An interventional study of pubourethral ligament plication in Stress Urinary Incontinence in Women and Pelvic Organ Prolapse (POP), sponsored by Peking University People's Hospital. Not yet recruiting at 5 sites in China. Open to female participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2026-11-09.
Sponsored by Peking University People's Hospital · Not applicable, Interventional, and Prevention
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:
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.
521 studies on the registry are indexed under Pelvic Organ Prolapse; 80 are open to participants now.
This study's planned enrollment of 236 is above the median of 80 across 336 interventional studies indexed under Pelvic Organ Prolapse.
Browse Pelvic Organ Prolapse studies →Peking University People's Hospital is the lead sponsor of 609 studies on the registry; 247 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Procedure: pubourethral ligament plication
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.
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.
Also known as: ULP
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: 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.
Time frame: 3 months after surgery
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.
Time frame: 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.
Time frame: 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.
Time frame: 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: 1. 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; 2. Positive cough stress test.
Time frame: 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: 1. 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; 2. Positive cough stress test.
Time frame: 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.
Time frame: 1 year after surgery
Incidence of adverse events and complications up to 1 year after surgery
All adverse events and procedure-related complications occurring from the perioperative period up to 1 year after surgery will be recorded, and their incidence will be compared between the two groups.
Time frame: Up to 1 year after surgery
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Nov 2026; primary completion for Apr 2028, 17 months later.
Of 162 non-industry interventional studies with no phase under Pelvic Organ Prolapse, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 43. This study's planned 17 months is below that.
Counting every sponsor, half of 179 studies reached it within 23 months; a quarter within 12 and three quarters within 48.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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