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临床试验/NCT06620419
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.

注册库
clinicaltrials.gov
开始日期
2024年5月15日
结束日期
2026年6月30日
最后更新
3个月前
研究类型
Interventional
研究设计
Single Group
性别
Male

研究者

发起方
Elidah, Inc.
责任方
Sponsor

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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