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

NCT07290114 | Recruiting

• 1 other identifier: HU-SUI-PLP-TOT-2025
• Study Type: interventional
• Target: 147
• Locations: 1 country
• Sites: 1

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.

Conditions

Stress Urinary Incontinence (SUI)

Keywords

Stress Urinary Incontinence, Pubo-Urethral Ligament Plication, PLP, Transobturator Tape, TOT, Mesh-free surgery, Midurethral sling

Outcome Measures

Primary Outcomes (1)

• Improvement in Stress Urinary Incontinence Symptoms (ICIQ-SF Score)

  Change in the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) score from baseline to postoperative 6 weeks. Lower scores indicate improvement in symptom severity.

  6-24 weeks postoperatively

Study Arms (2)

PLP Arm

EXPERIMENTAL

Patients undergoing mesh-free Pubo-Urethral Ligament Plication (PLP), a native tissue surgical technique performed to reinforce urethral support without the use of synthetic mesh.

Procedure: Pubo-Urethral Ligament Plication (PLP)

TOT Arm

ACTIVE COMPARATOR

Patients undergoing the Transobturator Tape (TOT) procedure, a widely used mesh-based midurethral sling technique performed to provide urethral support via the transobturator route.

Procedure: Transobturator Tape (TOT)

Interventions

Pubo-Urethral Ligament Plication (PLP) PROCEDURE

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.

PLP Arm

Transobturator Tape (TOT) PROCEDURE

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.

TOT Arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Mehmet Incebıyik: lead

Study Sites (1)

Harran University Research and Application Hospital

Şanliurfa, HALİLİYE, 63300, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Urinary Incontinence, Stress; Pelizaeus-Merzbacher Disease

Interventions

Suburethral Slings

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hereditary Central Nervous System Demyelinating Diseases; Brain Diseases, Metabolic, Inborn; Brain Diseases, Metabolic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Leukoencephalopathies; Demyelinating Diseases; Genetic Diseases, X-Linked; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolism, Inborn Errors; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Prostheses and Implants; Equipment and Supplies

Study Officials

• MEHMET İNCEBIYIK, MD

  Harran University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mehmet İNCEBIYIK, MD

CONTACT

+905353374889; drmehmetincebiyik@gmail.com

Ömer TAMMO, MD

CONTACT

drmehmetincebiyik@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor of Obstetrics and Gynecology

Model Details: Two-arm prospective parallel comparison of mesh-free PLP versus mesh-based TOT surgical techniques.

Study Record Dates

• First Submitted: December 4, 2025
• First Posted: December 18, 2025
• Study Start: January 13, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: December 18, 2025

Record last verified: 2025-12

Locations

TU (1)