Bulking Agents for the Treatment of Stress Urinary Incontinence in Females
NCT ID: NCT00629083
Last Updated: 2020-02-07
Study Results
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View full resultsBasic Information
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COMPLETED
NA
345 participants
INTERVENTIONAL
2008-04-30
2013-05-31
Brief Summary
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Detailed Description
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Subjects will be randomized to receive either a polyacrylamide hydrogel (Bulkamid®) treatment, or a collagen treatment (Contigen®) using a 2:1 ratio and will be masked to the treatment. Screening baseline evaluations and collagen skin testing will be completed to determine eligible subjects. Following a negative skin test, a subject will be randomized and treated with Bulkamid® or the comparator device at the Treatment Visit.
Subjects that are not continent will be considered for re-injection. A maximum of 3 injections (initial + 2 re-injections) are allowed. After the last injection, subjects will attend the 3-Month, 6-Month and 12-Month Follow-up Visits plus a telephone contact at 9 months.
The study will record objective incontinence measurements, subject's perception of effectiveness and quality of life assessments. Adverse events will be recorded throughout the study.
Each subject will be followed for 12 months from the last injection.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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1
Bulkamid Hydrogel injection
Bulkamid
Bulking injection with Bulkamid injection device
2
Contigen injection
Contigen
Transurethral bulking injection
Interventions
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Bulkamid
Bulking injection with Bulkamid injection device
Contigen
Transurethral bulking injection
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
FEMALE
No
Sponsors
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Regulatory and Clinical Research Institute Inc
OTHER
Contura
INDUSTRY
Responsible Party
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Principal Investigators
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Silvia Garcia-Codony
Role: STUDY_DIRECTOR
Contura
Locations
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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
Scott & White Memorial Hospital
Temple, Texas, United States
University of Vermont - The Continence Center
Burlington, Vermont, United States
Virgina Mason Medical Center - Section of Urology and Renal Transplantation
Seattle, Washington, United States
Can-Med Clinical Research, Inc.
Victoria, British Columbia, Canada
Gary Steinhoff Clinical Research
Victoria, British Columbia, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
Jewish General Hospital
Montreal, Quebec, Canada
University of Sherbrooke
Sherbrooke, Quebec, Canada
Hopital Tenon
Paris, , France
Countries
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Other Identifiers
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CONSUI-US01
Identifier Type: -
Identifier Source: org_study_id
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