Cross-linked Hyaluronic Acid/dextranomer for the Treatment of Stress Urinary Incontinence

NCT ID: NCT06606613

Last Updated: 2024-09-26

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-10
• Study Completion Date: 2025-04-10

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).

Conditions

Urinary Stress Incontinence (SI)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Intraurethral injection group

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

Group Type: EXPERIMENTAL

Intraurethral injection

Intervention Type: PROCEDURE

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-linked hyaluronic acid/dextranomer at approximately the 2, 4, 8, and 10 o'clock positions.

Drug: Cross-linked hyaluronic acid/dextranomer

Mid-urethral sling group

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

Group Type: ACTIVE_COMPARATOR

Mid-urethral sling

Intervention Type: PROCEDURE

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. The needle is placed in to the incision and passed medially through the obturator membrane. It has to be considered that the needle is passed very close to the bone in order not to damage the obturator vessel-nerve bundle. With the guidance of the opposite hand's index finger in the vaginal incision the tip of the needle has to be palpated afterwards passing with a 45-degree angle rotation. The next manoeuvre is passing the tip of the needle beside the urethra through the vaginal incision .

Interventions

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-linked hyaluronic acid/dextranomer at approximately the 2, 4, 8, and 10 o'clock positions.

Drug: Cross-linked hyaluronic acid/dextranomer

Intervention Type: 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. The needle is placed in to the incision and passed medially through the obturator membrane. It has to be considered that the needle is passed very close to the bone in order not to damage the obturator vessel-nerve bundle. With the guidance of the opposite hand's index finger in the vaginal incision the tip of the needle has to be palpated afterwards passing with a 45-degree angle rotation. The next manoeuvre is passing the tip of the needle beside the urethra through the vaginal incision .

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Izmir Bakircay University

OTHER

Sponsor Role: lead

Responsible Party

İBRAHİM KARACA

Associate Proffesor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

İzmir Bakircay University

Izmir, BAYRAKLI, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Central Contacts

İBRAHİM KARACA Associate Prof.

Role: CONTACT

ibrahim.karaca@bakircay.edu.tr

+905072864474

Facility Contacts

İBRAHİM KARACA, ASSOCIATE PROF.

Role: primary

ibrahim.karaca@bakircay.edu.tr

+905072864474

Other Identifiers

170924

Identifier Type: -

Identifier Source: org_study_id