Randomized Controlled Trial of Low Intensity Shockwaves Therapy for the Treatment of Post-Radical Prostatectomy Erectile Dysfunction. SHARP-ED TRIAL
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Change in number of participants reporting on Penetrative Intercourse
研究概览
简要总结
Research study designed to learn about and compare Shockwave therapy (SWT) vs placebo (no shockwaves) treatment in men with moderate to severe erectile dysfunction (ED) after Radical Prostatectomy
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Be willing and able to provide informed consent.
- •Be ≥ 40 and ≤ 75 years of age (inclusive).
- •Undergo radical prostatectomy for prostate cancer (nerve sparing or non-nerve sparing without neoadjuvant chemotherapy or radiation therapy.)
- •Be at least six weeks post radical prostatectomy.
- •Be in a stable sexual relationship for over 3 months prior to enrollment.
- •Have testosterone level of 300-1000 ng/dL within 1 month prior to enrollment.
- •Have an HbA1c level ≤ 7% within 3 months prior to enrollment.
- •Have undetectable PSA value at the time of enrollment
排除标准
- •Be currently participating in a clinical trial or have recently received an investigational therapy within the past 30 days that may interfere with the results of this study.
- •Be under judicial protection (prison or custody).
- •Be an adult under guardianship.
- •Refuse to sign the informed consent.
- •Have evidence of venous leak prior to surgery or use of PDE5i prior to surgery
- •Have past radiation therapy of the pelvic region or hormonal therapy with androgen deprivation within 12 months prior to enrollment.
- •Be recovering from any cancer within 12 months prior to enrollment (other than prostate cancer)
- •Have Neurological disease such as Alzheimer's or Parkinson's disease which affects erectile function (at the discretion of the investigator).
- •Have a Psychiatric diagnosis or medications such as antidepressants, anxiolytic, antipsychotic that affects erectile function or any other medications (at the discretion of the investigator).
- •Have an anatomical malformation of the penis, including Peyronie's disease.
- •Have testosterone level <300 or >1000 ng/dL within 1 month prior to enrollment.
- •Be using blood thinners with international normalized ratio (INR) to be >
- •Have received shockwave therapy for at least 6 months before enrollment.
- •Have detectable PSA value after the radical prostatectomy.
- •Require radiation therapy after radical prostatectomy.
- •Require hormonal therapy after radical prostatectomy.
研究组 & 干预措施
SWT group
Participants randomized to the treatment group will receive nine (9) shockwave sessions in total: one (1) shockwave session once per week for four (4) weeks, followed by one (1) shockwave session once per month (30±7 days) for the next five (5) months. 1,440 shocks of treatment energy will be applied in every session to each treated region (left and right corpora cavernosa and crura) for a total of 12,960 shocks. Participants will be in this group for up to 6 months.
干预措施: Shockwave Therapy (Device)
SHAM group
Participants randomized to the sham (control) group will have nine (9) sham therapy sessions in total: one (1) sham session once per week for four (4) weeks, followed by one (1) sham session once per month (30±7 days) for the next five (5) months. The shockwave machine will be set to deliver 1,440 shock treatments, but a barrier will be placed around the shockwave probe to ensure that no shockwaves are delivered. Participants will be in this group for up to 6 months.
干预措施: SHAM shockwave therapy (Other)
结局指标
主要结局
Change in number of participants reporting on Penetrative Intercourse
时间窗: Baseline to 6 months and Baseline to 12 months.
Number of participants reporting the ability to have penetrative intercourse with or without PDE5i but without the use of intracavernosal injections was chosen as the primary clinical efficacy assessment tool in this study.
次要结局
- Change in GAQ- Global Assessment Questions(Baseline to 6 months and Baseline to 12 months.)
- Change in Penile blood flow (Penile Duplex Ultrasound) measured in centimeters per second (cm/sec)(Baseline to 12 months.)
- Change in IIEF-EF Scores(Baseline to 6 months and Baseline to 12 months.)
- Change in SEP- Sexual Encounter Profile: Questions 2 and 3(Baseline to 6 months and Baseline to 12 months.)
- Change in EHS- Erection Hardness Score(Baseline to 6 months and Baseline to 12 months.)
研究者
Russell Saltzman
Regulatory Specialist
University of Miami