SUBCUTANEOUS TIBIAL NERVE STIMULATION FOR URGENCY URINARY INCONTINENCE: A FOLLOW-ON STUDY
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Overactive Bladder
- Sponsor
- Valencia Technologies Corporation
- Enrollment
- 23
- Locations
- 7
- Primary Endpoint
- Change From Baseline in Urgency Urinary Incontinence Episodes as Measured by a 3-day Voiding Diary.
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
This trial is a prospective, multicenter, single-arm follow-on study will evaluate the safety and effectiveness of eCoinTM tibial nerve stimulation in subjects with urgency urinary incontinence (UUI) as defined by the American Urological Association (30). The follow-on study will evaluate changes from baseline in OAB symptoms as measured by voiding diaries and patient-reported outcomes through 24 weeks of eCoinTM therapy (which is the same as 28 weeks from study device reimplantation).
Investigators
Eligibility Criteria
Inclusion Criteria
- •Individual participated in the eCoin Feasibility Study for Urgency Urinary Incontinence.
- •Individual was implanted with the study device during the eCoin Feasibility Study for Urgency Urinary Incontinence.
Exclusion Criteria
- •In the opinion of the investigator, individual is not a good candidate for participation in the study.
Outcomes
Primary Outcomes
Change From Baseline in Urgency Urinary Incontinence Episodes as Measured by a 3-day Voiding Diary.
Time Frame: 12 weeks after device activation.
Safety in All Patients. All Adverse Events Will be Reported in All Patients Who Were Implanted 4 Months After Implantation.
Time Frame: 16 weeks after device implantation.
Instances of a related adverse event.
Secondary Outcomes
- Safety in All Patients. All Adverse Events Will be Reported in All Patients Who Were Implanted 6 Months After Implantation.(28 weeks after device implantation.)
- Change From Baseline in Urgency Urinary Incontinence Episodes as Measured by a 3-day Voiding Diary.(24 weeks after device activation.)