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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Le résumé fourni par la source
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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Le contrôle bibliographique ouvert
DOI retrouvé dans Crossref DOI retrouvé ; titre concordant.
- Titre Crossref
- Clinical effectiveness of vaginal pessary self-management vs clinic-based care for pelvic organ prolapse (TOPSY): a randomised controlled superiority trial
- Date Crossref
- 01/12/2023
- Éditeur
- Elsevier BV
- Type
- journal-article
Ce recoupement confirme des métadonnées liées au DOI. Il ne confirme ni la méthode ni les conclusions de l’étude, et il ne compte pas comme une seconde source scientifique indépendante.
Où se fait cette recherche
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Glasgow Caledonian University Midwifery & Allied Health Professions Research Unit pays non établi dans la noticeUniversité ou école supérieure
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University of Manchester pays non établi dans la noticeUniversité ou école supérieure
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University of Stirling pays non établi dans la noticeUniversité ou école supérieure
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Manchester Academic Health Science Centre pays non établi dans la noticeÉtablissement de santé
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University Hospital Crosshouse pays non établi dans la noticeÉtablissement de santé
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University of Aberdeen Centre for Healthcare Randomised Trials pays non établi dans la noticeUniversité ou école supérieure
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Milton Keynes Hospital pays non établi dans la noticeÉtablissement de santé
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Queen Elizabeth University Hospital Department of Urogynaecology pays non établi dans la noticeÉtablissement de santé
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Aberdeen Royal Infirmary pays non établi dans la noticeÉtablissement de santé
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James Cook University Hospital Department of Urogynaecology pays non établi dans la noticeÉtablissement de santé
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University of Edinburgh Edinburgh Clinical Trials Unit pays non établi dans la noticeUniversité ou école supérieure
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Croydon University Hospital Department of Urogynaecology pays non établi dans la noticeÉtablissement de santé
Midwifery & Allied Health Professions Research Unit — Glasgow Caledonian University, University of Manchester et University of Stirling, avec 9 autres affiliations.
Une affiliation ne permet pas de déduire la nationalité d’un auteur.