Erectile DysfunctionNCT03237143
Low-intensity Extracorporeal Shock Wave for Erectile Disfunction
An observational study of Erectile Dysfunction, run by Boston Medical Group.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Erectile Dysfunction
- How many people
- 710 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2015to 30 Jun 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
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)
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: Quality of Erections After Completing a Low-intensity Extracorporeal Shock Wave Treatment Cycle
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.
- Conditions
- Erectile Dysfunction
- Medical subject headings
- Erectile Dysfunction
What is being measured
The primary outcome is the main question the study is designed to answer.
Erection hardness score
Erection hardness score (EHS)
Measured: one month after the last session
Secondary outcomes (1)
Erection hardness score
Erection hardness score (EHS)
Measured: At the end after the last session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2017
- Study start1 Jun 2015
- Primary completion30 Jan 2016
- Study completion30 Jun 2016
Why it stopped: The research question was resolved in a metanalysis
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Erectile DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 710 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Medical Group
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03237143
- Sponsor's protocol ID
- BMGC-1
- Status last verified
- Aug 2017
- First submitted
- 31 Jul 2017
- Last updated
- 5 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Erections After Completing a Low-intensity Extracorporeal Shock Wave Treatment Cycle
- ClinicalTrials.gov ID
- NCT03237143
- Acronym / sponsor ID
- BMGC-1
- Conditions
- Erectile Dysfunction
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The research question was resolved in a metanalysis
- Enrolment
- 710 participants (actual)
- Lead sponsor
- Boston Medical GroupIndustry (pharma, biotech, devices)
- Study start
- 1 Jun 2015 (actual)
- Primary completion
- 30 Jan 2016 (actual)
- Study completion
- 30 Jun 2016 (actual)
- First posted
- 2 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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)
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Erection hardness score
Time frame: one month after the last session
Erection hardness score (EHS)
1 secondary outcome
Erection hardness score
Time frame: At the end after the last session
Results and safety
The study was stopped early (reason given: The research question was resolved in a metanalysis). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2019.
- Derived from this study: PubMed 29430250Ayala 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Erectile Dysfunction, run by Boston Medical Group.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The research question was resolved in a metanalysis). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Erection hardness score (time frame: one month after the last session). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03237143, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2019.