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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

NCT07290114 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 147

Last updated 2025-12-18

No results posted yet for this study

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.

Conditions

  • Stress Urinary Incontinence (SUI)

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.

Sponsors & Collaborators

  • Mehmet Incebıyik

    lead OTHER

Principal Investigators

  • MEHMET İNCEBIYIK, MD · Harran University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-13
Primary Completion
2026-06-30
Completion
2026-09-30

Countries

  • Turkey (Türkiye)

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07290114 on ClinicalTrials.gov