Pubo-urethral ligament plication versus transobturator tape for female stress urinary incontinence
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
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 147 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | Female |
| Sponsor | Harran University Academic / other |
| Locations | 1 site (Şanliurfa, HALİLİYE) |
| Trial ID | NCT07290114 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Şanliurfa, HALİLİYE
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.