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Pivotal Study of eCoin for OAB With UUI
Overall Recruitment Status: Active, currently enrolling
 
Official Title
Pivotal Study of Subcutaneous Tibial Nerve Stimulation With eCoin for Overactive Bladder (OAB) With Urgency Urinary Incontinence (UUI)
 
Region Sponsors
California - Southern
Valencia Technologies Corporation
 
Acronym KP IRB No.
11576
 
Study Type Phase
Clinical Trial n/a
 
Study Population Description
Individuals with a diagnosis of Overactive Bladder, Urge Incontinence, Incontinence, Urinary, Urinary Urge Incontinence
 
Purpose
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.
 
Detailed Description
Change from baseline in urgency urinary incontinence episodes as measured by a 3-day voiding diary. Time Frame: 12 weeks after device activation. Long-term safety in all patients.Time Frame: 52 weeks after implantation. All adverse events will be reported in all patients who were implanted 12 months after implantation.
 
Gender Age Limit
Male & Female 18 - 80 years
 
Inclusion Criteria
  • Women and men between 18 and 80 years old
  • 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
  • Individual is without pharmacological treatment of overactive bladder (antimuscarinics and beta-3 agonists)
  • Individual has an inadequate response to or is intolerant of an anticholinergic medication
 
Exclusion Criteria
  • Predominant stress urinary incontinence with more than 1/3 stress urinary incontinent episodes when compared to total urinary incontinent episodes
  • Clinically significant bladder outlet obstruction
  • Clinically significant pelvic organ prolapse beyond the hymenal ring
  • Inadequate skin integrity or any evidence of an infection or inflammation in either lower leg

 
Keywords and/or Specific Medical Conditions
  • Behavioral Symptoms
  • Urinary Bladder, Overactive
  • Elimination Disorders
  • Urinary Incontinence
  • Enuresis
  • Urinary Incontinence, Urge
  • Lower Urinary Tract Symptoms
  • Urination Disorders
  • Mental Disorders
  • Urologic Diseases
  • Signs and Symptoms
  • Urological Manifestations
  • Urinary Bladder Diseases
  • Urology
 
KP Clinical Facility
  • San Diego
  • Southern California
 
Clinical Area
  • Urology


Principal Investigator:
John Nguyen, MD
Contact Information:
- Tiffany Castanon
-626-564-5667
-San Diego


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