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

Erectile Dysfunction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03308409
• Other study ID #: BMGC-3
• Status: Completed
• Phase: N/A
• Start date: October 18, 2017
• Est. completion date: October 15, 2023

Study information

• Verified date: October 2023
• Source: Boston Medical Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 277
• Est. completion date: October 15, 2023
• Est. primary completion date: October 15, 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Erectile Dysfunction

Intervention

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

Locations

Country	Name	City	State
Colombia	Boston Medical Group Colombia	Bogotá	Cundinamarca
Mexico	Boston Medical Group	Mexico City

Sponsors (1)

Lead Sponsor	Collaborator
Boston Medical Group

Countries where clinical trial is conducted

Colombia,  Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Erection Hardness Score	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
Secondary	Clinical improvement	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
Secondary	Number of satisfactory relations	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