Comparative Effectiveness and Safety of Three Protocols Usin Li-ESWT for Erectile Dysfunction
Erectile Dysfunction
About this trial
This is an interventional treatment trial for Erectile Dysfunction
Eligibility Criteria
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.
Sites / Locations
- Boston Medical Group ColombiaRecruiting
- Boston Medical Group
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Experimental
Experimental
Protocol 1
Protocol 2
Protocol 3
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 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 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