Stress Urinary Incontinence Clinical Trials

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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 With Short-Term Patient-Centered Outcomes

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Turkey
Harran University Research and Application Hospital
RECRUITING
Şanliurfa
Contact Information
Primary
Mehmet İNCEBIYIK, MD
drmehmetincebiyik@gmail.com
+905353374889
Backup
Ömer TAMMO, MD
drmehmetincebiyik@gmail.com
Time Frame
Start Date: 2025-01-13
Estimated Completion Date: 2026-09
Participants
Target number of participants: 147
Treatments
Experimental: 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.
Active_comparator: 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.
Sponsors
Leads: Mehmet Incebıyik

This content was sourced from clinicaltrials.gov