Pivotal Study of eCoin for Overactive Bladder With Urgency Urinary Incontinence
NCT ID: NCT03556891
Last Updated: 2025-10-02
Study Results
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View full resultsBasic Information
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COMPLETED
NA
133 participants
INTERVENTIONAL
2018-09-04
2024-09-18
Brief Summary
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Detailed Description
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Subjects were given the option to extend out to 3 years post activation, with annual visits at 2 and 3 years post activation (96 and 144 weeks post-activation).
Subjects who are still active in the original IDE study will be offered consecutive enrollment in the post approval study and will be given the option to receive a new implant. Subjects who are no longer active, or have exited the study will be given the option to reenter the study and complete two follow-up visits. Subjects re-entering the study will not have the option to receive a new implant. Post approval follow-up of subjects will occur through the year 5 visit (257 weeks post-activation of their original device). Reimplantation of a new eCoin would not reset their follow-up clock.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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eCoin Tibial Nerve Stimulation
eCoin Tibial Nerve Stimulation
Subcutaneous stimulation of the tibial nerve using the eCoin device.
Interventions
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eCoin Tibial Nerve Stimulation
Subcutaneous stimulation of the tibial nerve using the eCoin device.
Eligibility Criteria
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Inclusion Criteria
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 is intolerant of or has an inadequate response to any of anticholinergics, β3-adrenoceptor agonists, onabotulinumtoxinA, or percutaneous tibial nerve stimulation.
Exclusion Criteria
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.
18 Years
80 Years
ALL
No
Sponsors
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Valencia Technologies Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Scott MacDiarmid, MD
Role: PRINCIPAL_INVESTIGATOR
Alliance Urology
Locations
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Kaiser Permanente
Downey, California, United States
Sequoia Urology Center
Redwood City, California, United States
Kaiser Permanente
San Diego, California, United States
Sansum Clinic
Santa Barbara, California, United States
SurgOne PC
Englewood, Colorado, United States
Urology Associates of Norwalk
Norwalk, Connecticut, United States
Florida Bladder Institute
Naples, Florida, United States
North Shore Medical Group
Skokie, Illinois, United States
UnityPoint Clinic
Waterloo, Iowa, United States
Chesapeake Urology
Owings Mills, Maryland, United States
Adult & Pediatric Urology
Omaha, Nebraska, United States
Manhattan Medical Research
New York, New York, United States
Alliance Urology Specialists
Greensboro, North Carolina, United States
The Institute for Female Pelvic Medicine & Reconstructive Surgery (FPM Institute)
Allentown, Pennsylvania, United States
South Carolina OB/GYN
Columbia, South Carolina, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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111-3281
Identifier Type: -
Identifier Source: org_study_id
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