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

Development and Validation of a Risk Prediction Model for De Novo Stress Urinary Incontinence After Pelvic Floor Reconstruction Surgery: A Case-Control Study

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.

Study Overview

• Status: Recruiting
• Conditions: Pelvic Organ Prolapse (POP); Stress Urinary Incontinence (SUI)
• Intervention / Treatment: Diagnostic test: Telephone follow-up

• Study Type: Observational
• Enrollment (Estimated): 382

Contacts and Locations

• Study Contact: Name: Yiping Zhu; Phone Number: +86 13817665076; Email: zhuypurologist@163.com

Study Locations

• China
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200080
      • Recruiting
      • Shanghai General Hospital
      • Contact: Wenqian Geng; Phone Number: +86 21 3612 6254
      • Contact: Email: sydwlunli2020@163.com
      • Principal Investigator: Chuqiao Song

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Pelvic floor ultrasound	From enrollment to 3 days before surgery

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2024
• Primary Completion (Actual): December 18, 2025
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: May 16, 2026
• First Submitted That Met QC Criteria: May 16, 2026
• First Posted (Actual): May 22, 2026

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 16, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Case-Control Study
• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Pathological Conditions, Anatomical; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urination Disorders; Lower Urinary Tract Symptoms; Urological Manifestations; Urinary Incontinence; Prolapse; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Urinary Incontinence, Stress; Pelvic Organ Prolapse
• Other Study ID Numbers: 20224Y0261

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: all IPD collected throughout the trial
• IPD Sharing Time Frame: Raw data will be publicly available from December 31, 2028, valid for 3 years
• IPD Sharing Access Criteria: After obtaining permission from the project principal investigator via email, access to the IPD public website login will be granted.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No