The trial is taking place at:
M

Manhattan Medical Research | New York, NY

Veeva-enabled site

Pivotal Study of eCoin for Overactive Bladder With Urgency Urinary Incontinence

V

Valencia Technologies

Status

Active, not recruiting

Conditions

Urinary Urge Incontinence
Incontinence, Urinary
Urge Incontinence
Overactive Bladder

Treatments

Device: eCoin Tibial Nerve Stimulation

Study type

Interventional

Funder types

Industry

Identifiers

NCT03556891
111-3281

Details and patient eligibility

About

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.

Enrollment

133 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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

Primary 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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

133 participants in 1 patient group

eCoin Tibial Nerve Stimulation
Experimental group
Treatment:
Device: eCoin Tibial Nerve Stimulation

Trial documents
2

Trial contacts and locations

15

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Data sourced from clinicaltrials.gov

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