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eCoin Tibial Nerve Stimulation for OAB

NCT03029624 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2020-12-22

Study results available
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Summary

The study is a single arm, prospective study of the safety and effectiveness of the Valencia Technologies eCoin System to stimulate the tibial nerve for the treatment of patients with refractory urgency urinary incontinence.

Conditions

  • Urgency Urinary Incontinence

Interventions

DEVICE

eCoin

Patients are implanted with active implantable device called eCoin. eCoin is turned ON in order to deliver neuromodulation therapy.

Sponsors & Collaborators

  • Valencia Technologies Corporation

    lead INDUSTRY

Principal Investigators

  • Sharon English, MD · Urology Associates

  • Scott MacDiarmid, MD · Alliance Urology Specialists

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-03
Primary Completion
2017-12-30
Completion
2018-10-01
FDA Device
Yes

Countries

  • United States
  • New Zealand

Study Locations

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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 NCT03029624 on ClinicalTrials.gov