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Development and Validation of a Risk Prediction Model for De Novo Stress Urinary Incontinence After Pelvic Floor Reconstruction Surgery

Recruitingn/aAges 20 Years - 90 YearsFemaleShanghai General Hospital, Shanghai Jiao Tong Uni…
NCT07601282 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

This observational study aims to develop a predictive model for the occurrence of new-onset stress urinary incontinence (SUI) after pelvic organ prolapse (POP) repair surgery in women. The primary questions it seeks to answer are: Which risk factors and anatomical characteristics predispose women to new-onset stress urinary incontinence following pelvic organ prolapse repair surgery? Female POP patients without any preoperative symptoms of urinary incontinence will receive telephone follow-ups at 3, 6, and 12 months after undergoing standard surgical treatment.

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Patients with pelvic organ prolapse quantification (POP-Q) stage II or higher; 2. Patients who require surgical treatment for pelvic organ prolapse; 3. Patients with no evidence of urinary incontinence before surgery. Exclusion Criteria: 1. Patients confirmed to have urinary incontinence before surgery; 2. Patients with urinary or reproductive system infections; 3. Patients with a history of prior surgery for urinary incontinence; 4. Patients who have undergone previous mesh repair surgery for pelvic organ prolapse; 5. Patients with a history of psychiatric disorders, hearing impairment, or communication difficulties; 6. Patients receiving hormone replacement therapy; 7. Patients with neurodegenerative diseases such as stroke or multiple sclerosis, or neurological conditions such as spinal cord injury.
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What it tests

  • Telephone follow-up
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Where

1 site
Shanghai General Hospital
Shanghai, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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