Trials / Completed
CompletedNCT02857816
PRospective Study to Evaluate EffectivenesS With the NURO™ PErcutaneous Tibial Neuromodulation System in Patients With OAB
PRospective Study to Evaluate EffectivenesS With the NURO™ PErcutaneous Tibial Neuromodulation (PTNM) System in Patients With OAB
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 154 (actual)
- Sponsor
- MedtronicNeuro · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
To evaluate the NURO system for the treatment of OAB in drug naïve patients.
Detailed description
The purpose of this prospective, multicenter, single arm study is to evaluate the NURO system for the treatment of OAB in drug naïve patients. The study will assess change from baseline through 12 PTNM therapy sessions in UUI (urge urinary incontinence) episodes, voiding episodes, and patient reported outcomes. The study is expected to last approximately 14 weeks per subject following the enrollment visit. Subjects will be exited from the study after the final study visit is complete.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | NURO System PTNM Therapy |
Timeline
- Start date
- 2016-09-01
- Primary completion
- 2017-11-21
- Completion
- 2017-11-21
- First posted
- 2016-08-05
- Last updated
- 2019-01-14
- Results posted
- 2018-12-12
Locations
11 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT02857816. Inclusion in this directory is not an endorsement.