Pivotal Study of eCoin for Overactive Bladder With Urgency Urinary Incontinence

Pivotal Study of Subcutaneous Tibial Nerve Stimulation With eCoin for Overactive Bladder (OAB) With Urgency Urinary Incontinence (UUI)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Overactive Bladder; Urge Incontinence; Urinary Urge Incontinence; Incontinence, Urinary
• Intervention / Treatment: Device: eCoin Tibial Nerve Stimulation

• Study Type: Interventional
• Enrollment (Actual): 133
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: eCoin Tibial Nerve Stimulation	Device: eCoin Tibial Nerve Stimulation; Subcutaneous stimulation of the tibial nerve using the eCoin device.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Subjects Experiencing 50% or Better Improvement in Urgency Urinary Incontinence Episodes as Measured by a 3-day Voiding Diary.	Responder rate	48 weeks after device activation.
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.	52 weeks after implantation.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Moderate-term Safety in All Patients. Percentage of Patients With Device or Implantation Related Adverse Events.	All adverse events will be reported.	24 weeks after device activation
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	24 weeks after device activation

Collaborators and Investigators

• Sponsor: Valencia Technologies Corporation
• Investigators: Principal Investigator: Scott MacDiarmid, MD, Alliance Urology

Study record dates

Study Major Dates

• Study Start (Actual): September 4, 2018
• Primary Completion (Actual): April 12, 2020
• Study Completion (Estimated): April 28, 2024

Study Registration Dates

• First Submitted: May 22, 2018
• First Submitted That Met QC Criteria: June 3, 2018
• First Posted (Actual): June 14, 2018

Study Record Updates

• Last Update Posted (Estimated): January 18, 2024
• Last Update Submitted That Met QC Criteria: January 16, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Urologic Diseases; Urinary Bladder Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Elimination Disorders; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urinary Bladder, Overactive; Urinary Incontinence; Enuresis; Urinary Incontinence, Urge
• Other Study ID Numbers: 111-3281

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes