Bugge Carol, Kearney Rohna, Best Catherine, Goodman Kirsteen, Manoukian Sarkis, Melone Lynn, Dembinsky Melanie, Mason Helen, Elders Andrew, Graham Margaret, Agur Wael, Breeman Suzanne, Culverhouse Jane, Dwyer Lucy, Forrest Mark, Guerrero Karen, Hemming Christine, Khunda Aethele, Kucher Angela, McClurg Doreen, Norrie John, Thakar Ranee, Hagen Suzanne
School of Health and Life Sciences/Research Centre for Health, Glasgow Caledonian University, Glasgow, UK.
The Warrell Unit, Saint Mary's Hospital, Manchester University NHS Foundation Trust, Manchester Academic Health Science Centre, Manchester, UK.
BJOG. 2025 Nov;132(12):1762-1771. doi: 10.1111/1471-0528.18333. Epub 2025 Aug 20.
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).
Four-year questionnaire follow-up of trial participants.
UK pessary clinics.
Responders at 4 years aged ≥ 18 years at recruitment, using a pessary (except Shelf, Gellhorn or Cube) which had been retained ≥ 2 weeks.
limited manual dexterity; cognitive deficit; pregnancy; requiring non-English SM teaching.
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.
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.
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).
Pessary self-management is an effective and cost-effective long-term option for women with prolapse.
ISRCTN number: 62510577 (https://doi.org/10.1186/ISRCTN62510577).
