Mesh-Free Versus Mesh-Based Surgery for Female Stress Urinary Incontinence: A Prospective Comparison of Pubo-Urethral Ligament Plication and Transobturator Tape
Recruiting now · Not applicable
Conditions studied: Stress Urinary Incontinence (SUI)
In brief
This prospective clinical study aims to compare the short-term effectiveness, safety, and patient-reported outcomes of two surgical techniques used for the treatment of female stress urinary incontinence (SUI): Pubo-Urethral Ligament Plication (PLP), a mesh-free native tissue repair method, and the Transobturator Tape (TOT) procedure, a commonly used mesh-based mid-urethral sling technique. The study evaluates continence improvement, perioperative and postoperative complications, operative time, hospital stay, postoperative pain, and patient satisfaction. The goal is to provide evidence on whether a mesh-free surgical option such as PLP can offer comparable outcomes to mesh-based TOT, particularly for patients seeking alternatives to synthetic materials.
Key facts
- Study ID
- NCT07290114
- Run by
- Mehmet Incebıyik
- People needed
- 147
- Starts
- 2025-01-13
- Expected to finish
- 2026-09-01
- Last updated by the study team
- 2025-12-18
Who can join
Age: 18 and older, up to 80. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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 is running
- Harran University Research and Application Hospital — Şanliurfa, HALİLİYE, Turkey (Türkiye) (enrolling)
Full record on ClinicalTrials.gov
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