Evaluation of the effect of oral vitamin D supplementation in improving the symptoms of urgent urinary incontinence in postmenopausal women with vitamin D deficiency
Design
In this double-blind randomized clinical trial, postmenopausal women between 50 and 80 years of age with symptoms of urgent urinary incontinency and serum vitamin D3 level of less than 30 ng / ml will be randomly assigned into two groups. Patients in intervention group will receive 50,000 U vitamin D3 weekly for 8 weeks. the control group will receive placebo for the same period. then the patients will be assessed for clinical symptoms and serum level of vitamin D.
Settings and conduct
Ninety postmenopausal women between 50 and 80 years of age who were referred to the GYN clinic of Mahdieh Hospital with symptoms of urgent incontinence or history of nocturia. These patients will be randomly assigned into two groups; one group will receive vitamin D3 weekly for 8 weeks and the other group receives placebo weekly for the same period. In the follow-up, patients will be assessed for any improvement in symptoms and possible side effects of the drug. The Modified LUTS EPINCONT questionnaire will be used to assess the symptoms and severity of urinary incontinence. Likert Scale will also be used for assessment of patient's satisfaction after treatment.
Participants/Inclusion and exclusion criteria
Postmenopausal women between 50 and 80 years of age , serum level of vitamin D3 less than 30 ng / ml who have symptoms of urgent urinary incontinence with any severity
Intervention groups
Intervention group will receive 50,000 units of vitamin D for 8 weeks and the control group will receive placebo for the same period.
Main outcome variables
Oral vitamin D supplementation is effective in improving nocturia and reducing urgent urinary incontinence symptoms in postmenopausal women with vitamin D deficiency.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200417047109N1
Registration date:2020-11-24, 1399/09/04
Registration timing:registered_while_recruiting
Last update:2020-11-24, 1399/09/04
Update count:0
Registration date
2020-11-24, 1399/09/04
Registrant information
Name
mahsa arjmand
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 5541 1259
Email address
drmahsaarjmand@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-08-22, 1399/06/01
Expected recruitment end date
2021-08-23, 1400/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of vitamin D supplementation in post menopausal patients with urgent urinary incontinency and vitamin D deficiency
Public title
Effect of vitamin D supplementation in urinary incontinency
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
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
Exclusion criteria:
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
Age
From 50 years old to 80 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Double blinded
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.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahid Beheshti University of Medical Sciences
Street address
No 10, Rezaee Alley, Ostadzade Alley, Anari taft St, Kamali St
City
Tehran
Province
Tehran
Postal code
1317883611
Approval date
2020-08-12, 1399/05/22
Ethics committee reference number
435.IR.SBMU.RETECH.REC.1399
Health conditions studied
1
Description of health condition studied
urgent urinary incontinency
ICD-10 code
R39.15
ICD-10 code description
Urgency of urination
Primary outcomes
1
Description
Serum vitamin D level
Timepoint
Vitamin D level before and after 8 weeks of vitamin D administration
Method of measurement
Serum Level
2
Description
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)
3
Description
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
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Oral pearl Vitamin D 50,000 units weekly for up to 8 weeks
Category
Treatment - Drugs
2
Description
Control group: Oral placebo once a week for up to 8 weeks