Pubo-urethral ligament plication versus transobturator tape for female stress urinary incontinence
Official title: Mesh-Free Versus Mesh-Based Surgery for Female Stress Urinary Incontinence: A Prospective Comparison of Pubo-Urethral Ligament Plication and Transobturator Tape With Short-Term Patient-Centered Outcomes
Run by Harran University · NCT07290114 · Data updated 2026-11-12
This compares a mesh-free repair (PLP) with a mesh-based mid-urethral sling (TOT) to see if women with stress urinary incontinence get similar continence and fewer complications.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 80 Years |
| Sex | Women only |
| Enrollment | 147 (estimated) |
| Sponsor | Harran University Academic / other |
| Locations | 1 site (Şanliurfa, HALİLİYE) |
| Status | Recruiting |
| Started | January 13, 2025 |
| Main results expected | June 2026 |
| Study ends | September 2026 |
| Registry record updated | December 18, 2025 |
| Trial ID | NCT07290114 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Women aged 18–80 with clinically confirmed stress urinary incontinence who have tried conservative therapy and are choosing surgical treatment, able to consent and attend follow-up, are ideal candidates.
✕Probably not a fit
Women with predominant urge incontinence, pelvic organ prolapse stage II or greater, prior anti-incontinence surgery, active urinary infection, neurological bladder disease, or pregnancy plans may not benefit or are ineligible.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a single-center, prospective, comparative study enrolling women with clinically diagnosed stress urinary incontinence who elect surgical treatment. Patients and surgeons use shared decision-making to select either pubo-urethral ligament plication (PLP), a mesh-free native tissue repair, or transobturator tape (TOT), a mesh-based mid-urethral sling, and baseline and short-term outcomes are collected. The primary outcome is early continence improvement measured by validated tools (ICIQ-SF) and clinical exam, and secondary outcomes include operative time, hospital stay, postoperative pain, urinary retention, de novo urgency, wound complications, and patient satisfaction. Short-term follow-up visits capture perioperative and postoperative complications and patient-reported outcomes to compare effectiveness and safety profiles.
Why it matters
Potential benefit: If successful, PLP could provide a mesh-free surgical option with comparable continence results and fewer mesh-related complications for women seeking alternatives to synthetic implants.
How similar studies have gone: Mesh-based mid-urethral slings like TOT have a strong evidence base for effectiveness, while mesh-free native tissue repairs such as PLP have shown promising but less extensively validated results.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: Female patients aged 18-80 years Clinical diagnosis of stress urinary incontinence Failure of conservative management (pelvic floor exercises or medical therapy) Desire to undergo surgical treatment (PLP or TOT) Ability to provide informed consent Willingness to attend postoperative follow-up visits Exclusion Criteria: * Mixed urinary incontinence with predominant urge symptoms Active urinary tract infection Pelvic organ prolapse ≥ stage II Previous anti-incontinence surgery Neurological diseases affecting bladder function Pregnancy or planning pregnancy during follow-up Uncontrolled diabetes, bleeding disorders, or contraindications to surgery Use of medications affecting bladder function (e.g., anticholinergics) Inability to provide informed consent
Where it's running
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Harran University Research and Application Hospital
Şanliurfa, Hali̇li̇ye, Turkey (Türkiye) Recruiting
Study contacts
- Principal investigator: Mehmet İncebiyik, Md — Harran University
- Study coordinator: Mehmet İNCEBIYIK, MD
- Email: drmehmetincebiyik@gmail.com
- Phone: +905353374889
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Kinesthetic Pelvic Floor Imagery Added to Exercises for Stress Urinary Incontinence
In postmenopausal women with stress urinary incontinence, this study tests whether mentally rehearsing pelvic floor muscle contractions before doing the exercises helps reduce leakage.
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Compare two pelvic floor stimulation devices to see which helps with urinary incontinence in women
We’re testing if electromagnetic chair therapy can help women with mixed urinary incontinence as well as standard electrostimulation with biofeedback.
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Hybrid Transobturator Tape vs Standard Synthetic TOT for Stress Urinary Incontinence
This randomized trial tests whether a hybrid tape made from autologous tissue and polypropylene mesh works as well or better than a standard synthetic transobturator tape in women with stress urinary incontinence.
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Expiratory Muscle Strength Training added to pelvic floor training for women with stress urinary incontinence
This study tests whether adding expiratory muscle strength training to pelvic floor exercises helps improve urinary leakage in women with stress urinary incontinence.
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Risk predictor for new urinary incontinence after prolapse surgery
This study tests a model to predict which women might develop new stress urinary incontinence after pelvic organ prolapse repair.
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At-home electrical stimulation treatment for stress urinary incontinence in women
This trial will test whether a non-implantable at-home electrical stimulation device can reduce urine leakage in women with stress urinary incontinence.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.