Self-management of vaginal pessaries for pelvic organ prolapse: multi-method process evaluation, linked to the TOPSY randomised controlled trial
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Le résumé fourni par la source
BACKGROUND: Pelvic organ prolapse negatively affects women's quality of life globally. Vaginal pessaries are a common first-line treatment. The evidence base to support pessary self-management and to understand how it affects women's lives is poor. This study aimed to identify the acceptability, effectiveness, fidelity to delivery, and adherence for women treated with vaginal pessary for prolapse and the healthcare professionals who treat them and how these differed between self-management and clinic-based care. METHODS: Multi-method process evaluation embedded within a randomised controlled trial in 21 UK secondary care centres. Data were collected using the following: Recordings of self-management support appointments (n = 21) and 2-week post-support follow-up phone calls (n = 34), healthcare professional completed fidelity checklists of self-management support appointments (n = 156) and 2-week follow-up calls (n = 145), interviews with purposively sampled women randomised to each trial group at baseline (n = 36 total) and 18 months (n = 23), interviews with women who declined randomisation to the trial at baseline (n = 20) and 18 months (n = 18), interviews with healthcare professionals (n = 36), and a free-text response question in the trial questionnaire (n = 77 comments at baseline, n = 136 6 months, n = 127 12 months, n = 98 18 months). RESULTS: Self-management was acceptable with all intervention components perceived as important for women's self-management ability and to how the intervention worked. Women's adherence to self-management and clinic-based care varied. Pessary-related complications negatively influenced adherence in both groups. Emotional labour from healthcare professionals in both types of pessary management was a moderator on the pathway to effectiveness. Women's and healthcare professionals' positive attitudes were central to successful implementation. Self-managing women expressed self-efficacy differently than those who received clinic-based care in that they were more confident in addressing common pessary problems, and their confidence grew over time. Women in the clinic-based care group had confidence but in paternalistic pessary care. Self-management and clinic-based care were delivered differently, and thus, the trial was a true test of the effectiveness of self-management. CONCLUSIONS: This is the first study to provide a programme theory for pessary self-management. Given the acceptability of self-management, the programme theory developed could be used to support the implementation of self-management in clinical practice. Further research is needed to support widespread implementation. TRIAL REGISTRATION: ISRCTN62510577 (date of first recruitment was 16th May 2018).
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Le contrôle bibliographique ouvert
DOI retrouvé dans Crossref DOI retrouvé ; titre concordant.
- Titre Crossref
- Self-management of vaginal pessaries for pelvic organ prolapse: multi-method process evaluation, linked to the TOPSY randomised controlled trial
- Date Crossref
- 05/12/2025
- Éditeur
- Springer Science and Business Media LLC
- 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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University of Stirling pays non établi dans la noticeUniversité ou école supérieure
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Glasgow Caledonian University Patient and Public Involvement Representative pays non établi dans la noticeUniversité ou école supérieure
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South Tees Hospitals NHS Foundation Trust pays non établi dans la noticeÉtablissement de santé
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Manchester Academic Health Science Centre pays non établi dans la noticeÉtablissement de santé
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University of Manchester pays non établi dans la noticeUniversité ou école supérieure
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Manchester University NHS Foundation Trust Saint Mary's Hospital pays non établi dans la noticeÉtablissement de santé
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St Mary's Hospital pays non établi dans la noticeÉtablissement de santé
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NHS Greater Glasgow and Clyde pays non établi dans la noticeÉtablissement de santé
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University of Glasgow pays non établi dans la noticeUniversité ou école supérieure
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Faculty of Health Sciences and Sport pays non établi dans la noticeUniversité ou école supérieure
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School of Health and Life Sciences Research Centre for Health pays non établi dans la noticeUniversité ou école supérieure
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The James Cook University Hospital Department of Urogynaecology pays non établi dans la noticeUniversité ou école supérieure
University of Stirling, Patient and Public Involvement Representative — Glasgow Caledonian University et South Tees Hospitals NHS Foundation Trust, avec 9 autres affiliations.
Une affiliation ne permet pas de déduire la nationalité d’un auteur.