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

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine382 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

382

Conditions

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

Interventions

Telephone follow-upDIAGNOSTIC_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

Sex: FEMALEMin age: 20 YearsMax age: 90 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Pelvic floor ultrasound

Time frame: From enrollment to 3 days before surgery

Secondary Outcomes

Pelvic Floor Distress Inventory-20 (PFDI-20)

Time frame: 3 months, 6 months and 12 months after the surgery

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