Development and Validation of a Risk Prediction Model for De Novo Stress Urinary Incontinence After Pelvic Floor Reconstruction Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Telephone follow-up.
- Who it may be relevant to
- Registry conditions: Pelvic Organ Prolapse (POP), Stress Urinary Incontinence (SUI). Basic parameters: 20 years — 90 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Development and Validation of a Risk Prediction Model for De Novo Stress Urinary Incontinence After Pelvic Floor Reconstruction Surgery: A Case-Control Study
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.
Interventions
- Diagnostic test Telephone 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.
Primary outcome measures
- Pelvic floor ultrasound [Time frame: From enrollment to 3 days before surgery]
Secondary outcome measures (2)
- 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) [Time frame: 3 months, 6 months and 12 months after the surgery]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-control
Study locations
China · 1 center
- Shanghai General Hospital — Shanghai
Identifiers
NCT: NCT07601282 · 20224Y0261