Evaluating the Efficacy of High-Intensity Focused Electromagnetic Technology in Improving the Time of Recovery of Urinary Control of Continence and Quality of Life for Post-Surgical Patients
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- Mayo Clinic
- 入组人数
- 2,100
- 试验地点
- 2
- 主要终点
- Change in International Consultation on Incontinence Questionnaire Short-Form (ICIQ-SF)
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of High-Intensity Focused Electromagnetic (HIFEM) technology in improving the recovery time of urinary control and quality of life for male patients after radical prostatectomy (RP) and Holmium laser prostate surgery (HoLEP).
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Subjects who are male
- •Post-radical prostatectomy or post HoLEP
- •Experiencing urinary incontinence one-month post-RP
- •Have the capacity to make their own medical decisions
- •Able to complete the questionnaires and visits required.
排除标准
- •Subjects who are not male
- •Not post-radical prostatectomy or post HoLEP
- •Neurologic disease
- •Atonic or hypofunctional bladder (bladder contractility index (BCI) < 100; BCI = pDetQmax+5Qmax)
- •Status post pelvic radiation
- •Past surgical history of other GU surgeries
- •Gross hematuria
- •Concomitant use of medications that cause muscle relaxation or inhibition
- •Indwelling foley catheter at time of treatment
- •Documented urine leak
- •Not experiencing urinary incontinence
- •Do not have the capacity to make their own medical decisions
- •Unable to complete the questionnaires provided.
研究组 & 干预措施
Treatment Group
Subjects randomized to the treatment group will receive 2, 30-minute sessions, weekly for 3 weeks using the Emsella device.
After a 1 week wash-out period, subjects still experiencing urinary leakage will have the option to continue treatment for 3 additional weeks.
干预措施: EMSELLA® (Device)
Placebo Group
Subjects randomized to the placebo group will receive 2, 30-minute sessions, weekly for 3 weeks using a sham comparator device.
After a 1 week wash-out period, subjects in the placebo group who are experiencing urinary leakage will be offered the opportunity to cross-over to an active treatment group for an additional 3 weeks.
干预措施: Sham Comparator Device (Device)
结局指标
主要结局
Change in International Consultation on Incontinence Questionnaire Short-Form (ICIQ-SF)
时间窗: Baseline, 6 weeks, 15 weeks
The International Consultation on Incontinence Questionnaire (ICIQ-SF) is a 4-item questionnaire that assesses the frequency, amount, and impact of urinary leakage. The ICIQ-SF has a scoring range of 0-21, with higher scores indicating more severe symptoms.
Pad weight test
时间窗: Baseline, 6 weeks, 15 weeks
For the pad weight test, subjects will be provided with a small scale and asked to measure the weight of their pad before and after wearing for 24 hours.
次要结局
- Change in International Prostate Symptom Score (IPSS)(Baseline, 6 weeks, 15 weeks)
- Change in Male Sexual Health Questionnaire Short-Form (MSHQ-EjD-SF)(Baseline, 6 weeks, 15 weeks)
- Change in Quality of Life Scale(Baseline, 6 weeks, 15 weeks)
研究者
Mitchell Humphreys
Principal Investigator
Mayo Clinic