RCTrial to Test Low Intensity Shockwave Treatment in Patients With Mild/Moderate Erectile Dysfunction
NCT ID: NCT03741439
Last Updated: 2018-11-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
38 participants
INTERVENTIONAL
2018-01-17
2019-01-02
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Treatment arm
Receives real treatment according to manufactures instructions. 6 sessions of low intensity shockwave treatment with an electromagnetic emitter.
Treatment
Low intensity shockwave treatment in patients with mild/moderate ED using a electromagnetic emitter
Sham Arm
Receives sham treatment with same applicator, same sound, same time and number of shocks. But no real energy is delivered.
Sham
Sham treatment
Interventions
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Treatment
Low intensity shockwave treatment in patients with mild/moderate ED using a electromagnetic emitter
Sham
Sham treatment
Eligibility Criteria
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Inclusion Criteria
* Good response to any phospodiesterase inhibitor
Exclusion Criteria
* No decompensated diabetes
* No untreated hypogonadism
* No severe erectile dysfunction
40 Years
70 Years
MALE
No
Sponsors
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Pontificia Universidad Catolica de Chile
OTHER
University of Chile
OTHER
IVI Santiago de Chile
OTHER
Responsible Party
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Principal Investigators
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Marcelo Marconi, MD
Role: PRINCIPAL_INVESTIGATOR
Asistant Professor Urology Department Universidad Catolica de Chile
Locations
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Unidad de Andrologia - Red Salud UC/Christus
Santiago, Santiago Metropolitan, Chile
Countries
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Central Contacts
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Marcelo Marconi, MD
Role: CONTACT
Facility Contacts
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Other Identifiers
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Marconi01
Identifier Type: -
Identifier Source: org_study_id
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