Actively Recruiting
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
Led by Mehmet Incebıyik · Updated on 2025-12-18
147
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are comparing two surgical methods for treating female stress urinary incontinence (SUI) to understand their short-term effectiveness, safety, and patient satisfaction. The study looks at Pubo-Urethral Ligament Plication (PLP), a mesh-free native tissue repair, and Transobturator Tape (TOT), a mesh-based sling technique. The goal is to see if the mesh-free PLP offers similar outcomes to the more common mesh-based TOT, especially for patients preferring to avoid synthetic materials. Participants diagnosed with SUI who choose surgery will undergo either the PLP or TOT procedure based on shared decision-making with their surgeon. PLP strengthens urethral support by folding native tissues without mesh, while TOT places a synthetic tape under the midurethra using the transobturator route. The study collects data on surgery details, complications, pain, hospital stay, and patient satisfaction during follow-up visits. During the study, continence improvement will be measured using questionnaires like the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) and clinical exams 6 to 24 weeks after surgery. Researchers will also monitor pain, urinary retention, new urgency symptoms, wound healing, and overall satisfaction. Participants will attend postoperative follow-ups to help evaluate the outcomes and safety of each surgical technique.
CONDITIONS
Brief Title
Mesh-Free Versus Mesh-Based Surgery for Female Stress Urinary Incontinence: A Prospective Comparison of Pubo-Urethral Ligament Plication and Transobturator Tape
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female patients aged 18 to 80 years
- Clinical diagnosis of stress urinary incontinence
- Failure of conservative management such as pelvic floor exercises or medical therapy
- Desire to undergo surgical treatment with either PLP or TOT
- Ability to provide informed consent
- Willingness to attend postoperative follow-up visits
You will not qualify if you...
- Mixed urinary incontinence with predominant urge symptoms
- Active urinary tract infection
- Pelvic organ prolapse stage II or greater
- 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 such as anticholinergics
- Inability to provide informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to hospital discharge
Participants undergo one of two surgical procedures to treat stress urinary incontinence: mesh-free Pubo-Urethral Ligament Plication (PLP) or mesh-based Transobturator Tape (TOT). Immediate recovery and hospital discharge occur after surgery.
1 surgery visit and hospital stay
Duration - 6 to 24 weeks postoperatively
Participants attend follow-up visits to assess continence improvement, pain levels, urinary symptoms, wound healing, and patient satisfaction using questionnaires and clinical evaluations.
Multiple follow-up visits during this period
Trial Site Locations
Total: 1 location
1
Harran University Research and Application Hospital
Şanliurfa, HALİLİYE, Turkey (Türkiye), 63300
Actively Recruiting
Research Team
M
Mehmet İNCEBIYIK, MD
Ö
Ömer TAMMO, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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