Pelvic Organ Prolapse (POP), Stress Urinary Incontinence (SUI)
Conditions
Keywords
Case-Control Study
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.
Interventions
DIAGNOSTIC_TESTTelephone follow-up
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.
Sponsors
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 90 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pelvic floor ultrasound | From enrollment to 3 days before surgery |
Secondary
| 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 |
Countries
China
Contacts
CONTACTYiping Zhu
Outcome results
None listed