Clinical trial NCT03741439: RCTrial to Test Low Intensity Shockwave Treatment in Patients With Mild/Moderate Erectile Dysfunction
Official title: Randomized Controlled Trial to Test Low Intensity Shockwave Treatment in Patients With Mild and Moderate Erectile Dysfunction Using a Electromagnetic Emitter
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Erectile Dysfunction
Endothelial Dysfunction
Lead sponsor: IVI Santiago de Chile
Sponsor class: OTHER
Collaborators: name: Pontificia Universidad Catolica de Chile
name: University of Chile
First posted: 2018-11-14
Enrollment: 38
Sex: MALE
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes in IIEF-5
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: Unidad de Andrologia - Red Salud UC/Christus
state: Region Metropolitana
Study officials:
affiliation: Asistant Professor Urology Department Universidad Catolica de Chile
name: Marcelo Marconi, MD
role: PRINCIPAL_INVESTIGATOR
References: