Comparative Effectiveness and Safety of Three Protocols Usin Li-ESWT for Erectile Dysfunction

Boston Medical Group

Status: Completed

Conditions: Erectile Dysfunction

Treatments: Other: Low-intensity extracorporeal shock wave therapy (Li-ESWT)

Study type: Interventional

Funder types: Industry

Identifiers

NCT03308409

BMGC-3

Details and patient eligibility

About

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.

Enrollment: 277 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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277 participants in 3 patient groups

Protocol 1

Active Comparator group

Description:

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.

Treatment:

Other: Low-intensity extracorporeal shock wave therapy (Li-ESWT)

Protocol 2

Experimental group

Description:

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.

Treatment:

Other: Low-intensity extracorporeal shock wave therapy (Li-ESWT)

Protocol 3

Experimental group

Description:

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

Treatment:

Other: Low-intensity extracorporeal shock wave therapy (Li-ESWT)