Low Intensity Shockwave Therapy for Erectile Dysfunction
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 338
- 试验地点
- 2
- 主要终点
- Change in IIEF/SHIM score (International Index of Erectile-Function-5, Sexual Health Inventory in Men) Score at 1 month post-treatment
研究概览
简要总结
Low-intensity shockwave therapy (LiSWT) has been deemed "a safe and well-tolerated procedure but its efficacy for the treatment of ED is doubtful and deserves more investigation" by the European Society of Sexual Medicine. In a similar manner, the Sexual Medicine Society of North America and American Urological Association have put forth guideline statements recommending additional investigation of this treatment modality.2
The current clinical armamentarium only treats the symptoms of erectile dysfunction without improving upon the underlying pathophysiology. LiSWT has been used effectively in musculoskeletal disorders and cardiovascular applications. Animal studies have shown improvements in angiogenesis and stem cell recruitment in other systems (cardiac and musculoskeletal) using shockwave therapy. It has been used to treat erectile dysfunction since 2010 and is widely used in Europe and throughout the world. It is gaining widespread acceptance in the United States with a relative paucity of data in regards to its effectiveness.
While the majority of studies and meta-analyses show improvements in standardized erectile dysfunction questionnaires (IIEF/SHIM-Sexual Health Inventory in Men, International Index of Erectile Function-5) the durability remains unknown and many have lacked a sham-arm. In addition, many studies have failed to assess a population of men who have highly prevalent erectile dysfunction, those men undergoing prostate cancer treatment.
This is a prospective, randomized, single blind, sham-controlled clinical study aimed to evaluate the safety and efficacy of low-intensity shockwave therapy (LiSWT) on symptomatic ED patients in three distinct patient populations. LiSWT has shown the potential to improve baseline erectile function but requires further study, which is the aim of this investigation.
详细描述
It is estimated that about 1 in 10 adult males suffer from erectile dysfunction (ED) on a long-term basis. Oral therapies, including PDE5I, may be considered first-line therapies for the majority of patients with ED because of potential benefits and lack of invasiveness. This is a prospective, randomized, single-blind, sham-controlled clinical study aimed to evaluate the safety and efficacy of low-intensity shockwave therapy on symptomatic ED patients in three distinct patient populations.
The first arm of the study will be those men with erectile dysfunction as defined by IIEF score (International Index of Erectile Function-5). These men will either have PDE5i refractory or responsive erectile dysfunction. Subjects will receive either Sham treatment (no ultrasound energy delivered via a Sham probe) or LiSWT for erectile dysfunction. Follow up will occur at 1 month, 3 months, and 6 months following the end of treatment. Effectiveness will be measured by change in IIEF/SHIM (IIEF/SHIM-Sexual Health Inventory in Men, International Index of Erectile Function-5) score and EHS (Erection Hardness Score) score.
The Sexual Health Inventory in Men (also referred to as International Index of Erectile Function-5) is scored as follows:
22-25 No erectile dysfunction 17-21 Mild erectile dysfunction 12-16 Mild-to-moderate erectile dysfunction 8-11 Moderate erectile dysfunction 5-7 Severe erectile dysfunction
The patient responds to the following questions:
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, Outcomes Assessor)
盲法说明
Patients will be randomized to either the treatment group or sham group.
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
- 是
入选标准
- •The patient must be willing and able to provide informed consent.
- •The patient is a male between >30 and <80 years of age.
- •PDE5i responsive or non-responsive. If on PDE5i patient will discontinue medication for 2 weeks before baseline IIEF.
- •Baseline IIEF-EF score ≥ 8 and ≤
- •If taking PDE5i, stop medication for at least 4 weeks before baseline IIEF.
- •Testosterone level > 300 ng/dL. This includes patients on therapeutic testosterone therapy.
- •If diabetic, HgbA1C level ≤ 7.5% within 3 months prior to enrollment.
- •Men who have undergone radical prostatectomy ≥ 12 months ago
- •Men who have undergone radiation therapy, either brachytherapy or external bean therapy ≥ 12 months ago
排除标准
- •History of extensive pelvic surgery ever.
- •Past radiation therapy of the pelvic region within 12 months prior to enrollment.
- •Recovering from any non-prostate related cancer within 12 months prior to enrollment.
- •Neurological disease which affects erectile function at the discretion of the investigator.
- •Anatomical malformation of the penis, including Peyronie's disease.
- •Testosterone level <300 within 3 month prior to enrollment.
- •HgbA1C level > 7.5% within 3 month prior to enrollment.
- •History of spinal cord injury.
- •Recovering from any non-prostate cancer malignancy within 12 months prior to enrollment.
结局指标
主要结局
Change in IIEF/SHIM score (International Index of Erectile-Function-5, Sexual Health Inventory in Men) Score at 1 month post-treatment
时间窗: 1 month
The primary outcome will be change in (International Index of Erectile-Function-5, Sexual Health Inventory in Men) score from baseline (pre-treatment) to 1 month after the end of treatment. The IIEF/SHIM score is a validated instrument to assess erectile function. Over the past 6 months: 1. How do you rate your confidence that you could keep an erection? 2. When you had erections with sexual stimulation, how often were your erections hard enough for penetration (entering your partner)? 3. During sexual intercourse, how often were you able to maintain your erection after you had penetrated (entered) your partner? 4. During sexual intercourse, how difficult was it to maintain your erection to completion of intercourse? 5. When you attempted sexual intercourse, how often was it satisfactory for you? Each item is scored 1-5, with a higher number indicating better rigidity.
次要结局
- Changes in (International Index of Erectile-Function-5, Sexual Health Inventory in Men) at 3 and 6 months post-treatment(3 and 6 months)
- Change in Erection Hardness Score at 1, 3, and 6 months(1, 3, and 6 months)
- Adverse Event Rates(1, 3 and 6 months)
研究者
Ryan Smith, MD
Associate Professor of Urology
University of Virginia