Clinical trial NCT00629083: Bulking Agents for the Treatment of Stress Urinary Incontinence in Females
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress Urinary Incontinence
Keywords: SUI
Bulkamid
Urinary Incontinence
Lead sponsor: Contura
Sponsor class: INDUSTRY
Collaborators: name: Regulatory and Clinical Research Institute Inc
First posted: 2008-03-05
Enrollment: 345
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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

Detailed description: The study is a single-masked, randomized, comparative multi-center, 2-arm parallel study intended to demonstrate the safety and effectiveness of Bulkamid® vs. Contigen® for the treatment of stress urinary incontinence (SUI)due to intrinsic sphincter deficiency (ISD) in adult women who have SUI or stress predominant mixed incontinence.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Primary Effectiveness Endpoint
timeFrame: 12 Months
measure: The Number of Participants With Device- and Procedure-related Serious Adverse Events Through 12 Months Follow-up.
timeFrame: 12 months
Secondary outcomes:
measure: 24hr Pad Test
timeFrame: 12 months
measure: Number of Subjects Reporting as a Responder
timeFrame: 12 months
measure: IQoL
timeFrame: 12 months
measure: ICIQ-UI Short Form
timeFrame: 12 months
measure: Number of Incontinence Episodes
timeFrame: 12 months
Other outcomes:
Locations:
city: Encinitas
country: United States
facility: Incontinence Research Institute
state: California
city: Los Angeles
country: United States
facility: Tower Urology - Institute for Continence - Cedars-Sinai Medical Office
state: California
city: Oxnard
country: United States
facility: Sherif Aboseif, MD
state: California
city: Pasadena
country: United States
facility: South California Permanente Medical Group
state: California
city: Stanford
country: United States
facility: Stanford UniveritySchool of Medicine - Departmert of OB/GYN
state: California
city: Denver
country: United States
facility: Genitourinary Surgical Consultants
state: Colorado
city: Jacksonville
country: United States
facility: Mayo Clinic - Department of Urology
state: Florida
city: Miami
country: United States
facility: University of Miami and Jackson Memorial Hospital
state: Florida
city: Naples
country: United States
facility: Specialists in Urology
state: Florida
city: Winter Haven
country: United States
facility: Discovery Clinical Trials
state: Florida
city: Evanston
country: United States
facility: North Shore University Health System
state: Illinois
city: New Orleans
country: United States
facility: Ochsner Clinic
state: Louisiana
city: New Orleans
country: United States
facility: LSU Health Science Center
state: Louisiana
city: Troy
country: United States
facility: Michigan Urology
state: Michigan
city: Albany
country: United States
facility: Northeast Urogynecology
state: New York
city: Charlotte
country: United States
facility: McKay Urology
state: North Carolina
city: Cincinnati
country: United States
facility: The Urology Group
state: Ohio
city: West Chester
country: United States
facility: Midwest Institute for Research & Education
state: Ohio
city: Allentown
country: United States
facility: St. Lukes Hospital and Health Network
state: Pennsylvania
city: Philadelphia
country: United States
facility: Hospital for the University of Pennsylvannia - Penn Center for Continence and Public Health: Division of Urology
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina - Department of Urology
state: South Carolina
city: Dallas
country: United States
facility: Urology Clinics of North Texas
state: Texas
city: Dallas
country: United States
facility: UT Southwestern Medical Center at Dallas - Department of Urology
state: Texas
city: Houston
country: United States
facility: Vanguard Urologic Research Foundation
state: Texas
city: San Antonio
country: United States
facility: Urology San Antonio
state: Texas
city: Temple
country: United States
facility: Scott & White Memorial Hospital
state: Texas
city: Burlington
country: United States
facility: University of Vermont - The Continence Center
state: Vermont
city: Seattle
country: United States
facility: Virgina Mason Medical Center - Section of Urology and Renal Transplantation
state: Washington
city: Victoria
country: Canada
facility: Can-Med Clinical Research, Inc.
state: British Columbia
city: Victoria
country: Canada
facility: Gary Steinhoff Clinical Research
state: British Columbia
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
city: Montreal
country: Canada
facility: Jewish General Hospital
state: Quebec
city: Sherbrooke
country: Canada
facility: University of Sherbrooke
state: Quebec
city: Paris
country: France
facility: Hopital Tenon
Study officials:
affiliation: Contura
name: Silvia Garcia-Codony
role: STUDY_DIRECTOR
References: