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

NCT06606613 | Not Yet Recruiting Phase 2

• 1 other identifier: 170924
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Urinary Stress Incontinence (SI)

Keywords

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

Outcome Measures

Primary Outcomes (11)

• Need for addtional treatment within the 3st month

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

  Within the 3 st month

• Need for addtional treatment within the 1st month

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

  Within the 1st month

• Need for addtional treatment within the 6 st month

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

  Within the 6 st month

• 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.

  Within 6 months after intervention

• 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)

  Change from baseline at 6months.

• 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.

  Change from baseline at 3 month

• 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.

  Change from baseline at 1 month

• 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.

  Change from baseline at 6 month

• 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.

  Change from baseline at 3 month

• 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.

  Change from baseline at 6 month

• 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.

  Change from baseline at 1 month

Study Arms (2)

Intraurethral injection group

EXPERIMENTAL

Intraurethral Cross-linked hyaluronic acid/dextranomer injection was performed in female patients with Stress Urinary incontinence

Procedure: Intraurethral injection

Mid-urethral sling group

ACTIVE COMPARATOR

Mid-urethral sling procedure was performed in female patients with Stress Urinary incontinence

Procedure: Mid-urethral sling

Interventions

Intraurethral injection PROCEDURE

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

Intraurethral injection group

Mid-urethral sling PROCEDURE

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 .

Mid-urethral sling group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Gender Eligibility Details: Female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Izmir Bakircay University: lead

Study Sites (1)

İzmir Bakircay University

Izmir, BAYRAKLI, 35050, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Urinary Incontinence, Stress

Interventions

Suburethral Slings

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Prostheses and Implants; Equipment and Supplies

Central Study Contacts

İBRAHİM KARACA Associate Prof.

CONTACT

+905072864474; ibrahim.karaca@bakircay.edu.tr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Proffesor

Model Details: 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.

Study Record Dates

• First Submitted: September 18, 2024
• First Posted: September 23, 2024
• Study Start: October 10, 2024
• Primary Completion: March 10, 2025
• Study Completion: April 10, 2025
• Last Updated: September 26, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

TU (1)