Bulking Agents for the Treatment of Stress Urinary Incontinence in Females

Completed · Not applicable

Conditions studied: Stress Urinary Incontinence

In brief

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

Key facts

Study ID

NCT00629083

Run by

Contura

People needed

345

Starts

2008-04-01

Expected to finish

2013-05-01

Last updated by the study team

2020-02-07

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Incontinence Research Institute — Encinitas, California, United States
• Tower Urology - Institute for Continence - Cedars-Sinai Medical Office — Los Angeles, California, United States
• Sherif Aboseif, MD — Oxnard, California, United States
• South California Permanente Medical Group — Pasadena, California, United States
• Stanford UniveritySchool of Medicine - Departmert of OB/GYN — Stanford, California, United States
• Genitourinary Surgical Consultants — Denver, Colorado, United States
• Mayo Clinic - Department of Urology — Jacksonville, Florida, United States
• University of Miami and Jackson Memorial Hospital — Miami, Florida, United States
• Specialists in Urology — Naples, Florida, United States
• Discovery Clinical Trials — Winter Haven, Florida, United States
• North Shore University Health System — Evanston, Illinois, United States
• Ochsner Clinic — New Orleans, Louisiana, United States
• LSU Health Science Center — New Orleans, Louisiana, United States
• Michigan Urology — Troy, Michigan, United States
• Northeast Urogynecology — Albany, New York, United States
• McKay Urology — Charlotte, North Carolina, United States
• The Urology Group — Cincinnati, Ohio, United States
• Midwest Institute for Research & Education — West Chester, Ohio, United States
• St. Lukes Hospital and Health Network — Allentown, Pennsylvania, United States
• Hospital for the University of Pennsylvannia - Penn Center for Continence and Public Health: Division of Urology — Philadelphia, Pennsylvania, United States
• Medical University of South Carolina - Department of Urology — Charleston, South Carolina, United States
• Urology Clinics of North Texas — Dallas, Texas, United States
• UT Southwestern Medical Center at Dallas - Department of Urology — Dallas, Texas, United States
• Vanguard Urologic Research Foundation — Houston, Texas, United States
• Urology San Antonio — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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