A Real World Study of eCoin for Urgency Urinary Incontinence: Post Approval Evaluation (RECIPE)

Part of paid clinical trials in Homewood, Alabama.

Sponsor
Valencia Technologies Corporation
Study ID
NCT05685433
Status
Recruiting
Apply to this trial

Conditions

  • Incontinence, Urinary
  • Overactive Bladder
  • Urge Incontinence
  • Urinary Urge Incontinence

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • eCoin Tibial Nerve Stimulation — DEVICE
    Subcutaneous stimulation of the tibial nerve using the eCoin device.

Study Details

A prospective, multicenter, single-arm study to evaluate the safety and effectiveness of the eCoin® implanted tibial nerve stimulator in subjects with urgency urinary incontinence (UUI).

Key Dates

Start date
Jan 26, 2023
Status verified
Apr 2025
Primary completion
Mar 31, 2027
Completion
Dec 31, 2031

Study Design

Enrollment
200 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: eCoin Tibial Nerve Stimulation
    Subcutaneous stimulation of the tibial nerve using the eCoin device.

Primary Outcome Measure

Responder Rate [ Time Frame: 12 months ]

Central Contacts

Locations (22)

FacilityCityStateZIPSite coordinators
Urology Centers of AlabamaHomewoodAlabama35209
Alison Pickering, MD
USA HealthMobileAlabama36606-
Arkansas UrologyLittle RockArkansas72211
Lauren Hendrix, MD
Lauren Hendrix, MD (PRINCIPAL_INVESTIGATOR)
University of California, IrvineIrvineCalifornia92697
Dena Moskowitz, MD
Dena Moskowitz, MD (PRINCIPAL_INVESTIGATOR)
AIR ResearchLos AngelesCalifornia90017
John Kowalczyk, DO
John Kowalczyk, DO (PRINCIPAL_INVESTIGATOR)
Stanford HealthStanfordCalifornia94305
Craig Comiter, MD
Craig Comiter, MD (PRINCIPAL_INVESTIGATOR)
Urological Research Network CorpHialeahFlorida33016
Isabel H Lopez, MBA
[email protected]
786-431-2014
Edward Gheiler, MD (PRINCIPAL_INVESTIGATOR)
The Emory ClinicAtlantaGeorgia30322
Mersiha Torlak
[email protected]
404-778-4823
Brendan Browne, MD (PRINCIPAL_INVESTIGATOR)
Rush UniversityChicagoIllinois60612
Sarah Adelstein, MD
Sarah Adelstein, MD (PRINCIPAL_INVESTIGATOR)
The Iowa ClinicAnkenyIowa50023
Stephanie Morgan, MD
[email protected]
515-875-9815
Stephanie Morgan, MD (PRINCIPAL_INVESTIGATOR)
University of IowaIowa CityIowa52242
Annah Vollstedt, MD
Annah Vollstedt, MD (PRINCIPAL_INVESTIGATOR)
University of Kansas Medical Center Research Institute, IncKansas CityKansas66160
Kirk Redger, MD
Kirk Redger, MD (PRINCIPAL_INVESTIGATOR)
Cypress Medical ResearchWichitaKansas67226
Kevin Miller, MD
Kevin Miller, MD (PRINCIPAL_INVESTIGATOR)
Louisiana State University Health Sciences CenterShreveportLouisiana71103-
Minnesota UrologyWoodburyMinnesota55125
Michael Ehlert, MD
Michael Ehlert, MD (PRINCIPAL_INVESTIGATOR)
Specialty Clinical Research of St. LouisSt LouisMissouri63141
Travis Bullock, MD
Travis Bullock, MD (PRINCIPAL_INVESTIGATOR)
Weill Cornell Medicine: Department of UrologyNew YorkNew York10065
Larissa Rodriguez, MD
Larissa Rodriguez, MD (PRINCIPAL_INVESTIGATOR)
The Oregon ClinicPortlandOregon97225-
Southern UrogynecologyWest ColumbiaSouth Carolina29169
Andrea Pezzella, MD
Andrea Pezzella, MD (PRINCIPAL_INVESTIGATOR)
UPNT Research InstituteArlingtonTexas76017
Tracy Cannon-Smith, MD
Baylor College of MedicineHoustonTexas77030
Christopher Smith, MD
Christopher Smith, MD (PRINCIPAL_INVESTIGATOR)
The Methodist Hospital Research InstituteHoustonTexas77030
Kathleen Kobashi, MD

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By research site
Urology Centers of Alabama· Homewood, ALUSA Health· Mobile, ALArkansas Urology· Little Rock, ARUniversity of California, Irvine· Irvine, CAAIR Research· Los Angeles, CAStanford Health· Stanford, CA

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