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The trial is taking place at:
T

The Oregon Clinic | Pulmonary Critical Care & Sleep Medicine East

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

V

Valencia Technologies

Status

Enrolling

Conditions

Urinary Urge Incontinence
Incontinence, Urinary
Urge Incontinence
Overactive Bladder

Treatments

Device: eCoin Tibial Nerve Stimulation

Study type

Interventional

Funder types

Industry

Identifiers

NCT05685433
111-5702

Details and patient eligibility

About

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).

Full description

The goal of this prospective, multicenter, single-arm study is to assess the long-term safety and effectiveness of the FDA approved eCoin® implanted tibial nerve stimulator in a real world setting. Eligible subjects having overactive bladder (OAB) with urgency urinary incontinence (UUI) will be implanted with the eCoin® implanted tibial stimulator and complete voiding diaries and questionnaires at follow-up visits through 5 years.

Enrollment

200 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Women and men above 18 years old with gender percentages reflective of disease prevalence in the U.S. population
  • Individual with diagnosis of overactive bladder with urgency urinary incontinence.
  • Individual has at least one urgency urinary incontinence episode on each of three days as determined on a 3-day voiding diary.
  • Individual gives written informed consent.
  • Individual is mentally competent and able to understand all study requirements.
  • Individual is willing and able to complete a 3-day voiding diary and quality of life questionnaire.
  • Individual is without pharmacological treatment of overactive bladder (anticholinergic and β3-adrenoceptor agonists) for 2 weeks prior to baseline or longer if the physician judges that the therapeutic effect is still present.
  • Individual is intolerant of or has an inadequate response to any of anticholinergics, β3-adrenoceptor agonists, onabotulinumtoxinA, or who have undergone percutaneous tibial nerve stimulation (PTNS).
  • Individual is determined to be a suitable surgical candidate by physician.
  • Individual is appropriate for eCoin treatment based on the US FDA-approved IFU requirements.

Exclusion criteria

  • Individual is not appropriate for eCoin therapy based upon the US FDA-approved IFU requirements.
  • Individual has clinically significant bladder outlet obstruction. (Suspected bladder outlet obstruction will be initially assessed by uroflow study with those having a maximum flow rate < 15mL/s requiring additional evaluation.)
  • Individual has predominantly stress urinary incontinence (greater than 1/3 of leaks on baseline diary are stress).
  • Individual has an active urinary tract infection at time of enrollment.
  • Individual has known polyuria.
  • Individual has significant lower urinary tract pain or has been diagnosed with interstitial cystitis or bladder pain syndrome.
  • Individual has abnormal post void residual (i.e. greater than 200 cc initially and on repeat testing after double voiding)
  • Individual has clinically significant urethral stricture disease or bladder neck contracture. (Suspected disease or contracture will be initially assessed by uroflow study with those having a maximum flow rate < 15mL/s requiring additional evaluation.)
  • Individual has chronic venous insufficiency with a history of skin change (hyperpigmentation, lipodermatosclerosis, ulceration) in the ankle region.
  • Individual has morbid obesity and in the opinion of the investigator is not a good candidate for the study.
  • Individual has had diagnosis of bladder, urethral, or prostate cancer.
  • Individual has had a prior anti-stress incontinence sling surgery within the last year.
  • Individual is pregnant or intends to become pregnant during the study.
  • Individual has the presence of urinary fistula, bladder stone, or interstitial cystitis.
  • Individual has uncontrolled diabetes mellitus (Hemoglobin A1C>7) or diabetes with significant peripheral complications. (Uncontrolled diabetes will be ruled out by blood test excluding those with Hemoglobin A1C>7).
  • Individual has an implantable neurostimulator, pacemaker, or implantable cardiac defibrillator (ICD).
  • Individual has been treated with onabotulinumtoxinA in the previous 9 months prior to enrollment, or more time if the principal investigator judges that the therapeutic effect is present.
  • Individual has been treated with percutaneous tibial nerve stimulation (PTNS) within the previous 4 weeks prior to enrollment or more time if the principal investigator judges that the therapeutic effect is present.
  • Individual is currently using transcutaneous electrical nerve stimulation (TENS) in the pelvic region, back, or legs.
  • Individual is aware that he or she will need an MRI scan other than a head/neck/shoulder MRI during the study period.
  • Individual has a clotting or bleeding disorder or is using anticoagulant therapies and in the opinion of the investigator is not a good candidate for the study (antiplatelet and anticoagulant therapy may be continued or held at the discretion of the investigator).
  • Individual is neutropenic or immune-compromised.
  • Individual has had previous surgery and/or significant scarring at the implant location.
  • Individual has ongoing dermatologic condition at the implant site, including but not limited to dermatitis and autoimmune disorders.
  • Individual has a clinically significant peripheral neuropathy in the lower extremities.
  • Individual has neurogenic bladder dysfunction.
  • Individual has pitting edema at implant location (≥ 2+ is excluded).
  • Individual has inadequate skin integrity or any evidence of an infection or inflammation in either lower leg.
  • Individual has varicose veins and is symptomatic.
  • Individual has open wounds, trauma, or prior surgery in the lower extremities.
  • Individual has arterial disease in the lower extremities.
  • Individual has vasculitis in the lower extremities.
  • Individual has bladder stones or neoplasia. (Suspected bladder stones or neoplasia will be ruled out with a urine dipstick showing no more than trace blood, and microscopic analysis (which should be done in that case) shows ≥3 PBC's /HPF unless that subject has been worked up and found negative for clinically significant disease such as malignant neoplasm or stones.)
  • In the opinion of the investigator, Individual is not a good candidate for participation in the study.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

200 participants in 1 patient group

eCoin Tibial Nerve Stimulation
Experimental group
Description:
Subcutaneous stimulation of the tibial nerve using the eCoin device.
Treatment:
Device: eCoin Tibial Nerve Stimulation

Trial contacts and locations

20

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Central trial contact

Nicole Barber

Data sourced from clinicaltrials.gov

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