Bulking Agents for the Treatment of Stress Urinary Incontinence in Females
Trial ID or NCT#
NCT00629083
Status
RECRUITING
Purpose
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
Official Title
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
Eligibility Criteria
Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: Female
Accepts Healthy Volunteers: No
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.
Investigator(s)
Eric R. Sokol, MD
Urogynecologist,
Pelvic surgeon,
Minimally invasive gynecologic surgeon,
Pelvic reconstructive surgeon,
Obstetrician and Gynecologist (OB-GYN)
Associate Professor of Obstetrics and Gynecology (Gynecology-Urogynecology) and, by courtesy, of Urology
Contact us to find out if this trial is right for you.
Contact
Tine Bjornlund
6507247826
View on ClinicalTrials.gov