Vitamin D Supplementation in Older Adults with Urinary Incontinence

描述(由申请人提供)：尿失禁(UI)影响许多老年女性，并极大地降低生活质量。在美国，老年人最常见的用户界面类型是紧急用户界面和混合型用户界面。用于急症和混合性尿失禁的最常见的药物类型是抗血吸虫药物。然而，大多数服用UI药物的患者并不会完全干涸，而且由于费用、负面副作用或被认为无效，药物经常被停用。显然，迫切需要对尿崩症进行更有效的治疗。来自流行病学和临床队列研究的证据表明，较低的维生素D水平与尿崩症的风险增加相关，这表明维生素D可能在维持女性的可控性方面发挥作用。由于维生素D的潜在益处可能延伸到几个器官系统，维生素D很有可能通过支持骨骼肌力量和正常的逼尿肌活动来维持可控性。在拟议的研究中，我们假设适当的维生素D补充(将血清水平提高到30 ng/毫升或以上)将改善维生素D缺乏(25(OH)D血清水平低于20 ng/毫升)的老年女性的尿崩症症状。这项拟议的双盲、随机、安慰剂对照试验的主要目的是估计每周补充维生素D对患有尿崩症和维生素D缺乏症的老年女性的效果。第二个目的是评估提高血清25(OH)D水平是否会影响其他尿路和肠道症状。第三个目标是确定可能有助于改善一组女性尿失禁症状的潜在机制，包括盆底骨骼肌力量增加，逼尿肌活动减少，活动能力改善，以及发炎的尿液生物标志物。患有维生素D缺乏的绝经后妇女(n=100)将被招募并随机接受为期12周的每周口服安慰剂或50000国际单位维生素D3(胆钙化醇)。我们的治疗方案旨在使血清25(OH)D水平达到30 ng/mL或以上。尿失禁发作的变化将通过7天的膀胱日记和在基线和干预12周后实施的其他有效的尿路和肠道症状测量来评估。血钙和25(OH)D水平将在基线、6周访问和干预12周结束时进行监测。将在基线和12周内进行尿动力学(50%的研究组进行)、盆底力量评估、进一步测试的尿液收集和活动能力。预期结果将提供有关补充维生素D对尿路症状改善的影响的新知识，并为涉及补充维生素D的更大规模的随机对照临床试验提供信息。

DESCRIPTION (provided by applicant): 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 is to evaluate if improving serum 25(OH)D levels affect other urinary and bowel symptoms. The third aim is 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.