[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100580715":3},{"organization":4,"outcomesModule":7,"designInfo":77,"detailedDescription":84,"studyPopulation":80,"armGroups":85,"interventions":92,"overallOfficials":100,"centralContacts":104,"locations":110,"responsibleParty":127,"collaborators":80,"id":129,"slug":130,"hasResults":131,"nctId":132,"briefTitle":133,"officialTitle":134,"acronym":80,"eligibilityCriteria":135,"healthyVolunteers":131,"sex":136,"minAge":137,"maxAge":80,"enrollmentInfo":138,"targetDuration":80,"studyType":141,"phases":142,"briefSummary":144,"conditions":145,"keywords":80,"overallStatus":113,"whyStopped":80,"lastUpdateSubmitDate":149,"lastUpdatePostDateStruct":150,"startDateStruct":153,"completionDateStruct":155,"leadSponsor":157,"locationsCount":158},{"fullName":5,"class":6},"University of Wisconsin, Madison","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":20,"otherOutcomes":31},[9,13,16],{"measure":10,"description":11,"timeFrame":12},"Adherence to CBD (Epidiolex) regimen","Participants will complete a daily smartphone application-based drug diary recording when they take study drug.","90 days",{"measure":14,"description":15,"timeFrame":12},"Completion of 72-hour voiding diary","This assessment involves electronic participant documentation of urinary episodes at home.",{"measure":17,"description":18,"timeFrame":19},"Number of adverse events","Participants will be followed for adverse events for at least 30 days after the last dose of study drug.","120 days",[21,25,28],{"measure":22,"description":23,"timeFrame":24},"Change in urinary incontinence (UI) episodes","Measured in the 72-hour voiding diary, participant documentation of urinary episodes at home.","Baseline to 90 days",{"measure":26,"description":27,"timeFrame":24},"Change in symptoms associated with UI","Measured on 72-hour voiding diary, participant documentation of urinary episodes at home.",{"measure":29,"description":30,"timeFrame":24},"Change in urinary symptoms associated with neurogenic bladder","Measured using Neurogenic Bladder Symptom Score - Short Form (NGBSS-SF). NGBSS-SF is a 10 question survey assessing the following domains: bladder management strategy, incontinence, storage \\& voiding, consequences, and quality of life. The total score ranges from 0 (no symptoms) to 28 (most severe symptoms). A higher total score indicates greater severity of neurogenic bladder symptoms.",[32,36,39,42,45,48,51,54,57,60,63,66,69,73],{"measure":33,"description":34,"timeFrame":35},"Change in Urodynamics - bladder capacity","Bladder capacity assessment will be performed using pressure sensing urinary and rectal catheters during bladder filling with a solution of saline and iodinated contrast (and emptying if able) with fluoroscopic assessment. This assessment will only be completed for the first 10 participants to complete 3 months of treatment.","Baseline to 3 months",{"measure":37,"description":38,"timeFrame":35},"Change in Urodynamics - maximum detrusor pressure","Max detrusor pressure assessment (cm H20) during bladder storage will be performed using pressure sensing urinary and rectal catheters during bladder filling with a solution of saline and iodinated contrast with fluoroscopic assessment. This assessment will only be completed for the first 10 participants to complete 3 months of treatment.",{"measure":40,"description":41,"timeFrame":35},"Change in Urodynamics - bladder compliance","Bladder compliance assessment (mL\u002Fcm H20) will be performed using pressure sensing urinary and rectal catheters during bladder filling with a solution of saline and iodinated contrast (and emptying if able) with fluoroscopic assessment. This assessment will only be completed for the first 10 participants to complete 3 months of treatment.",{"measure":43,"description":44,"timeFrame":35},"Change in Urodynamics - neurogenic detrusor overactivity (NDO) episodes","NDO episode (involuntary, sudden contractions of the bladder muscle leading to a strong urge to urinate and potentially causing urine leakage) assessment will be performed using pressure sensing urinary and rectal catheters during bladder filling with a solution of saline and iodinated contrast with fluoroscopic assessment. This assessment will only be completed for the first 10 participants to complete 3 months of treatment.",{"measure":46,"description":47,"timeFrame":35},"Change in Urodynamics - urine leaks","Urine leak assessment will be performed using fluoroscopy during bladder filling with a solution of saline and iodinated contrast. This assessment will only be completed for the first 10 participants to complete 3 months of treatment.",{"measure":49,"description":50,"timeFrame":35},"Change in Urodynamics - vesicoureteral reflux","Vesicoureteral reflux assessment will be performed using fluoroscopy during bladder filling with a solution of saline and iodinated contrast. This assessment will only be completed for the first 10 participants to complete 3 months of treatment.",{"measure":52,"description":53,"timeFrame":35},"Change in Urodynamics - bladder neck appearance","Bladder neck appearance assessment will be performed using fluoroscopic assessment during bladder filling with a solution of saline and iodinated contrast (and emptying or leak if present). This assessment will only be completed for the first 10 participants to complete 3 months of treatment.",{"measure":55,"description":56,"timeFrame":35},"Change in Urodynamics - bladder shape","Bladder shape assessment will be performed using fluoroscopy during bladder filling with a solution of saline and iodinated contrast. This assessment will only be completed for the first 10 participants to complete 3 months of treatment.",{"measure":58,"description":59,"timeFrame":35},"Change in Urodynamics - presence of detrusor sphincter dyssynergia","Presence of detrusor sphincter dyssynergia assessment will be performed using pressure sensing urinary and rectal catheters, electromyography, and fluoroscopy during bladder filling with a solution of saline and iodinated contrast (and emptying or leaking if present). This assessment will only be completed for the first 10 participants to complete 3 months of treatment.",{"measure":61,"description":62,"timeFrame":35},"Change in Brief Pain Inventory (BPI)","BPI is a 9 item survey assessing pain severity and impact on quality of life. Participants rate their pain on a scale of 0 to 10, where 10 is the worst pain imaginable. Participants also rate how much the pain interferes with their daily life on a scale of 0 to 10, where 10 is complete interference. Total combined range is 1-10, where pain severity and interference are: Mild: A score of 1-4; Moderate: A score of 5-6; and, Severe: A score of 7-10.",{"measure":64,"description":65,"timeFrame":35},"Change in Neurogenic Bowel Dysfunction Score (NBD)","NBD is a 10 item system used to assess the severity of bowel dysfunction in individuals with neurological conditions, typically caused by spinal cord injuries, by assigning points based on the frequency and severity of symptoms like bowel movements, incontinence, and discomfort during defecation; a higher score indicates more severe neurogenic bowel dysfunction. The 10-items are scored on an ordinal scale. The NBD weighted score ranges between 0 and 47 points. A higher overall NBD score indicates more severe bowel symptoms. Score 0-6: Very minor; Score 7-9: Minor; Score 10-13: Moderate; and, Score 14+: Severe",{"measure":67,"description":68,"timeFrame":35},"Change in Pittsburgh Sleep Quality Index (PSQI) Questionnaire","PSQI is a 19 item questionnaire assessing quality of sleep. Each component score ranges from 0 to 3, with 3 indicating the most disturbance. Total score is a number between 0 and 21 that indicates how well someone sleeps. A higher score means worse sleep quality.",{"measure":70,"description":71,"timeFrame":72},"Patient Global Impression Scale (PGI-C)","The PGI-C is a single question survey assessing change in overall clinical status after intervention. Answers range from Very much improved to Very much worse.","3 months",{"measure":74,"description":75,"timeFrame":76},"Change in International Spinal Cord Injury Quality of Life Basic Data Set (SCI QOL)","The SCI QOL is a 3-item questionnaire to assess quality of life after spinal cord injury. It is scored on a 10 point Likert scale, with an overall range of 0-30. Lower scores indicate lower satisfaction with quality of life.","Baseline, 3 months, and 4 months",{"allocation":78,"interventionModel":79,"interventionModelDescription":80,"primaryPurpose":81,"observationalModel":80,"timePerspective":80,"maskingInfo":82},"NA","SINGLE_GROUP",null,"TREATMENT",{"masking":83,"maskingDescription":80,"whoMasked":80},"NONE","This pilot study assesses the feasibility of using 100mg of twice daily cannabidiol (Epidiolex) in adult spinal cord injury with neurogenic lower urinary tract dysfunction following resolution of spinal shock.",[86],{"label":87,"type":88,"description":89,"interventionNames":90},"CBD for urinary incontinence","EXPERIMENTAL","Participants will take CBD for 90 days",[91],"Drug: CBD",[93],{"type":94,"name":95,"description":96,"armGroupLabels":97,"otherNames":98},"DRUG","CBD","Twice daily 100mg cannabidiol (CBD)",[87],[99],"Epidiolex",[101],{"name":102,"affiliation":5,"role":103},"Javi Santiago","PRINCIPAL_INVESTIGATOR",[105],{"name":106,"role":107,"phone":108,"phoneExt":80,"email":109},"Maria Flory","CONTACT","608-262-8652","flory@ortho.wisc.edu",[111],{"facility":112,"status":113,"city":114,"state":115,"zip":116,"country":117,"countryCode":118,"cosmosGeoPoint":119,"geoPoint":124,"contacts":125},"University of Wisconsin - Madison","RECRUITING","Madison","Wisconsin","53705","United States","US",{"type":120,"coordinates":121},"Point",[122,123],-89.40123,43.07305,{"lat":123,"lon":122},[126],{"name":106,"role":107,"phone":108,"phoneExt":80,"email":109},{"type":128,"investigatorFullName":80,"investigatorTitle":80,"investigatorAffiliation":80,"oldNameTitle":80,"oldOrganization":80},"SPONSOR","100580715","phase-2-cbd-for-lower-urinary-tract-dysfunction-in-spinal-cord-injury-100580715",false,"NCT06840899","CBD for Lower Urinary Tract Dysfunction in Spinal Cord Injury","Cannabinoid Modulation for Neurogenic Lower Urinary Tract Dysfunction in Spinal Cord Injury","Inclusion Criteria:\n\n* \\>18 years of age\n* History of supra-sacral spinal cord injury of any mechanism\n* Urinary incontinence with ≥2 episodes of urinary incontinence per day (outside of spinal shock)\n* Willingness to participate in drug intervention trial\n* English-speaking (able to provide consent and complete questionnaires)\n\nExclusion Criteria:\n\n* History of intravesical Botox\n* Actively taking \\>15 mg of Oxybutynin single dose or equivalent dose of alternative anticholinergic medication for bladder symptoms\n* Use of Cannabis (any form) outside of study as determined by urine drug screen after washout period of 1 month if prior Cannabis use reported\n* Thought or mood disorder aside from depression","ALL","18 Years",{"count":139,"type":140},20,"ESTIMATED","INTERVENTIONAL",[143],"PHASE2","The goal of this feasibility study is to learn whether Cannabidiol (CBD) can improve urinary incontinence and other symptoms in people with recent spinal cord injury (SCI).\n\nParticipants will take Epidiolex (purified CBD) for 90 days",[146,147,148],"Supra-sacral Spinal Cord Injury","Spinal Cord Injury","Urinary Incontinence","2026-09-15",{"date":151,"type":152},"2026-09-16","ACTUAL",{"date":154,"type":152},"2026-02-13",{"date":156,"type":140},"2028-05",{"name":5,"class":6},1]