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NCT Number: NCT07601282

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

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.

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Key information

Conditions

Pelvic Organ Prolapse (POP) Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Pelvic Organ Prolapse Prolapse Signs and Symptoms Stress Urinary Incontinence (SUI) Urinary Incontinence Urinary Incontinence, Stress Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

20 year–90 year

Sex eligibility

Female

Study type

Observational

Primary location

Shanghai General Hospital

Shanghai, Shanghai Municipality, 200080, China

Location status: Recruiting

Location contact

Chuqiao Song

PRINCIPAL_INVESTIGATOR

Wenqian Geng

CONTACT

+86 21 3612 6254

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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

Study contacts

Contact information is provided by the study sponsor or research team.

Yiping Zhu

CONTACT

[email protected]

+86 13817665076

Sponsors and collaborators

Lead sponsor

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
May 22, 2026
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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