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Efficacy & Safety of a 2nd Series of Low Intensity Shock Waves for ED on Partial Responders to First Treatment

2012年7月25日 更新者:Rambam Health Care Campus

Efficacy and Safety of a Second Series of Low Intensity Extracorporeal Shock Wave Therapy (LI-ESWT) Treatment for Erectile Dysfunction Patients Who Were Partial Responders to the Initial Treatment.

Low intensity shock waves (LISW) have been proven in animal studies to induce local growth of new blood vessels. The investigators hypothesized that LISW therapy could improve the symptoms of patients with erectile dysfunction resulting from a problem of blood supply who respond to oral therapy (PDE-5 inhibitors). The current study will check the Efficacy and Safety of a Second Series of LISW Treatment for Erectile Dysfunction Patients Who Were Partial Responders to the Initial Treatment.

研究概览

详细说明

The patients will be selected out of the patients with Erectile Dysfunction who received Low intensity shock waves and Were Partial Responders to the treatment.

At the first meeting the patient will receive a full explanation of the study, the potential efficacy and risks. After that the patient will be asked to sign an informed consent form. The patient's general medical condition and any problems related to sexual dysfunction are already known from the previous study he was participating. Also the patient's sexual function is already known by sexual function questionnaires that were filled out in previous study. The criteria for inclusion and exclusion will be reviewed, as well as physical examination. Then shall the patient obtain reporting sexual encounter diaries (SEP) and will be asked to avoid using PDE5i's for a month (washout), if he did not do so of some reason after ending the previous study, then it would be the first visit (Visit 1). At visit 1 The patient will be questioning the sexual function questionnaires without PDE5i's and will pass examination performance Endothelial - FMD, the test takes about 10 minutes, it is not an invasive test (not involved in inserting an instrument or any medication) and is painless. The patient may be asked to also undergo Doppler ultrasound. At the end of visit 1 the patient will begin Series of 12 treatments, in which the subject will be treated twice a week for 3 weeks (6 treatments), then would be discontinuation of the study for 3 weeks, and at the end of this period will be treated twice a week for 3 weeks (6 treatments). Four weeks after the treatment series ends the patient will come for another visit and will be asked to fill in questionnaires and perform the FMD and/or Doppler ultrasound test again. The patient's ED condition will be followed up for a long term after the end of his participation in the study.

研究类型

介入性

注册 (预期的)

300

阶段

  • 第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Haifa、以色列
        • Rambam Health Care Campus

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 80年 (成人、年长者)

接受健康志愿者

有资格学习的性别

男性

描述

Inclusion Criteria:

  1. Incomplete response to active treatment (not placebo) on first round but patient is still unsatisfied.
  2. Recurring ED (had improved on first round of shock wave therapy but after a certain period of time became clinically worse again) after shock wave therapy.
  3. A minimum of two sexual attempts per month.
  4. An IIEF-ED domain score ≤ 25 post screening, with or without PDE5i intake according to assessment on final visit of Shockwave previous treatment.
  5. A stable heterosexual relationship with the same partner for more than three months

Exclusion Criteria:

  1. Subjects that did not respond at all to the first round as well as those that did not respond sufficiently.
  2. Any pelvic surgery during the period after the first round.
  3. Any unstable medical or psychiatric condition, spinal cord injury, or penile anatomical abnormalities arising during this period .
  4. cardiovascular conditions that prevent sexual activity.
  5. Recent Use of anti-androgens, or oral or injectable androgens
  6. Recent hormonal, neurologic, or psychological pathology

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:不适用
  • 介入模型:单组作业
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:打开标签
We will apply the cardiospec 1000 unit for LI-ESWL in the penile and inguinal areas, 300 shocks per area, total of 1500 shocks. Full description of treatment series can be seen in the detailed protocol.
其他名称:
  • Cardiospec 1000

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
IIEF-ED Domain score
大体时间:3 months
Severe ED (6≤IIEF-ED Domain score≤10): an increase of 7 points and above; Moderate ED (11≤IIEF-ED Domain score≤16): an increase of 5 points and above; Mild ED (17≤IIEF-ED Domain score≤25): an increase of 2 points and above.
3 months

次要结果测量

结果测量
措施说明
大体时间
Rigidity Score Questionaire
大体时间:3 months
An increase of at least 1 point is considered as a treatment success.
3 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Ilan Gruenwald, MD、Rambam Health Care Campus
  • 研究主任:Yoram Vardi, Prof. MD、Rambam Health Care Campus

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2012年7月1日

初级完成 (预期的)

2014年7月1日

研究完成 (预期的)

2015年1月1日

研究注册日期

首次提交

2012年5月15日

首先提交符合 QC 标准的

2012年5月16日

首次发布 (估计)

2012年5月17日

研究记录更新

最后更新发布 (估计)

2012年7月26日

上次提交的符合 QC 标准的更新

2012年7月25日

最后验证

2012年7月1日

更多信息

与本研究相关的术语

关键字

其他研究编号

  • 0179-12-RMB

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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