Clinical trial NCT03556891: Pivotal Study of eCoin for Overactive Bladder With Urgency Urinary Incontinence
Official title: Pivotal Study of Subcutaneous Tibial Nerve Stimulation With eCoin for Overactive Bladder (OAB) With Urgency Urinary Incontinence (UUI)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overactive Bladder
Urge Incontinence
Incontinence, Urinary
Urinary Urge Incontinence
Lead sponsor: Valencia Technologies Corporation
Sponsor class: INDUSTRY
First posted: 2018-06-14
Enrollment: 133
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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 is intolerant of or has an inadequate response to any of anticholinergics, β3-adrenoceptor agonists, onabotulinumtoxinA, or percutaneous tibial nerve stimulation.

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.

Primary outcomes:
measure: Percentage of Subjects Experiencing 50% or Better Improvement in Urgency Urinary Incontinence Episodes as Measured by a 3-day Voiding Diary.
timeFrame: 48 weeks after device activation.
measure: Long-term Safety in All Patients. Percentage of Patients With Device Related Adverse Events.
timeFrame: 52 weeks after implantation.
Secondary outcomes:
measure: Moderate-term Safety in All Patients. Percentage of Patients With Device or Implantation Related Adverse Events.
timeFrame: 24 weeks after device activation
measure: Moderate-term Effectiveness Data. Percentage of Subjects Experiencing 50% or Better Improvement in Urgency Urinary Incontinence Episodes as Measured by a 3-day Voiding Diary.
timeFrame: 24 weeks after device activation
Other outcomes:
Locations:
city: Downey
country: United States
facility: Kaiser Permanente
state: California
city: Redwood City
country: United States
facility: Sequoia Urology Center
state: California
city: San Diego
country: United States
facility: Kaiser Permanente
state: California
city: Santa Barbara
country: United States
facility: Sansum Clinic
state: California
city: Englewood
country: United States
facility: SurgOne PC
state: Colorado
city: Norwalk
country: United States
facility: Urology Associates of Norwalk
state: Connecticut
city: Naples
country: United States
facility: Florida Bladder Institute
state: Florida
city: Skokie
country: United States
facility: North Shore Medical Group
state: Illinois
city: Waterloo
country: United States
facility: UnityPoint Clinic
state: Iowa
city: Owings Mills
country: United States
facility: Chesapeake Urology
state: Maryland
city: Omaha
country: United States
facility: Adult & Pediatric Urology
state: Nebraska
city: New York
country: United States
facility: Manhattan Medical Research
state: New York
city: Greensboro
country: United States
facility: Alliance Urology Specialists
state: North Carolina
city: Allentown
country: United States
facility: The Institute for Female Pelvic Medicine & Reconstructive Surgery (FPM Institute)
state: Pennsylvania
city: Columbia
country: United States
facility: South Carolina OB/GYN
state: South Carolina
Study officials:
affiliation: Alliance Urology
name: Scott MacDiarmid, MD
role: PRINCIPAL_INVESTIGATOR
References: