Pessary or surgery for a symptomatic pelvic organ prolapse: the PEOPLE study, a multicentre prospective cohort study

Vaart, L. R. van der; Vollebregt, Astrid; Milani, Alfredo L.; Lagro-Janssen, Antoine L. M.; Duijnhoven, Ruben G.; Roovers, Jan‐Paul; Vaart, C. H. van der

doi:10.1111/1471-0528.16950

Cited by 28 publications

(19 citation statements)

References 51 publications

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“…Space-filling pessaries, such as the Gellhorn, are reserved for advanced prolapse [3]. A high rate of discontinuation was observed within 1 year with 56% of ring pessary users experiencing complications, including bleeding, extrusion, severe vaginal discharge, pain, and constipation [4]. However, our data indicated that self-management Gellhorn pessary was safe and relatively effective and that it increased patients' autonomy and ability to manage their POP [5].…”

Section: Introductionmentioning

confidence: 67%

Three-dimensional printing vaginal pessary to treat pelvic organ prolapse: A pilot study

TSENG¹,

Lin

Chang

et al. 2022

Preprint

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Objective Pelvic organ prolapse (POP) is a common gynecological condition and pessaries are offered as a first line management, however, each woman presents with unique anatomy and thus the effectiveness of commercially available pessaries may be limited by lack of customization. This study aims to apply three-dimensional (3D) printing technology in seeking resolution. Design, setting, population and methods This was a pilot study, 6 patients with mean age 68 years (57 to 74) were treated with Gellhorn pessary for symptomatic POP were enrolled in our study. We put the Gellhorn-type pessary into the vagina to restore the prolapsed parts and under transvaginal ultrasound (US) guided to evaluate the gap which Gellhorn pessary can’t cover. Ototoform (an impression silicone) was used to make a sphere-shape mode and have it hooked onto Gellhorn pessary (template). We collected template and then applied 3D printing to customize silicone vaginal pessary. Results All 6 patients were satisfied with the customized made pessaries. No patients complained of adverse effects, such as discomfort, expulsion of the pessary, urinary incontinence, difficulty in urination or bowel movement, and vaginal bleeding during the study. Conclusions Our study demonstrates that a tailor made pessary may offer better solution for women with POP. A customized pessary can be made with the help of transvaginal US and 3D printing technology. Any local clinic can use simple tools (i.e. transvaginal US and pessary) with assistance from a 3D printing center to create a well fit pessary. With our innovation, distant is not a boundary.

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Section: Introductionmentioning

confidence: 67%

Three-dimensional printing vaginal pessary to treat pelvic organ prolapse: A pilot study

TSENG¹,

Lin

Chang

et al. 2022

Preprint

View full text Add to dashboard Cite

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“…Participants were recruited between March 2015 and November 2019; the follow-up ended in June 2022. Detailed information about the PEOPLE Project is published elsewhere 7 9 12. No substantial changes were made to the protocol after the commencement of the RCT 7 12.…”

Section: Methodsmentioning

confidence: 99%

“…Due to the nature of the treatment, treatment allocation was not concealed. Women who actively opted for a treatment were asked to participate in an observational cohort performed alongside the RCT; their data were not included in economic evaluation but published in another article 9. Detailed information about study design and randomisation can be found elsewhere 7 12…”

Section: Methodsmentioning

confidence: 99%

“…An advantage of pessary therapy is its minimally invasive nature. However, adverse effects (eg, discomfort, pain or excessive discharge) may occur in up to 49% of women within 12–24 months after fitting a pessary 9 10. As for the surgery procedure, side-effects may include urinary tract infection and urinary bladder retention which may lead to longer hospital stay admission 7.…”

Section: Introductionmentioning

confidence: 99%

“…As for the surgery procedure, side-effects may include urinary tract infection and urinary bladder retention which may lead to longer hospital stay admission 7. A recent observational study in women with a strong treatment preference and a randomised controlled trial (RCT) in women without a preference found a high crossover rate from pessary therapy to surgery of 24% and 54%, respectively 7 9. Consequently, using pessary therapy as an initial treatment option might delay effective treatment, thereby increasing the demand for care and, thus, healthcare costs.…”

Section: Introductionmentioning

confidence: 99%

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

Ben,

van der Vaart,

E. Bosmans

et al. 2024

BMJ Open

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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 measuresThe 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 numberNTR4883.

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Effect of Pessary vs Surgery on Patient-Reported Improvement in Patients With Symptomatic Pelvic Organ Prolapse

Vaart

Vollebregt

Milani

et al. 2022

JAMA

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ImportancePelvic organ prolapse is a prevalent condition among women that negatively affects their quality of life. With increasing life expectancy, the global need for cost-effective care for women with pelvic organ prolapse will continue to increase.ObjectiveTo investigate whether treatment with a pessary is noninferior to surgery among patients with symptomatic pelvic organ prolapse.Design, Setting, and ParticipantsThe PEOPLE project was a noninferiority randomized clinical trial conducted in 21 participating hospitals in the Netherlands. A total of 1605 women with symptomatic stage 2 or greater pelvic organ prolapse were requested to participate between March 2015 through November 2019; 440 gave informed consent. Final 24-month follow-up ended at June 30, 2022.InterventionsTwo hundred eighteen participants were randomized to receive pessary treatment and 222 to surgery.Main Outcomes and MeasuresThe primary outcome was subjective patient-reported improvement at 24 months, measured with the Patient Global Impression of Improvement scale, a 7-point Likert scale ranging from very much better to very much worse. This scale was dichotomized as successful, defined as much better or very much better, vs nonsuccessful treatment. The noninferiority margin was set at 10 percentage points risk difference. Data of crossover between therapies and adverse events were captured.ResultsAmong 440 patients who were randomized (mean [SD] age, 64.7 [9.29] years), 173 (79.3%) in the pessary group and 162 (73.3%) in the surgery group completed the trial at 24 months. In the population, analyzed as randomized, subjective improvement was reported by 132 of 173 (76.3%) in the pessary group vs 132 of 162 (81.5%) in the surgery group (risk difference, −6.1% [1-sided 95% CI, −12.7 to ∞]; P value for noninferiority, .16). The per-protocol analysis showed a similar result for subjective improvement with 52 of 74 (70.3%) in the pessary group vs 125 of 150 (83.3%) in the surgery group (risk difference, −13.1% [1-sided 95% CI, −23.0 to ∞]; P value for noninferiority, .69). Crossover from pessary to surgery occurred among 118 of 218 (54.1%) participants. The most common adverse event among pessary users was discomfort (42.7%) vs urinary tract infection (9%) following surgery.Conclusions and RelevanceAmong patients with symptomatic pelvic organ prolapse, an initial strategy of pessary therapy, compared with surgery, did not meet criteria for noninferiority with regard to patient-reported improvement at 24 months. Interpretation is limited by loss to follow-up and the large amount of participant crossover from pessary therapy to surgery.Trial RegistrationNetherlands Trial Register Identifier: NTR4883

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Pessary or surgery for a symptomatic pelvic organ prolapse: the PEOPLE study, a multicentre prospective cohort study

Cited by 28 publications

References 51 publications

Three-dimensional printing vaginal pessary to treat pelvic organ prolapse: A pilot study

Three-dimensional printing vaginal pessary to treat pelvic organ prolapse: A pilot study

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

Effect of Pessary vs Surgery on Patient-Reported Improvement in Patients With Symptomatic Pelvic Organ Prolapse

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