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Bulking Agents for the Treatment of Stress Urinary Incontinence in Females
Not Recruiting
Trial ID: NCT00629083
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
Stanford Investigator(s)
Eric R. Sokol, MD
Professor of Obstetrics and Gynecology (Gynecology and Gynecologic Specialties/Urogynecology) and, by courtesy, of Urology
Eligibility
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.
Intervention(s):
device: Bulkamid
device: Contigen
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Tine Bjornlund
6507247826