Study explores self-management treatment for pelvic organ prolapse
Researchers at Saint Mary’s Hospital will explore the effectiveness of an innovative new self-management programme for women with pelvic organ prolapse.
The Treatment of Prolapse with Self-care Pessary (TOPSY) study – led by the University of Stirling in collaboration with Manchester University NHS Foundation Trust (MFT) and Glasgow Caledonian University (GCU) – 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, including those recruited at Saint Mary’s Hospital – part of MFT, it will also consider how pessaries – a latex or silicone device inserted into the vagina to support the vaginal walls and pelvic organs – affect women’s sexual activity and psychological wellbeing, and consider the risks and complications of their use for prolapse.
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 pessary, with the procedure typically carried out at a gynaecological clinic or GP surgery and the device replaced approximately every six months.
Dr Carol Bugge, Associate Professor of Health Sciences at Stirling, is leading the study – a two-year extension of the existing £1.2 million TOPSY trial and funded by the National Institute for Health Research (NIHR).
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.”
Since 2017, the TOPSY study has assessed 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.
Dr Rohna Kearney, Consultant Urogynaecologist at Saint Mary’s Hospital and TOPSY co-Chief investigator, 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.”
The Warrell Unit team at Saint Mary’s Hospital, working with colleagues across gynaecology and community gynaecology, recruited 50 women for the study. The self-management intervention was developed by Urogynaecology Specialist Nurse Lucy Dwyer, who is a co-applicant on the study, and Dr Kearney, while Urogynaecology Specialist Nurses Jane Smith and Angela Bryant supported the research team in teaching women self-management. Lucy is also now undertaking an NIHR funded PhD research programme exploring the barriers and facilitators for pessary self-management.
Fellow co-Chief Investigator, Professor Suzanne Hagen, Professor of Health Services Research at GCU, 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.”
Read more about research at Saint Mary’s Hospital on the Research and Innovation website.