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

Overactive Bladder Clinical Trial

— RECIPE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05685433
• Other study ID #: 111-5702
• Status: Recruiting
• Phase: N/A
• Start date: January 26, 2023
• Est. completion date: December 2030

Study information

• Verified date: April 2024
• Source: Valencia Technologies Corporation
• Contact: Nicole Barber
• Phone: 661-666-4583
• Email: clinical[@]valenciatechnologies.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2030
• Est. primary completion date: August 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 ß3-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, ß3-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.

Related Conditions & MeSH terms

• Enuresis
• Incontinence, Urinary
• Overactive Bladder
• Urge Incontinence
• Urinary Bladder, Overactive
• Urinary Incontinence
• Urinary Incontinence, Urge
• Urinary Urge Incontinence

Intervention

Device:
• eCoin Tibial Nerve Stimulation
Subcutaneous stimulation of the tibial nerve using the eCoin device.

Locations

Country	Name	City	State
United States	UPNT Research Institute	Arlington	Texas
United States	The Emory Clinic	Atlanta	Georgia
United States	Rush University	Chicago	Illinois
United States	Urology Centers of Alabama	Homewood	Alabama
United States	Baylor College of Medicine	Houston	Texas
United States	The Methodist Hospital Research Institute	Houston	Texas
United States	University of Iowa	Iowa City	Iowa
United States	University of California, Irvine	Irvine	California
United States	University of Kansas Medical Center Research Institute, Inc	Kansas City	Kansas
United States	Arkansas Urology	Little Rock	Arkansas
United States	AIR Research	Los Angeles	California
United States	USA Health	Mobile	Alabama
United States	Weill Cornell Medicine: Department of Urology	New York	New York
United States	The Oregon Clinic	Portland	Oregon
United States	Specialty Clinical Research of St. Louis	Saint Louis	Missouri
United States	Louisiana State University Health Sciences Center	Shreveport	Louisiana
United States	Stanford Health	Stanford	California
United States	Southern Urogynecology	West Columbia	South Carolina
United States	Cypress Medical Research	Wichita	Kansas
United States	Minnesota Urology	Woodbury	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Valencia Technologies Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Proportion of responders (50% improvement) after 12, 24, 36, 48, and 60 months of therapy.	Proportion of subjects achieving at least a 50% improvement in the number of urgency urinary incontinence episodes on a 3-day voiding diary.	12, 24, 36, 48, and 60 months
Other	Proportion of responders (75% improvement) after 12, 24, 36, 48, and 60 months of therapy.	Proportion of subjects achieving at least a 75% improvement in the number of urgency urinary incontinence episodes on a 3-day voiding diary.	12, 24, 36, 48, and 60 months
Other	Proportion of responders (100% improvement) after 12, 24, 36, 48, and 60 months of therapy.	Proportion of subjects achieving at least a 100% improvement in the number of urgency urinary incontinence episodes on a 3-day voiding diary.	12, 24, 36, 48, and 60 months
Other	Reduction in the number of urgency urinary incontinence episodes.	Reduction in the number of urgency urinary incontinence episodes on a 3-day voiding diary.	12, 24, 36, 48, and 60 months
Other	Reduction in the number of urgency urinary incontinence episodes for subjects with 8+ voids per day at baseline.	Reduction in the number of urgency urinary incontinence episodes on a 3-day voiding diary for subjects who experience more than 8 voids per day at baseline.	12, 24, 36, 48, and 60 months
Other	Reduction in urgency episodes.	Reduction in the number of urgency episodes on a 3-day voiding diary.	12, 24, 36, 48, and 60 months
Other	Reduction in nocturia episodes	Reduction in nocturia episodes on a 3-day voiding diary.	12, 24, 36, 48, and 60 months
Other	Patient reported qualify of life	Improvement in patient reported qualify of life utilizing the Overactive Bladder Symptom Quality of Life Questionnaire (OABq).	12, 24, 36, 48, and 60 months
Other	Patient reported overactive bladder condition improvement.	Improvement in patient reported overactive bladder condition utilizing the Patient Global Impression of Improvement (PGI-I) questionnaire.	12, 24, 36, 48, and 60 months
Other	Patient reported sexual health.	Assess patient reported sexual health using the PROMIS Sexual Function and Satisfaction survey.	12 months
Other	Patient reported satisfaction with eCoin.	Assess patient-reported satisfaction with eCoin therapy using the custom patient satisfaction rating survey.	12, 24, 36, 48, and 60 months
Other	Device-related adverse events from implantation.	Rate of device-related adverse events from implantation.	12, 24, 36, 48, and 60 months
Other	Procedure-related adverse events from implantation.	Rate of procedure-related adverse events from implantation.	12, 24, 36, 48, and 60 months
Other	Procedure-related adverse events due to suture technique	Rate of procedure-related adverse events occurring as a result of inappropriate suture technique.	12, 24, 36, 48, and 60 months
Primary	Responder Rate	Proportion of subjects achieving at least a 50% improvement in the number of urgency urinary incontinence episodes on a 3-day voiding diary.	12 months
Primary	Safety	Rate of all device or procedure related AEs.	12 months
Secondary	Responder Rate	Proportion of subjects achieving at least a 50% improvement in the number of urgency urinary incontinence episodes on a 3-day voiding diary.	24 months
Secondary	Safety Data	Rate of all device or procedure related AEs through 24 months post activation of eCoin.	24 months
Secondary	Safety data through 7 months post-reimplantation.	Rate of device or procedure-related AEs through 7 months post reimplantation.	7 months post reimplantation