Anticholinergic Therapy for Overactive Bladder in Parkinson's Disease: A Randomized, Double-blind, Crossover Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- compare cognitive side effects
研究概览
简要总结
The purpose of this research study is to investigate the cognitive (thinking, memory, knowledge, intelligence) side effects of two medications commonly used to treat overactive bladder (OAB) symptoms in veteran patients with Parkinson's disease (PD) seen at the Philadelphia PADRECC.
详细描述
This study will be a double-blinded cross-over clinical trial design to assess the prevalence of cognitive effects, the efficacy, and the effect on quality of life (QOL) of two anticholinergic medications commonly used in the treatment of overactive bladder (OAB): oxybutynin and darifenacin. This will be done by use of a well-established and validated computer-based cognitive battery. Secondary endpoints will assess efficacy of anticholinergic therapy on symptoms of OAB via QOL questionnaire and participant urinary diaries.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of idiopathic PD (ICD9=332.0)
- •MMSE 24, able to give informed consent and complete questionnaires and voiding diaries.
- •Urological work-up within 3 months of enrollment to:
- •Rule out treatable causes of urinary symptoms
- •Urinalysis (UA)
- •Post-void residual ultrasound (PVR)
- •Urinary cytology
- •Documented symptoms OAB on screening 3-day voiding diary:
- •Average of 1 urgency episode / 24 hours, and
- •Average of 8 micturitions / 24 hours
- •Subjective complaints of symptoms for 3 months
排除标准
- •Exposure to anticholinergics or antispasmodics within the last 4 weeks (among them: atropine, tolterodine, benztropine, trihexyphenidyl, dicyclomine, hyoscyamine, and scopolamine)
- •Exposure to drugs with known effects on cognition (i.e. opioids, benzodiazepines or sedating antihistamines) within the last week
- •Exposure to drugs contraindicated or cautioned in use with the 2 study medications (drugs that also use the cytochrome P450 enzyme, primarily CYP3A4). These include: ketoconazole, itraconazole, miconazole, erythromycin, clarithromycin, ritonavir, nelfinavir, nefazodone, flecainide, thioridazine and tricyclic antidepressants.
- •Nonpharmacological treatment of OAB within the last 4 weeks (for example: biofeedback, physical therapy, acupuncture)
- •Uncontrolled narrow angle glaucoma
- •History of gastric or urinary retention / dysmotility (ulcerative colitis, myasthenia gravis and severe constipation)
- •History of hepatic or renal impairment
- •History of severe gastro-esophageal reflux disease and/or use of bisphosphonates, patients at risk for esophagitis
- •Previous exposure to anticholinergic for OAB symptoms that resulted in side effects that caused cessation of the medication
研究组 & 干预措施
Arm 1
crossover design
干预措施: Oxybutynin and darifenacin (Drug)
结局指标
主要结局
compare cognitive side effects
时间窗: 10 weeks
次要结局
未报告次要终点