Pelvic Organ Prolapse (POP)NCT07601282
Development and Validation of a Risk Prediction Model for De Novo Stress Urinary Incontinence After Pelvic Floor Reconstruction Surgery
An observational study of Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SUI), run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 90 years, women only
- Conditions the study is for
- Pelvic Organ Prolapse (POP), Stress Urinary Incontinence (SUI)
- What is being tested?
- Telephone follow-up
- How many people
- 382 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2024to 31 Dec 2026
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 90 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients who visited the outpatient clinic of Shanghai General Hospital for pelvic organ prolapse.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai General Hospital
Shanghai, Shanghai Municipality, 200080
Wenqian Geng, +86 21 3612 6254
sydwlunli2020@163.com
About this study
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
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.
- Being tested
- Telephone follow-up
- Keywords
- Case-Control Study
- Medical subject headings
- Pelvic Organ Prolapse, Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Pelvic floor ultrasound
Measured: From enrollment to 3 days before surgery
Secondary outcomes (2)
Pelvic Floor Distress Inventory-20 (PFDI-20)
Measured: 3 months, 6 months and 12 months after the surgery
International Consultation on Incontinence Questionnaire Short Form (ICI-Q-SF)
Measured: 3 months, 6 months and 12 months after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2026
- Study start1 Dec 2024
- Primary completion18 Dec 2025
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic Organ Prolapse (POP)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 382 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhu Yiping, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07601282
- Sponsor's protocol ID
- 20224Y0261
- Status last verified
- May 2026
- First submitted
- 16 May 2026
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all IPD collected throughout the trial