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

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.