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NOT YET RECRUITING
NCT06606613
PHASE2

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

Sponsor: Izmir Bakircay University

View on ClinicalTrials.gov

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.

Official title: Midurethral Sling Versus Cross-linked Hyaluronic Acid/dextranomer (CLHA/Dx) for the Treatment of Stress Urinary Incontinence

Key Details

Gender

FEMALE

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2024-10-10

Completion Date

2025-04-10

Last Updated

2024-09-26

Healthy Volunteers

No

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

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 .

Locations (1)

İzmir Bakircay University

Izmir, BAYRAKLI, Turkey (Türkiye)