BJOG : an international journal of obstetrics and gynaecology · 2025
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.
СтатьяРандомизированное исследованиеСравнительное исследованиеEquivalence TrialМногоцентровое исследованиеНазвание и аннотация: Перевод пока не подготовлен
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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
Аннотация
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).
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).