Researchers at the University of Stirling will explore the clinical and economic effectiveness of an innovative self-management program 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 allow academics to assess the long-term outcomes of women who have completed a new self-care program and compared to those who received standard treatment. Involving more than 300 women, it will also examine how pessaries affect sexual activity and psychological well-being and examine the risks and complications of using pessaries for prolapse.
Dr Carol Bugge, from the Faculty of Health and Sport Sciences, Stirling, is leading the study – a two-year extension of the existing £1.2million trial of prolapse treatment with a pessary. Self-Care (TOPSY), funded by the National Institute for Health Research.
Dr Bugge said: ‘Pelvic organ prolapse is a common condition that negatively impacts women’s quality of life, however, research into pessary care is limited. This extension of our study will examine how self-management of illness affects long-term clinical outcomes and quality of life, compared to those following the standard treatment pathway. We will also examine the cost-effectiveness of self-management compared to the standard approach.
“Importantly, the research will provide evidence to address one of the top 10 uncertainties regarding pessary care, as identified by the James Lind Alliance, a partnership that brings together clinicians, patients and caregivers to agree priorities for health treatment research.
Dr. Carol Bugge is leading the study.
Pelvic organ prolapse is very common, affecting around 40% of women over the age of 40, and occurs when the pelvic organs – the bladder, intestines or uterus – descend into the vagina, causing distressing symptoms that affect life quality. Two-thirds of affected women initially choose to be fitted with a medical device called a pessary, which sits inside the vagina and helps support the pelvic organs. The procedure is usually performed in a gynecological clinic or doctor’s office and patients return approximately every six months to have the pessary replaced.
Since 2017, Dr. Bugge has been leading the TOPSY study to evaluate an alternative self-management approach, where women remove and reinsert the pessary themselves at home – aimed at giving patients more control and confidence over their health. Results from the original study will be available later this year – and the new two-year extension will allow researchers to assess women four years after the start of the trial, to examine the long-term impact of the self-management approach.
Monitoring
Professor Suzanne Hagen, from GCU, is co-chief investigator of the study. She said: “It’s so important to have extended follow-up in clinical trials like this so we can monitor how things change later. Having funding to re-approach participants after four years is quite unusual but very valuable. From the data collected, we will be able to say whether self-management of the pessary is an effective long-term strategy.
Co-Chief Investigator Dr Rohna Kearney, Consultant Urogynecologist at MFT’s Saint Mary’s Hospital, added: “We welcome the opportunity to capture the longer-term outcomes of self-administered vaginal pessaries for the prolapse. This will provide important information about the safety, effectiveness, and acceptability of self-management on continued pessary use and the need for surgery.
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