학술논문
Cost-effectiveness of pessary therapy versus surgery for symptomatic pelvic organ prolapse: an economic evaluation alongside a randomised non-inferiority controlled trial
Document Type
article
Author
F Milani; V Dietz; Jan-Paul W R Roovers; A van der Ster; Ângela J Ben; Lisa R van der Vaart; Judith E. Bosmans; Antoinette L M Lagro-Janssen; Carl H van der Vaart; Astrid Vollebregt; G G Bon; M Y Bongers; K Bos; A M W Broekman; H W F van Eijndhoven; R A Hakvoort; E W M Janszen; K Kluivers; G Link; D S Massop-Helmink; J M van der Ploeg; F M Sikkema; W A Spaans; K Verheijen-van de Waarsenburg; M Weemhoff; A E Weis-Potters; M M A Vernooij; J van Bavel
Source
BMJ Open, Vol 14, Iss 5 (2024)
Subject
Language
English
ISSN
2044-6055
Abstract
Objective To evaluate the cost-effectiveness of pessary therapy as an initial treatment option compared with surgery for moderate to severe pelvic organ prolapse (POP) symptoms in secondary care from a healthcare and a societal perspective.Design Economic evaluation alongside a multicentre randomised controlled non-inferiority trial with a 24-month follow-up.Setting 21 hospitals in the Netherlands, recruitment conducted between 2015 and 2022.Participants 1605 women referred to secondary care with symptomatic prolapse stage ≥2 were requested to participate. Of them, 440 women gave informed consent and were randomised to pessary therapy (n=218) or to surgery (n=222) in a 1:1 ratio stratified by hospital.Interventions Pessary therapy and surgery.Primary and secondary outcome measures The Patient Global Impression of Improvement (PGI-I), a 7-point scale dichotomised into successful versus unsuccessful, with a non-inferiority margin of −10%; quality-adjusted life-years (QALYs) measured by the EQ-5D-3L; healthcare and societal costs were based on medical records and the institute for Medical Technology Assessment questionnaires.Results For the PGI-I, the mean difference between pessary therapy and surgery was −0.05 (95% CI −0.14; 0.03) and −0.03 (95% CI −0.07; 0.002) for QALYs. In total, 54.1% women randomised to pessary therapy crossed over to surgery, and 3.6% underwent recurrent surgery. Healthcare and societal costs were significantly lower in the pessary therapy (mean difference=−€1807, 95% CI −€2172; −€1446 and mean difference=−€1850, 95% CI −€2349; −€1341, respectively). The probability that pessary therapy is cost-effective compared with surgery was 1 at willingness-to-pay thresholds between €0 and €20 000/QALY gained from both perspectives.Conclusions Non-inferiority of pessary therapy regarding the PGI-I could not be shown and no statistically significant differences in QALYs between interventions were found. Due to significantly lower costs, pessary therapy is likely to be cost-effective compared with surgery as an initial treatment option for women with symptomatic POP treated in secondary care.Trial registration number NTR4883.