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

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

October 10, 2024

Primary Completion Date

March 10, 2025

Study Completion Date

April 10, 2025

Conditions
Urinary Stress Incontinence (SI)
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 ."

Trial Locations (1)

35050

İzmir Bakircay University, Izmir

All Listed Sponsors
lead

Izmir Bakircay University

OTHER

NCT06606613 - Cross-linked Hyaluronic Acid/dextranomer for the Treatment of Stress Urinary Incontinence | Biotech Hunter | Biotech Hunter