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Sponsor decision not to pursue additional sites and enrollments for this study.
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A prospective, multi-center, study comparing continuous sacral neuromodulation (SNM) stimulation to daily cyclic stimulation of 2 hours "on" and 22 hours "off" using the Axonics System.
After consent is provided, the required visits are at Baseline, Day 0, 1-Month, and 3-Month. At the follow-up visits, a bladder diary is reviewed, symptoms are assessed, the PGI-I questionnaire is completed, and cyclic stimulation hours may be changed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Implanted group | This group will be participants with urinary urge incontinence (UUI) who have been previously implanted with an Axonics System and are satisfied with therapy |
| |
| De Novo group | This group will be participants who are newly implanted with an Axonics System. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Axonics System | Device | The Axonics System will be implanted as standard care |
|
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the efficacy of daily cyclic stimulation of 2 hours "on" and 22 hours "off" in reducing UUI episodes by > 50% in newly implanted participants, or maintenance of efficacy in currently implanted participants with an implanted Axonics System | Comparison of UUI episodes on a 3-day bladder diary at 3 months as compared to baseline UUI episodes | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate patient satisfaction with cyclic stimulation | Analysis of the Patient Global Impression of Improvement (PGI-I) scale. This scale evaluates the post-operative condition. The PGI-I has 1 question with 7 possible answers ranging from "very much better" (score of 1) to "very much worse" (score of 7). | 3 months |
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Inclusion Criteria:
Participants who are ≥ 21 years at the time of consent
Has a primary indication of UUI (participants with a secondary indication of UF or FI may also be enrolled)
Has a diagnosis of UUI for greater than or equal to 6 months prior to the date of consent
UUI episodes:
Willing and capable of providing informed consent
Agrees to return to the site for all study visits
Fluent (able to speak and read) in English
Exclusion Criteria:
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The sample size will include 60 de novo participants with UUI, or currently implanted participants with UUI. Participants may be implanted with either the rechargeable or recharge-free Axonics Systems.
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| Name | Affiliation | Role |
|---|---|---|
| Karen Noblett, MD | Axonics, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Florida Bladder Institute | Naples | Florida | 34109 | United States | ||
| LSU Health |
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| ID | Term |
|---|---|
| D053202 | Urinary Incontinence, Urge |
| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| New Orleans |
| Louisiana |
| 70112 |
| United States |
| University Hospitals-Cleveland Medical Center | Cleveland | Ohio | 44106 | United States |
| Urologic Specialists Oklahoma | Tulsa | Oklahoma | 74146 | United States |
| The Female Pelvic Health Center | Newton | Pennsylvania | 18940 | United States |
| Center for Pelvic Health | Franklin | Tennessee | 37067 | United States |
| 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 |