MedTrace Logo

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

NCT06606613 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-09-26

No results posted yet for this study

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.

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 .

Sponsors & Collaborators

  • Izmir Bakircay University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-10
Primary Completion
2025-03-10
Completion
2025-04-10

Countries

  • Turkey (Türkiye)

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06606613 on ClinicalTrials.gov