Cross-linked Hyaluronic Acid/dextranomer for the Treatment of Stress Urinary Incontinence
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Intraurethral injection, Mid-urethral sling.
- Who it may be relevant to
- Registry conditions: Urinary Stress Incontinence (SI). Basic parameters: 18 years — 75 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Turkey (Türkiye)
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Midurethral Sling Versus Cross-linked Hyaluronic Acid/dextranomer (CLHA/Dx) for the Treatment of Stress Urinary Incontinence
Overview
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 women.
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 (I-QoL) and the lower urinary tract symptoms of women were evaluated with the International Consultation on Incontinence Questionnaire Female Lower Urinary Tract Symptoms Modules (ICIQ-FLUTS). Incontinence status was assessed via the Stamey Incontinence Grade scale. The need for additional treatment (re-injection, other surgical approaches, etc.) was recorded.
Participants were followed up to 6 months after intervention. All outcomes of interest and complications were evaluated/recorded at three preplanned visits (postoperative 1st, 3rd, 6th, months).
Interventions
- Procedure Intraurethral injection
Procedure: Intraurethral injection Patients are positioned in the lithotomy position during the procedure. General and/or local anesthesia is administered depending on the investigator\'s preference. An applicator developed for intraurethral injection will be used. This device comprises a holder that is placed into and fixates the urethra (i.e., it distends the urethral circumference, thus smoothing out the longitudinal folds), allowing the use of four syringes to inject cross-linke - Procedure Mid-urethral sling
Procedure: Starting with the dorsal lithotomy position, a foley catheter is inserted to the urethra. Starting with 1-1.5 cm below the urethral meatus, a 1.5-2 cm vertical incision is made. Following the dissection of anterior vaginal mucosa, pubocervical fascia should be dissected sharply . Dissection is continued laterally to the ischiopubic ramus. Starting downwards from the tendinous insertion of the adductor longus muscle at the level of clitoris, a 1cm incision is made close to the bone. T
Primary outcome measures
- Need for addtional treatment within the 3st month [Time frame: Within the 3 st month]
- Need for addtional treatment within the 1st month [Time frame: Within the 1st month]
- Need for addtional treatment within the 6 st month [Time frame: Within the 6 st month]
- Presence of complication within 6 months after intervention [Time frame: Within 6 months after intervention]
- Change in the Stamey Incontinence Grade at 6months [Time frame: Change from baseline at 6months.]
- Change in the Incontinence Questionnaire Female Lower Urinary Tract Symptoms Modules (ICIQ-FLUTS) scores at 3 [Time frame: Change from baseline at 3 month]
- Change in the Incontinence Questionnaire Female Lower Urinary Tract Symptoms Modules (ICIQ-FLUTS) scores at 1 month [Time frame: Change from baseline at 1 month]
- Change in the Incontinence Questionnaire Female Lower Urinary Tract Symptoms Modules (ICIQ-FLUTS) scores at 6 month [Time frame: Change from baseline at 6 month]
- Change in the Incontinence Quality of Life Scale (I-QOL) scores at 3 months [Time frame: Change from baseline at 3 month]
- Change in the Incontinence Quality of Life Scale (I-QOL) scores at 6 months [Time frame: Change from baseline at 6 month]
Eligibility criteria
Inclusion criteria
- 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 criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Turkey (Türkiye) · 1 center
- İzmir Bakircay University — Izmir
Identifiers
NCT: NCT06606613 · 170924