Stress Urinary Incontinence in WomenNCT07923968
The Preventive Efficacy of ULP for Stress Urinary Incontinence After Pelvic Organ Prolapse Surgery
A study testing pubourethral ligament plication in people with Stress Urinary Incontinence in Women and Pelvic Organ Prolapse (POP), run by Peking University People's Hospital at 5 sites in China.
Trial summary
This study is for women planning surgery to repair pelvic organ prolapse.For patients with pelvic organ prolapse accompanied by occult stress urinary incontinence before the operation, the clinical phenomenon of de novo stress urinary incontinence (SUI) after pelvic floor reconstruction is relatively common. Read more about this study
- Who is it for?
- Ages 60 years and older, women only
- Conditions the study is for
- Stress Urinary Incontinence in Women, Pelvic Organ Prolapse (POP)
- What is being tested?
- pubourethral ligament plication
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 236 participants
- Where
- 5 sitesChina
- Study dates
- Nov 2026to Apr 2028
- Phase
- Interventional
- 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 60 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patients aged 60 years or older.
- Moderate-to-severe pelvic organ prolapse (POP-Q stage ≥ III, meeting the ICS diagnostic criteria for pelvic floor disorder) with bothersome symptoms, affecting quality of life and requiring surgical treatment.
- With preoperative features of occult stress urinary incontinence，meeting both of the following two criteria: 1) History of urinary leakage when increasing intra-abdominal pressure such as coughing,and the leakage symptoms have been alleviated or disappeared as the prolapsed vaginal mass enlarges. 2) Positive cough stress test after prolapse reduction, or 1g<1-hour pad test weight ≤10 g.
- Able to understand the study, voluntarily agree to participate, and provide written informed consent.
Who cannot join
- Previous anti-incontinence surgery, urethral support repair surgery, or pelvic organ prolapse surgery.
- Neurogenic bladder secondary to neurological disease.
- History of pelvic malignancy or pelvic radiation therapy.
- Unwilling or unable to complete scheduled follow-up assessments.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
China5 sites
Peking University People's Hospital
Beijing, Beijing Municipality, 100044
Shiyan Wang, Doctor of Medicine（MD）, +86 18810532993, 1810301256@pku.edu.cn
Siqi Li, Master of Medicine, +86 18801061320, lsqdoctor@163.com
The Third Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510150
Juan Liu
Women's Hospital School of Medicine Zhejiang University
Hangzhou, Zhejiang, 310006
Zhenwei Xie, +86 13588030456, xiezw@zju.edu.cn
Jiangxi Maternal and Child Health Hospital
Nanchang, Jiangxi, 330006
Liqun Wang
Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200233
Qingkai Wu
About this study
Official title: A Study on the Preventive Efficacy of Pubourethral Ligament Plication for Stress Urinary Incontinence After Pelvic Organ Prolapse Surgery
This study is for women planning surgery to repair pelvic organ prolapse.For patients with pelvic organ prolapse accompanied by occult stress urinary incontinence before the operation, the clinical phenomenon of de novo stress urinary incontinence (SUI) after pelvic floor reconstruction is relatively common. It manifests as involuntary leakage of urine during coughing, sneezing, or walking, seriously affecting daily life, social interaction, and physical and mental health.
The pubourethral ligament plication (ULP) is an anti-leakage operation based on autologous tissue repair, without the implantation of synthetic sling. By folding and tightening the pelvic urethral ligament and stimulating local regeneration of new collagen, it repairs the natural urethral support structure.A large number of literature reports have confirmed that its treatment efficacy for patients with preoperative stress urinary incontinence symptoms can reach 90%. Compared with midurethral suspension surgery, ULP takes less operating time, avoids sling-related complications and costs lessly.
Read more
However, it is not clear whether this surgical method can significantly reduce the postoperative leakage risk of this group of patients. This trial aims to answer this question and balance its benefits and risks.
The study would be conducted in 5 hospitals in China. Eligible participants would be randomly assigned to two groups:
- The experimental group: received standard prolapse repair surgery and the pubourethral ligament plication（ULP）
- The control group: only received standard prolapse repair surgery
Investigators would conduct the primary assessment 3 months after the surgery. The main objective is to test whether this additional procedure could reduce the occurrence of new urinary leakage after the surgery. Investigators would also follow participants for 1 year, recording urinary symptoms, quality of life, and surgical-related adverse conditions. The doctors responsible for evaluating the outcomes would be blinded to group assignment.
This study has been reviewed and approved by the Institutional Review Board (IRB) of Peking University People's Hospital.
- Being tested
- pubourethral ligament plication
- Keywords
- Pelvic organ prolapse, Occult stress urinary incontinence, Pubourethral ligament plication, Randomized controlled trial
- Medical subject headings
- Pelvic Organ Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pubourethral ligament plicationProcedure or surgery
Also called ULP
The pubourethral ligament plication(ULP) is invented by Professor Petros, the founder of the integral theory, to treat urinary incontinence. It is a native tissue repair technique without synthetic implantion, which involves multiple points of folding and suturing of the bilateral pubic urethral ligaments (PUL) using non-absorbable polyester sutures. This surgical method can elevate the bladder neck-proximal urethra complex for anatomical support and induces local neocollagen synthesis to reinforce the PUL. Its advantages are as follows: ① Avoiding the long-term complications and adverse events specific to synthetic implants; ② No blind trocar passage through the retropubic/obturator space, reducing the risk of collateral injury; ③ Reducing consumable cost, making it affordable and adoptable across diverse clinical settings.
| Study group | Role | What they receive |
|---|---|---|
| The experimental group | Experimental | Participants in the experimental arm will receive standardized pelvic reconstruction surgery with concomitant pubourethral ligament plication (ULP). The standardized pelvic reconstruction surgery refers to transvaginal mesh-augmented anterior pelvic reconstruction（TVM）+ apical repair (unilateral sacrospinous ligament fixation, SSLF) + fascia-reinforced posterior colporrhaphy and perineal body reconstruction with levator ani plication. Receives: Procedure: pubourethral ligament plication |
| The control group | No intervention | Participants in the control arm will receive standardized pelvic reconstruction surgery alone-transvaginal mesh-augmented anterior pelvic reconstruction (TVM) + apical repair (unilateral sacrospinous ligament fixation, SSLF) + fascia-reinforced posterior colporrhaphy and perineal body reconstruction with levator ani plication. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of overt stress urinary incontinence at 3 months postoperatively between the two groups.
Overt stress urinary incontinence is defined as meeting any one of the following criteria:
- The difference between the 3-month postoperative ICIQ-SF total score and the preoperative ICIQ-SF total score is ≥ 4 points, and ICIQ-SF question 6 identifies leakage mainly during coughing, sneezing, physical activity or exercise;
- Positive cough stress test.
Measured: 3 months after surgery
Secondary outcomes (6)
Incidence of urinary retention at 3 days after surgery between the two groups.
Urinary retention is defined as post-void residual urine volume > 100 mL after catheter removal, or requirement for reinsertion of urinary catheter.
Measured: 3 days after surgery
Difference in lower urinary tract symptoms at 3 months after surgery between the two groups.
Lower urinary tract symptoms will be assessed using the Overactive Bladder Symptom Score (OABSS).The score of OABSS ranges from 0 to 15. The higher the score, the more severe the lower urinary tract symptoms are.
Measured: 3 months after surgery
Difference in patient satisfaction at 3 months after surgery between the two groups
Patient satisfaction will be evaluated using the Patient Global Impression of Improvement (PGI-I) questionnaire.The score of PGI-I ranges from 0 to 7. The higher the score, the lower the patient's satisfaction is.
Measured: 3 months after surgery
The incidence of overt stress urinary incontinence at 6 months postoperatively between the two groups.
Overt stress urinary incontinence is defined as meeting any one of the following criteria:
- The difference between the 6-month postoperative ICIQ-SF total score and the preoperative ICIQ-SF total score is ≥ 4 points, and ICIQ-SF question 6 identifies leakage mainly during coughing, sneezing, physical activity or exercise;
- Positive cough stress test.
Measured: 6 months after surgery
The incidence of overt stress urinary incontinence at 1 year postoperatively between the two groups.
Overt stress urinary incontinence is defined as meeting any one of the following criteria:
- The difference between the 1-year postoperative ICIQ-SF total score and the preoperative ICIQ-SF total score is ≥ 4 points, and ICIQ-SF question 6 identifies leakage mainly during coughing, sneezing, physical activity or exercise;
- Positive cough stress test.
Measured: 1 year after surgery
Difference in POP-Q point Aa at 1 year after surgery between the two groups
The Pelvic Organ Prolapse Quantification system (POP-Q) will be measured and compared between groups at 1 year after surgery.
Measured: 1 year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2026
- Study startNov 2026 (estimated)
- Primary completionApr 2028 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress Urinary Incontinence in WomenStudies of the same condition, open and under way.
- More trials run by Peking University People's HospitalThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- After confirming eligibility, obtaining written informed consent and completing all baseline assessments, participants will be randomized centrally online before surgery. The random sequence is generated by an independent statistician who is not involved in study conduction or participant recruitment using SAS 9.4 or R 4.0. Stratified randomization by study site will be applied, with a 1:1 allocation ratio to the experimental arm or control arm.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 236 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Women's Hospital School Of Medicine Zhejiang University, Jiangxi Maternal and Child Health Hospital, The Third Affiliated Union Hospital of Guangzhou Medical College, Shanghai 6th People's Hospital
- Responsible party
- Principal investigator, Wang Shiyan, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07923968
- Sponsor's protocol ID
- 2026PHB531-001
- Status last verified
- Nov 2026
- First submitted
- 1 Nov 2026
- Last updated
- 9 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on the Preventive Efficacy of Pubourethral Ligament Plication for Stress Urinary Incontinence After Pelvic Organ Prolapse Surgery
- ClinicalTrials.gov ID
- NCT07923968
- Acronym / sponsor ID
- 2026PHB531-001
- Keywords
- Pelvic organ prolapse, Occult stress urinary incontinence, Pubourethral ligament plication, Randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 236 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Collaborators
- Women's Hospital School Of Medicine Zhejiang University, Jiangxi Maternal and Child Health Hospital, The Third Affiliated Union Hospital of Guangzhou Medical College, Shanghai 6th People's Hospital
- Study start
- Nov 2026 (estimated)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 9 Nov 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 study is for women planning surgery to repair pelvic organ prolapse.For patients with pelvic organ prolapse accompanied by occult stress urinary incontinence before the operation, the clinical phenomenon of de novo stress urinary incontinence (SUI) after pelvic floor reconstruction is relatively common. It manifests as involuntary leakage of urine during coughing, sneezing, or walking, seriously affecting daily life, social interaction, and physical and mental health.
The pubourethral ligament plication (ULP) is an anti-leakage operation based on autologous tissue repair, without the implantation of synthetic sling. By folding and tightening the pelvic urethral ligament and stimulating local regeneration of new collagen, it repairs the natural urethral support structure.A large number of literature reports have confirmed that its treatment efficacy for patients with preoperative stress urinary incontinence symptoms can reach 90%. Compared with midurethral suspension surgery, ULP takes less operating time, avoids sling-related complications and costs lessly.
However, it is not clear whether this surgical method can significantly reduce the postoperative leakage risk of this group of patients. This trial aims to answer this question and balance its benefits and risks.
The study would be conducted in 5 hospitals in China. Eligible participants would be randomly assigned to two groups:
- The experimental group: received standard prolapse repair surgery and the pubourethral ligament plication（ULP）
- The control group: only received standard prolapse repair surgery
Investigators would conduct the primary assessment 3 months after the surgery. The main objective is to test whether this additional procedure could reduce the occurrence of new urinary leakage after the surgery. Investigators would also follow participants for 1 year, recording urinary symptoms, quality of life, and surgical-related adverse conditions. The doctors responsible for evaluating the outcomes would be blinded to group assignment.
This study has been reviewed and approved by the Institutional Review Board (IRB) of Peking University People's Hospital.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- After confirming eligibility, obtaining written informed consent and completing all baseline assessments, participants will be randomized centrally online before surgery. The random sequence is generated by an independent statistician who is not involved in study conduction or participant recruitment using SAS 9.4 or R 4.0. Stratified randomization by study site will be applied, with a 1:1 allocation ratio to the experimental arm or control arm.
| Arm | Type | Receives |
|---|---|---|
| The experimental group | Experimental | Procedure: pubourethral ligament plicationParticipants in the experimental arm will receive standardized pelvic reconstruction surgery with concomitant pubourethral ligament plication (ULP). The standardized pelvic reconstruction surgery refers to transvaginal mesh-augmented anterior pelvic reconstruction（TVM）+ apical repair (unilateral sacrospinous ligament fixation, SSLF) + fascia-reinforced posterior colporrhaphy and perineal body reconstruction with levator ani plication. |
| The control group | No intervention | –Participants in the control arm will receive standardized pelvic reconstruction surgery alone-transvaginal mesh-augmented anterior pelvic reconstruction (TVM) + apical repair (unilateral sacrospinous ligament fixation, SSLF) + fascia-reinforced posterior colporrhaphy and perineal body reconstruction with levator ani plication. |
Who may qualify
- Ages
- 60 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Female patients aged 60 years or older.
- Moderate-to-severe pelvic organ prolapse (POP-Q stage ≥ III, meeting the ICS diagnostic criteria for pelvic floor disorder) with bothersome symptoms, affecting quality of life and requiring surgical treatment.
- With preoperative features of occult stress urinary incontinence，meeting both of the following two criteria: 1) History of urinary leakage when increasing intra-abdominal pressure such as coughing,and the leakage symptoms have been alleviated or disappeared as the prolapsed vaginal mass enlarges. 2) Positive cough stress test after prolapse reduction, or 1g<1-hour pad test weight ≤10 g.
- Able to understand the study, voluntarily agree to participate, and provide written informed consent.
Key exclusion criteria (4 listed)
- Previous anti-incontinence surgery, urethral support repair surgery, or pelvic organ prolapse surgery.
- Neurogenic bladder secondary to neurological disease.
- History of pelvic malignancy or pelvic radiation therapy.
- Unwilling or unable to complete scheduled follow-up assessments.
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 |
|---|---|---|
| pubourethral ligament plicationAlso: ULPThe pubourethral ligament plication(ULP) is invented by Professor Petros, the founder of the integral theory, to treat urinary incontinence. It is a native tissue repair technique without synthetic implantion, which involves multiple points of folding and suturing of the bilateral pubic urethral ligaments (PUL) using non-absorbable polyester sutures. This surgical method can elevate the bladder neck-proximal urethra complex for anatomical support and induces local neocollagen synthesis to reinforce the PUL. Its advantages are as follows: ① Avoiding the long-term complications and adverse events specific to synthetic implants; ② No blind trocar passage through the retropubic/obturator space, reducing the risk of collateral injury; ③ Reducing consumable cost, making it affordable and adoptable across diverse clinical settings. | Procedure or surgery | The experimental group |
Primary outcome
The incidence of overt stress urinary incontinence at 3 months postoperatively between the two groups.
Time frame: 3 months after surgery
Overt stress urinary incontinence is defined as meeting any one of the following criteria: 1. The difference between the 3-month postoperative ICIQ-SF total score and the preoperative ICIQ-SF total score is ≥ 4 points, and ICIQ-SF question 6 identifies leakage mainly during coughing, sneezing, physical activity or exercise; 2. Positive cough stress test.
6 secondary outcomes
Incidence of urinary retention at 3 days after surgery between the two groups.
Time frame: 3 days after surgery
Difference in lower urinary tract symptoms at 3 months after surgery between the two groups.
Time frame: 3 months after surgery
Difference in patient satisfaction at 3 months after surgery between the two groups
Time frame: 3 months after surgery
The incidence of overt stress urinary incontinence at 6 months postoperatively between the two groups.
Time frame: 6 months after surgery
The incidence of overt stress urinary incontinence at 1 year postoperatively between the two groups.
Time frame: 1 year after surgery
Difference in POP-Q point Aa at 1 year after surgery between the two groups
Time frame: 1 year after 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 9 Nov 2026.
- Individual participant dataSharing planned: No
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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.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pubourethral ligament plication in people with Stress Urinary Incontinence in Women and Pelvic Organ Prolapse (POP), run by Peking University People's Hospital at 5 sites 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 4 inclusion and 4 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: opening soon, as of the sponsor's last update on 9 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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 Shiyan Wang, Doctor of Medicine（MD） (+86 18810532993, 1810301256@pku.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of overt stress urinary incontinence at 3 months postoperatively between the two groups. (time frame: 3 months after 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 9 Nov 2026.