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

Suzanne Hagen; Rohna Kearney; Kirsteen Goodman; Catherine Best; Andrew Elders; Lynn Melone; Lucy Dwyer; Melanie Dembinsky; Margaret Graham; Wael Agur; Suzanne Breeman; Jane Culverhouse; Angela Forrest; Mark Forrest; Karen Guerrero; Christine Hemming; Aethele Khunda; Sarkis Manoukian; Helen Mason; Doreen McClurg; John Norrie; Ranee Thakar; Carol Bugge

doi:10.1016/j.eclinm.2023.102326

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

EClinicalMedicine. 2023 Nov 23:66:102326. doi: 10.1016/j.eclinm.2023.102326. eCollection 2023 Dec.

Authors

Suzanne Hagen¹, Rohna Kearney^{2

3}, Kirsteen Goodman¹, Catherine Best⁴, Andrew Elders¹, Lynn Melone¹, Lucy Dwyer^{2

5}, Melanie Dembinsky⁶, Margaret Graham⁷, Wael Agur⁸, Suzanne Breeman⁹, Jane Culverhouse¹⁰, Angela Forrest¹¹, Mark Forrest⁹, Karen Guerrero¹², Christine Hemming¹³, Aethele Khunda¹⁴, Sarkis Manoukian¹⁵, Helen Mason¹⁵, Doreen McClurg¹, John Norrie¹⁶, Ranee Thakar¹⁷, Carol Bugge⁶

Affiliations

¹ Nursing, Midwifery & Allied Health Professions Research Unit, Glasgow Caledonian University, Glasgow, UK.
² The Warrell Unit, Saint Mary's Hospital, Manchester, UK.
³ Division of Developmental Biology & Medicine, School of Medical Sciences, University of Manchester, UK.
⁴ Faculty of Health Sciences & Sport, University of Stirling, Stirling, UK.
⁵ Manchester Academic Health Science Centre, Manchester, UK.
⁶ Department of Nursing Health, Glasgow Caledonian University, Glasgow, UK.
⁷ Patient and Public Involvement Partner, Dunlop, UK.
⁸ Department of Gynaecology, University Crosshouse Hospital, UK.
⁹ Centre for Healthcare Randomised Trials, University of Aberdeen, Aberdeen, UK.
¹⁰ Patient and Public Involvement Partner, Manchester, UK.
¹¹ Patient and Public Involvement Partner, Milton Keynes, UK.
¹² Department of Urogynaecology, Queen Elizabeth University Hospital, UK.
¹³ Department of Gynaecology, Aberdeen Royal Infirmary, Aberdeen, UK.
¹⁴ Department of Urogynaecology, The James Cook University Hospital, Middlesbrough, UK.
¹⁵ Yunus Centre for Social Business & Health, Glasgow Caledonian University, Glasgow, UK.
¹⁶ Edinburgh Clinical Trials Unit, University of Edinburgh, UK.
¹⁷ Department of Urogynaecology, Croydon University Hospital, Croydon, UK.

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).

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