Effect of Vitamin D3 Supplementation on the severity of Stress Urinary Incontinence (SUI) in premenopausal women; A double-blind clinical trial

Effect of vitamin D3 supplementation on the severity of Stress Urinary Incontinence (SUI) in premenopausal women

Clinical trial with control group, With parallel groups, double blind, Randomized

In this clinical trial, 60 premenopausal women referred to the gynecology clinic affiliated to Kerman University of Medical Sciences will be participated in the study and will be allocated to quaternary blocks by random blocking method. They will be divided in two groups of intervention (vitamin D) and control (placebo).

Inclusion criteria: Willingness to participate in the study, Age : 40 to 49 years, Serum level of vitamin D less than 30 ng/ml, Confirmation of the diagnosis of stress urinary incontinence by a physician; exclusion criteria: reluctance to continue collaborating in the study, Any disorder that prevents the absorption of vitamin D. 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, Participants who have used estrogen or progesterone in the last 6 months.

In the intervention group, participants will be requested use of 50,000 units of vitamin D capsules weekly for 12 weeks in addition to daily Kegel exercise. In the control group, participant will be requested use of placebo capsules weekly for 12 weeks in addition to daily Kegel exercise.

Stress urinary incontinence

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.

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.