Evidence map›Paper›PMID 38692718›Full record

Trial reportBMJ open2024

Cost-effectiveness of pessary therapy versus surgery for symptomatic pelvic organ prolapse: an economic evaluation alongside a randomised non-inferiority controlled trial.

Ângela J Ben, Lisa R van der Vaart, Judith E Bosmans, Jan-Paul W R Roovers, Antoinette L M Lagro-Janssen, Carl H van der Vaart, Astrid Vollebregt, PEOPLE group

Abstract readMulticenter StudyRandomized Controlled TrialEquivalence Trial
In one paragraph

Trial report in BMJ open, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Cost-effectiveness and patient-reported outcomes of combined versus isolated robotic rectal and pelvic organ prolapse repair: A multicentre prospective cohort study.Colorectal disease : the official journal of the Association of Coloproctology of Great Britain and Ireland · 2026
    Article
  2. Article
  3. Article
  4. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors.

Ângela J BenDepartment of Health Sciences, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands a.jornadaben@vu.nl.ORCID 0000-0003-4793-9026
Lisa R van der VaartDepartment of Obstetrics and Gynaecology, Amsterdam Reproduction & Development Research Institute, University of Amsterdam, Amsterdam, The Netherlands.
Judith E BosmansDepartment of Health Sciences, VU University Amsterdam, Amsterdam, The Netherlands.
Jan-Paul W R RooversDepartment of Obstetrics and Gynecology, University of Amsterdam, Amsterdam, The Netherlands.
Antoinette L M Lagro-JanssenDepartment of Primary and Community Care, Radboud University Medical Center, Nijmegen, The Netherlands.
Carl H van der VaartDepartment of Obstetrics and Gynecology, University Medical Center Utrecht, Utrecht, The Netherlands.
Astrid VollebregtDepartment of Obstetrics and Gynecology, Spaarne Hospital, Haarlem, The Netherlands.
PEOPLE group

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo 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.

designEconomic evaluation alongside a multicentre randomised controlled non-inferiority trial with a 24-month follow-up.

setting21 hospitals in the Netherlands, recruitment conducted between 2015 and 2022.

participants1605 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.

interventionsPessary 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.

resultsFor 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.

conclusionsNon-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.

Indexed as

Cost-Benefit AnalysisPelvic Organ ProlapsePessariesQuality-Adjusted Life YearsAgedFemaleHumansMiddle AgedNetherlandsQuality of LifeTreatment Outcomehealth economicspelvic painurogynaecology

Identifiers

PMID38692718
PMCPMC11086579

What Socratic holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.