, Glasgow Caledonian University, Glasgow, UK;

关键词: Prolapse;    Pessary;    Self-management;    Quality of life;    Economic evaluation;    Randomised controlled trial (RCT);   

DOI  :  10.1186/s13063-020-04738-9

来源: Springer

【 摘 要 】

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.

【 授权许可】

CC BY