Nctid:
NCT06616675
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-20"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D053201", "term"=>"Urinary Bladder, Overactive"}, {"id"=>"D013577", "term"=>"Syndrome"}], "ancestors"=>[{"id"=>"D004194", "term"=>"Disease"}, {"id"=>"D010335", "term"=>"Pathologic Processes"}, {"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"}], "browseLeaves"=>[{"id"=>"M17522", "name"=>"Virus Diseases", "relevance"=>"LOW"}, {"id"=>"M16355", "name"=>"Syndrome", "asFound"=>"Syndrome", "relevance"=>"HIGH"}, {"id"=>"M27167", "name"=>"Urinary Bladder, Overactive", "asFound"=>"Overactive Bladder", "relevance"=>"HIGH"}, {"id"=>"M5026", "name"=>"Urinary Bladder Diseases", "relevance"=>"LOW"}, {"id"=>"M17319", "name"=>"Urologic Diseases", "relevance"=>"LOW"}, {"id"=>"M2875", "name"=>"Urogenital Diseases", "relevance"=>"LOW"}, {"id"=>"M27093", "name"=>"Female Urogenital Diseases", "relevance"=>"LOW"}, {"id"=>"M14127", "name"=>"Pregnancy Complications", "relevance"=>"LOW"}, {"id"=>"M8399", "name"=>"Female Urogenital Diseases and Pregnancy Complications", "relevance"=>"LOW"}, {"id"=>"M27095", "name"=>"Male Urogenital Diseases", "relevance"=>"LOW"}, {"id"=>"M29464", "name"=>"Lower Urinary Tract Symptoms", "relevance"=>"LOW"}, {"id"=>"M22659", "name"=>"Urological Manifestations", "relevance"=>"LOW"}, {"id"=>"T2845", "name"=>"Human T-cell Leukemia Virus Type 1", "asFound"=>"Human T-Lymphotropic Virus 1", "relevance"=>"HIGH"}], "browseBranches"=>[{"name"=>"Infections", "abbrev"=>"BC01"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"Urinary Tract, Sexual Organs, and Pregnancy Conditions", "abbrev"=>"BXS"}, {"name"=>"Rare Diseases", "abbrev"=>"Rare"}]}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"C101207", "term"=>"Darifenacin"}], "ancestors"=>[{"id"=>"D018727", "term"=>"Muscarinic Antagonists"}, {"id"=>"D018680", "term"=>"Cholinergic Antagonists"}, {"id"=>"D018678", "term"=>"Cholinergic Agents"}, {"id"=>"D018377", "term"=>"Neurotransmitter Agents"}, {"id"=>"D045504", "term"=>"Molecular Mechanisms of Pharmacological Action"}, {"id"=>"D045505", "term"=>"Physiological Effects of Drugs"}, {"id"=>"D064804", "term"=>"Urological Agents"}], "browseLeaves"=>[{"id"=>"M20760", "name"=>"Cholinergic Antagonists", "relevance"=>"LOW"}, {"id"=>"M207221", "name"=>"Darifenacin", "asFound"=>"Emotional distress", "relevance"=>"HIGH"}, {"id"=>"M20801", "name"=>"Muscarinic Antagonists", "relevance"=>"LOW"}, {"id"=>"M20758", "name"=>"Cholinergic Agents", "relevance"=>"LOW"}, {"id"=>"M20504", "name"=>"Neurotransmitter Agents", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}, {"name"=>"Urological Agents", "abbrev"=>"Urol"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE4"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"NONE"}, "primaryPurpose"=>"TREATMENT", "interventionModel"=>"PARALLEL"}, "enrollmentInfo"=>{"type"=>"ACTUAL", "count"=>42}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"2022-03-16", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-09", "completionDateStruct"=>{"date"=>"2023-12-20", "type"=>"ACTUAL"}, "lastUpdateSubmitDate"=>"2024-09-29", "studyFirstSubmitDate"=>"2024-09-25", "studyFirstSubmitQcDate"=>"2024-09-25", "lastUpdatePostDateStruct"=>{"date"=>"2024-10-01", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-09-27", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2023-12-20", "type"=>"ACTUAL"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Overactive Bladder Symptom Score", "timeFrame"=>"2 months or 20 sessions", "description"=>"Whether higher scores mean worse outcome"}]}, "oversightModule"=>{"isUsExport"=>false, "oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["Electrical stimulation", "Overactive bladder", "HLTV-1", "darifenacin"], "conditions"=>["HTLV-1", "Overactive Bladder Syndrome"]}, "referencesModule"=>{"references"=>[{"pmid"=>"34225282", "type"=>"RESULT", "citation"=>"Liu Y, Xu G, Geng J. Efficacy of Transcutaneous Electrical Nerve Stimulation in the Management of Neurogenic Overactive Bladder: A Randomized Controlled Trial. Am J Phys Med Rehabil. 2022 Jan 1;101(1):2-10. doi: 10.1097/PHM.0000000000001836."}, {"pmid"=>"29264126", "type"=>"RESULT", "citation"=>"Slovak M, Chapple CR, Barker AT. Non-invasive transcutaneous electrical stimulation in the treatment of overactive bladder. Asian J Urol. 2015 Apr;2(2):92-101. doi: 10.1016/j.ajur.2015.04.013. Epub 2015 Apr 16."}, {"pmid"=>"26724409", "type"=>"RESULT", "citation"=>"Andrade RC, Neto JA, Andrade L, Oliveira TS, Santos DN, Oliveira CJ, Prado MJ, Carvalho EM. Effects of Physiotherapy in the Treatment of Neurogenic Bladder in Patients Infected With Human T-Lymphotropic Virus 1. Urology. 2016 Mar;89:33-8. doi: 10.1016/j.urology.2015.09.036. Epub 2015 Dec 24."}]}, "descriptionModule"=>{"briefSummary"=>"In this study the investigators compare the parasacral transcutaneous electric nerve stimulation (PTENS) treatment with Darifenacin to improve OAB symptoms in patients infected with HTLV-1.", "detailedDescription"=>"Subjects presenting OAB according to ICS, associated with the HTLV-1 infection were invited by the investigators to participate in the study according inclusion criteria . Participants who accepted were randomly allocated to two groups (G1 and G2) by the free randomization website. Group 1 was treated with Darifenacin, and group 2 with the PTENS protocol.\n\nDrug Treatment Protocol:\n\nThe anticholinergic Fenazic (Adium) was used in a single dose of 15mg/day for 2 months.\n\nPTENS Protocol:\n\nThe treatment consisted of PTENS with the Neurodyn Portable TENS FES(21) neuromuscular stimulation device in an outpatient clinic. Two self-adhesive electrodes (5x9cm) were used, positioned one in each gluteal region, below the iliac spine to apply low-frequency biphasic current with 10 Hz. Pulse duration of 0.5 milliseconds was applied for 40 minutes with continuous stimulation, 3 times a week, for 20 sessions."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* HTLV-1 infection\n* Overactive bladder symptom\n* 18 years of age or older\n\nExclusion Criteria:\n\n* HTLV-1 infected subjects with HAM\n* Stroke\n* Parkinson\n* HIV infection\n* Prostatic hyperplasia\n* Pacemaker use\n* Genitourinary tract infection\n* Glaucoma"}, "identificationModule"=>{"nctId"=>"NCT06616675", "briefTitle"=>"Darifenacin x Parasacral Transcutaneous Electric Nerve Stimulation for OAB in Patients Infected With Human T-Lymphotropic Virus 1", "organization"=>{"class"=>"OTHER", "fullName"=>"Hospital Universitário Professor Edgard Santos"}, "officialTitle"=>"Darifenacin Versus Parasacral Transcutaneous Electric Nerve Stimulation for Overactive Bladder Syndrome in Patients Infected With Human T-Lymphotropic Virus 1 - Randomized Open Clinical Trial", "orgStudyIdInfo"=>{"id"=>"CAAE: 59171022.9.0000.0049"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"ACTIVE_COMPARATOR", "label"=>"Darifenacin Group", "description"=>"Anticholinergic treatment for OAB", "interventionNames"=>["Drug: Darifenacin"]}, {"type"=>"EXPERIMENTAL", "label"=>"PTENS Group", "description"=>"Neuromodulation using transcutaneous electrical sacral nerves stimulation", "interventionNames"=>["Device: Neuromodulation - Sacral nerve stimulation"]}], "interventions"=>[{"name"=>"Darifenacin", "type"=>"DRUG", "description"=>"Anticholinergic drug therapy for OAB treatment - Darifenacin, 15mg/day", "armGroupLabels"=>["Darifenacin Group"]}, {"name"=>"Neuromodulation - Sacral nerve stimulation", "type"=>"DEVICE", "description"=>"Neurodyn Portable TENS FES neuromuscular stimulation device in an outpatient clinic. Two self-adhesive electrodes (5x9cm) were used, positioned one in each gluteal region, below the iliac spine to apply low-frequency biphasic current with 10 Hz. Pulse duration of 0.5 milliseconds was applied for 40 minutes with continuous stimulation, 3 times a week, for 20 sessions.", "armGroupLabels"=>["PTENS Group"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"40110060", "city"=>"Salvador", "state"=>"Ba", "country"=>"Brazil", "facility"=>"Ambulatório de HTLV-1 - Com HUPES", "geoPoint"=>{"lat"=>-12.97111, "lon"=>-38.51083}}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"NO"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Hospital Universitário Professor Edgard Santos", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"Physiotherapist", "investigatorFullName"=>"Tatiane Souza Soares de Oliveira", "investigatorAffiliation"=>"Hospital Universitário Professor Edgard Santos"}}}}
