University of Stirling researchers will explore the clinical and cost effectiveness of an innovative self-management programme designed to help improve the lives of women with pelvic organ prolapse.
The study – involving Glasgow Caledonian University (GCU) and Manchester University NHS Foundation Trust (MFT) – will enable academics to assess the long-term outcomes of women who followed a new self-care programme and compare them with those who received standard treatment. Involving more than 300 women, it will also consider how pessaries affect sexual activity and psychological wellbeing and consider the risks and complications of pessary use for prolapse.
Dr Carol Bugge, of the Faculty of Health Sciences and Sport at Stirling, is leading the study – a two-year extension of the existing £1.2 million Treatment of Prolapse with Self-care Pessary (TOPSY) trial, funded by the National Institute for Health Research.
Dr Bugge said: “Pelvic organ prolapse is a common condition that adversely impacts the quality of life of women, however, research on pessary care is limited. This extension to our study will consider how self-management of the condition affects clinical outcomes and quality of life over the long term, compared to those who follow the standard treatment pathway. We will also consider the cost-effectiveness of self-management over the standard approach.
“Importantly, the research will provide evidence to address one of the top 10 uncertainties for pessary care as identified by the James Lind Alliance, a partnership which brings together clinicians, patients, and carers to agree research priorities on healthcare treatment.”
Dr Carol Bugge is leading the study.
Pelvic organ prolapse is very common, affecting about 40 per cent of women over 40 years of age, and occurs when pelvic organs – the bladder, bowel or womb – descend into the vagina, causing distressing symptoms that adversely affect quality of life. Two-thirds of affected women initially choose to be fitted with a medical device known as a pessary, which sits inside the vagina and helps to support the pelvic organs. The procedure is typically carried out at a gynaecological clinic or GP surgery and patients return approximately every six months to have the pessary replaced.
Since 2017, Dr Bugge has led the TOPSY study to assess an alternative self-management approach, where women remove and reinsert the pessary themselves at home – aiming to give patients more control and confidence over their health. The findings of the original study will be available later this year – and the new two-year extension will enable researchers to assess women four years after they started the trial, to consider the long-term impact of the self-management approach.
Professor Suzanne Hagen, of GCU, is co-chief investigator of the study. She said: “It is so important to have extended follow up in clinical trials like this so we can monitor how things change further down the line. To have funding to approach participants again after four years is quite unusual but very valuable. From the data collected we will be able to tell whether pessary self-management is an effective strategy in the long term.”
Fellow co-chief investigator, Dr Rohna Kearney, Consultant Urogynaecologist at MFT’s Saint Mary’s Hospital, added: “We welcome the opportunity to capture longer term outcomes of self-management of vaginal pessaries for prolapse. This will provide important information on the safety, efficacy and acceptability of self-management on continuation of pessary use and need for surgical intervention.”