Funded by the NIHR and led by the University of Stirling, this research is the first to look at self-management of pessaries for prolapse.
The management options in the past have been surgical or non-surgical, with women encouraged to improve pelvic floor tone as a first line option. If this is not sufficient, then either non-surgical intervention with vaginal pessaries, or a referral for surgical repair is required.
The training required to fit pessaries, the ability to review women regularly and the cost of delivering such a service can all be barriers to delivery from the healthcare side. For patients, needing to attend regularly for review appointments and pessary changes can be off-putting and logistically challenging. The TOPSY trial (Treatment of Prolapse with Self-Care Pessary) looked at how self-management of pelvic organ prolapse affected clinical outcomes and quality of life, compared to standard treatment, with cost effectiveness of self-management also considered.
Based in the UK, 340 women from 12 different clinical settings were randomly allocated into a self-management group, and a clinic group. The mean age was 63yrs old, and a range of pessary types, sizes and materials were used across both groups. The self-management group attended a 30 minute in-person session where they were taught how to remove, clean and re-insert a pessary. They were given an information leaflet, had a follow up call after 2 weeks, and contact details for their local clinical centre provided. Women in the clinic group received usual care, with pessary removal, cleaning and reinsertion being done by a healthcare professional. Although the frequency of appointments was decided by each centre, the median pessary change interval was 186 days (around 6 months) in this group.
The primary outcomes at 18 months were pelvic-floor specific quality of life measured using validated questionnaires, and cost effectiveness looking at net monetary benefit over the same period. The research found that women in the self-management group had similarly improved quality of life scores to those in the clinic group, with fewer complications (17% vs 22%), and used fewer healthcare services over the same period (costs of £578 per person average vs £728 per person). There were no serious adverse events in either group, and the quality-of-life outcomes were regardless of women’s age, whether or not they had a hysterectomy, and/or took hormone replacement therapy. While the study will continue until 4 year follow-up is completed, these results confirm the 2021 recommendation from the UK Clinical Guideline on the use of Vaginal Pessaries, that women who are physically and mentally able to self-manage should be offered this option. It also contains some useful patient resources and further detail that is well worth a read if this is something you might consider in your patient population. This is the first research published looking at self-management of pelvic organ prolapse in this way and offers a viable alternative to support women while reducing complications and cost. The NB team are always interested in when research becomes reality. If this is something you’re already doing in your surgery, or considering doing, get in touch and let us know and if you are looking for a more in depth review of Women's Health topics join us for the brand new Women's Health course.
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