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The SUCCESS Trial is designed to determine whether the Solace Bladder Control System is safe and effective for the treatment of Stress Urinary Incontinence (SUI) in adult females.
Subject will undergo treatment with the Solace Bladder Control System or a sham procedure, with the results being compared at 3 months.
All patients undergoing sham treatment are treated at 3 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | Subjects undergoing treatment with the Solace Bladder Control (Vesair) Balloon on day 0 |
|
| Solace Sham Treatment | Sham Comparator | Subjects undergoing sham treatment on day 0, and treatment with the Solace Bladder Control (Vesair) Balloon at 3 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Solace Bladder Control (Vesair) Balloon | Device | Subjects may undergo treatment every 12 months until study completion. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in quality of life as assessed by pad weight tests assessments and questionnaires | Comparison of increases in pad weight test and patient reported outcomes on questionnaires | 3 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of treatment-related adverse events | Site-reported adverse events designated as related to the treatment | 3 Months |
| Severity of treatment-related adverse events | Site-reported adverse events designated as related to the treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in quality of life in all patients assessed with pad weight tests and questionnaires | Comparison of increases in pad weight test and patient reported outcomes on questionnaires | 36 Months |
| Severity of all adverse events |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eric Rovner, MD | Medical University of South Carolina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Valley Urogynecology Associates | Phoenix | Arizona | 85016 | United States | ||
| Urological Associates of Southern Arizona |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29095516 | Derived | McCammon K, Jacoby K, Kalota S, Snyder J, Cline K, Robertson K, Rardin C, Kahan R, Green L, Zuckerman J, Rovner E. Three-month primary efficacy data for the SUCCESS Trial; a phase III, multi-center, prospective, randomized, controlled study treating female stress urinary incontinence with the vesair intravesical balloon. Neurourol Urodyn. 2018 Jan;37(1):440-448. doi: 10.1002/nau.23324. Epub 2017 Nov 2. |
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Individual records will not be made available to honor contracts with Investigators.
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|
| Solace Sham Treatment | Device | Sham treatment that resembles treatment with the Solace Bladder Control (Vesair) Balloon |
|
| 3 Months |
Site-reported adverse events designated as related to the treatment.
| 36 Months |
| Tucson |
| Arizona |
| 85715 |
| United States |
| Genitourinary Surgical Consultants | Denver | Colorado | 80220 | United States |
| Urology Associates of Norwalk | Norwalk | Connecticut | 06850 | United States |
| WomanCare | Arlington Heights | Illinois | 60004 | United States |
| Women's Health Institute of Illinois | Oak Lawn | Illinois | 60453 | United States |
| Regional Urology | Shreveport | Louisiana | 71106 | United States |
| Chesapeake Urology | Glen Burnie | Maryland | 21061 | United States |
| Chesapeake Urology | Owings Mills | Maryland | 21117 | United States |
| Female Pelvic Medicine and Urogynecology Institute of Michigan | Grand Rapids | Michigan | 49503 | United States |
| North Shore LIJ | Great Neck | New York | 11021 | United States |
| Premier Medical Group | Newburgh | New York | 12550 | United States |
| Premier Medical Group | Poughkeepsie | New York | 12601 | United States |
| Lyndhurst Clinical Research | Winston-Salem | North Carolina | 27103 | United States |
| Women and Infants Hospital | Providence | Rhode Island | 02905 | United States |
| MUSC Urology | Charleston | South Carolina | 29425 | United States |
| Sanford Female Pelvic Medicine and Reconstructive Surgery Clinic | Sioux Falls | South Dakota | 57105 | United States |
| Virginia Women's Center | Richmond | Virginia | 23233 | United States |
| Urology of Virginia | Virginia Beach | Virginia | 23462 | United States |
| Integrity Medical Research | Mountlake Terrace | Washington | 98043 | United States |
| ID | Term |
|---|---|
| D014550 | Urinary Incontinence, Stress |
| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| 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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