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Device
eCoin Neurostimulation for Urge Incontinence (ESSENCE Trial)
N/A
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
Timeline
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 belowSelect...
I have overactive bladder with daily urgency to urinate.
ESSENCE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2, 3 and 4 months post-activation
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2, 3 and 4 months post-activation
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
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Who is running the clinical trial?
Valencia Technologies CorporationLead Sponsor
5 Previous Clinical Trials
402 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My diabetes is not under control (A1C>7).I have a weakened immune system.You have a medical condition that might make it risky for you to take part in the study or could affect the study results.I have not responded well to certain bladder treatments or have had side effects.I have leg issues like previous surgery scars, skin conditions, nerve pain, swelling, poor skin at the implant site, severe varicose veins, open wounds, blood vessel problems, or skin changes due to poor blood flow in my legs.I have overactive bladder with daily urgency to urinate.I currently have a UTI or had 4 or more UTIs in the past year.You have more than 200cc of urine left in your bladder after you go to the bathroom.I have severe bladder pain or have been diagnosed with interstitial cystitis.I have a serious blockage in my bladder.I had surgery for stress incontinence in the last year.I have bladder control issues due to nerve problems.My doctor says I am fit for surgery.Most of my urine leaks happen when I cough, sneeze, or exercise.I have been diagnosed with cancer of the bladder, urethra, or prostate.
Research Study Groups:
This trial has the following groups:- Group 1: Subsensory
- Group 2: Sensory
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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
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