NCT04063852已完成不适用
Impact of Percutaneous Posterior Tibial Nerve Stimulation on Urinary and Global Quality of Life in Multiple Sclerosis Patients
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Urinary Frequency and/or Urinary Incontinence Episodes on 3 day voiding diary
研究概览
简要总结
This is a single-centered, prospective, longitudinal, observational cohort study of patients with MS who suffer from lower urinary tract symptoms (LUTS) and are refractory to two prior treatment modalities who have elected to pursue PTNS therapy for LUTS.
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
- 否
入选标准
- •Diagnosis of Multiple Sclerosis
- •Lower urinary tract symptoms (urinary frequency, urgency and/or incontinence)
- •Failed prior first and second line therapy (behavioral and pharmacotherapy)
- •Electing for Posterior Tibial Nerve Stimulation therapy for urinary symptoms
- •Patients performing Intermittent Catheterization are Eligible
排除标准
- •Indwelling catheters (urethral or suprapubic)
- •Currently pregnant or planning pregnancy
- •Unable to attend weekly office visits for PTNS
- •Urodynamic findings of bladder outlet obstruction
- •History of:
- •bladder reconstruction (augmentation cystoplasty, catheterizable channel) cystectomy bladder stones pacemaker or defibrillator malignancy of bladder sacral neuromodulation intravesical injection of onabotulinum toxin within 9 months
结局指标
主要结局
Urinary Frequency and/or Urinary Incontinence Episodes on 3 day voiding diary
时间窗: up to 24 months.
Change from baseline in the median number of urinary frequency and/or urinary incontinence episodes on a 3 day voiding diary at 3, 12, and 24 months
次要结局
未报告次要终点
研究者
Giulia Lane
Assistant Professor
University of Michigan
研究点 (1)
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