Urinary incontinence (UI) affects many older women and greatly reduces quality of life. In the U.S., the most common type of UI in older adults is urgency UI and mixed-type UI. The most common type of medication used for urgency and mixed UI is an antimuscarinic drug. However, most patients on UI medications do not become completely dry and medications are often discontinued due to costs, negative side effects, or perceived inefficacy. Clearly, more efficacious treatments for UI are urgently needed. Evidence emerging from epidemiologic and clinical cohort studies indicates that lower vitamin D levels are associated with increased risk for UI suggesting that vitamin D may have a role in maintaining continence in women. Because the potential benefits of vitamin D may extend to several organ systems, it is quite possible that vitamin D may maintain continence by supporting skeletal muscle strength and normal detrusor activity. In the proposed study, we hypothesize that adequate vitamin D supplementation (raising serum levels to 30 ng/mL or above) will improve UI symptoms in older women with vitamin D deficiency (25(OH)D serum levels less than 20 ng/mL). The primary aim of the proposed double-blind, randomized, placebo-controlled pilot trial is to estimate the effect size of weekly vitamin D supplementation in older women with UI and vitamin D deficiency.
The second aim i s to evaluate if improving serum 25(OH)D levels affect other urinary and bowel symptoms.
The third aim i s to identify potential mechanisms that may contribute to improved UI symptoms in a subgroup of women, including increased pelvic floor skeletal muscle strength, decreased detrusor muscle over activity, improved mobility, and inflammatory urinary biomarkers. Post-menopausal women with vitamin D deficiency (n=100) will be recruited and randomized to receive weekly oral placebo or 50,000 IU vitamin D3 (cholecalciferol) for 12 weeks. Our treatment regimen is intended to achieve serum 25(OH)D levels of 30 ng/mL or above. Changes in UI-episodes will be assessed by 7-day bladder diary and other validated measures of urinary and bowel symptoms administered at baseline and after 12-weeks of intervention. Serum calcium and 25(OH)D levels will be monitored at: baseline, 6-week visit, and the end of 12 weeks of the intervention. Urodynamic (done in 50% of the study group), an assessment of pelvic floor strength, urinary collection for further testing, and mobility will be performed at baseline and 12-weeks.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.
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.
|Fung, Constance H; Vaughan, Camille P; Markland, Alayne D et al. (2017) Nocturia is Associated with Poor Sleep Quality Among Older Women in the Study of Osteoporotic Fractures. J Am Geriatr Soc 65:2502-2509|
|Markland, A D; Jelovsek, J E; Whitehead, W E et al. (2017) Improving biofeedback for the treatment of fecal incontinence in women: implementation of a standardized multi-site manometric biofeedback protocol. Neurogastroenterol Motil 29:|
|Markland, Alayne D; Dunivan, Gena C; Vaughan, Camille P et al. (2016) Anal Intercourse and Fecal Incontinence: Evidence from the 2009-2010 National Health and Nutrition Examination Survey. Am J Gastroenterol 111:269-74|
|Vaughan, Camille P; Fung, Constance H; Huang, Alison J et al. (2016) Differences in the Association of Nocturia and Functional Outcomes of Sleep by Age and Gender: A Cross-sectional, Population-based Study. Clin Ther 38:2386-2393.e1|
|Vaughan, C P; Tangpricha, Vin; Motahar-Ford, N et al. (2016) Vitamin D and incident urinary incontinence in older adults. Eur J Clin Nutr 70:987-9|
|Gau, Jen-Tzer; Acharya, Utkarsh H; Khan, M Salman et al. (2015) Risk factors associated with lower defecation frequency in hospitalized older adults: a case control study. BMC Geriatr 15:44|