Urinary Stress Incontinence (SI)
Conditions
Keywords
Cross-linked hyaluronic acid/dextranomer, Mid-urethral sling, Female, Stress Urinary Incontinence
Brief 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.
Detailed description
This single-center prospective pre-post interventional study was conducted between October 2025 and April 2025 with 60 women . Quality of life was evaluated with the Incontinence Quality of Life Scale (I-QoL) and the lower urinary tract symptoms of women were evaluated with the International Consultation on Incontinence Questionnaire Female Lower Urinary Tract Symptoms Modules (ICIQ-FLUTS). Incontinence status was assessed via the Stamey Incontinence Grade scale. The need for additional treatment (re-injection, other surgical approaches, etc.) was recorded. Participants were followed up to 6 months after intervention. All outcomes of interest and complications were evaluated/recorded at three preplanned visits (postoperative 1st, 3rd, 6th, months).
Interventions
PROCEDUREIntraurethral 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
PROCEDUREMid-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
Izmir Bakircay University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
This is a single-center, prospective before-after (pre-post) interventional study, in which the effectiveness and safety of intraurethral cross-linked hyaluronic acid/dextranomer injection in female stress urinary incontinence patients were compared with those undergoing mid-urethral sling procedures.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* Temporary urinary incontinence. * Delirium. * Urinary tract infection. * Urethritis. * Pure urge incontinence. * Nocturnal enuresis. * Decreased bladder compliance or detrusor contraction observed in urodynamic -studies. * Leakage of urine with low bladder pressure. * Psychiatric conditions (severe depression and anxiety). * Body mass index (BMI) > 35 kg/m². * Use of medications that may influence bladder storage or emptying.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Turkey (Türkiye)
Contacts
Primary ContactİBRAHİM KARACA Associate Prof.
Outcome results
None listed