Vitamin D Supplementation in Older Adults with Urinary Incontinence

描述（由申请人提供）：尿失禁（UI）影响许多老年妇女，大大降低生活质量。在美国，老年人中最常见的UI类型是紧急UI和混合型UI。用于紧急和混合UI的最常见药物类型是抗毒蕈碱药物。然而，大多数使用UI药物的患者不会变得完全干燥，并且药物经常由于成本、负面副作用或感觉无效而中断。显然，迫切需要更有效的治疗UI。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UI风险增加有关，这表明维生素D可能在维持女性的肥胖方面发挥作用。由于维生素D的潜在益处可能扩展到几个器官系统，因此维生素D很可能通过支持骨骼肌力量和正常逼尿肌活动来维持排尿。在拟议的研究中，我们假设充足的维生素D补充（将血清水平提高至30 ng/mL或以上）将改善维生素D缺乏（血清25（OH）D水平低于20 ng/mL）的老年女性的UI症状。拟议的双盲、随机、安慰剂对照的试点试验的主要目的是估计每周补充维生素D对UI和维生素D缺乏的老年妇女的影响。第二个目的是评估改善血清25（OH）D水平是否会影响其他泌尿和肠道症状。第三个目的是确定可能有助于改善女性亚组UI症状的潜在机制，包括增加骨盆底骨骼肌强度，减少逼尿肌过度活动，改善流动性和炎症性尿生物标志物。将招募患有维生素D缺乏症的绝经后女性（n=100），并随机接受每周口服安慰剂或50，000 IU维生素D3（胆钙化醇），持续12周。我们的治疗方案旨在达到30 ng/mL或以上的血清25（OH）D水平。将通过7天膀胱日记和基线时和干预12周后给予的其他经验证的泌尿和肠道症状指标评估UI发作的变化。将在基线、6周访视和12周干预结束时监测血清钙和25（OH）D水平。尿动力学（在50%的研究组中进行），评估骨盆底力量，收集尿液进行进一步测试，并在基线和12周时进行mobility.The预期的结果将提供有关维生素D补充剂对UI症状改善的影响的新知识，并通知一个更大的，随机对照的临床试验，涉及维生素D补充剂。

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.