NCT05713422

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

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

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 305 (actual)
• Sponsor: Marjolein Spiering · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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

Conditions

• Pelvic Organ Prolapse

Timeline

• Start date: 2023-04-23
• Primary completion: 2025-12-01
• Completion: 2026-12-01
• First posted: 2023-02-06
• Last updated: 2024-08-05

Locations

2 sites across 1 country: Netherlands