New research has shown that empowering women to self-manage a common treatment for pelvic organ prolapse – a vaginal pessary – leads to fewer complications, while maintaining quality of life and could save the NHS more than £560 per patient.
Delivered by researchers from Manchester University NHS Foundation Trust (MFT), led by 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), the results are great news for the 40 per cent of women over the age of 40 in the UK, living with this condition.
Fifty women attending clinics at Saint Mary’s Hospital and Withington Hospital, both part of MFT, participated in the research which compared self-management of a vaginal pessary for pelvic organ symptoms, to hospital clinic care.
Pelvic organ prolapse occurs when pelvic organs – the bladder, bowel or womb – descend into the vagina, causing distressing symptoms, including pain and discomfort, that adversely affect quality of life. A commonly used treatment option for prolapse in the NHS, is a pessary, a soft, removable PVC or silicone device inserted into the vagina that holds the prolapsed organs back in place.
Study participants, who had an average age of 63, were assigned at random to either pessary self-management or clinic-based care (which usually involves regular six-monthly replacement appointments).
Women in the self-management group received a 30-minute teaching session on removing, cleaning and replacing the pessary with a specialist nurse or physiotherapist; information leaflet; two-week follow-up call and telephone support.
Gill, 62 from Glossop has been using a pessary for more than eight years for pelvic organ prolapse. She was invited to take part in the research whilst attending her regular six month check at Saint Mary’s Hospital, where she is a patient and was assigned to the self-management group.
Gill said: “When I was diagnosed with the condition, I really didn’t want to have surgery, if possible. Using a pessary has been successful for me but travelling to Saint Mary’s Hospital every six months, seemed to come up so frequently and was quite a time commitment.
“I wanted to take part in this study because it would give me back some of my time, requiring less visits and could also free up NHS appointments for other patients.
“However, what I discovered is that taking part in this study gave me autonomy over own body, which was very empowering. What’s great about this research is that it is helping to give women more choices about managing this condition in a way that suits them and helps to give them control of their own bodies.”
The six-year £1.1million study, “Treatment of Prolapse with Self-Care Pessary (TOPSY)”, funded by the National Institute for Health and Care Research (NIHR), involved 340 women with pelvic organ prolapse from 21 NHS centres across the UK and identified significant benefits from pessary self-management.
Dr Rohna, Kearney, Consultant Urogynaecologist, and co-Chief Investigator for the TOPSY study, said: “This research is fantastic news for women in the UK who suffer from prolapse because it demonstrates that self-management of vaginal pessary use is effective and is associated with less complications than clinic-based care.
“This was a very large, unique trial and the first in its field. I would like to thank our participants and the Saint Mary’s MCS research team for their key contribution to the delivery of this important research.
“We see approximately 1,200 new patients each year for prolapse symptoms and 750 women attend our nurse-led pessary clinic at MFT each year. Research is ongoing to look at longer term outcomes and more research is needed into how self-management can be supported into routine practice.”
It is hoped self-management can be rolled out more widely across the UK, but more research is needed into how it can be supported into routine practice.”
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.”
Professor Bugge, Chief Investigator for the TOPSY study, Glasgow Caledonian University said: “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.”
The research paper, “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.