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

Not Applicable

• Conditions: Erectile Dysfunction; Endothelial Dysfunction

• Registration Number: NCT03741439
• Lead Sponsor: IVI Santiago de Chile

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2018-01-17
• Status Verified: 2018-11
• Primary Completion: 2018-11-02
• Study First Submitted: 2018-11-11
• Study First Submitted QC: 2018-11-11
• Last Update Submitted: 2018-11-11
• Study First Posted: 2018-11-14
• Last Update Posted: 2018-11-14
• Study Completion: 2019-01-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 38

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Changes in IIEF-5	12 weeks	We expect a change of 3.5 points in the IIEF-5 score

Trial Locations

Locations (1)

Unidad de Andrologia - Red Salud UC/Christus; 🇨🇱 Santiago, Region Metropolitana, Chile