New research has shown that self-management of a pessary used to treat pelvic organ prolapse in women leads to fewer complications and could save the NHS money while maintaining quality of life.
The findings of this large clinical study, carried out by experts from Glasgow Caledonian University School of Health and Life Sciences’ Research Centre for Health (ReaCH) and funded by the National Institute for Health and Care Research (NIHR), is great news for the 40% of women over 50 in the UK who suffer from this condition.
Pelvic organ prolapse is a common condition that can be distressing to women. One treatment option for prolapse is a vaginal pessary. The pessary is inserted into the vagina and holds the prolapsed organs back in place.
In the UK, most women who use a pessary attend clinics for their care and have to return every six months for check-ups. However, lead researchers Professors Carol Bugge and Suzanne Hagen have identified big benefits from pessary self-management.
The six-year £1.1million study, Treatment of Prolapse with Self-Care Pessary (TOPSY), involved 340 women of all ages from 21 NHS centres across the UK and the results could change the lives of thousands of women with pelvic organ prolapse.
Professor Bugge said: “This research is great news for women in the UK who suffer from prolapse because it shows that women can safely self-manage their pessary from home. No matter their age, they may experience fewer complications and there will be less cost to the NHS in the long-run by freeing up appointments.
“Pessaries are a very commonly-used treatment in the NHS and the mainstay of treatment is that women have to return to clinics roughly every six months, which can be inconvenient and costly. This is why we have been looking into self-management for women. Our belief is that by giving the control of their health back to the women it would make their quality of life better.
“We are reaching out to women and healthcare professionals who provide pessary care with these results, so they can see that self-management is a valid option for them. It offers safety, it doesn’t worsen their quality of life, there are fewer complications and for services, it costs less and it frees appointments.”
Minister for the Women’s Health Strategy, Maria Caulfield, described the research findings as “an important step for women to manage their ongoing care for pelvic organ prolapse in the comfort of their own homes. It means women can continue to live their lives as usual and reduces the need for frequent visits to see clinicians.”
She added: “We recently announced a nationwide pelvic health service, backed by £11 million, to come into effect in 2024, while a £25 million investment into women’s health hubs is already improving access to diagnosis and treatment for conditions including pelvic organ prolapse.
“Research is a core part of our first-ever Women’s Health Strategy for England and is why between April 2022 and July 2023 we invested £53 million into the NIHR to focus specifically on research into women’s health issues.”
The trial involved a large collaborative team including Chief Investigator Professor Bugge and co-Chief Investigators Professor Hagen, from the University’s School of Health and Life Sciences’ Nursing, Midwifery and Allied Health Professions Research Unit, and Dr Rohna Kearney, of Saint Mary’s Hospital at Manchester University NHS Foundation Trust.
It is hoped self-management can be rolled out more widely across the UK but more research is needed into how it can be made routine practice.
Professor Bugge, who first began the study when working at the University of Stirling, explained: “We have created materials that help train health professionals in self-management. Practitioners need to have the skills to teach patients how to self-manage and that’s why we need more research to look into how best to make this happen on a larger scale.”
Professor Hagen added: “This was a very large unique trial and the first in its field. We have really made an excellent contribution to the evidence for prolapse management. It was a fully-powered trial with enough participants involved to give us robust answers. It was also diverse in terms of the age ranges of the women involved and their geographical location within the UK.”
Margaret Graham, 63, from Ayrshire, who has been using a pessary for the past 10 years for prolapse and was a patient representative in the study, said she was “impressed and amazed” at the rigour and care taken in the research. Margaret’s research paper about her involvement is here.
Margaret said: “It’s so important that women are presented and supported with as many options as possible for what can be nearly another half of their lives. I was really delighted when I was presented with the option of a pessary for this condition. I was gobsmacked that this simple silicone donut-shaped thing worked. I thought the only option was surgery and it was terrifying.
“The results of this study could really change thousands of women’s lives if a self-management programme was rolled out because it’s safer, has less complications and stops the need to attend clinics as often.”
Professor Andrew Farmer, Director of NIHR’s Health Technology Assessment (HTA) Programme, which funded the research, said: “These findings will undoubtedly be hugely encouraging for the many women affected by pelvic organ prolapse. The results once again highlight the continued contribution of evidence from high-quality independent research in transforming health and social care treatments and practice.”
The research paper, entitled Clinical effectiveness of vaginal pessary self‐management versus clinic-based care for pelvic organ prolapse (TOPSY): a randomised controlled superiority trial, has been published in The Lancet eClinicalMedicine journal.
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