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临床试验/NCT03237143
NCT03237143终止不适用

Quality of Erections After Completing a Low-intensity Extracorporeal Shock Wave Treatment Cycle

Boston Medical Group0 个研究点目标入组 710 人开始时间: 2015年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
710
主要终点
Erection hardness score

研究概览

简要总结

Introduction: Erectile dysfunction occurs in a high percentage of patients today, showing not only an association with various pathologies but also frequent refractoriness to conventional pharmacological treatment options such as monotherapy. The objective of this study is to evaluate the response to low-intensity extracorporeal shock wave therapy in a group of patients with organic vascular erectile dysfunction with a history of more than three months.

Materials and Methods: Observational retrospective study. The researchers reviewed clinical records of patients with a clinical diagnosis of organic vascular erectile dysfunction (ED) of more than 3 months duration, who received 5 outpatient shock wave therapy sessions, in the male sexual health clinics of the Boston Medical Group from Spain and Mexico. The patients were evaluated with the erection hardness score (EHS) before the first session, at the end of the last session and one month after the last session.

详细描述

Clinical records of patients over 18 years of age with a clinical diagnosis of organic vascular ED, of more than three months and with an erection hardness score (EHS)(17) of three or less, treated between April 2014 and February 2015 in the Boston Medical Group male sexual health clinics of twelve cities in Spain (Madrid, Barcelona, Valencia, Seville, Coruña, Bilbao, Malaga, Zaragoza, Murcia, Alicante, Cordoba and Jerez) and four in Mexico (Altavista, Reforma, Monterrey and Naucalpan), were reviewed. The researchers excluded patients with ED caused by side effects from drugs or spinal cord injury; situational ED (obvious psychological origin); lesions, loss of skin or penile implant; and patients who did not adequately complete the LI-ESWT (Low-intensity extracorporeal shock wave therapy).

After the initial assessment and diagnosis consultation, each patient received a treatment of 5 sessions (1 session per week) of 20 minutes of LI-ESWT, carried out with the DUOLITH SD1 (Storz Tägerwilen, Switzerland). They received 3,000 impulses per session at 0.1 mJ/mm2, divided over six sites, four on the penis and two on the crura. All sessions were outpatient visits and no anaesthetic was used. The EHS for all patients was measured at three stages: before the first session, at the end of the last session (5 weeks after the first session) and one month after the last session. When patients were receiving concomitant drug treatment for their dysfunction, they were asked to indicate their perception free of the effect thereof. All the clinical information was recorded by qualified physicians on a standardised form using centralised software on a secure server.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • patients over 18 years of age
  • clinical diagnosis of organic vascular ED of more than three months and with an erection hardness score (EHS) of three or less

排除标准

  • patients with ED caused by side effects from drugs or spinal cord injury
  • situational ED (obvious psychological origin)
  • lesions, loss of skin or penile implant
  • patients who did not adequately complete the LI-ESWT

结局指标

主要结局

Erection hardness score

时间窗: one month after the last session

Erection hardness score (EHS)

次要结局

  • Erection hardness score(At the end after the last session)

研究者

申办方类型
Industry
责任方
Sponsor

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