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

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18-75
SponsorIzmir Bakircay University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Temporary urinary incontinence.

Delirium.

Urinary tract infection.

Urethritis.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Intraurethral injection

    Procedure/Surgery

    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

    Procedure/Surgery

    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 .

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Intraurethral injection groupExperimental treatment 1 intervention
Group B: Mid-urethral sling groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Need for addtional treatment within the 3st month

Patients who are needed to treat with re-injection or other surgical approaches.

Time frame
Within the 3 st month
2

Need for addtional treatment within the 1st month

Patients who are needed to treat with re-injection or other surgical approaches

Time frame
Within the 1st month
3

Need for addtional treatment within the 6 st month

Patients who are needed to treat with re-injection or other surgical approaches

Time frame
Within the 6 st month
4

Presence of complication within 6 months after intervention

Presence of complication such as infection at injection site, urinary tract infection, hematuria, persistent pain, de novo urge incontinence) in all patients.

Time frame
Within 6 months after intervention

Secondary outcomes

Other outcomes

Sponsors and contacts

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