- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03308409
Comparative Effectiveness and Safety of Three Protocols Usin Li-ESWT for Erectile Dysfunction
October 31, 2023 updated by: Boston Medical Group
Clinical Randomized Multicentric Trial to Evaluate the Comparative Effectiveness and Safety of Three Protocols Using Low-intensity Shock Waves for the Treatment of Erectile Dysfunction
The patients with primary erectile dysfunction (IIEF-EF <26 points), will be randomly assigned to three shockwave treatment protocols: Protocol 1 six sessions, one per week; Protocol 2, six initial sessions, one per week, followed by monthly maintenance sessions (every 4 weeks) for five months; Protocol 3, six monthly sessions.
The EHS and IIEF-EF scores will be compared as well as the possible adverse events from the therapy upon beginning and completing the treatment and at the 3-month and 6-month follow-ups.
Self-esteem and quality of life will also be evaluated using the SEAR scale.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
277
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: José Saffon, Doctor
- Phone Number: 104 3208899777
- Email: jpsaffon@bostonmedical.com.co
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Men over 18 years of age
- Presence of ED for more than 3 months in over 50% of sexual intercourses.
- Baseline ED domain score under 26 on the IIEF-15 EF domain.
- Patient agrees to participate in the trial by providing signed informed consent.
Exclusion Criteria:
- EHS score of 4.
- Patients with an INR over 3.
- Patients with sickle-cell anemia.
- Patients with clinical suspicion of hypogonadism (AMS over 36).
- Endocrine diseases that present with ED, such as acromegaly, gigantism, Addison's disease, hyperprolactinemia, androgen deficiency.
- Active vesicular, prostrate or colon cancer.
- Radical prostatectomy or other radical pelvic surgery.
- History of pelvic radiation therapy.
- Patients with ED of psychological origin.
- Spinal cord injury or other neurological diseases associated with ED.
- Anatomical penile dysfunction, penile implant.
- Patients with active infections or lesions on the penis or pubic area.
- Patients with ED secondary to drug therapy (antiandrogen therapy, alpha blockers for BPH, use of corticosteroids, medication for Parkinson's disease, antipsychotics).
- Abuse of psychoactive substances.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Protocol 1
Low-intensity extracorporeal shock wave therapy (Li-ESWT): Six sessions, one per week, with 3000 pulses at 0.20 mj/mm2, at a frequency of 4Hz.
At all of the shockwave sessions, 2000 pulses will be distributed to the body of the penis and 1000 pulses will be applied to the base.
|
Low-intensity shock waves are acoustic wavelengths which are transmitted continuously at a frequency between 16 and 20 megahertz for under 10 microseconds.
They generate a pressure pulse and transport energy as they propagate through a medium.
Three different methods can be used to generate this type of wave: electro-hydraulics, electro-magnetics and piezoelectricity.
Regardless of the method, when the shock waves are applied to an organ they interact with the deep tissue.
This causes stress and small mechanical traumas, activating the release of angiogenic factors which induce new vascularization of the affected tissue, thereby improving blood flow.
|
Experimental: Protocol 2
Low-intensity extracorporeal shock wave therapy (Li-ESWT): Six initial sessions, one per week, with 3000 pulses at 0.20 mj/mm2, at a frequency of 4Hz for six weeks, followed by monthly maintenance sessions (every 4 weeks) for five months.
At all of the shockwave sessions, 2000 pulses will be distributed to the body of the penis and 1000 pulses will be applied to the base.
|
Low-intensity shock waves are acoustic wavelengths which are transmitted continuously at a frequency between 16 and 20 megahertz for under 10 microseconds.
They generate a pressure pulse and transport energy as they propagate through a medium.
Three different methods can be used to generate this type of wave: electro-hydraulics, electro-magnetics and piezoelectricity.
Regardless of the method, when the shock waves are applied to an organ they interact with the deep tissue.
This causes stress and small mechanical traumas, activating the release of angiogenic factors which induce new vascularization of the affected tissue, thereby improving blood flow.
|
Experimental: Protocol 3
Low-intensity extracorporeal shock wave therapy (Li-ESWT): Six monthly sessions in which 3000 pulses will be applied at 0.20 mj/mm2, at a frequency of 4Hz, with 2000 pulses distributed to the body of the penis and 1000 pulses applied to the base
|
Low-intensity shock waves are acoustic wavelengths which are transmitted continuously at a frequency between 16 and 20 megahertz for under 10 microseconds.
They generate a pressure pulse and transport energy as they propagate through a medium.
Three different methods can be used to generate this type of wave: electro-hydraulics, electro-magnetics and piezoelectricity.
Regardless of the method, when the shock waves are applied to an organ they interact with the deep tissue.
This causes stress and small mechanical traumas, activating the release of angiogenic factors which induce new vascularization of the affected tissue, thereby improving blood flow.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
IIEF-EF score 6 months after completing the treatment
Time Frame: 6 month follow-ups
|
This is a highly sensitive and specific scale for detecting changes in erectile function in response to treatment.
The degree of dysfunction is scored on a range of 0 to 30 points on the Erectile Functioning domain (questions 1, 2, 3, 4, 5, 15).
The categories are: severe between 0 and 10, moderate between 11 and 16, mild-to-moderate between 17 and 21, mild between 22 and 25, and no ED between 26 and 30.
|
6 month follow-ups
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Erection Hardness Score
Time Frame: 3-month and 6-month follow-ups
|
The EHS has a single Likert scale: 0 = Penis does not increase in size; 1= the penis increases in size but is not hard; 2 = the penis is hard but not hard enough for penetration; 3 = the penis is hard enough for penetration but not completely hard; 4 = the penis is completely hard and fully rigid
|
3-month and 6-month follow-ups
|
Clinical improvement
Time Frame: 6-month follow-ups
|
For patients with moderate ED, a 5-point increase in the IIEF-EF score is considered improvement.
For patients with mild ED a 2-point increase on this scale is considered improvement.
And for those with severe ED a 7-point change is considered improvement.
|
6-month follow-ups
|
Number of satisfactory relations
Time Frame: 3-month and 6-month follow-ups
|
According to the patient's journal records.
For the purpose of this study, satisfactory relations are defined as the increase in rigidity and duration of the erection as evaluated by the patient and his partner.
For patients who were not able to penetrate before treatment, satisfactory relations will include not only an increase in rigidity and duration of the erection but also the ability to penetrate.
|
3-month and 6-month follow-ups
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 18, 2017
Primary Completion (Actual)
October 15, 2023
Study Completion (Actual)
October 15, 2023
Study Registration Dates
First Submitted
October 9, 2017
First Submitted That Met QC Criteria
October 9, 2017
First Posted (Actual)
October 12, 2017
Study Record Updates
Last Update Posted (Actual)
November 1, 2023
Last Update Submitted That Met QC Criteria
October 31, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BMGC-3
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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