NCT06620419
进行中(未招募)
不适用
Clinical Evaluation of Perineal Electrical Stimulation for Urinary Incontinence in Men
Elidah, Inc.1 个研究点 分布在 1 个国家目标入组 30 人2024年5月15日
概览
- 阶段
- 不适用
- 干预措施
- Perineal-applied electrical stimulation
- 疾病 / 适应症
- Urinary Incontinence
- 发起方
- Elidah, Inc.
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Reduction in Leakage by Pad weight
- 状态
- 进行中(未招募)
- 最后更新
- 3个月前
概览
简要总结
The purpose of this research is to evaluate the effectiveness of the Elidah neuromuscular stimulation treatment to reduce incontinence in men post-prostatectomy.
研究者
入排标准
入选标准
- •Scheduled for robotic-assisted laparoscopic prostatectomy
- •Read and speak English
- •Predominant SUI of at least 1 pad/day
排除标准
- •History or symptoms of urinary incontinence, urinary retention, extra-urethral incontinence, overflow incontinence
- •Complete denervation of the pelvic floor
- •Severe Obesity as defined by BMI \>= 40
- •Has undergone pre-op pelvic floor exercise strengthening
- •Pelvic pain/painful bladder syndrome
- •Implanted cardiac device, untreated cardiac arrhythmia or suffer from other heart problems.
- •History of epilepsy
- •Underlying neurologic/neuromuscular disorder
- •Metal implants in the abdomen or pelvic area
- •Chronic coughing
研究组 & 干预措施
Treatment group
Self-applied electrical stimulation for 6 weeks.
干预措施: Perineal-applied electrical stimulation
结局指标
主要结局
Reduction in Leakage by Pad weight
时间窗: 6 weeks
24-hr pad weight
次要结局
- Safety measured by no Adverse events(6 weeks)
- Reduction in leakage at Night(6 weeks)
- Quality of Life Improvement(6 weeks)
- Reduction in leakage(6 weeks)
研究点 (1)
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