Actively Recruiting
Development and Validation of a Risk Prediction Model for De Novo Stress Urinary Incontinence After Pelvic Floor Reconstruction Surgery: A Case-Control Study
Led by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine · Updated on 2026-05-22
382
Participants Needed
1
Research Sites
54 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This observational study focuses on women undergoing pelvic organ prolapse (POP) repair surgery who do not have urinary incontinence before surgery. Researchers aim to develop a model that predicts which women may develop new stress urinary incontinence (SUI) after this surgery. The study looks at risk factors and anatomical features that could lead to this condition. Participants will receive standard surgical treatment for POP and then be followed up through telephone calls at 3, 6, and 12 months after surgery. During these calls, they will complete the Pelvic Floor Distress Inventory-20 (PFDI-20) and the International Consultation on Incontinence Questionnaire Short Form (ICI-Q-SF) verbally. If new SUI is suspected, participants will be encouraged to visit an outpatient clinic for further assessment including pelvic floor ultrasound. Women in the study will have pelvic floor ultrasounds before surgery and complete questionnaires at follow-up intervals. The study collects information on symptoms and anatomical changes to understand the occurrence of new SUI. The total involvement lasts at least one year post-surgery with regular phone assessments to monitor urinary function and pelvic health.
CONDITIONS
Brief Title
Development and Validation of a Risk Prediction Model for De Novo Stress Urinary Incontinence After Pelvic Floor Reconstruction Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
- Female patients aged 20 to 90 years
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 3 days before surgery
Participants undergo pelvic floor ultrasound before surgery to assess pelvic floor status.
1 visit (in-person)
Duration - Day of surgery
Participants have pelvic floor reconstruction surgery as part of their clinical care.
1 visit (in-person)
Duration - 12 months after surgery
Participants complete telephone follow-ups with questionnaires about urinary symptoms at 3, 6, and 12 months after surgery. Those suspected of postoperative de novo stress urinary incontinence may be advised to attend additional outpatient evaluations including pelvic floor ultrasound.
Telephone follow-ups at 3, 6, and 12 months; additional outpatient visits if needed
Trial Site Locations
Total: 1 location
1
Shanghai General Hospital
Shanghai, Shanghai Municipality, China, 200080
Actively Recruiting
Research Team
Y
Yiping Zhu
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here