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TerminatedNCT03237143Updated Feb 5, 2019

Low-intensity Extracorporeal Shock Wave for Erectile Disfunction

An observational study in Erectile Dysfunction, sponsored by Boston Medical Group. Terminated. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-02-05.

Sponsored by Boston Medical Group · Observational

Why this study was terminated
The research question was resolved in a metanalysis
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
710
Ages
18 Years and older
Sex
Male
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Study summary

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.

Read the detailed description

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.

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Conditions studied

  • Erectile Dysfunction

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03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients 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)

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
710 participants (actual)
Patient registry
No
05

What researchers measure

Primary outcomes

  1. Erection hardness score

    Erection hardness score (EHS)

    Time frame: one month after the last session

Secondary outcomes

  1. Erection hardness score

    Erection hardness score (EHS)

    Time frame: At the end after the last session

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • Ayala HAC, Cuartas JPS, Cleves DC. Impact on the Quality of Erections after Completing a Low-Intensity Extracorporeal Shock Wave Treatment Cycle on a Group of 710 Patients. Adv Urol. 2017;2017:1843687. doi: 10.1155/2017/1843687. Epub 2017 Dec 21. PubMed 29430250 ↗

Individual participant data

Plan to share: No

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Registry details

Key details

Study ID
NCT03237143
Lead sponsor
Boston Medical Group
Responsible party
Sponsor
First posted
Aug 2, 2017
Start date
Jun 1, 2015
Primary completion
Jan 30, 2016
Completion
Jun 30, 2016
Last update
Feb 5, 2019

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.

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