Risk predictor for new urinary incontinence after prolapse surgery
Official title: Development and Validation of a Risk Prediction Model for De Novo Stress Urinary Incontinence After Pelvic Floor Reconstruction Surgery: A Case-Control Study
Run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine · NCT07601282 · Data updated 2026-11-12
This study tests a model to predict which women might develop new stress urinary incontinence after pelvic organ prolapse repair.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 20 Years to 90 Years |
| Sex | Women only |
| Enrollment | 382 (estimated) |
| Sponsor | Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine Academic / other |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Status | Recruiting |
| Started | December 1, 2024 |
| Main results expected | December 18, 2025 |
| Study ends | December 31, 2026 |
| Registry record updated | May 22, 2026 |
| Trial ID | NCT07601282 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Women with pelvic organ prolapse requiring surgery, POP-Q stage II or higher, and with no preoperative urinary incontinence.
✕Probably not a fit
Women who already have urinary incontinence before surgery or who do not develop any postoperative data to identify predictors may not benefit from the model.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study follows women undergoing pelvic organ prolapse repair who have no urinary incontinence before surgery. It uses telephone follow-ups at 3, 6, and 12 months to collect data and identify risk factors and anatomical features associated with new-onset stress urinary incontinence. The goal is to develop a predictive model that can help clinicians anticipate which patients are at higher risk. The study is conducted at Shanghai General Hospital with no listed collaborators and does not involve an experimental treatment. The design relies on case-control-like data to derive predictors for postoperative SUI.
Why it matters
Potential benefit: If successful, the model could help doctors tailor preoperative counseling and postoperative monitoring for patients at higher risk of developing SUI after prolapse repair.
How similar studies have gone: Previous work in this area has explored predictors of postoperative SUI, but the exact predictive model for de novo SUI after POP repair is less established, making this approach relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
Shanghai General Hospital
Shanghai, Shanghai Municipality, China Recruiting
Study contacts
- Study coordinator: Yiping Zhu
- Email: zhuypurologist@163.com
- Phone: +86 13817665076
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.