Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Open label Study to Evaluate the Efficacy of the Home Based Electrical Transcutaneous NeuroModulation (eTNM) Treatment Via Nerve Stimulator URIS I in the Treatment of Overactive Bladder.
Open label, Multi center Study to Evaluate the Efficacy of the Home Based Electrical Transcutaneous NeuroModulation (eTNM) Treatment Via Nerve Stimulator URIS I in the Treatment of Overactive Bladder (OAB).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| eTNM arm | eTNM delivered by URIS I nerve stimulation device, self administered in the subject's home for 30 minutes per day, for a minimum of 34 therapy session between day 1- 42. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| eTNM delivered by URIS I nerve stimulation device | Device | eTNM delivered by URIS I nerve stimulation device, self administered in the subject's home for 30 minutes per day, for a minimum of 34 therapy session between day 1-42. |
| Measure | Description | Time Frame |
|---|---|---|
| Change of severe urgency episodes | The proportion of subjects with ≥ 50% change in severe urgency episodes (Grade 3 or 4) will be summarized by visit and for the full treatment period using the last observation. | baseline and end of study (6weeks treatment) |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
females age 18 years or older. The women had a diagnosis of OAB or mixed incontinence with the predominance of OAB symptoms. The women were dissatisfied with current or previous pharmacotherapy treatment of OAB for any reason within the past 12 months.
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MUDr. Michal Rejchrt | PÅ™Ãbram | Czech | 261 01 | Czechia |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D053201 | Urinary Bladder, Overactive |
| 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 |
Not provided
Not provided