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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age20-90
SponsorShanghai General Hospital, Shanghai Jiao Tong University School of Medicine

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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;

Trial population

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

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • 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.

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Pelvic floor ultrasound

Time frame
From enrollment to 3 days before surgery

Secondary outcomes

1

Pelvic Floor Distress Inventory-20 (PFDI-20)

Time frame
3 months, 6 months and 12 months after the surgery
2

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

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

Other outcomes

Sponsors and contacts

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