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Linear Piezoelectric Low Intensity Shockwave Treatment (LI-SWT) for the Treatment of Erectile Dysfunction in PDE5i Non Responder

2026年9月10日 更新者：HUNG PUI LONG WILSON、The University of Hong Kong

Linear Piezoelectric Low Intensity Shockwave Treatment (LI-SWT) for the Treatment of Erectile Dysfunction in PDE5i Non Responder: A Randomized-Controlled Trial

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.

研究概览

地位

招聘中

条件

干预/治疗

研究类型

介入性

注册 (估计的)

40

阶段

  • 不适用

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。

学习联系方式

学习地点

  • 香港
      • Hong Kong、香港
        • 招聘中
        • Queen Mary Hospital
        • 接触：
        • 首席研究员：
          • Pui Long Wilson Hung, MBBS

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

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  • Male
  • 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

Exclusion Criteria:

  • 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

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：随机化
  • 介入模型：交叉作业
  • 屏蔽：双倍的

武器和干预

参与者组/臂
干预/治疗
实验性的：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
设备：low-intensity shockwave therapy
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
假比较器：Sham
Sham comparator with the device deactivated
设备：Sham low-intensity shockwave therapy
Sham low-intensity shockwave therapy with device deactivated

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
Proportion of men with improvement in International Index of Erectile Function (IIEF) score at 1 month after traetment
大体时间：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.
1 month after Sham/LiSWT

次要结果测量

结果测量
措施说明
大体时间
Proportion of men meeting the Minimal Clinically Important Difference (MCID) in the International Index of Erectile Function (IIEF) score
大体时间：1 month
The International Index of Erectile Function (IIEF) is a self-administered questionnaire used to assess erectile function.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 a minimal clinically important difference (MCID) in the IIEF-5 score compared to baseline.
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
大体时间：6 and 12 months after treatment
IIEF is a self-administered questionnaire used to assess erectile function. 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 a minimal clinically important difference (MCID) in the IIEF-5 score compared to baseline.
6 and 12 months after treatment
Erectile hardness score (EHS) at 1,6, 12 months after treatment
大体时间：1, 6, 12 months after LiSWT treatment
vertical score assessing penile hardness on a 4-point single-item scale ranging from 1 to 4, where 1 indicates "penis is larger, but not hard" and 4 indicates "penis is completely hard and fully rigid." Higher scores indicate better erectile function/rigidity.
1, 6, 12 months after LiSWT treatment
Side effects and safety profile
大体时间：From initiation of first Sham/LiSWT treatment until 12 months after the last LiSWT treatment
e.g. tolerability, pain using the visual analogue scale, bleeding, bruising, penile plaque, penile deformity Safety and tolerability will be evaluated by recording the incidence, severity, and type of all treatment-related adverse events. Pain will be assessed using a Visual Analogue Scale (VAS), a single-item numeric scale ranging from 0 (no pain) to 10 (worst possible pain), where higher scores indicate greater pain intensity. Specific adverse events evaluated include penile pain, bleeding, bruising, formation of penile plaque, and penile deformity.
From initiation of first Sham/LiSWT treatment until 12 months after the last LiSWT treatment

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。

赞助

The University of Hong Kong

合作者

Queen Mary Hospital, Hong Kong

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 (实际的)

2026年1月7日

初级完成 (估计的)

2026年12月31日

研究完成 (估计的)

2027年3月31日

研究注册日期

首次提交

2026年6月24日

首先提交符合 QC 标准的

2026年9月10日

首次发布 (实际的)

2026年9月15日

研究记录更新

最后更新发布 (实际的)

2026年9月15日

上次提交的符合 QC 标准的更新

2026年9月10日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • LiSWTED

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

未定

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

在美国制造并从美国出口的产品

不

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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