NCT07290114 Mesh-Free Versus Mesh-Based Surgery for Female Stress Urinary Incontinence: A Prospective Comparison of Pubo-Urethral Ligament Plication and Transobturator Tape
| NCT ID | NCT07290114 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Mehmet Incebıyik |
| Condition | Stress Urinary Incontinence (SUI) |
| Study Type | INTERVENTIONAL |
| Enrollment | 147 participants |
| Start Date | 2025-01-13 |
| Primary Completion | 2026-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 147 participants in total. It began in 2025-01-13 with a primary completion date of 2026-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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
Contact & Investigator
MEHMET İNCEBIYIK, MD
PRINCIPAL INVESTIGATOR
Harran University
Frequently Asked Questions
Who can join the NCT07290114 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 80 Years, studying Stress Urinary Incontinence (SUI). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07290114 currently recruiting?
Yes, NCT07290114 is actively recruiting participants. Contact the research team at drmehmetincebiyik@gmail.com for enrollment information.
Where is the NCT07290114 trial being conducted?
This trial is being conducted at Şanliurfa, Turkey (Türkiye).
Who is sponsoring the NCT07290114 clinical trial?
NCT07290114 is sponsored by Mehmet Incebıyik. The principal investigator is MEHMET İNCEBIYIK, MD at Harran University. The trial plans to enroll 147 participants.