Bulking Agents for the Treatment of Stress Urinary Incontinence in Females

Trial ID or NCT#

NCT00629083

Status

not recruiting iconNOT 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:
  1. * 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:
  1. * 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.
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Investigator(s)

Eric R. Sokol, MD
Eric R. Sokol, MD
Urogynecologist, Pelvic surgeon, Minimally invasive gynecologic surgeon, Pelvic reconstructive surgeon, Obstetrician and Gynecologist (OB-GYN)
Professor of Obstetrics and Gynecology (Gynecology and Gynecologic Specialties/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