A new £1.1million trial led by the University of Stirling will assess whether a self-management program could help to improve the lives of women who suffer pelvic organ prolapse.
Pelvic organ prolapse is very common, affecting about 40 percent 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 gynecological clinic or GP surgery and patients return approximately every six months to have the pessary replaced.
It is possible that women could remove and reinsert their pessary themselves at home, thus offering them more control and confidence in their ability to maintain and improve their own health. Research into self-management in other clinical domains has indicated such an option can help improve the confidence and quality of life of patients.
The new research, Treatment of Prolapse with Self-Care Pessary, is funded by the National Institute for Health Research. It will assess if self-management is more effective at improving women's quality of life compared to standard care.
Chief Investigator Dr Carol Bugge, of the University of Stirling's Faculty of Health Sciences and Sport, said: "Pelvic organ prolapse is a common condition which can have a detrimental impact on the quality of life of women around the world.
"Many of those affected use pessaries to manage their condition and often they return to a clinic approximately every six months to have their pessary removed and replaced.
"Research has indicated that patients in other clinical domains can experience greater confidence and control if they are given the chance to manage their health at home and this trial will investigate whether that is the case in women with pelvic organ prolapse who use a pessary."
The trial involves a large collaborative team including co-Chief Investigators, Professor Suzanne Hagen, of The Nursing Midwifery and Allied Health Professions Research Unit at Glasgow Caledonian University, where the trial office will be situated, and Dr Rohna Kearney, of Saint Mary's Hospital at Manchester University NHS Foundation Trust, who will lead on the self-management intervention. It will complete in 2021.
Professor Hagen said: "We are delighted to be able to build on the experience at our unit to answer a question we know is important to women with a pessary."
Women who are aged 18 and over, have suffered a prolapse of any type or severity and have successfully used a pessary for at least two weeks, will be invited to participate in the trial.
There will be 330 women recruited over a 15-month period and they will be allocated, at random, to either standard care or self-management. Women in the standard care group will be seen at regular intervals at clinic, while those in the self-management group will have a 30-minute teaching appointment with a specialist health professional who will teach them how to remove, clean and re-insert their pessary.
All women will be asked to complete a questionnaire at the beginning of the study and then, six, 12 and 18 months later; and all women will be asked to attend a review appointment at 18 months.
This will help scientists to assess the impact of their care process on their quality of life.
Interviews will also be carried out with some women and health professionals, while the study will also gather cost information to determine whether self-management is more or less expensive than standard pessary care for the NHS and for women.
Dr Kearney, Consultant Urogynaecologist said: "We are delighted that Manchester University NHS Foundation Trust is involved in this study as it addresses a very important question for our patients considering or using a pessary to manage their prolapse symptoms".
Dr Bugge added: "We hope our work will make a tangible difference to women with prolapse by providing robust evidence about whether self-management is a means to improve their quality of life."