Low-intensity Shockwave Therapy for Post-radical Prostatectomy Erectile Dysfunction
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- To assess the effectiveness of LiSWT in participants with mild to moderate erectile dysfunction post-prostatectomy with the Erectile Hardness Score questionnaire.
研究概览
简要总结
This research study is trying to determine if Low-Intensity shock wave therapy (LiSWT) is safe and effective in patients with symptoms of erectile dysfunction (ED) after radical prostatectomy.
详细描述
Participants will be randomized to the active treatment group or the control/placebo group.
All patients on active treatment will receive Low-Intensity shock wave treatment. Participants assigned to the control group will receive the treatment using a sham applicator. The placebo group will receive the same treatment as the active group, but the transducer used for shock wave treatment will be capped, meaning that no shock waves will be transmitted to the penis.
Participants on active shock wave treatment will receive once a week Low-Intensity shock wave treatments of 0.2 mJ/ mm² over the lateral penile shaft (distal, mid, and proximal penile shaft), 500 impulses in each area, for a total of 1500 shocks along the penis once a week for six weeks, with a total of 6 treatments once a week.
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
- 45 Years 至 70 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Men age 45-70 who had robotic prostatectomy within 6 to 18 months
- •Documented nerve sparing during radical prostatectomy procedure
- •Mild to moderate ED after prostatectomy
- •IIEF score > 18 before surgery
- •Testosterone level > 300 mg/dl post-surgery
- •Sexually active
排除标准
- •Prior penile surgery
- •Lesions or active infections on the penis or perineum
- •Anatomical abnormalities in the genitalia or pelvic region
- •Unwilling to remove piercing from genital region
- •Post radical prostatectomy complications that could impact safety or effectiveness of ESWT (hematoma, unresolved anastomotic leak)
- •Previous or scheduled treatment with pelvic radiotherapy and/or androgen deprivation therapy
- •Anticoagulant medication (except acetylsalicylic acid up to 80 mg daily).
- •Any other condition that would prevent the patient from completing the study, as judged by the PI
研究组 & 干预措施
Active
- Patient lies down with legs extended.
- In order to get a proper transmission, a drop of silicone oil is applied on the anatomical stand-off before putting the ring.
- Connect the headpiece to the ring.
- Apply ultrasound gel for proper energy transmission on the shaft of the penis
- 1500 shocks to the lateral penile shaft (distal, mid, and proximal penile shaft), 500 impulses in each area, for a total of 1500 shocks along the penis
- Duration of the procedure: approximately 30 minutes
干预措施: Low-Intensity Shockwave therapy (LiSWT) (Device)
Control
- Patient lies down with legs extended.
- In order to get a proper transmission, a drop of silicone oil is applied on the anatomical stand-off before putting the ring.
- Connect the headpiece to the ring.
- Apply ultrasound gel for proper energy transmission on the shaft of the penis
- 1500 shocks to the lateral penile shaft (distal, mid, and proximal penile shaft), 500 impulses in each area, for a total of 1500 shocks along the penis
- Duration of the procedure: approximately 30 minutes
干预措施: Low-Intensity Shockwave therapy (LiSWT) (Device)
结局指标
主要结局
To assess the effectiveness of LiSWT in participants with mild to moderate erectile dysfunction post-prostatectomy with the Erectile Hardness Score questionnaire.
时间窗: 4 months
The Erection Hardness Score is a self-reported tool that measures the hardness of an erection. It involves a scale report from 0 to 4, 4 being the best quality of erection.
To assess the effectiveness of LiSWT in participants with mild to moderate erectile dysfunction post-prostatectomy with the International Index of Erectile Function questionnaire.
时间窗: 4 months
The International Index of Erectile Function is a multidimensional scale that can be used to evaluate ED. It addresses the most relevant aspects of male sexual function. It involves five questions with a scale report from 0 to 5, 5 being the best value.
次要结局
- To determine whether LiSWT improves the Resistive index in the Duplex Doppler Ultrasound.(4 months)
- To determine whether LiSWT improves the Peak systolic velocity in the Duplex Doppler Ultrasound.(4 months)
研究者
Brian Miles
Brian J Miles MD
The Methodist Hospital Research Institute