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Mesh-Free Versus Mesh-Based Surgery for Female Stress Urinary Incontinence: A Prospective Comparison of Pubo-Urethral Ligament Plication and Transobturator Tape

RecruitingNAAges 18 Years - 80 YearsFemaleMehmet Incebıyik
NCT07290114 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • Pubo-Urethral Ligament Plication (PLP)
  • Transobturator Tape (TOT)
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Where

1 site
Harran University Research and Application Hospital
Şanliurfa, Turkey (Türkiye)
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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