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

NCT07601282 | Recruiting DMC

• 1 other identifier: 20224Y0261
• Study Type: observational
• Target: 382
• Locations: 1 country
• Sites: 1

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.

Conditions

Pelvic Organ Prolapse (POP); Stress Urinary Incontinence (SUI)

Keywords

Case-Control Study

Outcome Measures

Primary Outcomes (1)

• Pelvic floor ultrasound

  From enrollment to 3 days before surgery

Secondary Outcomes (2)

• Pelvic Floor Distress Inventory-20 (PFDI-20)

  3 months, 6 months and 12 months after the surgery

• International Consultation on Incontinence Questionnaire Short Form (ICI-Q-SF)

  3 months, 6 months and 12 months after the surgery

Interventions

Telephone follow-up DIAGNOSTIC_TEST

Participants will be required to complete the PFDI-20 and ICI-Q-SF questionnaires verbally during telephone follow-ups. If postoperative de novo SUI is highly suspected, participants will be advised to attend an outpatient clinic for further evaluation, including a pelvic floor ultrasound examination.

Eligibility Criteria

• Age: 20 Years - 90 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who visited the outpatient clinic of Shanghai General Hospital for pelvic organ prolapse.

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.

Sponsors & Collaborators

• Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

Shanghai General Hospital

Shanghai, Shanghai Municipality, 200080, China

RECRUITING

MeSH Terms

Conditions

Pelvic Organ Prolapse; Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms

Central Study Contacts

Yiping Zhu

CONTACT

+86 13817665076; zhuypurologist@163.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate chief physician

Study Record Dates

• First Submitted: May 16, 2026
• First Posted: May 22, 2026
• Study Start: December 1, 2024
• Primary Completion: December 18, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 22, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Raw data will be publicly available from December 31, 2028, valid for 3 years
• Access Criteria: After obtaining permission from the project principal investigator via email, access to the IPD public website login will be granted.

Locations

CN (1)