Status:
COMPLETED
Comparative Effectiveness and Safety of Three Protocols Usin Li-ESWT for Erectile Dysfunction
Lead Sponsor:
Boston Medical Group
Conditions:
Erectile Dysfunction
Eligibility:
MALE
18+ years
Phase:
NA
Brief Summary
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 s...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 18 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 15 2023
Estimated Enrollment :
277 Patients enrolled
Trial Details
Trial ID
NCT03308409
Start Date
October 18 2017
End Date
October 15 2023
Last Update
November 1 2023
Active Locations (2)
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1
Boston Medical Group Colombia
Bogotá, Cundinamarca, Colombia, 11022
2
Boston Medical Group
Mexico City, Mexico