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IRCT20160606028304N2 IRCT 2020-06-06 Tabriz University of Medical Sciences Efficacy of Solifenacin and trospium chloride on neurogenic bladder Efficacy of Solifenacin and trospium chloride on neurogenic bladder after stroke: a multicentric three arms placebo-controlled trial 2021-07-01 anticipated 201 Complete https://irct.ir/trial/40121 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: researchers will be randomized patients in these healthing care units, and using wwww.randomiser.org to simple randomise and the patients IDs will be saved, Blinding description: The first group will receive one 10 mg tablet solifenacin daily, the second group will receive a 20 mg trospium chloride, and the third group will receive a placebo tablet that will be the same shape, color, and weight. Participants, the principal investigator, those evaluating the outcome, the Data Safety and Monitoring Committee, and those drafting the article will be blinded. 4 Condition 1: stroke. Condition 2: neurogenic bladder. Intervention 1: Intervention group 1, antimuscarinic drug approved in OAB treatment, Solifenacin: this group of patients will be treated with oral solifenacin 10mg tablet daily for 30 days. In this way, the drugs (30 tablets) will be placed inside sealed envelopes and the drug consumption checklist will be provided to the patients and after each drug consumption, the check list will be marked. drug is produced by Behestan Daru pharmaceutical company under the license of astellas company. its also available in market as Vesicare. Intervention 2: Intervention group 2: antimuscarinic drug approved in OAB treatment, trospium chloride: drug used in this group, is trospium chloride 20mg daily for 30 days. In this way, the drugs (30 tablets) will be placed inside sealed envelopes and the drug consumption checklist will be provided to the patients and after each drug consumption, the check list will be marked. This drug is available in the pharmaceutical market under the brand name Spasmax from Zeller Medical Pharmaceutical Company. Intervention 3: Intervention group, placebo: in this group placebo -made by Associate Pharmacist in uniform shape without pharmaceutical effect- was given to patients. We gave Placebo just like the treatment group once daily for 30 days. In this way, the placebo tablets (30 pieces) will be placed inside sealed envelopes, and the drug consumption checklist will be provided to the patients and after each drug consumption, they will be marked in the relevant checklist. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is Due to incomplete study I have no decision on publishing.
public Ali Pormohammad
Emam Reza hospital, Opposit side of Central Organization of University, Golgasht st.
tabriz Iran (Islamic Republic of) 5166614756 +98 41 3381 4472 alirmd@outlook.com Tabriz University of Medical Sciences scientific Ali Pormohammad
Emam Reza hospital, Opposit side of Central Organization of University, Golgasht st.
tabriz Iran (Islamic Republic of) 5166614756 +98 41 3335 2073 alirmd@outlook.com Tabriz University of Medical Sciences Iran (Islamic Republic of) Stroke diagnosis patients Normal cognitive function Lower urinary tract symptomes Patients with CVA should be ambulatory, able to communicate, and record a voiding diary age ≥18 years 18 years no limit Both Evidence of brain stem or bilateral signs on examination Mental disorders according to the patient's own statement Having history of LUTS surgery, pelvic and urologic surgery, or trauma Other severe neurological disease including dementia Severe psychiatric disease Prostate cancer Patients who refuse consent Abnormal liver function severe constipation patiensts with previous history of hypersensitivity reaction to anticholinergics or closed anterior chamber glaucoma I67.9 N31.9 Cerebrovascular disease, unspecified Neuromuscular dysfunction of bladder, unspecified Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group 1, antimuscarinic drug approved in OAB treatment, Solifenacin: this group of patients will be treated with oral solifenacin 10mg tablet daily for 30 days. In this way, the drugs (30 tablets) will be placed inside sealed envelopes and the drug consumption checklist will be provided to the patients and after each drug consumption, the check list will be marked. drug is produced by Behestan Daru pharmaceutical company under the license of astellas company. its also available in market as Vesicare. Intervention group 2: antimuscarinic drug approved in OAB treatment, trospium chloride: drug used in this group, is trospium chloride 20mg daily for 30 days. In this way, the drugs (30 tablets) will be placed inside sealed envelopes and the drug consumption checklist will be provided to the patients and after each drug consumption, the check list will be marked. This drug is available in the pharmaceutical market under the brand name Spasmax from Zeller Medical Pharmaceutical Company. Intervention group, placebo: in this group placebo -made by Associate Pharmacist in uniform shape without pharmaceutical effect- was given to patients. We gave Placebo just like the treatment group once daily for 30 days. In this way, the placebo tablets (30 pieces) will be placed inside sealed envelopes, and the drug consumption checklist will be provided to the patients and after each drug consumption, they will be marked in the relevant checklist. NBSS score. Timepoint: begining of study and 4 weeks after intervention. Method of measurement: questionnaire. ICIQ-UI score. Timepoint: begining of study and 4 weeks after intervention. Method of measurement: questionnaire. I-QOL test score. Timepoint: begining of study and 4 weeks after intervention. Method of measurement: questionnaire. Tabriz University of Medical Sciences Approved 2020-05-03 Iran National Committiee for Ethics in Biomedical Research Emam Reza Hospital, Opposit side of Central Organization of University, Golgasht st. Tabriz East Azarbaijan Iran (Islamic Republic of)