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IRCT20171225038070N1 IRCT 2018-07-08 Iran University of Medical Sciences Assessing the effectiveness of oxybutynin and phenazopyridine and celecoxib in reducing complications in the treatment of bladder tumors. Comparison of the efficacy of oxybutynin and phenazopyridine and celecoxib with placebo in the treatment of urinary tract symptoms after BCG therapy in bladder tumors patients 2016-07-05 anticipated 120 Complete https://irct.ir/trial/28892 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients were divided into four group with random allocation process. The randomized blocks were randomly assigned to the researcher by the design consultant in sealed envelopes. . The creation of a randomized table with the STATA software and its output will be random letters A, B, C, D for treatment groups 1 to 4. After qualifying for inclusion in the study and lack of exclusion criteria by one of the researchers, the envelope designation for the candidate number of the candidate for treatment of BCG is opened and the type of treatment A, B, C, D specified and the person will be treated once a week. And the drug will be delivered to the patient. In co-ordination with the pharmaceutical company, all treatments in the same coatings are provided in capsule form that can not be differentiated, Blinding description: Patients were selected according to a randomized table, and the presenter and the investigator were not included in the selected medication. In the case of a person in the study, the medication was placed in the same coat of coat. The designer was blinded to the use of a randomized table and sealed envelopes in which the names of the drugs were used. In the case of the researcher, according to the coding of the participating groups and the naming of groups with blind numbers. 3 Malignant neoplasm of bladder. Intervention 1: Intervention group1: Receive oxybutinine 5 mg every 12 hours for six weeks BCG treatment. Intervention 2: Intervention group2: phenazopyridine 100 mg every 8 hours for six weeks BCG treatmentIntervention group:. Intervention 3: Intervention group3: Receive celecxibe 100 mg every 12 hours for six weeks BCG treatment. Intervention 4: Control group: Receive placebo (Starch-filled capsules) every 12 hours for six weeks of BCG treatment. 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 No more information
public Javad Nikbakht
Hashemi Nejad Hospital, Vali Nejad Ave., Vali Asr St.
Tehran Iran (Islamic Republic of) 969714713 +98 21 8864 4435 javad.nikbakht64@gmail.com Iran University of Medical Sciences scientific Javad Nikbakht
Hashemi Nejad Hospital, Vali nejad Ave., Vali Asr St.
Tehran Iran (Islamic Republic of) 1969714713 +98 21 8864 4435 javad.nikbakht64@gmail.com Iran University of Medical Sciences Iran (Islamic Republic of) bladder cancer candidates for BCG therapy Non muscle bladder cancer 18 years no limit Both history of pelvic surgery severe urinary tract symptoms (IPSS over 20) overactive bladder complete urinary incontinence traumatic catheterization active TB symptoms C67 Malignant neoplasm of bladder Treatment - Drugs Treatment - Drugs Treatment - Drugs Placebo Intervention group1: Receive oxybutinine 5 mg every 12 hours for six weeks BCG treatment Intervention group2: phenazopyridine 100 mg every 8 hours for six weeks BCG treatmentIntervention group: Intervention group3: Receive celecxibe 100 mg every 12 hours for six weeks BCG treatment Control group: Receive placebo (Starch-filled capsules) every 12 hours for six weeks of BCG treatment Frequency. Timepoint: Six consecutive weeks at the same time as the induction treatment period for BCG.The days of 0, 7,14,21,28,35 of the intervention. Method of measurement: Ask the patient and register in the questionnaire. Urgency. Timepoint: Six consecutive weeks at the same time as the induction treatment period for BCG.The days of 0, 7,14,21,28,35 of the intervention. Method of measurement: Ask the patient and register in the questionnaire. Urine painful. Timepoint: Six consecutive weeks at the same time as the induction treatment period for BCG.The days of 0, 7,14,21,28,35 of the intervention. Method of measurement: Ask the patient and register in the questionnaire. Fever. Timepoint: Six consecutive weeks at the same time as the induction treatment period for BCG.The days of 0, 7,14,21,28,35 of the intervention. Method of measurement: Thermometer. Constipation. Timepoint: Six consecutive weeks at the same time as the induction treatment period for BCG.The days of 0, 7,14,21,28,35 of the intervention. Method of measurement: Ask the patient and register in the questionnaire. Heart burn. Timepoint: Six consecutive weeks at the same time as the induction treatment period for BCG.The days of 0, 7,14,21,28,35 of the intervention. Method of measurement: Ask the patient and register in the questionnaire. Feeling dry mouth. Timepoint: Six consecutive weeks at the same time as the induction treatment period for BCG.The days of 0, 7,14,21,28,35 of the intervention. Method of measurement: Ask the patient and register in the questionnaire. Flu-like symptoms. Timepoint: Six consecutive weeks at the same time as the induction treatment period for BCG.The days of 0, 7,14,21,28,35 of the intervention. Method of measurement: Ask the patient and register in the questionnaire. Arthralgia. Timepoint: Six consecutive weeks at the same time as the induction treatment period for BCG.The days of 0, 7,14,21,28,35 of the intervention. Method of measurement: Ask the patient and register in the questionnaire. Iran University of Medical Sciences Approved 2016-12-10 Ethics committee of Iran University of Medical Sciences Iran University of Medical Sciences, Hemmat Highway Tehran Tehran Iran (Islamic Republic of)