Bulking Agents for the Treatment of Stress Urinary Incontinence in Females

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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
Eric R. Sokol, MD

Professor of Obstetrics and Gynecology (Gynecology-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

Recruiting

I'm Interested

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Tine Bjornlund
6507247826