Urinary Incontinence, Vitamin D Deficiency
Conditions
Keywords
urinary incontinence, bowel incontinence, vitamin D, overactive bladder, lower urinary tract symptoms, quality of life
Brief summary
Urinary incontinence (UI) is a common disorder among older women that greatly affects quality of life. Emerging evidence from observational studies links vitamin D insufficiency with UI. Prior to a larger intervention trial of vitamin D among older women with low serum vitamin D levels and urgency UI, we propose a pilot study in 100 older women comparing weekly, oral vitamin D3 50,000 IU to placebo. We hypothesize that adequate vitamin D supplementation will improve UI symptoms in older women with vitamin D deficiency. Changes in UI-episodes will be assessed by a 7-day bladder diary and other validated symptom measures administered at baseline and after 12-weeks of intervention. Serum calcium and 25(OH)D levels will be monitored. The expected outcomes will provide new knowledge regarding the impact of vitamin D supplementation on UI symptom improvement and inform a larger, randomized controlled clinical trial involving vitamin D supplementation.
Interventions
DIETARY_SUPPLEMENTVitamin D3 50,000 IU
Capsule given by mouth once a week
OTHERPlacebo
One capsule given by mouth weekly
Sponsors
University of Alabama at Birmingham
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
(1) Post-menopausal women (age ≥50 years of age); (2)Urine leakage for 3 or more months; (3) at least 3 urinary urgency incontinence episodes on a 7-day bladder diary; and (4) serum 25(OH)D level (vitamin D) is \<30 ng/mL. Women who currently take a bladder medications (anticholinergic) for UI symptom control may enroll into the study if they agree to (1) cease taking these medications at least two weeks before the pre-intervention assessment and (2) not take these medications during the study's treatment and assessment period.
Exclusion criteria
(1) neurologic diseases known to affect UI; (2) Diseases known to affect vitamin D absorption and metabolism; (3) Prior pelvic floor radiation; (4) Obstructive causes of UI;(6)Current use of medications known to affect vitamin D levels; (7) Uncontrolled diabetes (Hemoglobin A1C\>9%); (8) albumin corrected serum Calcium \> 11.0 mg/dL; (9)history of hyperparathyroidism; (10) currently untreated kidney stones; (11) post void residual urine volume \>200 ml; and, (12) current treatment with vitamin D \>=1000IU/day (if not willing to stop taking).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in the number of incontinent episodes on a 7-day bladder diary | baseline to 12 weeks | The primary outcome measure is the percentage change in the number of incontinent episodes on a 7-day bladder diary from the baseline evaluation to the final visit at 12-weeks. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in quality of life (Overactive Bladder Questionnaire) | baseline to 12 weeks | Questionnaires |
| Change in satisfaction with treatment (Perceptions and Satisfaction Questionnaire) | baseline to 12 weeks | Questionnaire |
| Change in UI symptoms (ICIQ-UI and ICIQ-OAB scores) | baseline to 12 weeks | Questionnaires |
| Mechanisms of improvement based on measure of mobility | baseline to 12 weeks | Physical examination |
| Bowel incontinence symptoms | baseline to 12 weeks | Questionnaire |
| Change in safety of the treatments (side effects and unanticipated events) | baseline to 12 weeks | Checklist |
Countries
United States
Outcome results
None listed