Bulking Agents for the Treatment of Stress Urinary Incontinence in Females
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
1 other identifier
interventional
345
3 countries
34
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2008
Longer than P75 for not_applicable
34 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 26, 2008
CompletedFirst Posted
Study publicly available on registry
March 5, 2008
CompletedStudy Start
First participant enrolled
April 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2013
CompletedResults Posted
Study results publicly available
February 7, 2020
CompletedFebruary 7, 2020
December 1, 2019
5.1 years
February 26, 2008
December 2, 2019
January 28, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Primary Effectiveness Endpoint
The number of subjects with at least a 50% reduction from baseline in both leakage, as measured by the 24h Pad Test, and daily number of incontinence episodes
12 Months
The Number of Participants With Device- and Procedure-related Serious Adverse Events Through 12 Months Follow-up.
The number of participants with device- and procedure-related serious adverse events through 12 months follow-up.
12 months
Secondary Outcomes (5)
24hr Pad Test
12 months
Number of Subjects Reporting as a Responder
12 months
IQoL
12 months
ICIQ-UI Short Form
12 months
Number of Incontinence Episodes
12 months
Study Arms (2)
1
EXPERIMENTALBulkamid Hydrogel injection
2
ACTIVE COMPARATORContigen injection
Interventions
Eligibility Criteria
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.
- +10 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Conturalead
- Regulatory and Clinical Research Institute Inccollaborator
Study Sites (34)
Incontinence Research Institute
Encinitas, California, 92024, United States
Tower Urology - Institute for Continence - Cedars-Sinai Medical Office
Los Angeles, California, 90048, United States
Sherif Aboseif, MD
Oxnard, California, 93030, United States
South California Permanente Medical Group
Pasadena, California, 91101, United States
Stanford UniveritySchool of Medicine - Departmert of OB/GYN
Stanford, California, 94305, United States
Genitourinary Surgical Consultants
Denver, Colorado, 80220, United States
Mayo Clinic - Department of Urology
Jacksonville, Florida, 32224, United States
University of Miami and Jackson Memorial Hospital
Miami, Florida, 33136, United States
Specialists in Urology
Naples, Florida, 34102, United States
Discovery Clinical Trials
Winter Haven, Florida, 33881, United States
North Shore University Health System
Evanston, Illinois, 60201, United States
Ochsner Clinic
New Orleans, Louisiana, 70121, United States
LSU Health Science Center
New Orleans, Louisiana, 70122, United States
Michigan Urology
Troy, Michigan, 48084, United States
Northeast Urogynecology
Albany, New York, 12205, United States
McKay Urology
Charlotte, North Carolina, 28207, United States
The Urology Group
Cincinnati, Ohio, 45212, United States
Midwest Institute for Research & Education
West Chester, Ohio, 45069, United States
St. Lukes Hospital and Health Network
Allentown, Pennsylvania, 18104, United States
Hospital for the University of Pennsylvannia - Penn Center for Continence and Public Health: Division of Urology
Philadelphia, Pennsylvania, 19104, United States
Medical University of South Carolina - Department of Urology
Charleston, South Carolina, 29425, United States
Urology Clinics of North Texas
Dallas, Texas, 75231, United States
UT Southwestern Medical Center at Dallas - Department of Urology
Dallas, Texas, 75390, United States
Vanguard Urologic Research Foundation
Houston, Texas, 77030, United States
Urology San Antonio
San Antonio, Texas, 78229, United States
Scott & White Memorial Hospital
Temple, Texas, 76508, United States
University of Vermont - The Continence Center
Burlington, Vermont, 05403, United States
Virgina Mason Medical Center - Section of Urology and Renal Transplantation
Seattle, Washington, 98101, United States
Can-Med Clinical Research, Inc.
Victoria, British Columbia, V8T 5G1, Canada
Gary Steinhoff Clinical Research
Victoria, British Columbia, V8V3N1, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5, Canada
Jewish General Hospital
Montreal, Quebec, H3T 1E2, Canada
University of Sherbrooke
Sherbrooke, Quebec, J1H 5N4, Canada
Hopital Tenon
Paris, 75020, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Ieva Ankorina-Stark, Ph D, Chief Scientific Officer
- Organization
- Contura International A/S
Study Officials
- STUDY DIRECTOR
Silvia Garcia-Codony
Contura
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 26, 2008
First Posted
March 5, 2008
Study Start
April 1, 2008
Primary Completion
May 1, 2013
Study Completion
May 1, 2013
Last Updated
February 7, 2020
Results First Posted
February 7, 2020
Record last verified: 2019-12