Cross-linked Hyaluronic Acid/dextranomer for the Treatment of Stress Urinary Incontinence ((CLHA/Dx))

Izmir Bakircay University

Status and phase: Not yet enrolling; Phase 2

Conditions: Urinary Stress Incontinence (SI)

Treatments: Procedure: Intraurethral injection; Procedure: Mid-urethral sling

Study type: Interventional

Funder types: Other

Identifiers

NCT06606613

170924

Details and patient eligibility

About

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.

Full 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).

Enrollment: 60 estimated patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Intraurethral injection group

Experimental group

Description:

Intraurethral Cross-linked hyaluronic acid/dextranomer injection was performed in female patients with Stress Urinary incontinence

Treatment:

Procedure: Intraurethral injection

Mid-urethral sling group

Active Comparator group

Description:

Mid-urethral sling procedure was performed in female patients with Stress Urinary incontinence

Treatment:

Procedure: Mid-urethral sling