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
- Are there results?
- Not yet: the study is under way
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.
- More trials run by Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineThe sponsor's other registered studies.
- 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
- 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
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07601282
- Acronym / sponsor ID
- 20224Y0261
- Keywords
- Case-Control Study
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 382 participants (estimated)
- Lead sponsor
- Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 18 Dec 2025 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 22 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 90 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who visited the outpatient clinic of Shanghai General Hospital for pelvic organ prolapse.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telephone follow-upParticipants 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. | Diagnostic test | – |
Primary outcome
Pelvic floor ultrasound
Time frame: From enrollment to 3 days before surgery
2 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Individual participant dataSharing planned: Yes. all IPD collected throughout the trial
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yiping Zhu (+86 13817665076, zhuypurologist@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pelvic floor ultrasound (time frame: From enrollment to 3 days before surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.