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: Completed
• Conditions: Overactive Bladder; Urge Incontinence; Urinary Urge Incontinence; Incontinence, Urinary
• Intervention / Treatment: Device: eCoin Tibial Nerve Stimulation

Detailed Description

This study enrolled and implanted 133 subjects at 15 sites in the US under the original IDE.

Subjects were given the option to extend out to 3 years post activation, with annual visits at 2 and 3 years post activation (96 and 144 weeks post-activation).

Subjects who are still active in the original IDE study will be offered consecutive enrollment in the post approval study and will be given the option to receive a new implant. Subjects who are no longer active, or have exited the study will be given the option to reenter the study and complete two follow-up visits. Subjects re-entering the study will not have the option to receive a new implant. Post approval follow-up of subjects will occur through the year 5 visit (257 weeks post-activation of their original device). Reimplantation of a new eCoin would not reset their follow-up clock.

• 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 up to 52 weeks after implantation.	52 weeks after implantation.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Moderate-term Safety in All Patients. Percentage of Patients With Device Related Adverse Events.	All adverse events will be reported.	28 weeks after implantation
Percentage of Subjects Experiencing 50% or Better Improvement in Urgency Urinary Incontinence Episodes as Measured by a 3-day Voiding Diary	Responder rate	96 weeks after device activation.
Percentage of Subjects Experiencing 50% or Better Improvement in Urgency Urinary Incontinence Episodes as Measured by a 3-day Voiding Diary.	Responder rate	144 weeks after device activation
Percentage of Subjects Experiencing 50% or Better Improvement in Urgency Urinary Incontinence Episodes as Measured by a 3-day Voiding Diary.	Responder rate	205 weeks after device activation
Percentage of Subjects Experiencing 50% or Better Improvement in Urgency Urinary Incontinence Episodes as Measured by a 3-day Voiding Diary.	Responder rate	257 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 up to 96 weeks after implantation.	96 weeks after implantation
Long-term Safety in All Patients: Percentage of Patients With Device Related Adverse Events	All adverse events will be reported in all patients up to 144 weeks after implantation.	144 weeks after implantation
Long-term Safety in All Patients. Percentage of Patients With Device Related Adverse Events	All adverse events will be reported in all patients up to 205 weeks after implantation.	205 weeks after implantation
Long-term Safety in All Patients. Percentage of Patients With Device Related Adverse Events	All adverse events will be reported in all patients up to 257 weeks after implantation.	257 weeks after implantation

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 (Actual): September 18, 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): October 2, 2025
• Last Update Submitted That Met QC Criteria: September 16, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urination Disorders; Lower Urinary Tract Symptoms; Urological Manifestations; Urinary Bladder Diseases; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Urinary Incontinence; Urinary Bladder, Overactive; 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