Pivotal Study of eCoin for OAB With UUI



Status:Recruiting
Conditions:Overactive Bladder, Urology
Therapuetic Areas:Gastroenterology, Nephrology / Urology
Healthy:No
Age Range:18 - 80
Updated:10/27/2018
Start Date:July 1, 2018
End Date:January 31, 2020
Contact:Stacy G Chambliss
Email:info@valenciatechnologies.com
Phone:16617751414

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Trial Summary
Trial Overview
Inclusion Criteria

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.


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 has an inadequate response to or is intolerant of an anticholinergic
medication.

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.
We found this trial at
19
sites
MUSC
Charleston, South Carolina 29425
Principal Investigator: Eric Rovner, MD
Phone: 843-876-0630
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Charleston, SC
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The Institute for Female Pelvic Medicine & Reconstructive Surgery (FPM Institute)
Allentown, Pennsylvania 18103
Principal Investigator: Vincent Lucente, MD
Phone: 610-435-9575
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mi
from
Allentown, PA
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Florida Robotic and Minimally Invasive Urogynecology
Coconut Creek, Florida 33073
Principal Investigator: Amir Shariati, MD
Phone: 305-297-1723
?
mi
from
Coconut Creek, FL
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South Carolina OB/GYN
Columbia, South Carolina 29201
Principal Investigator: Thomas Giudice, MD
Phone: 803-727-0422
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mi
from
Columbia, SC
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Kaiser Permanente
Downey, California 90242
Principal Investigator: John Nguyen, MD
Phone: 562-657-2914
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from
Downey, CA
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Kershaw Health
Elgin, South Carolina 29045
Principal Investigator: Manish Patel, MD
Phone: 803-424-8058
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from
Elgin, SC
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SurgOne PC
Englewood, Colorado 80110
Principal Investigator: James Lukban, MD
Phone: 303-957-1310
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mi
from
Englewood, CO
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Alliance Urology Specialists
Greensboro, North Carolina
Principal Investigator: Scott MacDiarmid, MD
Phone: 336-232-5322
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mi
from
Greensboro, NC
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The Florida Bladder Institute
Naples, Florida 34109
Principal Investigator: Joseph Gauta, MD
Phone: 239-449-7979
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mi
from
Naples, FL
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Manhattan Medical Research
New York, New York 10016
Principal Investigator: Jed Kaminetsky, MD
Phone: 917-409-3917
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mi
from
New York, NY
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Urology Associates Of Norwalk
Norwalk, Connecticut 06859
Principal Investigator: Scott Serels, MD
Phone: 203-853-4200
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mi
from
Norwalk, CT
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Adult and Pediatric Urology P.C
Omaha, Nebraska 68114
Principal Investigator: Rebecca McCrery, MD
Phone: 402-399-7892
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mi
from
Omaha, NE
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The Urogynecology Center
Overland Park, Kansas 66209
Principal Investigator: Charles Butrick, MD
Phone: 913-530-1157
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mi
from
Overland Park, KS
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Chesapeake Urology
Owings Mills, Maryland 21117
Principal Investigator: Andrew Shapiro, MD
Phone: 443-231-1203
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mi
from
Owings Mills, MD
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Sequoia Urology Center
Redwood City, California 94062
Principal Investigator: Chris Threatt, MD
Phone: 650-362-8250
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from
Redwood City, CA
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Kaiser Permanente
San Diego, California 92120
Principal Investigator: Kim Ferrante, MD
Phone: 619-221-6274
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from
San Diego, CA
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Sansum Clinic
Santa Barbara, California 93105
Principal Investigator: Alexandra Rogers, MD
Phone: 805-879-0644
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from
Santa Barbara, CA
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North Shore Medical Group
Skokie, Illinois 60076
Principal Investigator: Peter Sand, MD
Phone: 224-364-7464
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from
Skokie, IL
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UnityPoint Clinic
Waterloo, Iowa 50703
Principal Investigator: Bilal Kaaki, MD
Phone: 319-235-5050
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from
Waterloo, IA
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