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eCoin Neurostimulation for Urge Incontinence (ESSENCE Trial)

Waitlist Available
Research Sponsored by Valencia Technologies Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Individual with diagnosis of overactive bladder with urgency urinary incontinence - daily UUI with a predominantly urgency component
Be older than 18 years old
Screening 3 weeks
Treatment Varies
Follow Up 2, 3 and 4 months post-activation
Awards & highlights

ESSENCE Trial Summary

This trial will compare two settings of a device implanted in the body to reduce UUI episodes and measure changes in quality of life.

Who is the study for?
This trial is for individuals with overactive bladder and daily urge urinary incontinence who haven't had adequate relief from standard treatments. Candidates must be suitable for surgery but can't join if they've had certain prior surgeries, need MRI scans outside the head/neck area, have neurogenic bladder issues, immune deficiencies, uncontrolled diabetes, or conditions that could interfere with the eCoin device.Check my eligibility
What is being tested?
The study tests the eCoin Peripheral Neurostimulator System's effectiveness on reducing urge urinary incontinence episodes. Participants will receive an implant and be randomly assigned to either sensory or subsensory stimulation groups to compare outcomes after three months of therapy.See study design
What are the potential side effects?
Potential side effects are not explicitly listed in the provided information. However, as with any surgical procedure and device implantation, there may be risks such as infection at the implant site, discomfort or pain related to stimulation, skin irritation or allergic reactions.

ESSENCE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
I have overactive bladder with daily urgency to urinate.

ESSENCE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2, 3 and 4 months post-activation
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2, 3 and 4 months post-activation for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Secondary outcome measures
Patient Satisfaction
Quality of Life with OABq
Reduction in UUI Episodes

ESSENCE Trial Design

2Treatment groups
Experimental Treatment
Group I: SubsensoryExperimental Treatment1 Intervention
Group II: SensoryExperimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

Valencia Technologies CorporationLead Sponsor
5 Previous Clinical Trials
402 Total Patients Enrolled

Media Library

eCoin Peripheral Neurostimulator System (Device) Clinical Trial Eligibility Overview. Trial Name: NCT05882318 — N/A
Urge Incontinence Research Study Groups: Subsensory, Sensory
Urge Incontinence Clinical Trial 2023: eCoin Peripheral Neurostimulator System Highlights & Side Effects. Trial Name: NCT05882318 — N/A
eCoin Peripheral Neurostimulator System (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05882318 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any current openings in this experiment?

"Data available on clinicaltrials.gov attests to the fact that this trial is actively searching for participants, which was originally made public on June 6th 2023 and edited most recently on the twentieth of June in 2023."

Answered by AI

How many people are taking part in this experiment?

"Affirmative. Records hosted on clinicaltrials.gov state that this scientific experiment, which commenced June 6th 2023, is enrolling subjects at present. A total of 50 participants need to be admitted across a single location."

Answered by AI
~0 spots leftby May 2024