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Pivotal Study of eCoin for Overactive Bladder With Urgency Urinary Incontinence

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03556891
Recruitment Status : Active, not recruiting
First Posted : June 14, 2018
Results First Posted : July 30, 2021
Last Update Posted : October 17, 2022
Sponsor:
Information provided by (Responsible Party):
Valencia Technologies Corporation

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.

Condition or disease Intervention/treatment Phase
Overactive Bladder Urge Incontinence Incontinence, Urinary Urinary Urge Incontinence Device: eCoin Tibial Nerve Stimulation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 133 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pivotal Study of Subcutaneous Tibial Nerve Stimulation With eCoin for Overactive Bladder (OAB) With Urgency Urinary Incontinence (UUI)
Actual Study Start Date : September 4, 2018
Actual Primary Completion Date : April 12, 2020
Estimated Study Completion Date : April 28, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: eCoin Tibial Nerve Stimulation Device: eCoin Tibial Nerve Stimulation
Subcutaneous stimulation of the tibial nerve using the eCoin device.




Primary Outcome Measures :
  1. Percentage of Subjects Experiencing 50% or Better Improvement in Urgency Urinary Incontinence Episodes as Measured by a 3-day Voiding Diary. [ Time Frame: 48 weeks after device activation. ]
    Responder rate

  2. Long-term Safety in All Patients. Percentage of Patients With Device Related Adverse Events. [ Time Frame: 52 weeks after implantation. ]
    All adverse events will be reported in all patients who were implanted 12 months after implantation.


Secondary Outcome Measures :
  1. Moderate-term Safety in All Patients. Percentage of Patients With Device or Implantation Related Adverse Events. [ Time Frame: 24 weeks after device activation ]
    All adverse events will be reported.

  2. 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. [ Time Frame: 24 weeks after device activation ]
    Moderate-term effectiveness data, responder rate



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03556891


Locations
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United States, California
Kaiser Permanente
Downey, California, United States, 90242
Sequoia Urology Center
Redwood City, California, United States, 94062
Kaiser Permanente
San Diego, California, United States, 92110
Sansum Clinic
Santa Barbara, California, United States, 93105
United States, Colorado
SurgOne PC
Englewood, Colorado, United States, 80113
United States, Connecticut
Urology Associates of Norwalk
Norwalk, Connecticut, United States, 06850
United States, Florida
Florida Bladder Institute
Naples, Florida, United States, 34109
United States, Illinois
North Shore Medical Group
Skokie, Illinois, United States, 60076
United States, Iowa
UnityPoint Clinic
Waterloo, Iowa, United States, 50703
United States, Maryland
Chesapeake Urology
Owings Mills, Maryland, United States, 21117
United States, Nebraska
Adult & Pediatric Urology
Omaha, Nebraska, United States, 68114
United States, New York
Manhattan Medical Research
New York, New York, United States, 10016
United States, North Carolina
Alliance Urology Specialists
Greensboro, North Carolina, United States, 27403
United States, Pennsylvania
The Institute for Female Pelvic Medicine & Reconstructive Surgery (FPM Institute)
Allentown, Pennsylvania, United States, 18103
United States, South Carolina
South Carolina OB/GYN
Columbia, South Carolina, United States, 29201
Sponsors and Collaborators
Valencia Technologies Corporation
Investigators
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Principal Investigator: Scott MacDiarmid, MD Alliance Urology
  Study Documents (Full-Text)

Documents provided by Valencia Technologies Corporation:
Study Protocol  [PDF] August 25, 2020
Statistical Analysis Plan  [PDF] August 28, 2019

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Responsible Party: Valencia Technologies Corporation
ClinicalTrials.gov Identifier: NCT03556891    
Other Study ID Numbers: 111-3281
First Posted: June 14, 2018    Key Record Dates
Results First Posted: July 30, 2021
Last Update Posted: October 17, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Urinary Incontinence
Enuresis
Urinary Bladder, Overactive
Urinary Incontinence, Urge
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Behavioral Symptoms
Elimination Disorders
Mental Disorders
Urinary Bladder Diseases