Pivotal Study of eCoin for Overactive Bladder With Urgency Urinary Incontinence

NCT03556891 | Completed Results DMC FDA Device

• 1 other identifier: 111-3281
• Study Type: interventional
• Target: 133
• Locations: 1 country
• Sites: 15

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.

Conditions

Overactive Bladder; Urge Incontinence; Incontinence, Urinary; Urinary Urge Incontinence

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (10)

• Moderate-term Safety in All Patients. Percentage of Patients With Device Related Adverse Events.

  28 weeks after implantation

• 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.

  24 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

  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.

  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.

  205 weeks after device activation

Study Arms (1)

eCoin Tibial Nerve Stimulation

EXPERIMENTAL

Device: eCoin Tibial Nerve Stimulation

Interventions

eCoin Tibial Nerve Stimulation DEVICE

Subcutaneous stimulation of the tibial nerve using the eCoin device.

eCoin Tibial Nerve Stimulation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Valencia Technologies Corporation: lead

Study Sites (15)

Kaiser Permanente

Downey, California, 90242, United States

Location

Sequoia Urology Center

Redwood City, California, 94062, United States

Location

Kaiser Permanente

San Diego, California, 92110, United States

Location

Sansum Clinic

Santa Barbara, California, 93105, United States

Location

SurgOne PC

Englewood, Colorado, 80113, United States

Location

Urology Associates of Norwalk

Norwalk, Connecticut, 06850, United States

Location

Florida Bladder Institute

Naples, Florida, 34109, United States

Location

North Shore Medical Group

Skokie, Illinois, 60076, United States

Location

UnityPoint Clinic

Waterloo, Iowa, 50703, United States

Location

Chesapeake Urology

Owings Mills, Maryland, 21117, United States

Location

Adult & Pediatric Urology

Omaha, Nebraska, 68114, United States

Location

Manhattan Medical Research

New York, New York, 10016, United States

Location

Alliance Urology Specialists

Greensboro, North Carolina, 27403, United States

Location

The Institute for Female Pelvic Medicine & Reconstructive Surgery (FPM Institute)

Allentown, Pennsylvania, 18103, United States

Location

South Carolina OB/GYN

Columbia, South Carolina, 29201, United States

Location

MeSH Terms

Conditions

Urinary Bladder, Overactive; Urinary Incontinence, Urge; Urinary Incontinence

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Urination Disorders

Limitations and Caveats

A limitation of the study was the lack of blinding and comparison. Considering that neuromodulation studies are generally not blinded since the therapy itself is sensed, a control group with a similar safety profile to eCoin could not be achieved. We also acknowledge that a 12-month endpoint provides only medium-term data on the durability of response and future longer follow up data will be needed.

Results Point of Contact

• Title: Jackie Dister
• Organization: Valencia Technologies

jdister@valenciatechnologies.com

7604294787

Study Officials

• Scott MacDiarmid, MD

  Alliance Urology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2018
• First Posted: June 14, 2018
• Study Start: September 4, 2018
• Primary Completion: April 12, 2020
• Study Completion: September 18, 2024
• Last Updated: October 2, 2025
• Results First Posted: July 30, 2021

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (15)