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Cited by 29Pelvic floor disorders treatmentsUterine Myomas and TreatmentsSexual function and dysfunction studies

Clinical effectiveness of vaginal pessary self-management vs clinic-based care for pelvic organ prolapse (TOPSY): a randomised controlled superiority trial

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Hagen, Suzanne, Kearney, Rohna, Goodman, Kirsteen, Best, Catherine, Elders, Andrew, Melone, Lynn, Dwyer, Lucy, Dembinsky, Melanie +15 more·2023·eClinicalMedicine
DOI 10.1016/j.eclinm.2023.102326PMC PMC10701109
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Abstract

Background: Prolapse affects 30-40% of women. Those using a pessary for prolapse usually receive care as an outpatient. This trial determined effectiveness and cost-effectiveness of pessary self-management (SM) vs clinic-based care (CBC) in relation to condition-specific quality of life (QoL). Methods: Parallel-group, superiority randomised controlled trial, recruiting from 16 May 2018 to 7 February 2020, with follow-up to 17 September 2021. Women attending pessary clinics, ≥18 years, using a pessary (except Shelf, Gellhorn or Cube), with pessary retained ≥2 weeks were eligible. Limited manual dexterity; cognitive deficit; pregnancy; or requirement for non-English teaching were exclusions. SM group received a 30-min teaching session; information leaflet; 2-week follow-up call; and telephone support. CBC group received usual routine appointments. The primary clinical outcome was pelvic floor-specific QoL (PFIQ-7), and incremental net monetary benefit for cost-effectiveness, 18 months post-randomisation. Group allocation was by remote web-based application, minimised on age, user type (new/existing) and centre. Participants, intervention deliverers, researchers and the statistician were not blinded. The primary analysis was intention-to-treat based. Trial registration: https://doi.org/10.1186/ISRCTN62510577. Findings: The requisite 340 women were randomised (169 SM, 171 CBC) across 21 centres. There was not a statistically significant difference between groups in PFIQ-7 at 18 months (mean SM 32.3 vs CBC 32.5, adjusted mean difference SM-CBC -0.03, 95% CI -9.32 to 9.25). SM was less costly than CBC. The incremental net benefit of SM was £564 (SE £581, 95% CI -£576 to £1704). A lower percentage of pessary complications was reported in the SM group (mean SM 16.7% vs CBC 22.0%, adjusted mean difference -3.83%, 95% CI -6.86% to -0.81%). There was no meaningful difference in general self-efficacy. Self-managing women were more confident in self-management activities. There were no reported suspected unexpected serious adverse reactions, and 31 unrelated serious adverse events (17 SM, 14 CBC). Interpretation: Pessary self-management is cost-effective, does not improve or worsen QoL compared to CBC, and has a lower complication rate. Funding: National Institute for Health and Care Research, Health Technology Assessment Programme (16/82/01).

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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 [43]

    The Results (Cost utility analysis, Table 7; page not provided) report an incremental net benefit of £564.32 over 18 months and lower costs for self-management. But the estimated cost saving was £150.53, not £564, and the paper does not establish that the cost difference was statistically significant. Incremental net benefit combines costs and QALYs; it is not itself a cost saving. (LLM, conf=0.88)

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  • In 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 [43]

    The Results (Primary outcome and Secondary outcomes; page numbers unavailable) report similar quality of life and fewer pessary-related complications in the self-management group at 18 months. The Methods (Outcomes; page number unavailable) specify follow-up through 18 months, so this paper does not support the claim about an assessment at 4 years. (LLM, conf=0.90)

    Experimental — accuracy not yet measured

  • Level 1 evidence exists for a dose-dependent positive impact of PFM training on POP symptoms and associated distress.

    “Level 1 evidence exists for a dose‐dependent positive impact of PFM training on POP symptoms and associated distress”

    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 [41]

    The Methods describe a trial of vaginal pessary self-management versus clinic-based care, not pelvic floor muscle (PFM) training. The Results report no significant difference between those pessary-care groups in pelvic floor-specific quality of life. Searches for PFM training, dose dependence, and level 1 evidence found no passage addressing the attributed claim; the pessary result does not contradict a claim about PFM training. (LLM, conf=0.78)

    Experimental — accuracy not yet measured

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Authors
Hagen, S., Kearney, R., Goodman, K., Best, C., Elders, A., Melone, L., Dwyer, L., Dembinsky, M., Graham, M., Agur, W., Breeman, S., Culverhouse, J., Forrest, A., Forrest, M., Guerrero, K., Hemming, C., Khunda, A., Manoukian, S., Mason, H., McClurg, D., Norrie, J., Thakar, R., & Bugge, C.
Affiliations
  • Glasgow Caledonian University (GB)
  • University of Manchester (GB)
  • University of Stirling (GB)
  • Manchester Academic Health Science Centre (GB)
  • University Hospital Crosshouse (GB)
  • University of Aberdeen (GB)
  • Queen Elizabeth University Hospital (GB)
  • Aberdeen Royal Infirmary (GB)
  • James Cook University Hospital (GB)
  • University of Edinburgh (GB)
  • Croydon University Hospital (GB)
Corresponding author
Hagen, Suzanne
ORCID
Venue
eClinicalMedicine
Publisher
Elsevier BV
Published
2023-12
Volume
66
Pages
102326
ISSN
2589-5370 (ISSN-L)
DOI
10.1016/j.eclinm.2023.102326
PMC
PMC10701109
OpenAlex
W4388954873
Cited by
29
References
30
Citations by year
2026: 13 · 2025: 6 · 2024: 10
FWCI
6.07
Type
journal article
Language
en
Open access
Licence
Locations
  • EClinicalMedicine (publishedVersion, cc-by)
  • PubMed Central (publishedVersion, cc-by)
  • PubMed (publishedVersion)
  • ResearchOnline (Glasgow Caledonian University) (acceptedVersion, cc-by)
  • Stirling Online Research Repository (University of Stirling) (submittedVersion, cc-by)
  • DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
Funders
  • National Institute for Health and Care Research
  • Chief Scientist Office
  • Scottish Government Health and Social Care Directorate
  • Health Technology Assessment Programme (16/82/01)
Topics
  • Health Sciences › Medicine › Rheumatology › Pelvic floor disorders treatments
  • Health Sciences › Medicine › Obstetrics and Gynecology › Uterine Myomas and Treatments
  • Health Sciences › Medicine › Psychiatry and Mental health › Sexual function and dysfunction studies
Keywords
pelvic organ prolapse, pessary, clinic-based care, PFIQ-7, cost-effectiveness, pessary complications, telephone support, patient education, women's health services, pelvic floor dysfunction, self-efficacy, health-related quality of life, patient-centered care

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