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 |
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.
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
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Allentown, Pennsylvania 18103
Principal Investigator: Vincent Lucente, MD
Phone: 610-435-9575
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Coconut Creek, Florida 33073
Principal Investigator: Amir Shariati, MD
Phone: 305-297-1723
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Columbia, South Carolina 29201
Principal Investigator: Thomas Giudice, MD
Phone: 803-727-0422
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Downey, California 90242
Principal Investigator: John Nguyen, MD
Phone: 562-657-2914
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Elgin, South Carolina 29045
Principal Investigator: Manish Patel, MD
Phone: 803-424-8058
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Greensboro, North Carolina
Principal Investigator: Scott MacDiarmid, MD
Phone: 336-232-5322
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Naples, Florida 34109
Principal Investigator: Joseph Gauta, MD
Phone: 239-449-7979
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New York, New York 10016
Principal Investigator: Jed Kaminetsky, MD
Phone: 917-409-3917
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Norwalk, Connecticut 06859
Principal Investigator: Scott Serels, MD
Phone: 203-853-4200
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Omaha, Nebraska 68114
Principal Investigator: Rebecca McCrery, MD
Phone: 402-399-7892
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Overland Park, Kansas 66209
Principal Investigator: Charles Butrick, MD
Phone: 913-530-1157
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Owings Mills, Maryland 21117
Principal Investigator: Andrew Shapiro, MD
Phone: 443-231-1203
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Redwood City, California 94062
Principal Investigator: Chris Threatt, MD
Phone: 650-362-8250
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San Diego, California 92120
Principal Investigator: Kim Ferrante, MD
Phone: 619-221-6274
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Santa Barbara, California 93105
Principal Investigator: Alexandra Rogers, MD
Phone: 805-879-0644
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Skokie, Illinois 60076
Principal Investigator: Peter Sand, MD
Phone: 224-364-7464
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