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Pivotal Study of eCoin for Overactive Bladder With Urgency Urinary Incontinence

Primary Purpose

Overactive Bladder, Urge Incontinence, Incontinence, Urinary

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
eCoin Tibial Nerve Stimulation
Sponsored by
Valencia Technologies Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overactive Bladder

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Primary Inclusion Criteria:

  1. Women and men between 18 and 80 years old.
  2. 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.
  3. Individual is without pharmacological treatment of overactive bladder (antimuscarinics and beta-3 agonists).
  4. 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:

  1. Predominant stress urinary incontinence with more than 1/3 stress urinary incontinent episodes when compared to total urinary incontinent episodes.
  2. Clinically significant bladder outlet obstruction.
  3. Clinically significant pelvic organ prolapse beyond the hymenal ring.
  4. Inadequate skin integrity or any evidence of an infection or inflammation in either lower leg.

Sites / Locations

  • Kaiser Permanente
  • Sequoia Urology Center
  • Kaiser Permanente
  • Sansum Clinic
  • SurgOne PC
  • Urology Associates of Norwalk
  • Florida Bladder Institute
  • North Shore Medical Group
  • UnityPoint Clinic
  • Chesapeake Urology
  • Adult & Pediatric Urology
  • Manhattan Medical Research
  • Alliance Urology Specialists
  • The Institute for Female Pelvic Medicine & Reconstructive Surgery (FPM Institute)
  • South Carolina OB/GYN

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

eCoin Tibial Nerve Stimulation

Arm Description

Outcomes

Primary Outcome Measures

Percentage of Subjects Experiencing 50% or Better Improvement in Urgency Urinary Incontinence Episodes as Measured by a 3-day Voiding Diary.
Responder rate
Long-term Safety in All Patients. Percentage of Patients With Device Related Adverse Events.
All adverse events will be reported in all patients who were implanted 12 months after implantation.

Secondary Outcome Measures

Moderate-term Safety in All Patients. Percentage of Patients With Device or Implantation Related Adverse Events.
All adverse events will be reported.
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.
Moderate-term effectiveness data, responder rate

Full Information

First Posted
May 22, 2018
Last Updated
October 11, 2022
Sponsor
Valencia Technologies Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT03556891
Brief Title
Pivotal Study of eCoin for Overactive Bladder With Urgency Urinary Incontinence
Official Title
Pivotal Study of Subcutaneous Tibial Nerve Stimulation With eCoin for Overactive Bladder (OAB) With Urgency Urinary Incontinence (UUI)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 4, 2018 (Actual)
Primary Completion Date
April 12, 2020 (Actual)
Study Completion Date
April 28, 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
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overactive Bladder, Urge Incontinence, Incontinence, Urinary, Urinary Urge Incontinence

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
133 (Actual)

8. Arms, Groups, and Interventions

Arm Title
eCoin Tibial Nerve Stimulation
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
eCoin Tibial Nerve Stimulation
Intervention Description
Subcutaneous stimulation of the tibial nerve using the eCoin device.
Primary Outcome Measure Information:
Title
Percentage of Subjects Experiencing 50% or Better Improvement in Urgency Urinary Incontinence Episodes as Measured by a 3-day Voiding Diary.
Description
Responder rate
Time Frame
48 weeks after device activation.
Title
Long-term Safety in All Patients. Percentage of Patients With Device Related Adverse Events.
Description
All adverse events will be reported in all patients who were implanted 12 months after implantation.
Time Frame
52 weeks after implantation.
Secondary Outcome Measure Information:
Title
Moderate-term Safety in All Patients. Percentage of Patients With Device or Implantation Related Adverse Events.
Description
All adverse events will be reported.
Time Frame
24 weeks after device activation
Title
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.
Description
Moderate-term effectiveness data, responder rate
Time Frame
24 weeks after device activation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Scott MacDiarmid, MD
Organizational Affiliation
Alliance Urology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kaiser Permanente
City
Downey
State/Province
California
ZIP/Postal Code
90242
Country
United States
Facility Name
Sequoia Urology Center
City
Redwood City
State/Province
California
ZIP/Postal Code
94062
Country
United States
Facility Name
Kaiser Permanente
City
San Diego
State/Province
California
ZIP/Postal Code
92110
Country
United States
Facility Name
Sansum Clinic
City
Santa Barbara
State/Province
California
ZIP/Postal Code
93105
Country
United States
Facility Name
SurgOne PC
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80113
Country
United States
Facility Name
Urology Associates of Norwalk
City
Norwalk
State/Province
Connecticut
ZIP/Postal Code
06850
Country
United States
Facility Name
Florida Bladder Institute
City
Naples
State/Province
Florida
ZIP/Postal Code
34109
Country
United States
Facility Name
North Shore Medical Group
City
Skokie
State/Province
Illinois
ZIP/Postal Code
60076
Country
United States
Facility Name
UnityPoint Clinic
City
Waterloo
State/Province
Iowa
ZIP/Postal Code
50703
Country
United States
Facility Name
Chesapeake Urology
City
Owings Mills
State/Province
Maryland
ZIP/Postal Code
21117
Country
United States
Facility Name
Adult & Pediatric Urology
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Facility Name
Manhattan Medical Research
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Alliance Urology Specialists
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27403
Country
United States
Facility Name
The Institute for Female Pelvic Medicine & Reconstructive Surgery (FPM Institute)
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18103
Country
United States
Facility Name
South Carolina OB/GYN
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29201
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Pivotal Study of eCoin for Overactive Bladder With Urgency Urinary Incontinence

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