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The Solace European Confirmatory (SOLECT) 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 on Day 0 | Experimental | Subjects who are treated with the Solace Bladder Control System upon entry into the trial. |
|
| Sham Treatment on Day 0 | Sham Comparator | Patients who undergo a sham procedure upon entry into the trial, with treatment with the Solace Bladder Control System at 3 months after the sham procedure. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Solace Bladder Control System | 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 |
|---|---|---|
| Incidence of all adverse events | Rate of incidence of all adverse events for all patients | 36 Months |
| Improvement in quality of life in all patients assessed with pad weight tests and questionnaires | 36 Months |
Inclusion Criteria:
Exclusion Criteria (must answer NO):
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| Name | Affiliation | Role |
|---|---|---|
| Giovanni Tommaselli, M.D. | University of Naples | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Antwerp Hospital (Universitair Ziekenhuis Antwerpen) | Antwerp | Edegem | 2650 | Belgium | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25598453 | Result | Wyndaele JJ, De Wachter S, Tommaselli GA, Angioli R, de Wildt MJ, Everaert KC, Michielsen DP, Van Koeveringe GA. A randomized, controlled clinical trial of an intravesical pressure-attenuation balloon system for the treatment of stress urinary incontinence in females. Neurourol Urodyn. 2016 Feb;35(2):252-9. doi: 10.1002/nau.22708. Epub 2015 Jan 16. |
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Pending publication of results
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| ID | Term |
|---|---|
| D014550 | Urinary Incontinence, Stress |
| D014549 | Urinary Incontinence |
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| ID | Term |
|---|---|
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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| Solace Sham Treatment | Device | Sham procedure that resembles treatment with the Solace Bladder Control System |
|
| 3 Months |
| Severity of all adverse events | Severity of all adverse events for all patients | 36 Months |
| UZ Brussel |
| Brussels |
| B-1090 |
| Belgium |
| UZ Gent | Ghent | Belgium |
| University of Naples (Università Degli Studi Di Napoli "Federico II" ) | Naples (Napoli) | 80131 | Italy |
| Universita Campus Bio-medico di Roma | Rome | Italy |
| Catharina Ziekenhuis | Eindhoven | Netherlands |
| Maastricht University Medical Center | Maastricht | 6229 HX | Netherlands |
| D059411 | Lower Urinary Tract Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |