Ignite Creation Date:
2025-12-25 @ 2:54 AM
Ignite Modification Date:
2025-12-26 @ 1:35 AM
Study NCT ID:
NCT05685433
Status:
RECRUITING
Last Update Posted:
2025-10-20
First Post:
2023-01-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Real World Study of eCoin for Urgency Urinary Incontinence: Post Approval Evaluation (RECIPE)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D053201', 'term': 'Urinary Bladder, Overactive'}, {'id': 'D053202', 'term': 'Urinary Incontinence, Urge'}, {'id': 'D014549', 'term': 'Urinary Incontinence'}], 'ancestors': [{'id': 'D001745', 'term': 'Urinary Bladder Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D059411', 'term': 'Lower Urinary Tract Symptoms'}, {'id': 'D020924', 'term': 'Urological Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D014555', 'term': 'Urination Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-01-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2031-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-16', 'studyFirstSubmitDate': '2023-01-05', 'studyFirstSubmitQcDate': '2023-01-05', 'lastUpdatePostDateStruct': {'date': '2025-10-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-01-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Proportion of responders (50% improvement) after 12, 24, 36, 48, and 60 months of therapy.', 'timeFrame': '12, 24, 36, 48, and 60 months', 'description': 'Proportion of subjects achieving at least a 50% improvement in the number of urgency urinary incontinence episodes on a 3-day voiding diary.'}, {'measure': 'Proportion of responders (75% improvement) after 12, 24, 36, 48, and 60 months of therapy.', 'timeFrame': '12, 24, 36, 48, and 60 months', 'description': 'Proportion of subjects achieving at least a 75% improvement in the number of urgency urinary incontinence episodes on a 3-day voiding diary.'}, {'measure': 'Proportion of responders (100% improvement) after 12, 24, 36, 48, and 60 months of therapy.', 'timeFrame': '12, 24, 36, 48, and 60 months', 'description': 'Proportion of subjects achieving at least a 100% improvement in the number of urgency urinary incontinence episodes on a 3-day voiding diary.'}, {'measure': 'Reduction in the number of urgency urinary incontinence episodes.', 'timeFrame': '12, 24, 36, 48, and 60 months', 'description': 'Reduction in the number of urgency urinary incontinence episodes on a 3-day voiding diary.'}, {'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', 'description': '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.'}, {'measure': 'Reduction in urgency episodes.', 'timeFrame': '12, 24, 36, 48, and 60 months', 'description': 'Reduction in the number of urgency episodes on a 3-day voiding diary.'}, {'measure': 'Reduction in nocturia episodes', 'timeFrame': '12, 24, 36, 48, and 60 months', 'description': 'Reduction in nocturia episodes on a 3-day voiding diary.'}, {'measure': 'Patient reported qualify of life', 'timeFrame': '12, 24, 36, 48, and 60 months', 'description': 'Improvement in patient reported qualify of life utilizing the Overactive Bladder Symptom Quality of Life Questionnaire (OABq).'}, {'measure': 'Patient reported overactive bladder condition improvement.', 'timeFrame': '12, 24, 36, 48, and 60 months', 'description': 'Improvement in patient reported overactive bladder condition utilizing the Patient Global Impression of Improvement (PGI-I) questionnaire.'}, {'measure': 'Patient reported sexual health.', 'timeFrame': '12 months', 'description': 'Assess patient reported sexual health using the PROMIS Sexual Function and Satisfaction survey.'}, {'measure': 'Patient reported satisfaction with eCoin.', 'timeFrame': '12, 24, 36, 48, and 60 months', 'description': 'Assess patient-reported satisfaction with eCoin therapy using the custom patient satisfaction rating survey.'}, {'measure': 'Device-related adverse events from implantation.', 'timeFrame': '12, 24, 36, 48, and 60 months', 'description': 'Rate of device-related adverse events from implantation.'}, {'measure': 'Procedure-related adverse events from implantation.', 'timeFrame': '12, 24, 36, 48, and 60 months', 'description': 'Rate of procedure-related adverse events from implantation.'}, {'measure': 'Procedure-related adverse events due to suture technique', 'timeFrame': '12, 24, 36, 48, and 60 months', 'description': 'Rate of procedure-related adverse events occurring as a result of inappropriate suture technique.'}], 'primaryOutcomes': [{'measure': 'Responder Rate', 'timeFrame': '12 months', 'description': 'Proportion of subjects achieving at least a 50% improvement in the number of urgency urinary incontinence episodes on a 3-day voiding diary.'}, {'measure': 'Safety: 12 months rate of all device or procedure related AEs.', 'timeFrame': '12 months', 'description': 'Rate of all device or procedure related AEs.'}], 'secondaryOutcomes': [{'measure': 'Responder Rate', 'timeFrame': '24 months', 'description': 'Proportion of subjects achieving at least a 50% improvement in the number of urgency urinary incontinence episodes on a 3-day voiding diary.'}, {'measure': 'Safety Data', 'timeFrame': '24 months', 'description': 'Rate of all device or procedure related AEs through 24 months post activation of eCoin.'}, {'measure': 'Safety data through 7 months post-reimplantation.', 'timeFrame': '7 months post reimplantation', 'description': 'Rate of device or procedure-related AEs through 7 months post reimplantation.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Overactive Bladder', 'Urge Incontinence', 'Incontinence, Urinary', 'Urinary Urge Incontinence']}, 'descriptionModule': {'briefSummary': '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).', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Women and men above 18 years old with gender percentages reflective of disease prevalence in the U.S. population\n* Individual with diagnosis of overactive bladder with urgency urinary incontinence.\n* Individual has at least one urgency urinary incontinence episode on each of three days as determined on a 3-day voiding diary.\n* Individual gives written informed consent.\n* Individual is mentally competent and able to understand all study requirements.\n* Individual is willing and able to complete a 3-day voiding diary and quality of life questionnaire.\n* 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.\n* 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).\n* Individual is determined to be a suitable surgical candidate by physician.\n* Individual is appropriate for eCoin treatment based on the US FDA-approved IFU requirements.\n\nExclusion Criteria:\n\n* Individual is not appropriate for eCoin therapy based upon the US FDA-approved IFU requirements.\n* 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.)\n* Individual has predominantly stress urinary incontinence (greater than 1/3 of leaks on baseline diary are stress).\n* Individual has an active urinary tract infection at time of enrollment.\n* Individual has known polyuria.\n* Individual has significant lower urinary tract pain or has been diagnosed with interstitial cystitis or bladder pain syndrome.\n* Individual has abnormal post void residual (i.e. greater than 200 cc initially and on repeat testing after double voiding)\n* 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.)\n* Individual has chronic venous insufficiency with a history of skin change (hyperpigmentation, lipodermatosclerosis, ulceration) in the ankle region.\n* Individual has morbid obesity and in the opinion of the investigator is not a good candidate for the study.\n* Individual has had diagnosis of bladder, urethral, or prostate cancer.\n* Individual has had a prior anti-stress incontinence sling surgery within the last year.\n* Individual is pregnant or intends to become pregnant during the study.\n* Individual has the presence of urinary fistula, bladder stone, or interstitial cystitis.\n* 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).\n* Individual has an implantable neurostimulator, pacemaker, or implantable cardiac defibrillator (ICD).\n* 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.\n* 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.\n* Individual is currently using transcutaneous electrical nerve stimulation (TENS) in the pelvic region, back, or legs.\n* Individual is aware that he or she will need an MRI scan other than a head/neck/shoulder MRI during the study period.\n* 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).\n* Individual is neutropenic or immune-compromised.\n* Individual has had previous surgery and/or significant scarring at the implant location.\n* Individual has ongoing dermatologic condition at the implant site, including but not limited to dermatitis and autoimmune disorders.\n* Individual has a clinically significant peripheral neuropathy in the lower extremities.\n* Individual has neurogenic bladder dysfunction.\n* Individual has pitting edema at implant location (≥ 2+ is excluded).\n* Individual has inadequate skin integrity or any evidence of an infection or inflammation in either lower leg.\n* Individual has varicose veins and is symptomatic.\n* Individual has open wounds, trauma, or prior surgery in the lower extremities.\n* Individual has arterial disease in the lower extremities.\n* Individual has vasculitis in the lower extremities.\n* 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.)\n* In the opinion of the investigator, Individual is not a good candidate for participation in the study."}, 'identificationModule': {'nctId': 'NCT05685433', 'acronym': 'RECIPE', 'briefTitle': 'A Real World Study of eCoin for Urgency Urinary Incontinence: Post Approval Evaluation (RECIPE)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Valencia Technologies Corporation'}, 'officialTitle': 'A Real World Study of eCoin for Urgency Urinary Incontinence: Post Approval Evaluation (RECIPE)', 'orgStudyIdInfo': {'id': '111-5702'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'eCoin Tibial Nerve Stimulation', 'description': 'Subcutaneous stimulation of the tibial nerve using the eCoin device.', 'interventionNames': ['Device: eCoin Tibial Nerve Stimulation']}], 'interventions': [{'name': 'eCoin Tibial Nerve Stimulation', 'type': 'DEVICE', 'description': 'Subcutaneous stimulation of the tibial nerve using the eCoin device.', 'armGroupLabels': ['eCoin Tibial Nerve Stimulation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35209', 'city': 'Homewood', 'state': 'Alabama', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Alison Pickering, MD', 'role': 'CONTACT'}], 'facility': 'Urology Centers of Alabama', 'geoPoint': {'lat': 33.47177, 'lon': -86.80082}}, {'zip': '36606', 'city': 'Mobile', 'state': 'Alabama', 'status': 'WITHDRAWN', 'country': 'United States', 'facility': 'USA Health', 'geoPoint': {'lat': 30.69436, 'lon': -88.04305}}, {'zip': '72211', 'city': 'Little Rock', 'state': 'Arkansas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Lauren Hendrix, MD', 'role': 'CONTACT'}, {'name': 'Lauren Hendrix, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Arkansas Urology', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '92697', 'city': 'Irvine', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Dena Moskowitz, MD', 'role': 'CONTACT'}, {'name': 'Dena Moskowitz, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of California, Irvine', 'geoPoint': {'lat': 33.66946, 'lon': -117.82311}}, {'zip': '90017', 'city': 'Los Angeles', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'John Kowalczyk, DO', 'role': 'CONTACT'}, {'name': 'John Kowalczyk, DO', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'AIR Research', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '94305', 'city': 'Stanford', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Craig Comiter, MD', 'role': 'CONTACT'}, {'name': 'Craig Comiter, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Stanford Health', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}, {'zip': '33016', 'city': 'Hialeah', 'state': 'Florida', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Isabel H Lopez, MBA', 'role': 'CONTACT', 'email': 'isabel@besturology.net', 'phone': '786-431-2014'}, {'name': 'Edward Gheiler, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Urological Research Network Corp', 'geoPoint': {'lat': 25.8576, 'lon': -80.27811}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Mersiha Torlak', 'role': 'CONTACT', 'email': 'mersiha.torlak@emory.edu', 'phone': '404-778-4823'}, {'name': 'Brendan Browne, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The Emory Clinic', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Sarah Adelstein, MD', 'role': 'CONTACT'}, {'name': 'Sarah Adelstein, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Rush University', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '50023', 'city': 'Ankeny', 'state': 'Iowa', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Stephanie Morgan, MD', 'role': 'CONTACT', 'email': 'spmorgan@iowaclinic.com', 'phone': '515-875-9815'}, {'name': 'Stephanie Morgan, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The Iowa Clinic', 'geoPoint': {'lat': 41.72971, 'lon': -93.60577}}, {'zip': '52242', 'city': 'Iowa City', 'state': 'Iowa', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Annah Vollstedt, MD', 'role': 'CONTACT'}, {'name': 'Annah Vollstedt, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Iowa', 'geoPoint': {'lat': 41.66113, 'lon': -91.53017}}, {'zip': '66160', 'city': 'Kansas City', 'state': 'Kansas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kirk Redger, MD', 'role': 'CONTACT'}, {'name': 'Kirk Redger, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Kansas Medical Center Research Institute, Inc', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}, {'zip': '67226', 'city': 'Wichita', 'state': 'Kansas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kevin Miller, MD', 'role': 'CONTACT'}, {'name': 'Kevin Miller, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Cypress Medical Research', 'geoPoint': {'lat': 37.69224, 'lon': -97.33754}}, {'zip': '71103', 'city': 'Shreveport', 'state': 'Louisiana', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'United States', 'facility': 'Louisiana State University Health Sciences Center', 'geoPoint': {'lat': 32.52515, 'lon': -93.75018}}, {'zip': '55125', 'city': 'Woodbury', 'state': 'Minnesota', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Michael Ehlert, MD', 'role': 'CONTACT'}, {'name': 'Michael Ehlert, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Minnesota Urology', 'geoPoint': {'lat': 44.92386, 'lon': -92.95938}}, {'zip': '63141', 'city': 'St Louis', 'state': 'Missouri', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Travis Bullock, MD', 'role': 'CONTACT'}, {'name': 'Travis Bullock, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Specialty Clinical Research of St. Louis', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '10065', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Larissa Rodriguez, MD', 'role': 'CONTACT'}, {'name': 'Larissa Rodriguez, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Weill Cornell Medicine: Department of Urology', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '97225', 'city': 'Portland', 'state': 'Oregon', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'United States', 'facility': 'The Oregon Clinic', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '29169', 'city': 'West Columbia', 'state': 'South Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Andrea Pezzella, MD', 'role': 'CONTACT'}, {'name': 'Andrea Pezzella, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Southern Urogynecology', 'geoPoint': {'lat': 33.99349, 'lon': -81.07398}}, {'zip': '76017', 'city': 'Arlington', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Tracy Cannon-Smith, MD', 'role': 'CONTACT'}], 'facility': 'UPNT Research Institute', 'geoPoint': {'lat': 32.73569, 'lon': -97.10807}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Christopher Smith, MD', 'role': 'CONTACT'}, {'name': 'Christopher Smith, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Baylor College of Medicine', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kathleen Kobashi, MD', 'role': 'CONTACT'}], 'facility': 'The Methodist Hospital Research Institute', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'centralContacts': [{'name': 'Dylan Beyer', 'role': 'CONTACT', 'email': 'dbeyer@valenciatechnologies.com', 'phone': '8019207775'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Valencia Technologies Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}