N/A
Completed N=23
eCoin for OAB Feasibility Follow-on Study
Overactive Bladder · Urge Incontinence · Incontinence, Urinary · Urinary Urge Incontinence
Source: ClinicalTrials.gov NCT03655054 ↗
Enrolled (actual)
23
Serious AEs
0.0%
Results posted
Apr 2021
Primary outcomePrimary: Change From Baseline in Urgency Urinary Incontinence Episodes as Measured by a 3-day Voiding Diary. — -2.2 episodes/day
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Urgency Urinary Incontinence Episodes as Measured by a 3-day Voiding Diary. |
-3.7 | — |
| PRIMARY Safety in All Patients. All Adverse Events Will be Reported in All Patients Who Were Implanted 4 Months After Implantation. |
8 | — |
| SECONDARY Change From Baseline in Urgency Urinary Incontinence Episodes as Measured by a 3-day Voiding Diary. |
-3.7 | — |
| SECONDARY Safety in All Patients. All Adverse Events Will be Reported in All Patients Who Were Implanted 6 Months After Implantation. |
8 | — |
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.
Data sourced from ClinicalTrials.gov (NCT03655054). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.