Bulking Agents for the Treatment of Stress Urinary Incontinence in Females

Inclusion Criteria: * Be female 18 or more years of age. * Females of childbearing potential or \<2 years post-menopausal must be using 2 forms of contraception. * 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. Exclusion Criteria: * 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 screening. * 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 the treatment. * 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 diabetes. * 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.