Status:
NOT_YET_RECRUITING
Cross-linked Hyaluronic Acid/dextranomer for the Treatment of Stress Urinary Incontinence
Lead Sponsor:
Izmir Bakircay University
Conditions:
Urinary Stress Incontinence (SI)
Eligibility:
FEMALE
18-75 years
Phase:
PHASE2
Brief Summary
The investigators aimed to evaluate the effectiveness and safety of intraurethral cross-linked hyaluronic acid/dextranomer (CLHA/Dx) injection for the treatment of stress urinary incontinence (SUI) in...
Detailed Description
This single-center prospective pre-post interventional study was conducted between October 2025 and April 2025 with 60 women . Quality of life was evaluated with the Incontinence Quality of Life Scale...
Eligibility Criteria
Inclusion
- Diagnosis of Stress Urinary Incontinence.
- Presence of incontinence during the Valsalva maneuver.
- Positive Marshall-Marchetti test result.
- Post-void residual urine volume of ≤100 mL.
Exclusion
- Temporary urinary incontinence.
- Delirium.
- Urinary tract infection.
- Urethritis.
- Pure urge incontinence.
- Nocturnal enuresis.
- Decreased bladder compliance or detrusor contraction observed in urodynamic -studies.
- Leakage of urine with low bladder pressure.
- Psychiatric conditions (severe depression and anxiety).
- Body mass index (BMI) \> 35 kg/m².
- Use of medications that may influence bladder storage or emptying.
Key Trial Info
Start Date :
October 10 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 10 2025
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06606613
Start Date
October 10 2024
End Date
April 10 2025
Last Update
September 26 2024
Active Locations (1)
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1
İzmir Bakircay University
Izmir, BAYRAKLI, Turkey (Türkiye), 35050