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IRCT20200417047109N1 IRCT 2020-11-24 Shahid Beheshti University of Medical Sciences Effect of vitamin D supplementation in urinary incontinency Evaluation of the effect of vitamin D supplementation in post menopausal patients with urgent urinary incontinency and vitamin D deficiency 2020-08-22 anticipated 90 Complete https://irct.ir/trial/51924 observational Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The randomization block method is used for randomization. The letters A and B are written on paper and placed in an envelope. By selecting one of the papers in the envelope, the patient determines to be in the group receiving medication or placebo, Blinding description: In this double-blind study, the patient and the researcher do not know which group receives the drug or placebo. The drug and placebo will be given to the patient in separate envelopes by the health care provider. The researcher will gather information blindly at the end of the study through an interview with the patient. 3 urgent urinary incontinency. Intervention 1: Intervention group: Oral pearl Vitamin D 50,000 units weekly for up to 8 weeks. Intervention 2: Control group: Oral placebo once a week for up to 8 weeks. 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 There is no more information
public Mahsa Arjmand
Shousha Square, Fadaiyan-e-Islam Street, Shishegar Khane Alley, Shahid Rajab Nia Street
Tehran Iran (Islamic Republic of) 1185817311 +98 21 5506 2628 mahdiyeh_hospital@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Mahsa Arjmand
No 10,Anari Taft,Kamali street,south kargar.Tehran,Iran
Tehran Iran (Islamic Republic of) 1185817311 +98 21 5541 1259 drmahsaarjmand@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Menopausal women between 50 and 80 years of age Serum level of vitamin D3 below 30ng / ml Urgent urinary incontinence of any degree Written informed consent for participation in the study 50 years 80 years Female Any underlying condition that impairs vitamin D absorption, such as IBD and gastric bypass surgery Chronic liver or kidney disease Any neurological disorder that affects the urinary system such as MS, degenerative muscle disorders, CVA, and Spinal cord injury Diabetes History of chronic cough or chronic constipation History of vesiculovaginal fistula Progesterone and estrogen supplement in the last six months Urinary tract infection during the test Severe bladder prolapse (stages 3 and 4 cystocele and apical). Patients using diuretics Not knowing Persian language R39.15 Urgency of urination Treatment - Drugs Placebo Intervention group: Oral pearl Vitamin D 50,000 units weekly for up to 8 weeks Control group: Oral placebo once a week for up to 8 weeks Serum vitamin D level. Timepoint: Vitamin D level before and after 8 weeks of vitamin D administration. Method of measurement: Serum Level. Severity of urinary incontinence symptoms before and after treatment. Timepoint: Before and after treatment. Method of measurement: Modified LUTS EPINCONT questionnaire (based on total incontinence frequency and leakage volume). The degree of disturbance in the patient's quality of life due to urinary incontinency (before and after treatment). Timepoint: At the beginning of the study and after the end of treatment. Method of measurement: Modified LUTS EPINCONT questionnaire. Shahid Beheshti University of Medical Sciences Approved 2020-08-12 Ethics Committee of Shahid Beheshti University of Medical Sciences No 10, Rezaee Alley, Ostadzade Alley, Anari taft St, Kamali St Tehran Tehran Iran (Islamic Republic of)