Treatment of Spinal Cord Injury Patients for Neurogenic Bladder: an Open Label Pilot Study of Anticholinergic Agent vs. Mirabegron (MYRBETRIQ ®) to Evaluate Cognitive Impact and Efficacy
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change in cognitive measure - Logical Memory I (Immediate) - baseline and post treatment with mirabegron
研究概览
简要总结
We propose to test the hypothesis that cognition will improve with substitution of mirabegron for the anticholinergic agent (AC) in elderly persons with spinal cord injury (SCI) who require neurogenic bladder (NGB) treatment.
详细描述
The strong evidence for detrimental effects of AC agents on cognition, led the American Urological Association to update its guidelines in 2015 to include mirabegron as an alternative first-line agent for treatment of overactive bladder (OAB). NGB symptoms are very similar to OAB so the conditions are often treated similarly; however, data is lacking on the use of this promising agent for NGB. We thus propose to test the hypothesis that cognition will improve with substitution of mirabegron for the AC agent in elderly persons with SCI who require NGB treatment.
Subjects eligible for enrollment will have been treated with an anticholinergic agent for at least 3 months prior to enrollment. Baseline measurements will be recorded for subjects currently treated with an AC agent, after enrollment, the subject will start treatment with the study drug. Measurements from baseline (AC agent) will be compared to measurements taken after study intervention (mirabegron).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Both genders with spinal cord injury being treated for neurogenic bladder and age >60 years
- •All ethnic groups
- •Veterans will be enrolled to allow mailing of study medication by VA pharmacies.
- •Laboratory results:
- •Normal clinical labs for CBC (complete blood count), CMP (comprehensive metabolic panel), and UA (urinalysis) within past 6 months or repeat at screening if none. For example: HCT (hematocrit) ≥34%, GFR (glomerular filtration rate) ≥ 30 mL/min, liver enzymes (AST (aspartate aminotransferase test) < 2 x upper limit of normal, ALT (alanine aminotransferase test) < 2 x upper limit of normal, alkaline phosphatase < 2 X upper limit of normal), normal electrolytes, urinalysis and asymptomatic for UTI (urinary tract infection)
- •Taking a minimum regimen for 3 months of anticholinergic agent.
排除标准
- •Diagnosis of dementia or cognitive impairment from another condition such as TBI (traumatic brain injury), ALZ (alzheimers), Lewy body dementia or vascular dementia
- •End stage renal disease (GFR <30) or bladder obstruction
- •Poorly controlled blood pressure (BP), systolic BP>180, diastolic BP>110 mmHg)
- •Renal function - exclude if serum creatinine >2x normal range
- •Liver function - exclude if >2x normal liver enzyme levels
- •History of, or currently active treatment for cardiac dysrhythmias, including atrial fibrillation (eg. apixaban. If subject is currently taking metoprolol they will be monitored and dose may need to be adjusted on mirabegron)
- •Current treatment with desipramine, digoxin
- •Active/unstable conditions: inflammatory, thyroid, autoimmune, gastrointestinal (GI), hematologic, or neoplastic disorders. Exclude subjects with clinical lab values outside the normal range (other than as specified above).
- •Subject is considered unsuitable for the study in the opinion of the investigator for any other reason
研究组 & 干预措施
Neurogenic Bladder
Spinal Cord Injury patients with known neurogenic bladder on treatment with Anticholinergic Agents at baseline switched to mirabegron as the study intervention
干预措施: Mirabegron (Drug)
结局指标
主要结局
Change in cognitive measure - Logical Memory I (Immediate) - baseline and post treatment with mirabegron
时间窗: Change from Week 0 to Week 26
Wechsler Memory Scale, 4th edition (WMS-IV) subtest
次要结局
- Change in memory and executive function (TEXAS) - baseline and post treatment with mirabegron(Change from Week 0 to Week 26)
- Change in cognitive measure of executive function (SDMT) - baseline and post treatment with mirabegron(Change from Week 0 to Week 26)
- Change in Neurogenic Bladder Symptom Score (NBSS) - baseline and post treatment with mirabegron(Change from Week 0 to Week 26)
- Change in Neurogenic Bowel Dysfunction Score (NBD) - baseline and post treatment with mirabegron(Change from Week 0 to Week 26)
- Change in cognitive measure of executive function (Stroop test) - baseline and post treatment with mirabegron(Change from Week 0 to Week 26)
- Change in cognitive measure of memory (SLUMS) - baseline and post treatment with mirabegron(Change from Week 0 to Week 26)
- Change in cognitive measure - Logical Memory II (Delayed) - baseline and post treatment with mirabegron(Change from Week 0 to Week 26)