Neuropathic Investigation and Anticholinergic Treatment of Bladder Dysfunction in Diabetes and Stroke Patients
试验速览
- 阶段
- 早期 1 期
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Develop and quantify methods for evaluating bladder dysfunction in diabetes and stroke. Develop pilot data of medical therapy (Toviaz) in diabetic and stroke bladder dysfunction.
研究概览
简要总结
Develop and quantify methods for evaluating bladder dysfunction in diabetes and stroke
详细描述
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Specific Aims:
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To investigate clinical bladder dysfunction in a cohort of 10 diabetic and 10 stroke patients as assessed by a combined neurophysiologic and urologic assessment.
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To develop and quantify appropriate study methods for evaluating symptomatic and asymptomatic bladder dysfunction in diabetic and stroke patients.
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To develop pilot data of medical therapy (Toviaz) in diabetic and stroke bladder dysfunction.
Evaluation:
Incontinence will be defined as losing bladder control at least once per week or use of an indwelling catheter to control incontinent episodes.
Incontinence will be measured at baseline and follow-up. Urinary frequency is defined as urinary voiding greater than 8 times per 24-hour period and/or more than one voiding per night. Pad count, leakage episodes, and nocturia will be measures of incontinence. The amount and frequency of voiding, and nocturia will also be measured. These items will be assessed using the Voiding Diary. Overall patient satisfaction will be assessed using the Analog Scale of Voiding Satisfaction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 85 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Stroke Population:
- •Ischemic or hemorrhagic stroke in the anterior or posterior circulation within the past month in persons 21 years of age and over
- •NIH Stroke Scale Score of 4 or greater one month post-stroke
- •Modified Rankin Scale of 2 or greater
- •Patients with motor or verbal impairment with surrogacy consent
- •Inclusion Criteria:
- •Diabetic Population:
- •Clinically stable diabetes type 2 females 21 years of age or older
- •Peripheral neuropathy associated with diabetes Dyck stage 2 or 3
- •Clinical evaluation by neurologist reveals no other likely cause of neuropathy
排除标准
- •Stroke Population:
- •Patients with cardiac pacemaker or other indwelling device that would preclude neurophysiologic testing;
- •Patients with an indwelling urinary catheter that cannot be removed
- •Patients who are on warfarin or similar anticoagulants that cannot be stopped for the study procedures
- •Patients with a poor prognosis due to stroke or underlying illness who, it is anticipated, would be unable to participate for the period of the study
- •Females with current pregnancy, multiparity >/=4, prior pelvic floor dysfunction, or pelvic floor tumor. Women with incontinence prior to stroke, cystocele, rectocele, or urethral stricture
- •Patients unable to tolerate Detrol LA; such patients would include those with significant renal or hepatic disease, those currently taking drugs metabolized by the cytochrome P450 enzyme system that might confound interpretation of responses ( Delaviridine, indinavir, nelfinavir, ritonavir, amiodarone, aprepitant, cimetidine, ciprofloxacin, clarithromycin, diltiazem, erythromycin, fluconazole, fluvoxamine, grapefruit juice, itraconazole, ketoconazole, mifepristone, nefazodone, norfloxacin, verapamil, efavirenz, nevirapine, carbamazepine, phenobarbital, phenyltoin, rifampin, St. John's wort, troglitazone, oxcarbazepine, pioglitazone, rifabutin); those with urinary retention, gastric retention, uncontrolled narrow angel glaucoma, or those with a known sensitivity to the drug or its ingredients
- •Patients who have a history of diabetes
- •Pregnancy or actively seeking pregnancy
- •Patients who are cognitively impaired
- •Diabetes Population:
- •Exclusion Criteria:
- •Patients with cardiac pacemaker or other indwelling device that would preclude neurophysiologic testing;
- •Patients with an indwelling urinary catheter that cannot be removed
- •Patients who are on warfarin or similar anticoagulants that cannot be stopped for the study procedures
- •Patients with a poor prognosis due to underlying illness who, it is anticipated, would be unable to participate for the period of the study
- •Females with current pregnancy, multiparity >/=4, prior pelvic floor dysfunction, pelvic floor tumor, cystocele, rectocele, or urethral stricture
- •Patients unable to tolerate Detrol LA; such patients would include those with significant renal or hepatic disease, those currently taking drugs metabolized by the cytochrome P450 enzyme system that might confound interpretation of responses ( Delaviridine, indinavir, nelfinavir, ritonavir, amiodarone, aprepitant, cimetidine, ciprofloxacin, clarithromycin, diltiazem, erythromycin, fluconazole, fluvoxamine, grapefruit juice, itraconazole, ketoconazole, mifepristone, nefazodone, norfloxacin, verapamil, efavirenz, nevirapine, carbamazepine, phenobarbital, phenyltoin, rifampin, St. John's wort, troglitazone, oxcarbazepine, pioglitazone, rifabutin); those with urinary retention, gastric retention, uncontrolled narrow angel glaucoma, or those with a known sensitivity to the drug or its ingredients
- •Pregnancy or actively seeking pregnancy
结局指标
主要结局
Develop and quantify methods for evaluating bladder dysfunction in diabetes and stroke. Develop pilot data of medical therapy (Toviaz) in diabetic and stroke bladder dysfunction.
时间窗: 18 months
Patients assessed by neurophysiologic and urologic assessment; develop study methods for evaluation; develop pilot data of medical therapy.
次要结局
未报告次要终点