MedTrace Logo

Pivotal Study of eCoin for Overactive Bladder With Urgency Urinary Incontinence

NCT03556891 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 133

Last updated 2025-10-02

Study results available
· View outcomes & findings →

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

Interventions

DEVICE

eCoin Tibial Nerve Stimulation

Subcutaneous stimulation of the tibial nerve using the eCoin device.

Sponsors & Collaborators

  • Valencia Technologies Corporation

    lead INDUSTRY

Principal Investigators

  • Scott MacDiarmid, MD · Alliance Urology

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-04
Primary Completion
2020-04-12
Completion
2024-09-18
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03556891 on ClinicalTrials.gov