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IRCT20190724044318N2 IRCT 2021-02-11 Kerman University of Medical Sciences Effect of Vitamin D3 Supplementation on the severity of Stress Urinary Incontinence (SUI) in premenopausal women SUI Effect of Vitamin D3 Supplementation on the severity of Stress Urinary Incontinence (SUI) in premenopausal women; A double-blind clinical trial 2021-01-20 anticipated 60 Complete https://irct.ir/trial/53474 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, participants will be selected based on referring to the gynecology clinic affiliated to Kerman University of Medical Sciences and provided they have all the inclusion criteria. The method of assigning individuals is random and in the method of random permutation blocks with block size 4 (using the table related to random permutations) and with a ratio of 1 to 1. The randomization list is prepared by a statistician. Codes assigned to eligible individuals will be placed in sealed envelopes by someone outside the study who is unaware of the research objectives. Then, after identifying all the members of the group, the intervention will be done individually in 12 weeks, Blinding description: In this double-blind study, researchers and patients did not know the type of intervention and drug delivery to two groups (vitamin D-placebo) by trained midwives a women's clinic affiliated with Kerman University of Medical Sciences, which does not know the nature of the research, will be held. N/A Stress Urinary Incontinence. Intervention 1: Intervention group: Vitamin D capsule 5000 units prepared by Dana Pharmaceutical Company should be taken weekly for 12 weeks along with Kegel exercise. Kegel exercise is taught to people in a face-to-face session for 10 minutes at first and the pamphlet related to Sports will be provided to them. Intervention 2: Control group: Take a placebo capsule prepared by Dana Pharmaceutical Company on a weekly basis for 12 weeks with Kegel exercise. Kegel exercise is taught to people in a face-to-face session for 10 minutes at first and the pamphlet related to Sports will be provided to them. 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 information available
public Maryam Ali Kamali
Kerman University of Medical Sciences,Medical University Campus,Haft-Bagh Highway, Kerman, Iran
Kerman Iran (Islamic Republic of) 7616913555 +98 34 3342 5400 m_kamali1984@yahoo.com Kerman University of Medical Sciences scientific Maryam Ali Kamali
Kerman University of Medical Sciences,Medical University Campus,Haft-Bagh Highway, Kerman, Iran
Kerman Iran (Islamic Republic of) 7616913555 +98 34 3342 5400 m_kamali1984@yahoo.com Kerman University of Medical Sciences Iran (Islamic Republic of) Age : 40 to 49 years. Serum level of vitamin D3 less than 30 ng/ml Confirmation of the diagnosis of stress urinary incontinence by a physician Having a telephone line to follow up the intervention Having at least literate 40 years 49 years Female Use of participants from treatments other than the recommended treatment Any disorder that prevents the absorption of vitamin D3. Such as inflammatory bowel disease (IBD) . Chronic diabetes Chronic liver or kidney disease Hysterectomy History of neoplasia Urinary-genital system Any neurological disease that affects the urinary system or bowel movements, including multiple sclerosis People who have used estrogen or progesterone in the last 6 months. N39.3 Stress incontinence (female) (male) Treatment - Drugs Placebo Intervention group: Vitamin D capsule 5000 units prepared by Dana Pharmaceutical Company should be taken weekly for 12 weeks along with Kegel exercise. Kegel exercise is taught to people in a face-to-face session for 10 minutes at first and the pamphlet related to Sports will be provided to them. Control group: Take a placebo capsule prepared by Dana Pharmaceutical Company on a weekly basis for 12 weeks with Kegel exercise. Kegel exercise is taught to people in a face-to-face session for 10 minutes at first and the pamphlet related to Sports will be provided to them. Stress Urinary Incontinence. Timepoint: Before the intervention and 4th – 8th and 12th weeks of the intervention. Method of measurement: ICIQ-SF standard questionnaire. Kerman University of Medical Sciences Approved 2021-01-04 Ethics Committee of Kerman University of Medical Sciences Kerman University of Medical Sciences,Medical University Campus,Haft-Bagh Highway, Kerman, Iran Kerman Kerman Iran (Islamic Republic of)