A Real World Study of eCoin for Urgency Urinary Incontinence: Post Approval Evaluation (RECIPE)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorValencia Technologies Corporation
About this trial
A prospective, multicenter, single-arm study to evaluate the safety and effectiveness of the eCoin® implanted tibial nerve stimulator in subjects with urgency urinary incontinence (UUI).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Women and men above 18 years old with gender percentages reflective of disease prevalence in the U.S. population
Individual with diagnosis of overactive bladder with urgency urinary incontinence.
Individual has at least one urgency urinary incontinence episode on each of three days as determined on a 3-day voiding diary.
Individual gives written informed consent.
Disqualifiers
Individual is not appropriate for eCoin therapy based upon the US FDA-approved IFU requirements.
Individual has clinically significant bladder outlet obstruction. (Suspected bladder outlet obstruction will be initially assessed by uroflow study with those having a maximum flow rate < 15mL/s requiring additional evaluation.)
Individual has predominantly stress urinary incontinence (greater than 1/3 of leaks on baseline diary are stress).
Individual has an active urinary tract infection at time of enrollment.
Trial design
Design model
Single group
Treatments tested in this trial
eCoin Tibial Nerve Stimulation
DeviceSubcutaneous stimulation of the tibial nerve using the eCoin device.
Treatment groups
200 Participants
are divided into 1 treatment groupGroup A: eCoin Tibial Nerve StimulationExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Responder Rate
Proportion of subjects achieving at least a 50% improvement in the number of urgency urinary incontinence episodes on a 3-day voiding diary.
Time frame
12 months2
Safety: 12 months rate of all device or procedure related AEs.
Rate of all device or procedure related AEs.
Time frame
12 monthsSecondary outcomes
1
Responder Rate
Proportion of subjects achieving at least a 50% improvement in the number of urgency urinary incontinence episodes on a 3-day voiding diary.
Time frame
24 months2
Safety Data
Rate of all device or procedure related AEs through 24 months post activation of eCoin.
Time frame
24 months3
Safety data through 7 months post-reimplantation.
Rate of device or procedure-related AEs through 7 months post reimplantation.
Time frame
7 months post reimplantationOther outcomes
1
Proportion of responders (50% improvement) after 12, 24, 36, 48, and 60 months of therapy.
Proportion of subjects achieving at least a 50% improvement in the number of urgency urinary incontinence episodes on a 3-day voiding diary.
Time frame
12, 24, 36, 48, and 60 months2
Proportion of responders (75% improvement) after 12, 24, 36, 48, and 60 months of therapy.
Proportion of subjects achieving at least a 75% improvement in the number of urgency urinary incontinence episodes on a 3-day voiding diary.
Time frame
12, 24, 36, 48, and 60 months3
Proportion of responders (100% improvement) after 12, 24, 36, 48, and 60 months of therapy.
Proportion of subjects achieving at least a 100% improvement in the number of urgency urinary incontinence episodes on a 3-day voiding diary.
Time frame
12, 24, 36, 48, and 60 months4
Reduction in the number of urgency urinary incontinence episodes.
Reduction in the number of urgency urinary incontinence episodes on a 3-day voiding diary.
Time frame
12, 24, 36, 48, and 60 monthsSponsors and contacts
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Source ClinicalTrials.gov