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

IVI Santiago de Chile

Status: Unknown

Conditions: Endothelial Dysfunction; Erectile Dysfunction

Treatments: Device: Treatment; Device: Sham

Study type: Interventional

Funder types: Other

Identifiers

NCT03741439

Marconi01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 38 estimated patients

Sex: Male

Ages: 40 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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38 participants in 2 patient groups

Treatment arm

Experimental group

Description:

Receives real treatment according to manufactures instructions. 6 sessions of low intensity shockwave treatment with an electromagnetic emitter.

Treatment:

Device: Treatment

Sham Arm

Sham Comparator group

Description:

Receives sham treatment with same applicator, same sound, same time and number of shocks. But no real energy is delivered.

Treatment:

Device: Sham