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| Name | Class |
|---|---|
| Regulatory and Clinical Research Institute Inc | OTHER |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Bulkamid Hydrogel injection |
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| 2 | Active Comparator | Contigen injection |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bulkamid | Device | Bulking injection with Bulkamid injection device |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Silvia Garcia-Codony | Contura | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Incontinence Research Institute | Encinitas | California | 92024 | United States | ||
| Tower Urology - Institute for Continence - Cedars-Sinai Medical Office |
Pelvic Organ Prolapse Quantification, upright cystometry, Valsalva Leak Point Pressure, post-void residual measurement, daily number of incontinence episodes and a 24-hour pad test were completed prior to randomization to confirm eligibility in the trial.
The first subject was enrolled on June 4, 2008, and the last subject was enrolled on June 6, 2011. All participating study centers were in hospitals or clinics in the United States, Canada or France. The sites and investigators were qualified to treat stress urinary incontinence in women by experience and expertise.
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| ID | Title | Description |
|---|---|---|
| FG000 | Bulkamid Hydrogel | Bulkamid hydrogel is a proprietary, cross-linked polyacrylamide hydrogel developed for urethral bulking. The hydrogel consists of a backbone of cross-linked polyacrylamide, with water molecules loosely bound to the polymer matrix. |
| FG001 | Contigen Injection |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Contigen |
| Device |
Transurethral bulking injection |
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| 12 months |
| 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 |
| 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 |
| Number of Incontinence Episodes | The total number of incontinence episodes experienced by the subject over three consecutive days. | 12 months |
| 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 |
Contigen is a sterile non-pyrogenic implantable device composed of highly purified bovine dermal collagen that was lightly crosslinked with glutaraldehyde and dispersed in phosphate-buffered physiological saline |
| COMPLETED |
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| NOT COMPLETED |
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There was no difference in the analysis population from the assignment in participant flow.
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| ID | Title | Description |
|---|---|---|
| BG000 | Bulkamid Hydrogel Injection | Bulkamid: Bulking injection with Bulkamid injection device |
| BG001 | Contigen Injection | Contigen: Transurethral bulking injection |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Region of Enrollment | Number | participants |
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| 24-hour Pad Test | The 24-hour pad test is a standard test used to quantify the amount of urine leaked in a 24-hour period. The patient receives a known quantity and weight of dry pads at a clinic visit, wears them for 24 hours, stores the wet pads in a waterproof/airproof bag, and returns the used and unused pads to the clinic, where they are weighed and the amount of leaked urine (wet pads) is measured by weight. | There were 345 subjects enrolled but not all of them provided baseline data for the 24-hour pad test. 223/228 test subjects and 112/117 control subjects provided baseline 24-hour pad test data. | Mean | Standard Deviation | g |
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| Daily Number of Incontinence Episodes | Mean | Standard Deviation | number of daily episodes |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Intent-to-treat (ITT) population. | Posted | Number | participants | 12 Months |
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| 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. | ITT | Posted | Count of Participants | Participants | 12 months |
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| 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. | Complete Case (CC): Randomized subjects with complete data for a specific endpoint at a particular time point (no imputed data). | Posted | Mean | Standard Deviation | grams | 12 months |
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| 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. | Complete Case (CC): Randomized subjects with complete data for a specific endpoint at a particular time point (no imputed data). | Posted | Count of Participants | Participants | 12 months |
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| 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. | Complete Case (CC): Randomized subjects with complete data for a specific endpoint at a particular time point (no imputed data). | Posted | Mean | Standard Deviation | score on a scale | 12 months |
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| 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). | Complete Case (CC): Randomized subjects with complete data for a specific endpoint at a particular time point (no imputed data). | Posted | Mean | Standard Deviation | score on a scale | 12 months |
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| Secondary | Number of Incontinence Episodes | The total number of incontinence episodes experienced by the subject over three consecutive days. | This analysis was performed on the Complete Case (CC) analysis set. | Posted | Mean | Standard Deviation | Episodes | 12 months |
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Adverse event data were collected from each participant through her study completion visit, typically at 12 months.
The definition of adverse event and/or serious adverse event used to collect adverse event information do not differ from the clinicaltrials.gov definitions.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Bulkamid Hydrogel Injection | Bulkamid: Bulking injection with Bulkamid injection device | 0 | 228 | 5 | 228 | 0 | 228 |
| EG001 | Contigen Injection | Contigen: Transurethral bulking injection | 0 | 117 | 0 | 117 | 0 | 117 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastrointestinal disorder | Gastrointestinal disorders | Study-specific | Systematic Assessment |
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| Respiratory disorder | Respiratory, thoracic and mediastinal disorders | Study-specific | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ieva Ankorina-Stark, Ph D, Chief Scientific Officer | Contura International A/S | 011 45 8110 0900 | ieva.ankorina-stark@contura.com |
| ID | Term |
|---|---|
| D014550 | Urinary Incontinence, Stress |
| D014549 | Urinary Incontinence |
| ID | Term |
|---|---|
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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