NCT07601282 Development and Validation of a Risk Prediction Model for De Novo Stress Urinary Incontinence After Pelvic Floor Reconstruction Surgery
| NCT ID | NCT07601282 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine |
| Condition | Pelvic Organ Prolapse (POP) |
| Study Type | OBSERVATIONAL |
| Enrollment | 382 participants |
| Start Date | 2024-12-01 |
| Primary Completion | 2025-12-18 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 382 participants in total. It began in 2024-12-01 with a primary completion date of 2025-12-18.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07601282 clinical trial?
This trial is open to female participants only, aged 20 Years or older, up to 90 Years, studying Pelvic Organ Prolapse (POP). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07601282 currently recruiting?
Yes, NCT07601282 is actively recruiting participants. Contact the research team at zhuypurologist@163.com for enrollment information.
Where is the NCT07601282 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT07601282 clinical trial?
NCT07601282 is sponsored by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine. The trial plans to enroll 382 participants.