[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07264868":3,"trial-entities:NCT07264868":149,"trial-summary:NCT07264868":154},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":15,"conditions":17,"keywords":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":40,"secondary_outcomes":63,"sex":93,"minimum_age":94,"maximum_age":95,"healthy_volunteers":96,"eligibility_criteria":97,"std_ages":117,"locations":120,"central_contacts":140,"overall_officials":144,"references":147,"see_also_links":148},"NCT07264868","HSC-MS-25-0582","Home Neuromodulation for Neurogenic Bladder Management in Spinal Cord Injury","Home Neuromodulation for Neurogenic Bladder Management in Spinal Cord Injury: A Hybrid Implementation-Efficacy Trial","RECRUITING","2028-09-01","2026-05","2026-05-11","2026-05-07","The University of Texas Health Science Center, Houston","OTHER",null,"The purpose of this study is to determine the safety and efficacy of Injectrode Tibial Nerve Stimulation for bladder function in people with spinal cord injury.",[18,19],"Spinal Cord Injury (SCI)","Neurogenic Bladder (NB)",[],"INTERVENTIONAL","TREATMENT",[24],"NA",{"count":26,"type":27},21,"ESTIMATED",[29,36],{"type":30,"name":31,"description":32,"armGroupLabels":33},"DEVICE","iTNS","The stimulation current will be gradually increased until bilateral toe flexion is achieved, then reduced to just below the motor contraction threshold. A 20 Hz frequency and 200 µs pulse width will be applied continuously for 30 minutes, five times a week.",[34,35],"Bilateral iTNS","Unilateral iTNS",{"type":30,"name":37,"description":38,"armGroupLabels":39},"Sham iTNS","The sham devices are designed to mimic active stimulation by initially delivering electrical current sufficient to evoke toe flexion. However, once the current is reduced to the sensory stimulation threshold, the device automatically ramps down to 0mA while maintaining the appearance of normal functioning on the display screen.",[37,35],[41,45,48,50,54,57,60],{"measure":42,"description":43,"timeFrame":44},"Safety as assessed by the number of device-related adverse events","Adverse events include lead migration and fracture, hematoma, wound infection, delayed healing, nerve injury, and autonomic dysreflexia occurrence during the procedure.","From baseline to 8 weeks",{"measure":46,"timeFrame":47},"Accuracy as assessed by the percentage of sessions where toe flexion was achieved as recorded in subject logs.","From baseline to week 8",{"measure":49,"timeFrame":47},"Reliability as assessed by the average minimum current (mA) required to elicit toe flexion when testing for accuracy",{"measure":51,"description":52,"timeFrame":53},"Feasibility of Injectrode procedure as assessed by surveys","Feasibility to check if reproducible training pathway can enable non-interventional physicians to competently perform Injectrode implantation and removal","Week 8",{"measure":55,"description":56,"timeFrame":53},"Physician acceptability of Injectrode device as assessed by a survey","The acceptability survey ranges from 0 - 32, with a higher score indicating greater acceptability of the Injectrode device.",{"measure":58,"description":59,"timeFrame":53},"Participant acceptability of Injectrode device as assessed by a survey","The acceptability survey ranges from 0 - 25, with a higher score indicating greater acceptability of the Injectrode device.",{"measure":61,"description":62,"timeFrame":53},"Feasibility and acceptability of the Injectrode treatment as assessed by a qualitative interview","A semi-structured interview will be conducted with participants and providers to explore their perceptions of the Injectrode treatment. Responses will be summarized using qualitative coding and descriptive statistics of themes.",[64,67,69,72,75,77,79,81,83,85,87,89,91],{"measure":65,"timeFrame":66},"Number of participants for whom bladder medication dosage reduced","from baseline to 8 weeks",{"measure":68,"timeFrame":66},"Change in magnitude of dosage of medication",{"measure":70,"timeFrame":71},"Change in bladder function during urodynamics as assessed by the maximum detrusor pressure (Max Pdet) in cmH20.","Baseline, Week 4, and Week 8",{"measure":73,"timeFrame":74},"Change in Bladder function as assessed by the presence or absence of detrusor overactivity (DO) during urodynamics.","baseline, Week 4, and Week 8",{"measure":76,"timeFrame":74},"Change in bladder capacity (maximum volume in mL) during urodynamics before voiding or discomfort.",{"measure":78,"timeFrame":74},"Change in the presence or absence of leaks during urodynamics.",{"measure":80,"timeFrame":74},"Change in bladder sensation during urodynamics as defined by the infused volume (mL) at time of reported first sensation of filling.",{"measure":82,"timeFrame":71},"Change in bladder sensation during urodynamics as defined by infused volume (mL) at time of reported urgency\u002F desire to void.",{"measure":84,"timeFrame":71},"Change in bladder sensation during urodynamics as defined by the infused volume (mL) at the time of reported discomfort.",{"measure":86,"timeFrame":74},"Change in detrusor compliance during urodynamics as reported by the change in bladder volume divided by the change in bladder pressure.",{"measure":88,"timeFrame":71},"Change in the number of incontinence episodes as self-reported in the bladder diary.",{"measure":90,"timeFrame":71},"Change in the frequency of catheterization as self-reported in the bladder diary.",{"measure":92,"timeFrame":71},"Change in the volume of catheterization as self-reported in the bladder diary.","ALL","18 Years","75 Years",false,{"inclusion":98,"exclusion":106,"raw_text":116},[99,100,101,102,103,104,105],"Non-progressive chronic (\\>1 year) SCI","Neurologic level of injury T9 and above","Stable over active bladder (OAB) medications (≥3 months)","No contraindication to MRI (per MRI Safety Questionnaire)","English or Spanish speaking","Tolerate and be able to evoke toe flexion bilaterally with transcutaneous tibial nerve stimulation (tTNS) (self or assisted)","Pass the tTNS competency checklist to perform or direct performance of tTNS.",[107,108,109,110,111,112,113,114,115],"Ongoing\u002Factive genitourinary oncologic diagnoses","History of other central nervous system disorder (CNS) disorders and\u002For peripheral neuropathy","Pregnancy or planning to become pregnant.","Lower Motor Neuron bladder","Restorative bladder surgery such as augmentation cystoplasty","Botulinum toxin-A injections in the bladder within 6 months of trial enrolment (injection in other sites is allowed)","Anticoagulation treatment or prophylaxis","Advanced peripheral vascular disease (gangrene, amputation, etc.)","History of intolerance to electrical stimulation, particularly of the leg","Inclusion Criteria:\n\n* Non-progressive chronic (\\>1 year) SCI\n* Neurologic level of injury T9 and above\n* Stable over active bladder (OAB) medications (≥3 months)\n* No contraindication to MRI (per MRI Safety Questionnaire)\n* English or Spanish speaking\n* Tolerate and be able to evoke toe flexion bilaterally with transcutaneous tibial nerve stimulation (tTNS) (self or assisted)\n* Pass the tTNS competency checklist to perform or direct performance of tTNS.\n\nExclusion Criteria:\n\n* Ongoing\u002Factive genitourinary oncologic diagnoses\n* History of other central nervous system disorder (CNS) disorders and\u002For peripheral neuropathy\n* Pregnancy or planning to become pregnant.\n* Lower Motor Neuron bladder\n* Restorative bladder surgery such as augmentation cystoplasty\n* Botulinum toxin-A injections in the bladder within 6 months of trial enrolment (injection in other sites is allowed)\n* Anticoagulation treatment or prophylaxis\n* Advanced peripheral vascular disease (gangrene, amputation, etc.)\n* History of intolerance to electrical stimulation, particularly of the leg",[118,119],"ADULT","OLDER_ADULT",[121],{"facility":122,"status":8,"city":123,"state":124,"zip":125,"country":126,"contacts":127,"geoPoint":137},"The University of Texas Health Science Center at Houston","Houston","Texas","77030","United States",[128,133],{"name":129,"role":130,"phone":131,"email":132},"Argyrios Stampas, MD","CONTACT","713-797-5938","argyrios.stampas@uth.tmc.edu",{"name":134,"role":130,"phone":135,"email":136},"Danira Garcia Gutierrez","(713) 797-7133","Danira.GarciaGutierrez@uth.tmc.edu",{"lat":138,"lon":139},29.76328,-95.36327,[141,143],{"name":129,"role":130,"phone":142,"email":132},"(713) 797-5938",{"name":134,"role":130,"phone":135,"email":136},[145],{"name":129,"affiliation":13,"role":146},"PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":150,"biomarkers":153},[151,152],"Neurogenic Bladder","Spinal Cord Injury",[],{"nct_id":4,"found":155,"summary":156,"prompt_version":166},true,{"design":157,"status":158,"heading":159,"summary":160,"follow_up":161,"word_count":162,"commitments":163,"compensation":164,"drugs_mentioned":165},"This is an interventional study planning to enroll 21 participants. It compares active iTNS to a sham iTNS device, which mimics the real treatment.","completed","Home Neuromodulation for Neurogenic Bladder in Spinal Cord Injury","This study is testing a device called iTNS (transcutaneous tibial nerve stimulation) to see if it's safe and effective for managing neurogenic bladder (bladder problems due to nerve damage) in people with spinal cord injury (SCI). You might be able to join if you are 18-75 years old, have a chronic SCI above T9, and your bladder medications are stable. The study will look at how safe the iTNS device is by tracking any side effects, and how well it works by checking if toe flexion (bending your toes) can be achieved during stimulation. The study plans to enroll 21 participants, but its current status is unclear.","Participants will be followed for safety, accuracy, and reliability from baseline to 8 weeks.",107,"The iTNS device will be applied continuously for 30 minutes, five times a week. The study will assess safety, accuracy, and reliability from baseline to 8 weeks.","Not stated in the trial record.",[31],"v2"]