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

Condition(s) studied

Investigational drug(s) / intervention(s)

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

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 .

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.

Eligibility

Primary outcome measure(s)

• Need for addtional treatment within the 3st month — Within the 3 st month
  Patients who are needed to treat with re-injection or other surgical approaches.
• Need for addtional treatment within the 1st month — Within the 1st month
  Patients who are needed to treat with re-injection or other surgical approaches
• Need for addtional treatment within the 6 st month — Within the 6 st month
  Patients who are needed to treat with re-injection or other surgical approaches
• Presence of complication within 6 months after intervention — 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.
• Change in the Stamey Incontinence Grade at 6months — Change from baseline 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)
• Change in the Incontinence Questionnaire Female Lower Urinary Tract Symptoms Modules (ICIQ-FLUTS) scores at 3 — Change from baseline at 3 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.
• Change in the Incontinence Questionnaire Female Lower Urinary Tract Symptoms Modules (ICIQ-FLUTS) scores at 1 month — Change from baseline 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.
• Change in the Incontinence Questionnaire Female Lower Urinary Tract Symptoms Modules (ICIQ-FLUTS) scores at 6 month — Change from baseline 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.
• Change in the Incontinence Quality of Life Scale (I-QOL) scores at 3 months — Change from baseline at 3 month
  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.
• Change in the Incontinence Quality of Life Scale (I-QOL) scores at 6 months — Change from baseline at 6 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.
• Change in the Incontinence Quality of Life Scale (I-QOL) scores at 1 month — Change from baseline 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.

Trial sites (1)

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