Development and Validation of a Risk Prediction Model for De Novo Stress Urinary Incontinence After Pelvic Floor Reconstruction Surgery
Recruiting now
Conditions studied: Pelvic Organ Prolapse (POP), Stress Urinary Incontinence (SUI)
In brief
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.
Key facts
- Study ID
- NCT07601282
- Run by
- Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
- People needed
- 382
- Starts
- 2024-12-01
- Expected to finish
- 2026-12-31
- Last updated by the study team
- 2026-05-22
Who can join
Age: 20 and older, up to 90. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Patients with pelvic organ prolapse quantification (POP-Q) stage II or higher;
- Patients who require surgical treatment for pelvic organ prolapse;
- Patients with no evidence of urinary incontinence before surgery.
You may not qualify if…
- Patients confirmed to have urinary incontinence before surgery;
- Patients with urinary or reproductive system infections;
- Patients with a history of prior surgery for urinary incontinence;
- Patients who have undergone previous mesh repair surgery for pelvic organ prolapse;
- Patients with a history of psychiatric disorders, hearing impairment, or communication difficulties;
- Patients receiving hormone replacement therapy;
- Patients with neurodegenerative diseases such as stroke or multiple sclerosis, or neurological conditions such as spinal cord injury.
Where it is running
- Shanghai General Hospital — Shanghai, Shanghai Municipality, China (enrolling)
Full record on ClinicalTrials.gov
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