N/A
N=133
Pivotal Study of eCoin for Overactive Bladder With Urgency Urinary Incontinence
Overactive Bladder · Urge Incontinence · Incontinence, Urinary · Urinary Urge Incontinence
Bottom Line
View on ClinicalTrials.gov: NCT03556891 ↗Enrolled (actual)
133
Serious AEs
3.0%
Results posted
Jul 2021
Primary outcome: Primary: Percentage of Subjects Experiencing 50% or Better Improvement in Urgency Urinary Incontinence Episodes as Measured by a 3-day Voiding Diary. — 68 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- eCoin Tibial Nerve Stimulation (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Valencia Technologies Corporation
- Primary completion
- Apr 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Subjects Experiencing 50% or Better Improvement in Urgency Urinary Incontinence Episodes as Measured by a 3-day Voiding Diary. |
67 | — |
| PRIMARY Long-term Safety in All Patients. Percentage of Patients With Device Related Adverse Events. |
16 | — |
| SECONDARY Moderate-term Safety in All Patients. Percentage of Patients With Device Related Adverse Events. |
14 | — |
| SECONDARY Moderate-term Effectiveness Data. Percentage of Subjects Experiencing 50% or Better Improvement in Urgency Urinary Incontinence Episodes as Measured by a 3-day Voiding Diary. |
69 | — |
| SECONDARY Percentage of Subjects Experiencing 50% or Better Improvement in Urgency Urinary Incontinence Episodes as Measured by a 3-day Voiding Diary |
78 | — |
| SECONDARY Percentage of Subjects Experiencing 50% or Better Improvement in Urgency Urinary Incontinence Episodes as Measured by a 3-day Voiding Diary. |
67 | — |
| SECONDARY Percentage of Subjects Experiencing 50% or Better Improvement in Urgency Urinary Incontinence Episodes as Measured by a 3-day Voiding Diary. |
67 | — |
| SECONDARY Percentage of Subjects Experiencing 50% or Better Improvement in Urgency Urinary Incontinence Episodes as Measured by a 3-day Voiding Diary. |
67 | — |
| SECONDARY Long-term Safety in All Patients: Percentage of Patients With Device Related Adverse Events. |
20 | — |
| SECONDARY Long-term Safety in All Patients: Percentage of Patients With Device Related Adverse Events |
20 | — |
| SECONDARY Long-term Safety in All Patients. Percentage of Patients With Device Related Adverse Events |
23 | — |
| SECONDARY Long-term Safety in All Patients. Percentage of Patients With Device Related Adverse Events |
23 | — |
Summary
This trial is a prospective, multicenter, single-arm study of the safety and effectiveness of eCoinTM tibial nerve stimulation in subjects having overactive bladder (OAB) with urgency urinary incontinence (UUI). The study will evaluate changes from baseline in OAB symptoms as measured by voiding diaries and patient reported-outcomes through 48 weeks of eCoinTM therapy or 52 weeks of implantation.
Eligibility Criteria
Primary Inclusion Criteria:
- Women and men between 18 and 80 years old.
- Diagnosis of overactive bladder with urgency urinary incontinence or mixed urge and stress incontinence with a predominant urgency component (selfreported), for at least 6 months.
- Individual is without pharmacological treatment of overactive bladder (antimuscarinics and beta-3 agonists).
- Individual is intolerant of or has an inadequate response to any of anticholinergics, β3-adrenoceptor agonists, onabotulinumtoxinA, or percutaneous tibial nerve stimulation.
Primary Exclusion Criteria:
- Predominant stress urinary incontinence with more than 1/3 stress urinary incontinent episodes when compared to total urinary incontinent episodes.
- Clinically significant bladder outlet obstruction.
- Clinically significant pelvic organ prolapse beyond the hymenal ring.
- Inadequate skin integrity or any evidence of an infection or inflammation in either lower leg.
Data sourced from ClinicalTrials.gov (NCT03556891). 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.