RCTrial to Test Low Intensity Shockwave Treatment in Patients With Mild/Moderate Erectile Dysfunction

Erectile Dysfunction Clinical Trial

Official title:

Randomized Controlled Trial to Test Low Intensity Shockwave Treatment in Patients With Mild and Moderate Erectile Dysfunction Using a Electromagnetic Emitter

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03741439
• Other study ID #: Marconi01
• Status: Recruiting
• Phase: N/A
• Start date: January 17, 2018
• Est. completion date: January 2, 2019

Study information

• Verified date: November 2018
• Source: IVI Santiago de Chile
• Contact: Marcelo Marconi, MD
• Phone: +56979685115
• Email: mmarconi[@]andro.cl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Even though, the efficacy of Low-Intensity Shockwave Therapy (LIST) to treat Erectile Dysfunction (ED) has been documented by numerous trials; it is still not recommended by clinical guidelines. Different types of: shockwave generators, treatment protocols and ED severities of patients included in the studies, explain the lack of recommendations for a standard treatment. Ideally, each shockwave generator should have its own efficacy data from randomized controlled trials, using standardized protocols, and in defined populations.

Objective: to test the efficacy of a electromagnetic shockwave generator (Dornier Aries) in treating patients with mild and moderate ED in a randomized controlled trial.

Patients and methods: 38 patients with mild/moderate ED (IIEF-5= 11-21), are being prospectively randomized (1:1) to receive 6 sessions of LIST or sham (same: number of sessions, time and sound, with out transmitting energy). The patients and who analyzed the data are blind to randomization. The following parameters were analyzed: IIEF-5, IIEF-15, Sexual Encounter Profile (SEP) 2 and 3, Global Assessment Question (GAQ) 1 and Erection Hardness Score (EHS) at: baseline (T0), at the end of the 6 sessions (T1); at 6 (T2) and 12 weeks (T3). During all the study patients were instructed to receive no other treatment for ED.

After ending T3 we expect to treat placebo patients to see impact of changing arm study.

Description:

We are test the efficacy of a electromagnetic shockwave generator (Dornier Aries) in treating patients with mild and moderate ED in a randomized controlled trial.

Patients and methods: 38 patients with mild/moderate ED (IIEF-5= 11-21), are being prospectively randomized (1:1) to receive 6 sessions of LIST or sham (same: number of sessions, time and sound, with out transmitting energy). The patients and who analyzed the data are blind to randomization. The following parameters were analyzed: IIEF-5, IIEF-15, Sexual Encounter Profile (SEP) 2 and 3, Global Assessment Question (GAQ) 1 and Erection Hardness Score (EHS) at: baseline (T0), at the end of the 6 sessions (T1); at 6 (T2) and 12 weeks (T3). During all the study patients were instructed to receive no other treatment for ED.

After ending T3 we expect to treat placebo patients to see impact of changing arm study.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 38
• Est. completion date: January 2, 2019
• Est. primary completion date: November 2, 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years to 70 Years

Eligibility

Inclusion Criteria:

• Mild/moderate erectile dysfunction

• Good response to any phospodiesterase inhibitor

Exclusion Criteria:

• No history of erectile dysfunction

• No decompensated diabetes

• No untreated hypogonadism

• No severe erectile dysfunction

Related Conditions & MeSH terms

• Endothelial Dysfunction
• Erectile Dysfunction

Intervention

Device:
• Treatment
Low intensity shockwave treatment in patients with mild/moderate ED using a electromagnetic emitter
• Sham
Sham treatment

Locations

Country	Name	City	State
Chile	Unidad de Andrologia - Red Salud UC/Christus	Santiago	Region Metropolitana

Sponsors (3)

Lead Sponsor	Collaborator
IVI Santiago de Chile	Pontificia Universidad Catolica de Chile, University of Chile

Country where clinical trial is conducted

Chile, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in IIEF-5	We expect a change of 3.5 points in the IIEF-5 score	12 weeks