Stress Urinary Incontinence Clinical Trial
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
NCT number | NCT00629083 |
Other study ID # | CONSUI-US01 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | April 2008 |
Est. completion date | May 2013 |
Verified date | December 2019 |
Source | Contura |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Completed |
Enrollment | 345 |
Est. completion date | May 2013 |
Est. primary completion date | May 2013 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Canada | Jewish General Hospital | Montreal | Quebec |
Canada | University of Sherbrooke | Sherbrooke | Quebec |
Canada | Sunnybrook Health Sciences Centre | Toronto | Ontario |
Canada | Can-Med Clinical Research, Inc. | Victoria | British Columbia |
Canada | Gary Steinhoff Clinical Research | Victoria | British Columbia |
France | Hopital Tenon | Paris | |
United States | Northeast Urogynecology | Albany | New York |
United States | St. Lukes Hospital and Health Network | Allentown | Pennsylvania |
United States | University of Vermont - The Continence Center | Burlington | Vermont |
United States | Medical University of South Carolina - Department of Urology | Charleston | South Carolina |
United States | McKay Urology | Charlotte | North Carolina |
United States | The Urology Group | Cincinnati | Ohio |
United States | Urology Clinics of North Texas | Dallas | Texas |
United States | UT Southwestern Medical Center at Dallas - Department of Urology | Dallas | Texas |
United States | Genitourinary Surgical Consultants | Denver | Colorado |
United States | Incontinence Research Institute | Encinitas | California |
United States | North Shore University Health System | Evanston | Illinois |
United States | Vanguard Urologic Research Foundation | Houston | Texas |
United States | Mayo Clinic - Department of Urology | Jacksonville | Florida |
United States | Tower Urology - Institute for Continence - Cedars-Sinai Medical Office | Los Angeles | California |
United States | University of Miami and Jackson Memorial Hospital | Miami | Florida |
United States | Specialists in Urology | Naples | Florida |
United States | LSU Health Science Center | New Orleans | Louisiana |
United States | Ochsner Clinic | New Orleans | Louisiana |
United States | Sherif Aboseif, MD | Oxnard | California |
United States | South California Permanente Medical Group | Pasadena | California |
United States | Hospital for the University of Pennsylvannia - Penn Center for Continence and Public Health: Division of Urology | Philadelphia | Pennsylvania |
United States | Urology San Antonio | San Antonio | Texas |
United States | Virgina Mason Medical Center - Section of Urology and Renal Transplantation | Seattle | Washington |
United States | Stanford UniveritySchool of Medicine - Departmert of OB/GYN | Stanford | California |
United States | Scott & White Memorial Hospital | Temple | Texas |
United States | Michigan Urology | Troy | Michigan |
United States | Midwest Institute for Research & Education | West Chester | Ohio |
United States | Discovery Clinical Trials | Winter Haven | Florida |
Lead Sponsor | Collaborator |
---|---|
Contura | Regulatory and Clinical Research Institute (RCRI) |
United States, Canada, France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | 24hr Pad Test | A measure of urine leaked during a 24-hour period on a known weight and quantity of pads at the 12-month endpoint. | 12 months | |
Secondary | Number of Subjects Reporting as a Responder | At the 12-month primary endpoint follow-up visit, the subject was asked to provide her perception of treatment effectiveness by circling the most accurate description of her condition: cured/dry; much improved; improved; no change; worse. The response was dichotomized into responder or non-responder. A subject was classified as a responder if she reported that the treatment had cured, much improved, or improved her incontinence condition. | 12 months | |
Secondary | IQoL | The IQoL is a validated instrument consisting of 22 questions grouped into three subscales: avoidance and limiting behaviors; psychosocial impacts, and social embarrassment. It is a subject self-reported quality-of-life measure specific to urinary problems that is used to assess the impact of urinary incontinence and urinary problems and their treatment. The subject scores each question on a scale of 1 to 5 with higher scores indicating more positive responses. The maximum score was 110 points and the minimum score was 22. | 12 months | |
Secondary | ICIQ-UI Short Form | The ICIQ-UI Short Form assesses the impact of symptoms of incontinence on quality of life and outcome of treatment. The questionnaire consists of three questions with a maximum score of 21 and a minimum score of zero (0). A lower score represents a decrease in the severity of symptoms (i.e., improvement). | 12 months | |
Secondary | Number of Incontinence Episodes | The total number of incontinence episodes experienced by the subject over three consecutive days. | 12 months |
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