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RECRUITING
NCT07290114
NA

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

Sponsor: Mehmet Incebıyik

View on ClinicalTrials.gov

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.

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

Key Details

Gender

FEMALE

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

147

Start Date

2025-01-13

Completion Date

2026-09

Last Updated

2025-12-18

Healthy Volunteers

No

Interventions

PROCEDURE

Pubo-Urethral Ligament Plication (PLP)

A mesh-free native tissue surgical technique that reinforces urethral support by plicating the pubo-urethral ligament. The procedure aims to restore midurethral stability without the use of synthetic mesh.

PROCEDURE

Transobturator Tape (TOT)

A mesh-based midurethral sling procedure performed through the transobturator route to provide urethral support. The tape is positioned under the midurethra to treat stress urinary incontinence.

Locations (1)

Harran University Research and Application Hospital

Şanliurfa, HALİLİYE, Turkey (Türkiye)