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

Autor:	Hagen S; Nursing, Midwifery & Allied Health Professions Research Unit, Glasgow Caledonian University, Glasgow, UK., Kearney R; The Warrell Unit, Saint Mary's Hospital, Manchester, UK.; Division of Developmental Biology & Medicine, School of Medical Sciences, University of Manchester, UK., Goodman K; Nursing, Midwifery & Allied Health Professions Research Unit, Glasgow Caledonian University, Glasgow, UK., Best C; Faculty of Health Sciences & Sport, University of Stirling, Stirling, UK., Elders A; Nursing, Midwifery & Allied Health Professions Research Unit, Glasgow Caledonian University, Glasgow, UK., Melone L; Nursing, Midwifery & Allied Health Professions Research Unit, Glasgow Caledonian University, Glasgow, UK., Dwyer L; The Warrell Unit, Saint Mary's Hospital, Manchester, UK.; Manchester Academic Health Science Centre, Manchester, UK., Dembinsky M; Department of Nursing Health, Glasgow Caledonian University, Glasgow, UK., Graham M; Patient and Public Involvement Partner, Dunlop, UK., Agur W; Department of Gynaecology, University Crosshouse Hospital, UK., Breeman S; Centre for Healthcare Randomised Trials, University of Aberdeen, Aberdeen, UK., Culverhouse J; Patient and Public Involvement Partner, Manchester, UK., Forrest A; Patient and Public Involvement Partner, Milton Keynes, UK., Forrest M; Centre for Healthcare Randomised Trials, University of Aberdeen, Aberdeen, UK., Guerrero K; Department of Urogynaecology, Queen Elizabeth University Hospital, UK., Hemming C; Department of Gynaecology, Aberdeen Royal Infirmary, Aberdeen, UK., Khunda A; Department of Urogynaecology, The James Cook University Hospital, Middlesbrough, UK., Manoukian S; Yunus Centre for Social Business & Health, Glasgow Caledonian University, Glasgow, UK., Mason H; Yunus Centre for Social Business & Health, Glasgow Caledonian University, Glasgow, UK., McClurg D; Nursing, Midwifery & Allied Health Professions Research Unit, Glasgow Caledonian University, Glasgow, UK., Norrie J; Edinburgh Clinical Trials Unit, University of Edinburgh, UK., Thakar R; Department of Urogynaecology, Croydon University Hospital, Croydon, UK., Bugge C; Department of Nursing Health, Glasgow Caledonian University, Glasgow, UK.
Jazyk:	angličtina
Zdroj:	EClinicalMedicine [EClinicalMedicine] 2023 Nov 23; Vol. 66, pp. 102326. Date of Electronic Publication: 2023 Nov 23 (Print Publication: 2023).
DOI:	10.1016/j.eclinm.2023.102326
Abstrakt:	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). Competing Interests: 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. (© 2023 The Authors.)
Databáze:	MEDLINE
Externí odkaz:	Zobrazit plný text záznamu