Bugge C (2017) Treatment of prolapse with self-care pessary: the TOPSY trial. [ISRCTN registry]. United Kingdom: Springer Nature. https://w3.abdn.ac.uk/hsru/topsy; https://doi.org/10.1186/isrctn62510577
Background and study aims
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. Two thirds of women initially choose a vaginal support pessary to treat their prolapse symptoms. It is usually fitted at a gynaecological clinic and the woman returns every 6 months to have it removed and changed. However, it is possible that women could remove, clean and reinsert their pessary themselves at home (self-management), thus offering them more confidence in their ability to maintain and improve their own health. The aim of this study is to assess if self-management of prolapse using a vaginal pessary is more effective at improving women's quality of life than standard follow up care.
Who can participate?
Women aged 18 and over with any severity or kind of prolapse who have successfully used a pessary for at least 2 weeks
What does the study involve?
Women are randomly allocated to either self-management or standard care. Women in the standard care group are seen every 6 months in a hospital or community clinic for pessary removal and reinsertion. Women in the self-management group have a 30-minute appointment with a specialist nurse or physiotherapist to ensure they know how to change and clean their pessary and to allow them time to practice. Women have a follow-up phone call 2 weeks after they have received the training to discuss any issues they may have. There is a telephone number that women can call throughout the study to report any issues or concerns they have. All women complete quality of life questionnaires at the start and at 6, 12 and 18 months. Information is collected to find out if self-management is more or less expensive for the NHS and for women. To help understand how and why aspects of self-management may/ may not work some self-management sessions are recorded and some women and health professionals are interviewed.
What are the possible benefits and risks of participating?
The support systems may help to manage the participants’ pelvic organ prolapse. Taking part in the study will not benefit the participant further but the information gained may help improve the treatment of women with pelvic organ prolapse. Pessaries are widely used in the NHS as treatment for pelvic organ prolapse. Both self-management and clinic-based care are already used within the NHS. Participation in the study is to help evaluate the support systems so no additional risks are expected. Women in the self-management group are asked to remove, clean and replace their pessary at least once every 6 months. They also receive a leaflet outlining possible complications to look out for. Some of the questions asked may seem personal but the information is important to help understand the study in full.
Where is the study run from?
St Mary's Hospital (UK)
When is the study starting and how long is it expected to run for?
November 2017 to July 2021
Who is funding the study?
Health Technology Assessment Programme (UK)
Who is the main contact?
Dr Carol Bugge
|Type of media||ISRCTN registry|
|Funders||Health Technology Assessment Programme|
|Place of publication||United Kingdom|