Study Stopped
The research question was resolved in a metanalysis
Low-intensity Extracorporeal Shock Wave for Erectile Disfunction
Quality of Erections After Completing a Low-intensity Extracorporeal Shock Wave Treatment Cycle
1 other identifier
observational
710
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2015
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 30, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2016
CompletedFirst Submitted
Initial submission to the registry
July 31, 2017
CompletedFirst Posted
Study publicly available on registry
August 2, 2017
CompletedFebruary 5, 2019
August 1, 2017
8 months
July 31, 2017
February 1, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Erection hardness score
Erection hardness score (EHS)
one month after the last session
Secondary Outcomes (1)
Erection hardness score
At the end after the last session
Eligibility Criteria
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)
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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.
PMID: 29430250DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 31, 2017
First Posted
August 2, 2017
Study Start
June 1, 2015
Primary Completion
January 30, 2016
Study Completion
June 30, 2016
Last Updated
February 5, 2019
Record last verified: 2017-08
Data Sharing
- IPD Sharing
- Will not share