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

Not Applicable

Completed

• Conditions: Erectile Dysfunction
• Interventions: Other: Low-intensity extracorporeal shock wave therapy (Li-ESWT)

• Registration Number: NCT03308409
• Lead Sponsor: Boston Medical Group

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-10-09
• Study First Submitted QC: 2017-10-09
• Study First Posted: 2017-10-12
• Study Start: 2017-10-18
• Status Verified: 2023-10
• Primary Completion: 2023-10-15
• Study Completion: 2023-10-15
• Last Update Submitted: 2023-10-31
• Last Update Posted: 2023-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 277

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Protocol 1	Low-intensity extracorporeal shock wave therapy (Li-ESWT)	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.
Protocol 2	Low-intensity extracorporeal shock wave therapy (Li-ESWT)	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.
Protocol 3	Low-intensity extracorporeal shock wave therapy (Li-ESWT)	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

Primary Outcome Measures

Name	Time	Method
IIEF-EF score 6 months after completing the treatment	6 month follow-ups	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.

Secondary Outcome Measures

Name	Time	Method
Number of satisfactory relations	3-month and 6-month follow-ups	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.
Erection Hardness Score	3-month and 6-month follow-ups	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
Clinical improvement	6-month follow-ups	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.

Trial Locations

Locations (2)

Boston Medical Group; 🇲🇽 Mexico City, Mexico

Boston Medical Group Colombia; 🇨🇴 Bogotá, Cundinamarca, Colombia