Four Year Clinical and Cost Effectiveness of Vaginal Pessary Self‐Management Versus Clinic‐Based Care for Pelvic Organ Prolapse (TOPSY): Long Term Follow‐Up of a Randomised Controlled Superiority Trial
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Objective: To compare long‐term clinical and cost‐effectiveness of pessary self‐management (SM) with clinic‐based care (CBC) for pelvic floor‐specific quality of life (QoL). Design: Four‐year questionnaire follow‐up of trial participants. Setting: UK pessary clinics. Sample: Responders at 4 years aged ≥ 18 years at recruitment, using a pessary (except Shelf, Gellhorn or Cube) which had been retained ≥ 2 weeks. Exclusions: limited manual dexterity; cognitive deficit; pregnancy; requiring non‐English SM teaching. Methods: SM group received a 30‐min teaching session; information leaflet; 2‐week follow‐up call; and telephone support. CBC group received routine appointments. Allocation was by remote web‐based application, minimised on age, user type (new/existing) and centre with no blinding. Participants were invited to opt into a 4‐year follow‐up. The primary analysis was intention to treat. Outcome Measures: The primary outcomes were pelvic floor‐specific QoL (PFIQ‐7) and incremental net monetary benefit (INB) 4 years post‐randomisation. Secondary outcomes included complications and prolapse symptoms. Results: Of 340 women randomised, 186 (55%) responded at 4 years (86/169 [51%] SM, 100/171 [58%] CBC). There was no statistically significant group difference in PFIQ‐7 at 4 years (mean SM 32.9 vs. CBC 31.4, adjusted mean difference [AMD] SM‐CBC 4.86, 95% CI −6.41 to 16.12). There was a statistically non‐significant lower percentage of pessary complications for SM (SM 17.7% vs. CBC 22.0%, AMD 3.01 CI −0.58 to 6.61). At 4‐years, SM was cost‐effective (INB £2240). There was one potentially related serious adverse event (SM group). Conclusions: Pessary self‐management is an effective and cost‐effective long‐term option for women with prolapse. Trial Registration: ISRCTN number: 62510577 (https://doi.org/10.1186/ISRCTN62510577)
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In the TOPSY trial, there were significant cost savings to the healthcare system with self-management having an incremental net benefit of £564 UK at 18 months.
“There were significant cost savings to the healthcare system with self‐management having an incremental net benefit of £564 UK at 18 months [43, 44].”
From How Can We Improve the Assessment and Indifferent Outcomes From Pelvic Organ Prolapse Management From Conservative and Surgical Therapies? ICI‐RS 2025 (2026) · cites this paper as [44]
The Results > Cost-Effectiveness section reports significantly different resource use through 18 months and says self-management was less costly than clinic-based care. It does not report an incremental net benefit of £564 at 18 months; its reported £2,240 net benefit is for the four-year follow-up. Page numbers are unavailable in our copy. (LLM, conf=0.87)
Experimental — accuracy not yet measuredIn the TOPSY trial, women who self-managed their pessary had a similar quality of life but experienced fewer pessary-associated complications than women who attended a clinic, when assessed at 18 months and at 4 years.
“The TOPSY trial compared self‐management of pessary for prolapse symptoms with clinic‐based care and reported that women who self‐managed had a similar quality of life but experienced fewer pessary‐associated complications than women who attended a clinic, when assessed at 18 months and at 4 years.”
From How Can We Improve the Assessment and Indifferent Outcomes From Pelvic Organ Prolapse Management From Conservative and Surgical Therapies? ICI‐RS 2025 (2026) · cites this paper as [44]
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“There were significant cost savings to the healthcare system with self‐management having an incremental net benefit of £564 UK at 18 months [43, 44].”
Self-citation
- Authors
- Bugge, C., Kearney, R., Best, C., Goodman, K., Manoukian, S., Melone, L., Dembinsky, M., Mason, H., Elders, A., Graham, M., Agur, W., Breeman, S., Culverhouse, J., Dwyer, L., Forrest, M., Guerrero, K., Hemming, C., Khunda, A., Kucher, A., McClurg, D., Norrie, J., Thakar, R., & Hagen, S.
- Affiliations
- Glasgow Caledonian University (GB)
- Manchester Academic Health Science Centre (GB)
- University of Stirling (GB)
- University of Aberdeen (GB)
- PPI Representative Glasgow UK
- NHS Ayrshire and Arran (GB)
- NHS Greater Glasgow and Clyde (GB)
- Aberdeen Royal Infirmary (GB)
- James Cook University Hospital (GB)
- Queen's University Belfast (GB)
- St George's, University of London (GB)
- Corresponding author
- Bugge, Carol
- ORCID
- Venue
- BJOG: An International Journal of Obstetrics & Gynaecology
- Publisher
- Wiley
- Published
- 2025-08-20
- Volume
- 132
- Issue
- 12
- Pages
- 1762-1771
- ISSN
- 0306-5456 (ISSN-L)
- 1470-0328
- 1471-0528
- PMC
- PMC12501713
- OpenAlex
- W4413337630
- Cited by
- 6
- References
- 44
- Citations by year
- 2026: 5 · 2025: 1
- FWCI
- 4.34
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- Locations
- BJOG An International Journal of Obstetrics & Gynaecology (publishedVersion, cc-by)
- Europe PMC (PubMed Central) (publishedVersion, cc-by)
- PubMed (publishedVersion)
- PubMed Central (publishedVersion, cc-by)
- ResearchOnline (acceptedVersion, cc-by)
- Research Portal (Queen's University Belfast) (submittedVersion, cc-by)
- ResearchOnline (Glasgow Caledonian University) (submittedVersion, cc-by)
- Funders
- National Institute for Health and Care Research
- Health Technology Assessment Programme
- Topics
- Health Sciences › Medicine › Rheumatology › Pelvic floor disorders treatments
- Health Sciences › Medicine › Psychiatry and Mental health › Sexual function and dysfunction studies
- Health Sciences › Medicine › Obstetrics and Gynecology › Uterine Myomas and Treatments
- Keywords
- pessary, pelvic organ prolapse, self-management, clinic-based care, cost-effectiveness, quality of life, PFIQ-7, pessary complications, long-term follow-up, telephone support, women's health services, incremental net monetary benefit, serious adverse events, pelvic floor dysfunction
- MeSH terms
- Self-Management, Cost-Effectiveness Analysis, Adult, Aged, Cost-Benefit Analysis, Female, Follow-Up Studies, United Kingdom, Humans, Middle Aged, Pessaries, Quality of Life, Surveys and Questionnaires, Treatment Outcome, Pelvic Organ Prolapse
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