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To assess the post-market clinical outcomes of the Axonics SNM System for treatment of overactive bladder in male patients.
To assess the post-market clinical outcomes of the Axonics SNM System for treatment of overactive bladder in male patients who have a prior history of radical prostatectomy or radiation for prostate cancer or who have a history of cytoreductive surgical intervention for benign prostatic hyperplasia (BPH).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Post-prostatectomy | Other | History of radical prostatectomy for cancer treatment at least 6 months prior to enrollment |
|
| Radiation | Other | History of radiation for cancer treatment at least 6 months prior to enrollment |
|
| Benign Prostatic Hyperplasia (BPH) | Other | History of cytoreductive BPH surgery at least 6 months prior to enrollment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Axonics SNM System | Device | To assess clinical outcomes of the Axonics SNM System in the male OAB population. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse event reporting (Safety) | Device related, procedure-related and all serious adverse events | 6 months, 1 year |
| Performance/Effectiveness - Reduction in UUI or UF episodes | Demonstrate a ≥ 50% reduction in the number of UUI or UF episodes on a 3-day diary | 6 months, 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Performance/Effectiveness - Improvement in Quality of Life scoring | International Consultation of Incontinence Questionnaire Overactive Bladder Quality of Life (ICIQ-OABqol): questions in each subscale are scored by a summed range of 0 to 100, with a higher score indicating better quality of life. Overall score ≥ 10 points from baseline to follow-up is indicative of a clinically meaningful improvement. |
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Key Inclusion Criteria:
Key Exclusion Criteria:
Only male patients will be enrolled in this study.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Catherine Cabiling | Contact | 714-225-0903 | catherine.cabiling@bsci.com | |
| Erum Shaikh | Contact | 657-626-4310 | Erum.Shaikh@bsci.com |
| Name | Affiliation | Role |
|---|---|---|
| Gita Ghadimi, OD | Boston Scientific Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Recruiting | Birmingham | Alabama | 35205 | United States |
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| 6 months, 1 year |
| Urology Associates | Active, not recruiting | Fairhope | Alabama | 36532 | United States |
| Mayo Clinic | Recruiting | Scottsdale | Arizona | 85259 | United States |
|
| El Camino Health | Recruiting | Mountain View | California | 94040 | United States |
|
| Tri Valley Urology | Recruiting | Murrieta | California | 92562 | United States |
|
| University of Miami | Recruiting | Miami | Florida | 33136 | United States |
|
| Advanced Urology Institute | Recruiting | Oxford | Florida | 34481 | United States |
|
| Louisiana State University | Recruiting | New Orleans | Louisiana | 70112 | United States |
|
| WK Clinical Research | Recruiting | Shreveport | Louisiana | 71103 | United States |
|
| Anne Arundel Urology | Recruiting | Annapolis | Maryland | 21401 | United States |
|
| Mayo Clinic | Recruiting | Rochester | Minnesota | 55905 | United States |
|
| Integrated Medical Professionals | Recruiting | New York | New York | 10016 | United States |
|
| Associated Urologists of North Carolina (AUNC) | Recruiting | Raleigh | North Carolina | 27612 | United States |
|
| University Hospitals Cleveland | Recruiting | Cleveland | Ohio | 44106 | United States |
|
| Utica Park Urology | Recruiting | Tulsa | Oklahoma | 74104 | United States |
|
| MidLantic Urology | Recruiting | Bala-Cynwyd | Pennsylvania | 19004 | United States |
|
| Lowcountry Urology Clinics | Recruiting | North Charleston | South Carolina | 29406 | United States |
|
| Urology Partners of North Texas (UPNT) | Active, not recruiting | Arlington | Texas | 76017 | United States |
| Texas Oncology | Completed | Houston | Texas | 77070 | United States |
| Potomac Urology | Recruiting | Woodbridge | Virginia | 22191 | United States |
|
| ID | Term |
|---|---|
| D053201 | Urinary Bladder, Overactive |
| D011470 | Prostatic Hyperplasia |
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D001745 | Urinary Bladder Diseases |
| 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 |
| D011469 | Prostatic Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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