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Citation

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 & Bugge C (2023) Clinical effectiveness of vaginal pessary self-management vs clinic-based care for pelvic organ prolapse (TOPSY): a randomised controlled superiority trial. eClinicalMedicine, 66, p. 102326. https://doi.org/10.1016/j.eclinm.2023.102326

Abstract
Summary 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).

Keywords
Pelvic organ prolapse; Pessary; Self-management; Randomised controlled trial

Notes
Additional authors: Karen Guerrero, Christine Hemming, Aethele Khunda, Sarkis Manoukian, Helen Mason, Doreen McClurg, John Norrie, Ranee Thakar

Journal
eClinicalMedicine: Volume 66

• Published Version