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IRCT20210714051893N1 IRCT 2021-08-22 Qazvin University of Medical Sciences "Combination therapy in recurrence of enuresis" Recurrence of primary enuresis after treatment with desmopressin compare with combination therapy desmopressin and tolterodine in children aged 5-16 years 2021-09-23 anticipated 124 Complete https://irct.ir/trial/57552 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be divided into two groups. (By random allocation method with variable blocks that creates six different states (TCCT). TCTC TTCC. CTTC. CTCT. CCTT). Then the order will be selected by random numbers created by the computer). The therapist and the patient do not know about the group allocation. In addition, the Quickcals graphpad program is used for randomization, Blinding description: Double-blind, Patients and the therapist are not aware of the type of allocation. For this purpose, the drugs are divided into packages containing codes 1 or 2. Only the principal investigator is aware of the type of intervention. 3 Primary monocympetic nocturnal enuresis. Intervention 1: Control group: Patients will be randomly divided into two groups: (CCTT) by random allocation with variable blocks that create six different states. CTCT. CTTC. TTCC TCTC. (TCCT) and then the blocks are selected with random numbers generated by the computer. The therapist and the patient are not aware of the therapeutic allocation. The first group is given 10 micrograms of Desmopressin nasal spray (one puff) one hour before bedtime and patients will be visited after the start of monthly treatment.If there is a partial or no response within two weeks of treatment, possible factors for resistance to treatment, such as constipation, bladder disorders, or improper medication, are evaluated. Failure to respond to treatment to one or more overnight wetting for two consecutive weeks during treatment and response to treatment refers to being dry for two consecutive weeks (provided the medication is used continuously). Night in between and then cut off.Re-visit two weeks after treatment and recurrence of enuresis (wetting more than three nights a week) will be checked. It is used as an active ingredient and each puff contains 10 micrograms of desmopressin acetate. The following recommendations will be made to patients in both groups.1. Adequate fluid intake during the day by limiting fluids to two hours before bedtime 2. Do not drink caffeinated beverages in the afternoon and evening 3. Empty the bladder before bedtime. Intervention 2: Intervention group: The second group given 10 microgram of Desmopressin nasal spray (one puff)with Tolterodine tablets (1/2 of tablet)(Sanamad Pharmaceutical Company) one hour before bedtime. will also be prescribed to the second group of patients. Yes - There is a plan to make this available What will be shared: The analysis result of all data can be detected and tracked. When: 6 months after printing the results. To whom: All researchers. Conditions: To conduct further research in the future. Where to obtain: To Research Center of Qazvin University of Medical Sciences. How to obtain: Administrative and academic process according to university rules. Comments:
public Fereshteh Sobhani
Qods hospital,Qods square
Qazvin Iran (Islamic Republic of) 3415914595 +98 28 3333 4807 fereshteh.sobhani23@gmail.com Qazvin University of Medical Sciences scientific Fereshteh Sobhani
Qodshospital,Qods square
Qazvin Iran (Islamic Republic of) 3415914595 +98 28 3333 4807 fereshteh.sobhani23@gmail.com Qazvin University of Medical Sciences Iran (Islamic Republic of) Patients have monosymptomatic primary enuresis. Patients without any anatomical disorder of kidney in sonography Patients aged 5 -16 years Knowledgeably compliance for entry or exit from research 5 years 16 years Both Patients with enuresis with symptoms of daily urinary disorders, such as urgent urinary incontinence, frequent urination, or reduced urination frequency per day, urinary retention maneuvers during the day. Patients with urinary tract infection (positive urine culture), fasting blood sugar, renal dysfunction (high creatinine), Anatomical abnormalities of the kidney on ultrasound, patients previously treated for enuresis patients with incomplete information, and no referrals if the child does not have enuresis (has gained control of urination) and later has enuresis secondary enuresis N39.44 Nacturnal enuresis Treatment - Drugs Treatment - Drugs Control group: Patients will be randomly divided into two groups: (CCTT) by random allocation with variable blocks that create six different states. CTCT. CTTC. TTCC TCTC. (TCCT) and then the blocks are selected with random numbers generated by the computer. The therapist and the patient are not aware of the therapeutic allocation. The first group is given 10 micrograms of Desmopressin nasal spray (one puff) one hour before bedtime and patients will be visited after the start of monthly treatment.If there is a partial or no response within two weeks of treatment, possible factors for resistance to treatment, such as constipation, bladder disorders, or improper medication, are evaluated. Failure to respond to treatment to one or more overnight wetting for two consecutive weeks during treatment and response to treatment refers to being dry for two consecutive weeks (provided the medication is used continuously). Night in between and then cut off.Re-visit two weeks after treatment and recurrence of enuresis (wetting more than three nights a week) will be checked. It is used as an active ingredient and each puff contains 10 micrograms of desmopressin acetate. The following recommendations will be made to patients in both groups.1. Adequate fluid intake during the day by limiting fluids to two hours before bedtime 2. Do not drink caffeinated beverages in the afternoon and evening 3. Empty the bladder before bedtime. Intervention group: The second group given 10 microgram of Desmopressin nasal spray (one puff)with Tolterodine tablets (1/2 of tablet)(Sanamad Pharmaceutical Company) one hour before bedtime. will also be prescribed to the second group of patients. Nocturnal enuresis. Timepoint: After starting treatment, patients will be visited monthly. If there is a partial or no response up to two weeks after treatment, possible factors of resistance to treatment such as constipation, bladder disorders or not taking the drug properly will be investigated. Failure to respond to treatment refers to one or more night wetting in two consecutive weeks during treatment and response to treatment is defined as dryness in two consecutive weeks.After three months of treatment, the drugs are discontinued overnight for one month. Re-visits are performed two weeks after treatment and recurrence of nocturnal enuresis (more than three nights wetting per week) will be checked. Method of measurement: Response to treatment questionnaire. Early enuresis recurrence. Timepoint: En After starting treatment, patients will be visited monthly. If there is a partial or no response up to two weeks after treatment, possible factors of resistance to treatment such as constipation, bladder disorders or not taking the drug properly will be investigated. Failure to respond to treatment refers to one or more night wetting in two consecutive weeks during treatment and response to treatment is defined as dryness in two consecutive weeks.After three months of treatment, the drugs are discontinued overnight for one month. Re-visits are performed two weeks after treatment and recurrence of nocturnal enuresis (more than three nights wetting per week) will be checked. Method of measurement: En Response to treatment questionnaire. Qazvin University of Medical Sciences Approved 2021-06-23 Ethics Committee of Qazvin University of Medical Sciences Qods hospital,Qods square Qazvin Qazvin Iran (Islamic Republic of)