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

NCT03308409 | Completed

• 1 other identifier: BMGC-3
• Study Type: interventional
• Target: 277
• Locations: 2 countries
• Sites: 2

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 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.

Conditions

Erectile Dysfunction

Outcome Measures

Primary Outcomes (1)

• IIEF-EF score 6 months after completing the treatment

  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 Outcomes (3)

• Erection Hardness Score

  3-month and 6-month follow-ups

• Clinical improvement

  6-month follow-ups

• Number of satisfactory relations

  3-month and 6-month follow-ups

Study Arms (3)

Protocol 1

ACTIVE COMPARATOR

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.

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

Protocol 2

EXPERIMENTAL

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.

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

Protocol 3

EXPERIMENTAL

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

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

Interventions

Low-intensity extracorporeal shock wave therapy (Li-ESWT) OTHER

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.

Protocol 1; Protocol 2; Protocol 3

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boston Medical Group: lead

Study Sites (2)

Boston Medical Group Colombia

Bogotá, Cundinamarca, 11022, Colombia

Location

Boston Medical Group

Mexico City, Mexico

Location

MeSH Terms

Conditions

Erectile Dysfunction

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Patients who met the selection criteria were randomly assigned to one of three groups: weekly protocol, monthly protocol, or booster protocol, in a 1:1:1 ratio.

Study Record Dates

• First Submitted: October 9, 2017
• First Posted: October 12, 2017
• Study Start: October 18, 2017
• Primary Completion: October 15, 2023
• Study Completion: October 15, 2023
• Last Updated: November 1, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1); CO (1)