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临床试验/NCT03202251
NCT03202251已完成不适用

The Impact of Deep Brain Stimulation in Patients With Lower Urinary Tract Symptoms: A Prospective, Observational, Cohort Study

The Methodist Hospital Research Institute1 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2017年4月11日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
6
试验地点
1
主要终点
Change from Baseline in AUASS (American Urological Association Symptom Score)

研究概览

简要总结

Deep brain stimulation (DBS) is a neurosurgical procedure using a device that improves motor symptoms of specific neurological and movement disorders such as Parkinson's disease or Essential Tremor. As part of the patient's care, the DBS is implanted when symptoms cannot be satisfactorily controlled with medications or conventional therapies. Lower urinary tract symptoms are common in patients who have underlying neurological or movement disorders and control over lower urinary tract function is poorly understood. In this study investigators are evaluating the effects of DBS on lower urinary tract function.

详细描述

Deep brain stimulation (DBS) is a neurosurgical procedure that improves motor symptoms of specific neurological and movement disorders such as Parkinson's disease or Essential Tremor. DBS is implanted when symptoms cannot be satisfactorily controlled with medications or conventional therapies. After insertion of deep electrodes, electrical stimulation will be delivered to modulate specific neurons in certain areas of the brain. Despite, the known motor effects for DBS, its nonmotor effects on other organs such as the urinary tract and bladder function remains unclear. Lower urinary tract symptoms such as frequency, urgency, urinary incontinence, or incomplete bladder emptying are common in patients who have underlying neurological or movement disorders. In addition, central neural control over lower urinary tract function is still poorly understand. In this trial investigators plan to evaluate the effects of Deep Brain Stimulators (DBS) on lower urinary tract function. This trial is designed to test the hypothesis that DBS improves objective and subjective symptoms of lower urinary tract function in specific patient populations. The investigators plan to test this hypothesis by using validated patient reported outcome questionnaires and urodynamic testing (both are part of routine care for neurogenic bladder) before and after DBS implantation. In addition, this trial will shed some light in understanding higher neural control of bladder and potentially identify target areas for future intervention.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients who are a candidate for Deep Brain Stimulation (DBS) as standard care for neurologic symptoms and have a moderate or greater urinary bother American Urological Association Symptom Score (AUASS≥8)

排除标准

  • Pregnant, breastfeeding mothers and all individuals younger than 18 years of age will be excluded. Patients with history of urinary diversion or augmentation cystoplasty will also be excluded.

结局指标

主要结局

Change from Baseline in AUASS (American Urological Association Symptom Score)

时间窗: Change in AUA symptoms score at Post DBS Implant (≥ 60 days after procedure) measurement compared to Pre-DBS (≤60 day prior to procedure) measurement.

Subjective assessment of Deep Brain Stimulation (DBS) effect on urinary symptoms measured by AUASS questionnaire (from none= 0 to most severe=35)

Change from Baseline in I-QOL (Incontinence Quality of Life score)

时间窗: Change in I-QOL score at Post DBS Implant (≥ 60 days after procedure) measurement compared to Pre-DBS (≤60 day prior to procedure) measurement.

Subjective assessment of DBS effect on urinary incontinence related QOL measured by I-QOL questionnaire. Scores would be from 0 to 100. Higher scores indicate less impact of urinary incontinence on quality of life

次要结局

  • Change from baseline in Bladder Compliance(Change in bladder compliance at Post DBS Implant (≥ 60 days after procedure) urodynamic study compared to Pre-DBS (≤60 day prior to procedure) urodynamic study.)
  • Change from Baseline in Neurogenic Detrusor Overactivity (NDO)(Change in Neurogenic Detrusor Overactivity pattern at Post DBS Implant (≥ 60 days after procedure) urodynamic study compared to Pre-DBS (≤60 day prior to procedure) urodynamic study.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Rose Khavari, M.D.

Director of Research, Center for Restorative Pelvic Medicine

The Methodist Hospital Research Institute

研究点 (1)

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