Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2024 May;28(23):1-121.
doi: 10.3310/NWTB5403.

Clinical and cost-effectiveness of pessary self-management versus clinic-based care for pelvic organ prolapse in women: the TOPSY RCT with process evaluation

Carol Bugge  1 , Suzanne Hagen  2 , Andrew Elders  2 , Helen Mason  3 , Kirsteen Goodman  2 , Melanie Dembinsky  4 , Lynn Melone  2 , Catherine Best  5 , Sarkis Manoukian  3 , Lucy Dwyer  6   7 , Aethele Khunda  8 , Margaret Graham  4 , Wael Agur  9 , Suzanne Breeman  10 , Jane Culverhouse  11 , Angela Forrest  11 , Mark Forrest  10 , Karen Guerrero  12 , Christine Hemming  13 , Doreen McClurg  2 , John Norrie  14 , Ranee Thakar  15 , Rohna Kearney  6   7
Affiliations
Randomized Controlled Trial

Clinical and cost-effectiveness of pessary self-management versus clinic-based care for pelvic organ prolapse in women: the TOPSY RCT with process evaluation

Carol Bugge et al. Health Technol Assess. 2024 May.

Abstract

Background: Pelvic organ prolapse is common, causes unpleasant symptoms and negatively affects women's quality of life. In the UK, most women with pelvic organ prolapse attend clinics for pessary care.

Objectives: To determine the clinical effectiveness and cost-effectiveness of vaginal pessary self-management on prolapse-specific quality of life for women with prolapse compared with clinic-based care; and to assess intervention acceptability and contextual influences on effectiveness, adherence and fidelity.

Design: A multicentre, parallel-group, superiority randomised controlled trial with a mixed-methods process evaluation.

Participants: Women attending UK NHS outpatient pessary services, aged ≥ 18 years, using a pessary of any type/material (except shelf, Gellhorn or Cube) for at least 2 weeks. Exclusions: women with limited manual dexterity, with cognitive deficit (prohibiting consent or self-management), pregnant or non-English-speaking.

Intervention: The self-management intervention involved a 30-minute teaching appointment, an information leaflet, a 2-week follow-up telephone call and a local clinic telephone helpline number. Clinic-based care involved routine appointments determined by centres' usual practice.

Allocation: Remote web-based application; minimisation was by age, pessary user type and centre.

Blinding: Participants, those delivering the intervention and researchers were not blinded to group allocation.

Outcomes: The patient-reported primary outcome (measured using the Pelvic Floor Impact Questionnaire-7) was prolapse-specific quality of life, and the cost-effectiveness outcome was incremental cost per quality-adjusted life-year (a specifically developed health Resource Use Questionnaire was used) at 18 months post randomisation. Secondary outcome measures included self-efficacy and complications. Process evaluation data were collected by interview, audio-recording and checklist. Analysis was by intention to treat.

Results: Three hundred and forty women were randomised (self-management, n = 169; clinic-based care, n = 171). At 18 months post randomisation, 291 questionnaires with valid primary outcome data were available (self-management, n = 139; clinic-based care, n = 152). Baseline economic analysis was based on 264 participants (self-management, n = 125; clinic-based care, n = 139) with valid quality of life and resource use data. Self-management was an acceptable intervention. There was no group difference in prolapse-specific quality of life at 18 months (adjusted mean difference -0.03, 95% confidence interval -9.32 to 9.25). There was fidelity to intervention delivery. Self-management was cost-effective at a willingness-to-pay threshold of £20,000 per quality-adjusted life-year gained, with an estimated incremental net benefit of £564.32 and an 80.81% probability of cost-effectiveness. At 18 months, more pessary complications were reported in the clinic-based care group (adjusted mean difference 3.83, 95% confidence interval 0.81 to 6.86). There was no group difference in general self-efficacy, but self-managing women were more confident in pessary self-management activities. In both groups, contextual factors impacted on adherence and effectiveness. There were no reported serious unexpected serious adverse reactions. There were 32 serious adverse events (self-management, n = 17; clinic-based care, n = 14), all unrelated to the intervention. Skew in the baseline data for the Pelvic Floor Impact Questionnaire-7, the influence of the global COVID-19 pandemic, the potential effects of crossover and the lack of ethnic diversity in the recruited sample were possible limitations.

Conclusions: Self-management was acceptable and cost-effective, led to fewer complications and did not improve or worsen quality of life for women with prolapse compared with clinic-based care. Future research is needed to develop a quality-of-life measure that is sensitive to the changes women desire from treatment.

Study registration: This study is registered as ISRCTN62510577.

Funding: This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 16/82/01) and is published in full in Health Technology Assessment; Vol. 28, No. 23. See the NIHR Funding and Awards website for further award information.

Keywords: COST–BENEFIT ANALYSIS; FEMALE; HEALTH CARE; HEALTH RESOURCES; HUMANS; INFORMED CONSENT; OUTCOME ASSESSMENT; OUTPATIENTS; PELVIC ORGAN PROLAPSE; PESSARIES; PROCESS EVALUATION; QUALITATIVE METHODS; QUALITY OF LIFE; QUALITY-ADJUSTED LIFE-YEARS; RANDOMISED CONTROLLED TRIAL; SELF-EFFICACY; SELF-MANAGEMENT; STATE MEDICINE.

Plain language summary

Pelvic organ prolapse is a common and distressing condition experienced by large numbers of women. Prolapse is when the organs that are usually in the pelvis drop down into the vagina. Women experience a feeling of something coming down into the vagina, along with bowel, bladder and sexual problems. One possible treatment is a vaginal pessary. The pessary is a device that is inserted into the vagina and holds the pelvic organs back in their usual place. Women who use a vaginal pessary usually come back to clinic every 6 months to have their pessary removed and replaced; this is called clinic-based care. However, it is possible for a woman to look after the pessary herself; this is called self-management. This study compared self-management with clinic-based care. Three hundred and forty women with prolapse took part; 171 received clinic-based care and 169 undertook self-management. Each woman had an equal chance of being in either group. Women in the self-management group received a 30-minute teaching appointment, an information leaflet, a 2-week follow-up telephone call and a telephone number for their local centre. Women in the clinic-based care group returned to clinic as advised by the treating healthcare professional. Self-management was found to be acceptable. Women self-managed their pessary in ways that suited their lifestyle. After 18 months, there was no difference between the groups in women’s quality of life. Women in the self-management group experienced fewer pessary complications than women who received clinic-based care. Self-management costs less to deliver than clinic-based care. In summary, self-management did not improve women’s quality of life more than clinic-based care, but it did lead to women experiencing fewer complications and cost less to deliver in the NHS. The findings support self-management as a treatment pathway for women using a pessary for prolapse.

PubMed Disclaimer

References

    1. Bugge C, Adams EJ, Gopinath D, Stewart F, Dembinsky M, Sobiesuo P, Kearney R. Pessaries (mechanical devices) for managing pelvic organ prolapse in women. Cochrane Database Syst Rev 2020; 11;CD004010; based on Bugge C, Adams L, Gopinath D,Reid F. Pessaries (mechanical devices) for pelvic organ prolapse in women. Cochrane Database Syst Rev 2013;2013:CD004010. - PMC - PubMed
    1. Cooper J, Annappa M, Dracocardos D, Cooper W, Muller S, Mallen C. Prevalence of genital prolapse symptoms in primary care: a cross-sectional survey. Int Urogynecol J 2015;26:505–10. - PubMed
    1. National Institute for Health and Care Excellence. Urinary Incontinence and Pelvic Organ Prolapse in Women: Management. 2019. URL: www.nice.org.uk/guidance/ng123 (accessed January 2022). - PubMed
    1. Wu JM, Kawasaki A, Hundley AF, Dieter AA, Myers ER, Sung VW. Predicting the number of women who will undergo incontinence and prolapse surgery, 2010 to 2050. Am J Obstet Gynaecol 2011;205:230.e1–5. - PMC - PubMed
    1. Gyhagen M, Åkervall S, Milsom I. Clustering of pelvic floor disorders 20 years after one vaginal or one cesarean birth. Int Urogynecol J 2015;26:1115–21. https://doi.org/10.1007/s00192-015-2663-3 - PubMed

Publication types