BMJ Open. 2024 May 1;14(5):e075016. doi: 10.1136/bmjopen-2023-075016.
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.
PMID:38692718 | DOI:10.1136/bmjopen-2023-075016
