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Bulking Agents for the Treatment of Stress Urinary Incontinence in Females
Trial ID: NCT00629083
The primary purpose of this study is to demonstrate the safety and effectiveness of Bulkamid® in the treatment of stress urinary incontinence (SUI) due to intrinsic sphincter deficiency (ISD) in adult women who have SUI or stress predominant mixed incontinence
A Single-Masked, Randomized, Multi-Center, 2-Arm Parallel Study Comparing the Safety and Effectiveness of Bulkamid® and Contigen® as Bulking Agents for the Treatment of Stress Urinary Incontinence in Females
- Be female 18 or more years of age.
- Females of childbearing potential or <2 years post-menopausal must be using 2 forms of
- Suffer from SUI for at least 6 months.
- Have failed 2 previous non-invasive therapies for 3 months each.
- Have at least 3 incontinence episodes measured over 3 days.
- Have a baseline 24h pad test weight greater than or equal to 5 gm.
- Have VLPP ≤ 100 cm H2O.
- Have maximum cystometric capacity equal or higher than (≥) 250 mL.
- Have PVR urine ≤ 100 mL.
- Have a life expectancy of more than 2 years.
- Has urethral hypermobility >30 deg.
- Has predominant urge incontinence.
- Has detrusor overactivity.
- Regularly or intermittently users of urethral catheter.
- Has had previous radiation treatment in the pelvic floor.
- Has had previous urethral surgery (i.e. fistula, diverticula)or urethral bulking.
Failed sling or colposuspension procedure for at least 6 months may be included.
- Suffers from known polyuria.
- Has had three (3) or more culture-proven bacterial UTIs in the last 12 months.
- Has a current infection (urethritis, cystitis or vaginitis).
- Has unevaluated hematuria.
- Has a Prolapse Stage greater than II.
- Has a BMI>35 kg/m2.
- Is taking pharmacological treatment for stress urinary incontinence, 4 weeks prior to
- Is allergic to bovine collagen.
- Is known to suffer from severe allergies or anaphylaxis.
- Suffers from autoimmune diseases (e.e. connective tissue diseases) that could confound
- Is currently taking or has taken systemic corticosteroids within the past 3 months.
- Currently has cancer or has a history of any cancer within the past 5 years (skin
cancer with no evidence of skin malignancy, for at least 2 years, can be included).
- Currently suffering from unstable cardiovascular disease, cancer or uncontrolled
- Has active herpes genitalis.
- Is currently participating in any other clinical trial or has participated in another
clinical trial within 3 months of screening/baseline visit.
- Is pregnant, lactating or intending to become pregnant.
- Is not physically able to perform study procedure.
- Has a neurogenic bladder
- Had a vaginal delivery within 3 months prior to screening.