Linear Piezoelectric Low Intensity Shockwave Treatment (LI-SWT) for the Treatment of Erectile Dysfunction in PDE5i Non Responder: A Randomized-Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Proportion of men with improvement in International Index of Erectile Function (IIEF) score at 1 month after traetment
研究概览
简要总结
The goal of this clinical trial is to assess the efficacy and safety of linear piezoelectric Li-SWT for erectile dysfunction patients who have poor treatment respond from PDE5i oral treatment. Participants will be randomised to either receive 4 cycles, once per week, of Li-SWT treatment on the penis or the Sham group, where the treatment appears to be identical but the shockwave machine is deactivated. Investigators will compare the before and after treatment erectile function using the IIEF questionnaire of the two groups 1 month after treatment to assess the treatment outcome. After that, the Sham group patient would be offered to receive compensatory Li-SWT treatment and their post treatment response will be assessed.
All the patients completing the Li-SWT treatment will be followed up at 6 and 12 months to assess the efficacy and adverse events.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Age 30-80 years
- •ED for at least 6 months, defined by IIEF-EF score 8-21 (moderate - mild)
- •Sexually active in a stable, heterosexual relationship of more than 3 months duration.
- •Agree to comply with all study related tests/procedures
- •Morning serum testosterone >12nmol/L
- •Inadequate response after at least 4 attempts using highest tolerated PDE5i
排除标准
- •Previous penile surgery (e.g. penile lengthening, penile cancer surgery, penile plication, grafting, penile implant).
- •Previous history of priapism or penile fracture
- •Morning serum testosterone level <12nmol/L
- •Current or previous hormone usage, other than prescribed testosterone, clomiphene or thyroid medication. (Subjects with prior or current use of hormonal treatment for prostate cancer are also excluded
- •Psychogenic ED as determined by study investigator
- •Anatomical (Peyronie's Disease or penile curvature) abnormality
- •Neurological disease (Parkinson's, spinal cord injury)
- •Anti-coagulation therapy and/or INR >1.5 (Patients on aspirin are eligible) 7
- •Current or prior history of sexually transmitted disease
- •Tumor tissue/Treatment for cancer in the penile or pelvic region in past 5 years
- •Electronic devices implanted in the body (e.g. cardiac pacemaker, deep brain stimulator, spinal cord neurostimulator etc.)
- •Any other medical conditions or medical history that are deemed unsafe or high risk for the study treatment per investigator's discretion
研究组 & 干预措施
LiSWT
LiSWT with 8Hz, 0.16 mJ/mm2, wave focus penetration depth 10-15mm at corpora cavernosa (2000 shock), crus of the penis (2000 shock), Once per week for 4 weeks
干预措施: low-intensity shockwave therapy (Device)
Sham
Sham comparator with the device deactivated
干预措施: Sham low-intensity shockwave therapy (Device)
结局指标
主要结局
Proportion of men with improvement in International Index of Erectile Function (IIEF) score at 1 month after traetment
时间窗: 1 month after Sham/LiSWT
Total scores range from 5 to 25, where higher scores indicate better erectile function/lower severity of erectile dysfunction. This outcome measure reports the proportion of participants achieving an improvement in IIEF score compared to baseline.
次要结局
- Proportion of men meeting the Minimal Clinically Important Difference (MCID) in the International Index of Erectile Function (IIEF) score(1 month)
- Proportion of men meeting the Minimal Clinically Important Difference (MCID) in the International Index of Erectile Function - Erectile Function (IIEF-EF) domain score at 6 and 12 months after treatment(6 and 12 months after treatment)
- Erectile hardness score (EHS) at 1,6, 12 months after treatment(1, 6, 12 months after LiSWT treatment)
- Side effects and safety profile(From initiation of first Sham/LiSWT treatment until 12 months after the last LiSWT treatment)
研究者
HUNG PUI LONG WILSON
Associate Consultant
The University of Hong Kong