Ignite Creation Date:
2025-12-24 @ 9:19 PM
Ignite Modification Date:
2025-12-25 @ 7:07 PM
Study NCT ID:
NCT07300904
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-24
First Post:
2025-12-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Tensi+ for Treating Overactive Bladder: A Randomized Controlled Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D053201', 'term': 'Urinary Bladder, Overactive'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2027-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-21', 'studyFirstSubmitDate': '2025-12-21', 'studyFirstSubmitQcDate': '2025-12-21', 'lastUpdatePostDateStruct': {'date': '2025-12-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-12-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Treatment success', 'timeFrame': '12 weeks', 'description': 'Percentage of responders in urgency events, where a responder is defined as a subject that either achieves a 50% or greater reduction, from baseline to Week 12, in total urgency events per day, or returns to normal (0 events per day) at Week 12. This endpoint will be evaluated through 3-day bladder diaries.'}], 'secondaryOutcomes': [{'measure': 'Frequency of urinary voids', 'timeFrame': '12 weeks', 'description': 'Percentage of responders in urinary frequency, where a responder is defined as a subject that either achieves a 30% or greater reduction, from baseline to Week 12, in total urinary frequency per day, or returns to normal'}, {'measure': 'Urge urinary incontinence', 'timeFrame': '12 weeks', 'description': 'Percentage of responders in urge urinary incontinence, where a responder is defined as a subject that either achieves a 30% or greater reduction, from baseline to Week 12, in total urinary frequency per day, or returns to normal (0 events per day)'}, {'measure': 'Overall Responder Rate Across OAB Symptoms', 'timeFrame': '12 weeks', 'description': 'Overall Responder rate defined as the percentage of responders who meet at least the responder criteria in one of the 3 symptoms of OAB, from baseline to Week 12 (urgency, frequency and UUI) from baseline'}, {'measure': 'Quality of life measures', 'timeFrame': '12 weeks', 'description': 'Measured using the OAB-q Short Form (SF) questionnaire, which includes 19 questions scored from 1 ("none of the time") to 6 ("all of the time"). The total score ranges from 19 (best QOL) to 114 (worst QOL). A decrease in score from baseline to Week 12 indicates an improvement in quality of life.'}, {'measure': 'Endurance of effect', 'timeFrame': '24 weeks', 'description': 'Maintenance of responder status from the primary endpoint (Week 12) through the last follow-up visit without relapse (Week 24), indicating a sustained treatment effect until the end-of-study visit.'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Overactive Bladder', 'Transcutaneous Tibial Nerve Stimulation', 'Urology'], 'conditions': ['Overactive Bladder (OAB)']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to evaluate the safety and effectiveness of the Tensi+ device using Transcutaneous Posterior Tibial Nerve Stimulation (TPTNS) for treating patients suffering from OAB symptoms urinary frequency, urgency, with or without urge urinary incontinence.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '22 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult subjects aged 22 years or older and,\n* Diagnosed with OAB symptoms (characterized by urinary urgency, with or without UUI),\n* Symptoms persisting for at least 3 months, and\n* Documented with 2 or more urgency episodes per day (with or without incontinence) in two 3-day bladder diaries and,\n* With at least 11 or more voids per day (urinary frequency) documented in two 3-day bladder diaries\n* Willing and capable of providing informed consent\n* Capable of participating in all testing associated with this clinical investigation\n\nExclusion Criteria:\n\n* Patients with pacemakers or implanted defibrillators or any other implanted electronic device\n* Patients prone to excessive bleeding\n* Patients with nerve damage that could impact the percutaneous tibial nerve or pelvic floor function\n* Patients who are pregnant or planning to become pregnant while using this product\n* Patients with ankle joint problems, ankle oedema or dermatological oedema in the area where the electrodes should be placed\n* Patients wearing a metal implant near the stimulated area\n* Patient with cognitive deficiency\n* Administration of intravesical injection of botulinum toxin within 12 months of study enrollment, or treatment within the previous year with other forms neuromodulation for OAB\n* Patients treated with medical therapy OAB treatment washout inferior to 30 days\n* Patients with diabetic neuropathy\n* Patients with uncontrolled diabetes and HbA1c levels above 7%\n* Guillain-Barré syndrome\n* Chronic inflammatory demyelinating polyneuropathy (CIDP)\n* Multiple sclerosis\n* A primary diagnosis of stress urinary incontinence (SUI)\n* Patients with recurrent rrinary tract infections (UTIs) defined as more than 2 episodes per year, or with any baseline lower urinary tract pathology identified at the time of the 3-day bladder diary assessment.\n* Currently participating in another clinical trial'}, 'identificationModule': {'nctId': 'NCT07300904', 'briefTitle': 'Tensi+ for Treating Overactive Bladder: A Randomized Controlled Trial', 'organization': {'class': 'INDUSTRY', 'fullName': 'Stimuli Technology'}, 'officialTitle': 'A Randomized, Controlled, Blinded, Prospective, Multi-center Study Evaluating Tensi+ With Transcutaneous Tibial Nerve Stimulation for the Treatment of Overactive Bladder Syndrome', 'orgStudyIdInfo': {'id': 'CIP-PF0001-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Tensi+ device to be delivered for use by patient', 'interventionNames': ['Device: Tensi+']}, {'type': 'SHAM_COMPARATOR', 'label': 'Identical Tensi+ Sham device to be delivered for use by patient', 'interventionNames': ['Device: Tensi+']}], 'interventions': [{'name': 'Tensi+', 'type': 'DEVICE', 'description': 'Transcutaneous Tibial Nerve Stimulation', 'armGroupLabels': ['Identical Tensi+ Sham device to be delivered for use by patient', 'Tensi+ device to be delivered for use by patient']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90211', 'city': 'Beverly Hills', 'state': 'California', 'country': 'United States', 'contacts': [{'name': 'Karyn Eilber', 'role': 'CONTACT', 'email': 'Karyn.Eilber@cshs.org', 'phone': '310-385-2992'}, {'name': 'Karyn Eilber', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Cedars-Sinai', 'geoPoint': {'lat': 34.07362, 'lon': -118.40036}}, {'zip': '10017', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'contacts': [{'name': 'Benjamin Brucker', 'role': 'CONTACT', 'email': 'benjamin.brucker@nyulangone.org', 'phone': '646-825-6324'}, {'name': 'Benjamin Brucker', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'NYU Langone Health', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'city': 'Toronto', 'country': 'Canada', 'contacts': [{'name': 'Dean Elterman', 'role': 'CONTACT', 'email': 'Dean.Elterman@uhn.ca', 'phone': '416 603 5800', 'phoneExt': 'ext. 5033'}, {'name': 'Dean Elterman', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Toronto Western Hospital', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'centralContacts': [{'name': 'Akshaya Mariadassou', 'role': 'CONTACT', 'email': 'a.mariadassou@stimuli-technology.com', 'phone': '+331 84 60 48 25'}, {'name': 'Sarah Todeschini', 'role': 'CONTACT', 'email': 's.todeschini@stimuli-technology.com', 'phone': '+331 84 60 48 25'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stimuli Technology', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}