Posterior Tibial Nerve Stimulation's Effectiveness in UI Frequency in Overactive Patients in Home
NCT03595215 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 18
Last updated 2021-05-21
Summary
This pilot clinical study, which focuses on feasibility and proof-of-principle, will be conducted in 11 female subjects (55-100 years old) with UI. Subjects will use the device three times a week for 8 weeks and complete 3-day "voiding diaries" to record instances of UI episodes and OAB quality of life.
Conditions
Interventions
- DEVICE
-
TENS
Transcutaneous electrical nerve stimulation
Sponsors & Collaborators
- collaborator OTHER
-
Theranova, L.L.C.
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 55 Years
- Max Age
- 100 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-09-10
- Primary Completion
- 2019-07-10
- Completion
- 2019-09-17
- FDA Device
- Yes
Countries
- United States
Study Locations
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