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Superiority of Perineoplasty as Concomitant Surgical Procedure During Pelvic Organ Prolapse Repair — SUPPORT  

Pelvic Organ Prolapse Clinical Trial

Official title:
Superiority of Perineoplasty as Concomitant Surgical Procedure During Pelvic Organ Prolapse Repair; a Comparative Cohort Trial (SUPPORT)

Clinical Trial Summary

The goal of this study is to evaluate whether adding perineoplasty is, in comparison to performing vaginal prolapse surgery without adding perineoplasty, superior with respect to efficacy and cost-effectiveness and non-inferior with respect to morbidity, in patients undergoing vaginal surgical correction of pelvic organ prolapse at 24 months after surgery.

Clinical Trial Description

Preoperative measurements, performed at baseline: - Patient characteristics (age, BMI, smoking, obstetric history) - Physical examination including POP-Q score. The genital hiatus (gh) at rest (as part of the POP-Q) will be used to assess the wideness of the vaginal introitus. - Pelvic Floor Distress Inventory (PFDI-20) questionnaire and Patient Global Impression of Severity (PGI-S) - Pelvic Floor Ultrasound 2DStudy measurements; - Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-ir), Dutch Perineal Support Questionnaire (DPSQ), General Quality of Life (EQ-5D-5L), Medical Consumption Questionnaire (iMCQ) and Productivity Cost Questionnaire (iPCQ) - Patient and surgeons considerations with respect to level III repair; Postoperative measurements: - Regular physical check-up will be at 4-8 weeks after procedure. - Physical examination including POP-Q score - Patient Global Impression of Improvement score (PGI-I) - Pelvic Floor Ultrasound 2D - iMCQ, iPCQ, EQ-5D-5L questionnaire Extra follow up: - Physical check-up 12 & 24 months after surgery: - Physical examination including POP-Q score - Pelvic Floor Ultrasound 2D - PFDI-20, PGI-I, DPSQ, PISQ-ir, iMCQ, iPCQ, EQ-5D-5L questionnaire ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05713422
Study type Observational [Patient Registry]
Source Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Contact Jan-Paul Roovers, Prof
Phone +31 20 5669111
Email onderzoeksbureauvkc@amsterdamumc.nl
Status Recruiting
Phase
Start date April 23, 2023
Completion date December 2026
View Details
See also
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