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
Last Updated: 2025-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
147 participants
INTERVENTIONAL
2025-01-13
2026-09-30
Brief Summary
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Detailed Description
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Eligible patients with a clinical diagnosis of SUI who elect to undergo surgical treatment will be allocated to one of the two interventions based on shared decision-making between the surgeon and the patient. The study will collect demographic data, operative parameters, perioperative complications, and short-term postoperative outcomes. Continence outcomes will be assessed using validated questionnaires such as the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF), as well as objective clinical evaluation during follow-up visits. Pain levels, urinary retention, de-novo urgency, wound complications, and overall patient satisfaction will also be recorded.
The primary aim of the study is to compare early continence improvement between the PLP and TOT procedures. Secondary aims include comparing perioperative and postoperative complications, operative time, postoperative pain, hospital discharge time, and patient-reported satisfaction. By directly comparing a mesh-free native tissue technique with a commonly used mesh-based sling, this study seeks to provide updated, patient-centered data that may guide surgical decision-making, especially in settings where mesh-related concerns or patient preference favor native tissue repair options.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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PLP Arm
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.
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.
TOT Arm
Patients undergoing the Transobturator Tape (TOT) procedure, a widely used mesh-based midurethral sling technique performed to provide urethral support via the transobturator route.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
80 Years
FEMALE
No
Sponsors
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Mehmet Incebıyik
OTHER
Responsible Party
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Mehmet Incebıyik
Assistant Professor of Obstetrics and Gynecology
Principal Investigators
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MEHMET İNCEBIYIK, MD
Role: PRINCIPAL_INVESTIGATOR
Harran University
Locations
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Harran University Research and Application Hospital
Şanliurfa, HALİLİYE, Turkey (Türkiye)
Countries
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Central Contacts
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Facility Contacts
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MEHMET İNCEBIYIK, MD
Role: primary
Role: backup
Other Identifiers
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HU-SUI-PLP-TOT-2025
Identifier Type: -
Identifier Source: org_study_id