This is a plain English summary of an original research article. The views expressed are those of the author(s) and reviewer(s) at the time of publication.
Women who have pelvic organ prolapse may use a pessary to hold pelvic organs in place. Approximately every 6 months, pessaries are removed, cleaned, and reinserted (or replaced). This is usually carried out at an outpatient clinic or GP surgery; women can also do this themselves, at home (self-management).
A trial compared the two approaches and found that, compared with clinic-based care, self-management was associated with:
- a similar quality of life
- fewer complications
- lower costs to the NHS.
The findings suggest that self-management of pessaries is a good option for some women. To encourage this on a larger scale, more understanding is needed about the training clinicians may need to assist women, the researchers say.
More information on pelvic organ prolapse can be found on the NHS website.
Is pessary self-management as good as clinic-based care for pelvic organ prolapse?
Many women in the UK (up to 40%) have pelvic organ prolapse (when organs of the pelvis bulge into the vagina). Fewer (up to 10% of all women) report symptoms. Pelvic organ prolapse becomes more likely with pregnancy and childbirth, age, and being overweight. Prolapse can cause discomfort, problems emptying the bladder and bowel, and harm women’s quality of life.
The condition can be managed with surgery, but most women choose initially to have non-surgical treatment, such as a pessary. Women with a pessary either visit a clinic regularly to have the pessary checked and re-inserted (or replaced) or do this themselves at home (self-management).
Studies suggest that pessary self-management is more convenient, has fewer side-effects, and increases the likelihood that women will continue using a pessary. However, this is the first randomised controlled trial to compare the effectiveness and value for money of self-management, with clinic visits.
What’s new?
The findings were based on data from 340 women from 21 clinics in the UK who had used a pessary for at least two weeks. Half (169 women) were in the self-management group and half (171 women) in the clinic group. Their average age was 64 years and most participants (91%) were white.
The self-management group attended a 30-minute in person session, during which a clinician taught them to remove, clean and reinsert a pessary. They received an information leaflet, a 2-week follow-up call and further telephone support (if needed). The other group visited a clinic roughly every 6 months to have their pessary cleaned and reinserted.
The main outcomes were quality of life (questionnaire specific to pelvic floor issues) and cost-effectiveness (including GP and hospital appointments and prescriptions).
At 18 months, women in the self-management group:
- had a similar quality of life to women in the clinic group
- had fewer complications overall (17%) than the clinic group (22%)
- used fewer health care services (£578 per person on average) than the clinic group (£728 per person on average).
There were no serious adverse events related to pessary use in either group.
Quality of life was the same regardless of women’s age (older compared with younger than 65 years), whether or not they had their womb removed (hysterectomy), and/or took hormone therapy.
Why is this important?
Women who self-managed their pessaries had a similar quality of life and fewer complications than those who received clinic-based care. Self-management offered better value for money. The findings suggest that self-management could be routinely offered to those women who are physically and mentally able to self-manage.
The researchers suggest that complications in the self-management group may have been less frequent because women had more confidence in their ability to manage the pessary. For example, to take the pessary out, put it back in, or use it for shorter periods of time.
In interviews with women involved in the study (18 who self-managed and 18 who received clinic-based care), both women and clinicians reported that self-management was acceptable. One woman said, “I love being in control and being able to remove the pessary when I feel I need to.” It saved women a trip to the clinic: “Now, I can go annually. For me, that’s just so much easier in terms of my lifestyle.”
The teaching provided in pessary self-management, and the telephone support, was important to women and provided reassurance: “that gives you confidence… that you’re not totally abandoned.”
By 18 months, several participants (20%) had crossed over from the self-management to the clinic group, often because they struggled to insert or remove the pessary. This reflects routine practice, and implies that the benefits and savings among women who continued to self-manage may be greater than was shown in the trial. Women could not switch from the clinic group to self-management because they did not receive the teaching and telephone support.
Ethnic diversity in the trial sample was limited. It did not include women who could not speak English, lacked dexterity, or were pregnant. These findings may therefore not apply to these groups of women.
What’s next?
The researchers suggest that self-management could be rolled out across the UK. However, they say more research is needed for it to become routine practice. Clinicians may need more training to support women who want to self-manage their pessary.
Women in the study are being followed up after 4 years to compare long-term outcomes for pessary self-management and clinic-based care.
You may be interested to read
This is a summary of: Hagen S, and others. Clinical effectiveness of vaginal pessary self-management vs clinic-based care for pelvic organ prolapse (TOPSY): a randomised controlled superiority trial. eClinical Medicine 2023; 66. DOI: 10.1016/j.eclinm.2023.102326.
A video on managing vaginal prolapse with a pessary.
A leaflet on pelvic prolapse from the Royal College of Obstetricians and Gynaecologists and Pelvic, Obstetric and Gynaecological Physiotherapy.
An NIHR press release about the study.
A paper about self-management of vaginal pessaries: Bugge C and others. Does self-management of vaginal pessaries improve care for women with pelvic organ prolapse?. British Medical Journal 2021; 372. DOI: 10.1136/bmj.n310.
A paper about the development of the pessary self-management intervention: Dwyer L, and others. Theoretical and practical development of the TOPSY self-management intervention for women who use a vaginal pessary for pelvic organ prolapse. Trials 2022; 23. DOI: 10.1186/s13063-022-06681-3.
A paper about the cost-effectiveness of self-management and clinic-based care: Manoukian S, and others. Cost-effectiveness of two models of pessary care for pelvic organ prolapse: Findings from the TOPSY randomised controlled trial. Value in Health 2024. DOI:10.1016/j.jval.2024.03.004.
Information on taking part in NIHR research on pelvic prolapse.
Funding: This study was funded by the NIHR Health Technology Assessment programme.
Conflicts of Interest: Multiple authors report receiving fees and funding from pharmaceutical companies. See paper for full details.
Disclaimer: Summaries on NIHR Evidence are not a substitute for professional medical advice. They provide information about research which is funded or supported by the NIHR. Please note that the views expressed are those of the author(s) and reviewer(s) at the time of publication. They do not necessarily reflect the views of the NHS, the NIHR or the Department of Health and Social Care.
