Four Year Clinical and Cost Effectiveness of Vaginal Pessary Self‐Management Versus Clinic‐Based Care for Pelvic Organ Prolapse ( TOPSY ): Long Term Follow‐Up of a Randomised Controlled Superiority Trial

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OBJECTIVE: To compare long-term clinical and cost-effectiveness of pessary self-management (SM) with clinic-based care (CBC) for pelvic floor-specific quality of life (QoL). DESIGN: Four-year questionnaire follow-up of trial participants. SETTING: UK pessary clinics. SAMPLE: Responders at 4 years aged ≥ 18 years at recruitment, using a pessary (except Shelf, Gellhorn or Cube) which had been retained ≥ 2 weeks. EXCLUSIONS: limited manual dexterity; cognitive deficit; pregnancy; requiring non-English SM teaching. METHODS: SM group received a 30-min teaching session; information leaflet; 2-week follow-up call; and telephone support. CBC group received routine appointments. Allocation was by remote web-based application, minimised on age, user type (new/existing) and centre with no blinding. Participants were invited to opt into a 4-year follow-up. The primary analysis was intention to treat. OUTCOME MEASURES: The primary outcomes were pelvic floor-specific QoL (PFIQ-7) and incremental net monetary benefit (INB) 4 years post-randomisation. Secondary outcomes included complications and prolapse symptoms. RESULTS: Of 340 women randomised, 186 (55%) responded at 4 years (86/169 [51%] SM, 100/171 [58%] CBC). There was no statistically significant group difference in PFIQ-7 at 4 years (mean SM 32.9 vs. CBC 31.4, adjusted mean difference [AMD] SM-CBC 4.86, 95% CI -6.41 to 16.12). There was a statistically non-significant lower percentage of pessary complications for SM (SM 17.7% vs. CBC 22.0%, AMD 3.01 CI -0.58 to 6.61). At 4-years, SM was cost-effective (INB £2240). There was one potentially related serious adverse event (SM group). CONCLUSIONS: Pessary self-management is an effective and cost-effective long-term option for women with prolapse. TRIAL REGISTRATION: ISRCTN number: 62510577 (https://doi.org/10.1186/ISRCTN62510577).

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