Clinical trial NCT05685433: A Real World Study of eCoin for Urgency Urinary Incontinence: Post Approval Evaluation (RECIPE)
Official title: A Real World Study of eCoin for Urgency Urinary Incontinence: Post Approval Evaluation (RECIPE)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Overactive Bladder
Urge Incontinence
Incontinence, Urinary
Urinary Urge Incontinence
Lead sponsor: Valencia Technologies Corporation
Sponsor class: INDUSTRY
First posted: 2023-01-17
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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).

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Responder Rate
timeFrame: 12 months
measure: Safety: 12 months rate of all device or procedure related AEs.
timeFrame: 12 months
Secondary outcomes:
measure: Responder Rate
timeFrame: 24 months
measure: Safety Data
timeFrame: 24 months
measure: Safety data through 7 months post-reimplantation.
timeFrame: 7 months post reimplantation
Other outcomes:
measure: Proportion of responders (50% improvement) after 12, 24, 36, 48, and 60 months of therapy.
timeFrame: 12, 24, 36, 48, and 60 months
measure: Proportion of responders (75% improvement) after 12, 24, 36, 48, and 60 months of therapy.
timeFrame: 12, 24, 36, 48, and 60 months
measure: Proportion of responders (100% improvement) after 12, 24, 36, 48, and 60 months of therapy.
timeFrame: 12, 24, 36, 48, and 60 months
measure: Reduction in the number of urgency urinary incontinence episodes.
timeFrame: 12, 24, 36, 48, and 60 months
measure: Reduction in the number of urgency urinary incontinence episodes for subjects with 8+ voids per day at baseline.
timeFrame: 12, 24, 36, 48, and 60 months
measure: Reduction in urgency episodes.
timeFrame: 12, 24, 36, 48, and 60 months
measure: Reduction in nocturia episodes
timeFrame: 12, 24, 36, 48, and 60 months
measure: Patient reported qualify of life
timeFrame: 12, 24, 36, 48, and 60 months
measure: Patient reported overactive bladder condition improvement.
timeFrame: 12, 24, 36, 48, and 60 months
measure: Patient reported sexual health.
timeFrame: 12 months
measure: Patient reported satisfaction with eCoin.
timeFrame: 12, 24, 36, 48, and 60 months
measure: Device-related adverse events from implantation.
timeFrame: 12, 24, 36, 48, and 60 months
measure: Procedure-related adverse events from implantation.
timeFrame: 12, 24, 36, 48, and 60 months
measure: Procedure-related adverse events due to suture technique
timeFrame: 12, 24, 36, 48, and 60 months
Locations:
city: Homewood
country: United States
facility: Urology Centers of Alabama
state: Alabama
city: Mobile
country: United States
facility: USA Health
state: Alabama
city: Little Rock
country: United States
facility: Arkansas Urology
state: Arkansas
city: Irvine
country: United States
facility: University of California, Irvine
state: California
city: Los Angeles
country: United States
facility: AIR Research
state: California
city: Stanford
country: United States
facility: Stanford Health
state: California
city: Atlanta
country: United States
facility: The Emory Clinic
state: Georgia
city: Chicago
country: United States
facility: Rush University
state: Illinois
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: Kansas City
country: United States
facility: University of Kansas Medical Center Research Institute, Inc
state: Kansas
city: Wichita
country: United States
facility: Cypress Medical Research
state: Kansas
city: Shreveport
country: United States
facility: Louisiana State University Health Sciences Center
state: Louisiana
city: Woodbury
country: United States
facility: Minnesota Urology
state: Minnesota
city: Saint Louis
country: United States
facility: Specialty Clinical Research of St. Louis
state: Missouri
city: New York
country: United States
facility: Weill Cornell Medicine: Department of Urology
state: New York
city: Portland
country: United States
facility: The Oregon Clinic
state: Oregon
city: West Columbia
country: United States
facility: Southern Urogynecology
state: South Carolina
city: Arlington
country: United States
facility: UPNT Research Institute
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Houston
country: United States
facility: The Methodist Hospital Research Institute
state: Texas
Study officials:
References: