Low Intensity Extracorporeal Shock Wave Treatment (LI-ESWT) for Erectile Dysfunction (ED): Comparison of 6 Sessions Once a Week vs 12 Sessions Twice Per Week
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- The percent of subjects who achieve clinically important difference (MCID) in the EF domain score of the IIEF
研究概览
简要总结
The present study aims to identify and compare the efficacy and safety of two different session frequency protocols (once vs twice per week) of low intensity extracorporeal shockwave treatment (LI-ESWT) using Aries ED device, in men with mild-moderate and severe vasculogenic ED, who have previously responded to oral PDE5-Is
详细描述
This is a randomized, 2 parallel arms, clinical trial. All patients will be PDE5I users/responders. After 1 month wash-out period, ED patients will be screened, in order to randomized 42 men with vasculogenic ED who had International Index of Erectile Function ED (IIEF-ED) domain scores between 6-25 and abnormal penile triplex-based hemodynamic parameters (peak flow velocity <35cm/sec). Then the 42 pts will be randomized to receive either one or two shockwave treatment sessions per week, without treatment interval. Every week all subjects may have at least one attempt for intercourse. All patients will complete 6 weeks of treatment.
Study visits and duration
Visit 1 (day 0): the basic work-up will take place, including medical and sexual history, as well as necessary lab tests, if needed. One month wash-out period will follow. During this period, all subjects will be asked to avoid any drug related to ED (PDE5i) and have at least 2-4 attempts for intercourse. Furthermore, patients will undergo triplex ultrasonography, unless they have already done so in the last 6 months. all patients will complete the IIEF-ED domain and will be randomized (1:1) to one of the two parallel study groups, using an online program. Groups A will receive treatment once per week for 6 weeks (6 sessions totally), and Groups B will receive treatment two times per week for 6 weeks (12 sessions totally). PDE5i use is prohibited throughout the study.
Treatment Visits: Patients will receive LI-ESWT , according to the study protocol.Interval between 2 treatments will be 7+2days for Group A and 3+1 day for Group B.At visit 6 and 12 a penile ultrasonography will be conducted in order to check for potential adverse events related to the treatment.
Follow-up visits 1 - 3 (4, 12 and 24 weeks post treatment): Patients will complete the IIEF-ED questionnaire and return the completed SEP diaries for the last 4 weeks prior to every visit. Visit data will also be recorded (protocol compliance, adverse events). At Week 12, triplex will be performed by the standard protocol. For Week 4 there is a + 3 days visit window, whereas for Weeks 12 and 24 there is a + 2 weeks visit window.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Consent to participate
- •Presence of vasculogenic erectile dysfunction for at least 6 months
- •Positive response to PDE5i
- •IIEF-ED score > 6 and IIEF score < 26 after wash out of PDE5i
- •Abnormal penile triplex-based hemodynamic parameters (peak flow velocity <35cm/sec)
- •Stable heterosexual relationship for more than 3 months
- •Sexually active and agree to suspend all ED therapy for the duration of study
排除标准
- •Any cause of ED other than vascular related
- •Previous radiation therapy to pelvis
- •History of radical prostatectomy
- •Clinically significant chronic haematological disease
- •Cardiovascular conditions that prevent sexual activity
- •Peyronie's Disease or penile curvature
- •History of heart attack, stroke or any life- threatening arrhythmia within the prior 6 month
- •Anti-androgens oral or injectables androgens
- •Untreated Hypogonadism as demonstrated by abnormal testosterone levels
- •Malignancy within the past 5 years
- •Any unstable medical, psychiatric condition or spinal cord injury
- •Anatomical or neurological abnormalities in the treatment area
- •Use of any treatment for ED within 7 days of screening ( oral medications, vacuum devices, constrictive devices, injections or urethral suppositories)
- •Known allergy to ultrasound gel
研究组 & 干预措施
Group A
Patients will receive one session of low intensity extracorporeal shock wave treatment (LI-ESWT) per week for 6 weeks (6 sessions totally).
干预措施: Dornier Aries- ED device (Device)
Group B
Patients will receive two sessions of low intensity extracorporeal wave treatment (LI-ESWT) per week for 6 weeks (12 sessions totally).
干预措施: Dornier Aries- ED device (Device)
结局指标
主要结局
The percent of subjects who achieve clinically important difference (MCID) in the EF domain score of the IIEF
时间窗: at 6 month follow up visit
MCID is defined according to baseline ED severity as: * Improvement by 2 or more in the EF domain score of the IIEF for patients with mild ED ( EF scores 17-25) at baseline. * Improvement by 5 or more in the EF domain score of the IIEF for patients with moderate ED(EF scores 11-16) at baseline * Improvement by 7 or more in the EF domain score of the IIEF for patients with severe ED (EF scores 0-10) at baseline
次要结局
- Change in the EF domain score of the IIEF(baseline and 6 month follow up visit.)
- Change in Sexual Encounter Profile Question 3 (SEP3) score(baseline and 6 month follow up visit.)
- Change in mean peak systolic velocity (PSV)(baseline and 3 month follow up visit)
- Number of patients with treatment related adverse events(30 weeks)
研究者
Dimitrios Hatzichristou
President
Institute for the Study of Urological Diseases, Greece