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Effectiveness of eCoin at Sensory and Subsensory Amplitudes (ESSENCE)

Primary Purpose

Urge Incontinence

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
eCoin Peripheral Neurostimulator System
Sponsored by
Valencia Technologies Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urge Incontinence focused on measuring Neuromodulation, eCoin device, Stimulation, Tibial nerve

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria: Individual with diagnosis of overactive bladder with urgency urinary incontinence - daily UUI with a predominantly urgency component Individual is intolerant of or has an inadequate response to any of anticholinergics, β3-adrenoceptor agonists, onabotulinumtoxinA, or who have undergone percutaneous tibial nerve stimulation (PTNS). Individual is determined to be a suitable surgical candidate by physician. Key Exclusion Criteria: Individual is not appropriate for eCoin therapy based upon the US FDA-approved IFU requirements. Individual has predominantly stress urinary incontinence (greater than 1/3 of leaks on baseline diary are stress). Individual has clinically significant bladder outlet obstruction. Individual has an active urinary tract infection at time of enrollment or has had four or more symptomatic UTI's in the last 12 months. Individual has significant lower urinary tract pain or has been diagnosed with interstitial cystitis or bladder pain syndrome that is actively being managed. Individual has post void residual greater than 200 cc. Individual has an active diagnosis of bladder, urethral, or prostate cancer. Individual has had a prior anti-stress incontinence surgery within the last year. Individual has uncontrolled diabetes mellitus (Hemoglobin A1C>7). Individual is neutropenic or immune-compromised. Individual has lower extremity pathology such as: Previous surgery and/or significant scarring at the planned implant location Ongoing dermatologic condition at the implant site, including but not limited to dermatitis and autoimmune disorders Clinically significant peripheral neuropathy in the lower extremities Pitting edema at the implant location (≥ 2+ is excluded) Inadequate skin integrity or any evidence of an infection or inflammation in either lower leg Moderate to severe varicose veins Open wounds or recent trauma Arterial and/or vasculitis disease in the lower extremities Chronic venous insufficiency with a history of skin change (hyperpigmentation, lipodermatosclerosis, ulceration) in the ankle region Individual has neurogenic bladder dysfunction. Individual is aware that he or she will need an MRI scan other than a head/neck/shoulder MRI during the study period. Any condition that, in the investigator's opinion, would preclude participation in the study (e.g., comorbidity that places subject at increased risk for surgical intervention, medical condition that may increase the risk associated with study participation or may interfere with interpretation of study results, inability to adhere to the visit schedule, such as morbid obesity, clotting or bleeding disorder)

Sites / Locations

  • Genesis ResearchRecruiting
  • Urology Associates of Central CaliforniaRecruiting
  • Cypress Medical Research CenterRecruiting
  • Adult & Pediatric Urology P.C.Recruiting
  • Associated Urologists of North CarolinaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Sensory

Subsensory

Arm Description

Outcomes

Primary Outcome Measures

Reduction in UUI Episodes
The primary endpoint is to explore the effect of two different eCoin amplitude settings on the reduction of UUI episodes per day on a 3-day voiding diary

Secondary Outcome Measures

Quality of Life with OABq
Change from baseline in the patient reported quality of life as assessed by the Health Related Quality of Life (HRQL) portion of the Overactive Bladder questionnaire (OABq) survey Higher scores on the HRQL portion indicate better quality of life.
Patient Satisfaction
Improvement from baseline of patient satisfaction with UUI symptoms as gathered from patient satisfaction surveys
Reduction in UUI Episodes
Reduction from baseline in the number of urgency urinary incontinence episodes per day on a 3-day voiding diary (72 hours)

Full Information

First Posted
May 19, 2023
Last Updated
August 8, 2023
Sponsor
Valencia Technologies Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT05882318
Brief Title
Effectiveness of eCoin at Sensory and Subsensory Amplitudes
Acronym
ESSENCE
Official Title
Evaluating Effectiveness of Sensory and Subsensory Stimulation Amplitudes With eCoin® Tibial Nerve Stimulation in Urgency Urinary InContinence Episodes and Quality of Life
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 6, 2023 (Actual)
Primary Completion Date
May 1, 2024 (Anticipated)
Study Completion Date
July 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Valencia Technologies Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The goal of this prospective, multi-center, double-blinded randomized controlled is to learn about effectiveness and QOL with eCoin at two different amplitude settings in subjects with urge urinary incontincence (UUI). The main question it aims to answer is: The reduction in UUI episodes per day on a 3-day voiding diary in both groups after 3 months of therapy Participants will be implanted with the eCoin device and randomized to either a sensory or subsensory stimulation group and complete voiding diaries and patient reported-outcomes through 3 months of therapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urge Incontinence
Keywords
Neuromodulation, eCoin device, Stimulation, Tibial nerve

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sensory
Arm Type
Experimental
Arm Title
Subsensory
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
eCoin Peripheral Neurostimulator System
Intervention Description
The eCoin device is a leadless, coin-sized tibial neurostimulator for treatment of urgency urinary incontinence. It emits a dome-shaped electrical field to deliver low-duty cycle stimulation to the tibial nerve. The device is to be implanted under local anesthetic in the lower leg, and once activated delivers automatic 30-minute treatment sessions without the need for patient management.
Primary Outcome Measure Information:
Title
Reduction in UUI Episodes
Description
The primary endpoint is to explore the effect of two different eCoin amplitude settings on the reduction of UUI episodes per day on a 3-day voiding diary
Time Frame
3 months post-activation
Secondary Outcome Measure Information:
Title
Quality of Life with OABq
Description
Change from baseline in the patient reported quality of life as assessed by the Health Related Quality of Life (HRQL) portion of the Overactive Bladder questionnaire (OABq) survey Higher scores on the HRQL portion indicate better quality of life.
Time Frame
2, 3 and 4 months post-activation
Title
Patient Satisfaction
Description
Improvement from baseline of patient satisfaction with UUI symptoms as gathered from patient satisfaction surveys
Time Frame
2, 3 and 4 months post-activation
Title
Reduction in UUI Episodes
Description
Reduction from baseline in the number of urgency urinary incontinence episodes per day on a 3-day voiding diary (72 hours)
Time Frame
2 and 4 months post-activation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: Individual with diagnosis of overactive bladder with urgency urinary incontinence - daily UUI with a predominantly urgency component Individual is intolerant of or has an inadequate response to any of anticholinergics, β3-adrenoceptor agonists, onabotulinumtoxinA, or who have undergone percutaneous tibial nerve stimulation (PTNS). Individual is determined to be a suitable surgical candidate by physician. Key Exclusion Criteria: Individual is not appropriate for eCoin therapy based upon the US FDA-approved IFU requirements. Individual has predominantly stress urinary incontinence (greater than 1/3 of leaks on baseline diary are stress). Individual has clinically significant bladder outlet obstruction. Individual has an active urinary tract infection at time of enrollment or has had four or more symptomatic UTI's in the last 12 months. Individual has significant lower urinary tract pain or has been diagnosed with interstitial cystitis or bladder pain syndrome that is actively being managed. Individual has post void residual greater than 200 cc. Individual has an active diagnosis of bladder, urethral, or prostate cancer. Individual has had a prior anti-stress incontinence surgery within the last year. Individual has uncontrolled diabetes mellitus (Hemoglobin A1C>7). Individual is neutropenic or immune-compromised. Individual has lower extremity pathology such as: Previous surgery and/or significant scarring at the planned implant location Ongoing dermatologic condition at the implant site, including but not limited to dermatitis and autoimmune disorders Clinically significant peripheral neuropathy in the lower extremities Pitting edema at the implant location (≥ 2+ is excluded) Inadequate skin integrity or any evidence of an infection or inflammation in either lower leg Moderate to severe varicose veins Open wounds or recent trauma Arterial and/or vasculitis disease in the lower extremities Chronic venous insufficiency with a history of skin change (hyperpigmentation, lipodermatosclerosis, ulceration) in the ankle region Individual has neurogenic bladder dysfunction. Individual is aware that he or she will need an MRI scan other than a head/neck/shoulder MRI during the study period. Any condition that, in the investigator's opinion, would preclude participation in the study (e.g., comorbidity that places subject at increased risk for surgical intervention, medical condition that may increase the risk associated with study participation or may interfere with interpretation of study results, inability to adhere to the visit schedule, such as morbid obesity, clotting or bleeding disorder)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jackie Dister
Phone
7604294787
Email
jdister@valenciatechnologies.com
Facility Information:
Facility Name
Genesis Research
City
Downey
State/Province
California
ZIP/Postal Code
90241
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alicia Buenrostro
Phone
562-923-0706
Email
alicia.buenrostro@uniohp.com
First Name & Middle Initial & Last Name & Degree
Pooya Banapour
Facility Name
Urology Associates of Central California
City
Fresno
State/Province
California
ZIP/Postal Code
93720
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kristin Santeufemia
Phone
559-321-2924
Email
ksanteufemia@urologyassociates.net
First Name & Middle Initial & Last Name & Degree
William Schiff, M.D.
Facility Name
Cypress Medical Research Center
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67226
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Addie Hayes, RN, CCRC
Phone
316-425-6333
Email
addiehayes@cypressmrc.com
First Name & Middle Initial & Last Name & Degree
Kevin Miller, MD
Facility Name
Adult & Pediatric Urology P.C.
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amy Nelson
Email
anelson@adultpediatricuro.com
First Name & Middle Initial & Last Name & Degree
Rebecca McCrery, MD
Facility Name
Associated Urologists of North Carolina
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kip Moffett
Phone
919-758-8677
Email
kmoffett@auncurology.com
First Name & Middle Initial & Last Name & Degree
Mark Jalkut

12. IPD Sharing Statement

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Effectiveness of eCoin at Sensory and Subsensory Amplitudes

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