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

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 18 to 75 years
• Women only
• No healthy volunteers
• Adult, Older adult

Trial locations and contacts

1 site in 1 country.

About this study

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

Conditions

Urinary Stress Incontinence (SI)

Being tested

Intraurethral injection, Mid-urethral sling

Keywords

Cross-linked hyaluronic acid/dextranomer, Mid-urethral sling, Female, Stress Urinary Incontinence

Medical subject headings

Urinary Incontinence, Stress

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• Intraurethral injectionProcedure or 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 slingProcedure or 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 .

What is being measured

The primary outcome is the main question the study is designed to answer.

1. Need for addtional treatment within the 3st month

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

   Measured: 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

   Measured: 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

   Measured: 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.

   Measured: Within 6 months after intervention

5. Change in the Stamey Incontinence Grade at 6months

   All patients were evaluated as follows: Grade 0: No incontinence; Grade 1: Incontinence with coughing or straining; Grade 2: Incontinence with change in position or walking; Grade 3: Total incontinence at all times.Stamey grading is specifically a 4-level scale of incontinence severity, ranging from 0 (continent/dry) to 3 (total incontinence, regardless of activity)

   Measured: Change from baseline at 6months.

6. Change in the Incontinence Questionnaire Female Lower Urinary Tract Symptoms Modules (ICIQ-FLUTS) scores at 3

   All patients were evaluated with the ICIQ-FLUTS which is a questionnaire for evaluating female lower urinary tract symptoms and impact on quality of life of the patients.The ICIQ-FLUTS consists of 12 questions related to LUTS divided into three areas: filling (4 questions), voiding (3 questions), and incontinence (5 questions). The answers are based on experiences with LUTS in the previous four weeks. The score is calculated by domain and it ranges from zero to ten in each question. As the score increases, the severity of the symptom increases.

   Measured: Change from baseline at 3 month

7. Change in the Incontinence Questionnaire Female Lower Urinary Tract Symptoms Modules (ICIQ-FLUTS) scores at 1 month

   All patients were evaluated with the ICIQ-FLUTS which is a questionnaire for evaluating female lower urinary tract symptoms and impact on quality of life of the patients.The ICIQ-FLUTS consists of 12 questions related to LUTS divided into three areas: filling (4 questions), voiding (3 questions), and incontinence (5 questions). The answers are based on experiences with LUTS in the previous four weeks. The score is calculated by domain and it ranges from zero to ten in each question. As the score increases, the severity of the symptom increases.

   Measured: Change from baseline at 1 month

8. Change in the Incontinence Questionnaire Female Lower Urinary Tract Symptoms Modules (ICIQ-FLUTS) scores at 6 month

   All patients were evaluated with the ICIQ-FLUTS which is a questionnaire for evaluating female lower urinary tract symptoms and impact on quality of life of the patients.The ICIQ-FLUTS consists of 12 questions related to LUTS divided into three areas: filling (4 questions), voiding (3 questions), and incontinence (5 questions). The answers are based on experiences with LUTS in the previous four weeks. The score is calculated by domain and it ranges from zero to ten in each question. As the score increases, the severity of the symptom increases.

   Measured: Change from baseline at 6 month

9. Change in the Incontinence Quality of Life Scale (I-QOL) scores at 3 months

   All patients were evaluated İth. the I-QOL which has 22 questions with the following 3 subscales: avoid and limiting behaviors (items), psychosocial impacts (9 items), and social embarassment (5 items).The I-QOL is divided into 3 subscales:Avoidance and limiting behavior (ALB),Psychosocial impact (PSI),Social embarrassment (SE). Subjects use a 5-point response scale with values ranging from 1 (extremely) to 5 (not at all). A mean score for each subscale is calculated (averaging the scores for the items in each subscale) as well as a total score for all 22 items (sum of all subscale scores).The scores are then transformed to a 'Scale score' ranging from 0-100 points for ease of interpretation: Scale score = (sum of the items - lowest possible score)/possible raw score range X 100.

   Measured: Change from baseline at 3 month

10. Change in the Incontinence Quality of Life Scale (I-QOL) scores at 6 months

    All patients were evaluated with the I-QOL which has 22 questions with the following 3 subscales: avoid and limiting behaviors (items), psychosocial impacts (9 items), and social embarassment (5 items).The I-QOL is divided into 3 subscales:Avoidance and limiting behavior (ALB),Psychosocial impact (PSI),Social embarrassment (SE). Subjects use a 5-point response scale with values ranging from 1 (extremely) to 5 (not at all). A mean score for each subscale is calculated (averaging the scores for the items in each subscale) as well as a total score for all 22 items (sum of all subscale scores).The scores are then transformed to a 'Scale score' ranging from 0-100 points for ease of interpretation: Scale score = (sum of the items - lowest possible score)/possible raw score range X 100.

    Measured: Change from baseline at 6 month

11. Change in the Incontinence Quality of Life Scale (I-QOL) scores at 1 month

    All patients were evaluated with the I-QOL which has 22 questions with the following 3 subscales: avoid and limiting behaviors (items), psychosocial impacts (9 items), and social embarassment (5 items).The I-QOL is divided into 3 subscales:Avoidance and limiting behavior (ALB),Psychosocial impact (PSI),Social embarrassment (SE). Subjects use a 5-point response scale with values ranging from 1 (extremely) to 5 (not at all). A mean score for each subscale is calculated (averaging the scores for the items in each subscale) as well as a total score for all 22 items (sum of all subscale scores).The scores are then transformed to a 'Scale score' ranging from 0-100 points for ease of interpretation: Scale score = (sum of the items - lowest possible score)/possible raw score range X 100.

    Measured: Change from baseline at 1 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted23 Sep 2024
2. Study start10 Oct 2024 (estimated)
3. Primary completion10 Mar 2025 (estimated)
4. Study completion10 Apr 2025 (estimated)

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Other trials for Urinary Stress Incontinence (SI)Studies of the same condition, open and under way.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.