Clinical trial NCT06606613: Cross-linked Hyaluronic Acid/dextranomer for the Treatment of Stress Urinary Incontinence
Official title: Midurethral Sling Versus Cross-linked Hyaluronic Acid/dextranomer (CLHA/Dx) for the Treatment of Stress Urinary Incontinence
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Urinary Stress Incontinence (SI)
Keywords: Cross-linked hyaluronic acid/dextranomer
Mid-urethral sling
Female
Stress Urinary Incontinence
Lead sponsor: Izmir Bakircay University
Sponsor class: OTHER
First posted: 2024-09-23
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a single-center, prospective before-after (pre-post) interventional study, in which the effectiveness and safety of intraurethral cross-linked hyaluronic acid/dextranomer injection in female stress urinary incontinence patients were compared with those undergoing mid-urethral sling procedures.
Primary purpose: TREATMENT

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 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).

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) \&amp;gt; 35 kg/m².
* Use of medications that may influence bladder storage or emptying.

Primary outcomes:
measure: Need for addtional treatment within the 3st month
timeFrame: Within the 3 st month
measure: Need for addtional treatment within the 1st month
timeFrame: Within the 1st month
measure: Need for addtional treatment within the 6 st month
timeFrame: Within the 6 st month
measure: Presence of complication within 6 months after intervention
timeFrame: Within 6 months after intervention
measure: Change in the Stamey Incontinence Grade at 6months
timeFrame: Change from baseline at 6months.
measure: Change in the Incontinence Questionnaire Female Lower Urinary Tract Symptoms Modules (ICIQ-FLUTS) scores at 3
timeFrame: Change from baseline at 3 month
measure: Change in the Incontinence Questionnaire Female Lower Urinary Tract Symptoms Modules (ICIQ-FLUTS) scores at 1 month
timeFrame: Change from baseline at 1 month
measure: Change in the Incontinence Questionnaire Female Lower Urinary Tract Symptoms Modules (ICIQ-FLUTS) scores at 6 month
timeFrame: Change from baseline at 6 month
measure: Change in the Incontinence Quality of Life Scale (I-QOL) scores at 3 months
timeFrame: Change from baseline at 3 month
measure: Change in the Incontinence Quality of Life Scale (I-QOL) scores at 6 months
timeFrame: Change from baseline at 6 month
measure: Change in the Incontinence Quality of Life Scale (I-QOL) scores at 1 month
timeFrame: Change from baseline at 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: İ̇zmi̇r
country: Turkey
facility: İzmir Bakircay University
state: Bayrakli
Study officials:
References: