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

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

Suzanne Hagen  1 , Rohna Kearney  2   3 , Kirsteen Goodman  1 , Catherine Best  4 , Andrew Elders  1 , Lynn Melone  1 , Lucy Dwyer  2   5 , Melanie Dembinsky  6 , Margaret Graham  7 , Wael Agur  8 , Suzanne Breeman  9 , Jane Culverhouse  10 , Angela Forrest  11 , Mark Forrest  9 , Karen Guerrero  12 , Christine Hemming  13 , Aethele Khunda  14 , Sarkis Manoukian  15 , Helen Mason  15 , Doreen McClurg  1 , John Norrie  16 , Ranee Thakar  17 , Carol Bugge  6
Affiliations

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

Suzanne Hagen et al. EClinicalMedicine. .

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.

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Conflict of interest statement

All authors declare a grant from National Institute for Health and Care Research (NIHR) Health Technology Assessment (HTA) programme relating to the research described in the manuscript. In addition Lucy Dwyer reports being a member of the NICE guideline committee for non-surgical management and prevention of pelvic floor dysfunction and a member of the UK Clinical Guideline for best practice in the use of vaginal pessaries for pelvic organ prolapse committee; Aethele Khunda reports receiving an educational grant from Olympus Medical Systems to cover travel and accommodation costs to attend a laparoscopic urogynaecology workshop; Wael Agur reports grants from NIHR, consulting fees and payment for testimony from Oaklaw Consultancy Ltd., for Medico-legal Consultancy and financial/non-financial interest associated with Medical Innovation Systems; Karen Guerrero reports payment for expert testimony for the Medical Advisor NHS Scotland Central Legal Office and for NHS-funded study leave; Christine Hemming reports grants from NIHR HTA for two RCTs (11/129/183 and 07/60/18); John Norrie reports being a member of the following committees: NIHR CTU Standing Advisory Committee (2018-23), NIHR HTA & EME Editorial Board (2015–2019), EME Funding Committee Member (2019–2022), HTA General Committee (2016–2019), HTA Post-Funding Committee (2016–2019), HTA Funding Committee Policy Group (2016–2019), COVID-19 Reviewing (2020); Ranee Thakar reports a voluntary role at Royal College of Obstetricians and Gynaecologists; Rohna Kearney reports being topic lead for prolapse on NICE guideline NG123 published 2019; Angela Forrest reports payment for attending project meetings relating to the research; Suzanne Breeman reports grants from NIHR HTA for the VUE trial (11/129/183) and the PROSPECT trial (07/60/18 and NIHR133665). Suzanne Hagen, Carol Bugge, Andrew Elders, Helen Mason, Kirsteen Goodman, Doreen McClurg, Melanie Dembinsky, Lynn Melone, Catherine Best, Sarkis Manoukian, Margaret Graham, Jane Culverhouse and Mark Forrest have no additional disclosures to report relating to the manuscript.

Figures

Fig. 1
Fig. 1
Trial profile. CBC = clinic-based care; CRF = case report form; PFIQ-7 = Pelvic Floor Impact Questionnaire short form 7. Note: “Discontinued intervention” categories are not mutually exclusive e.g., participants can both discontinue pessary use and revert to CBC; Participants may not have completed the PFIQ-7 but still completed other parts of the trial e.g., completed other outcome measures or attended 18-month clinic visit.
Fig. 2
Fig. 2
Sensitivity analyses of treatment population definitions and missing data assumptions. CACE = Complier Average Causal Effect model; MCAR = missing completely at random; MNAR = missing not at random; PMM = pattern mixture model, mean difference between trial groups in PFIQ-7 at 18 months with 95% confidence intervals.
Fig. 3
Fig. 3
Subgroup analyses. Mean difference between trial groups in PFIQ-7 at 18 months with 95% confidence intervals.
See this image and copyright information in PMC

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