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

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ClinicalTrials.gov Identifier: NCT03741439
Recruitment Status : Recruiting
First Posted : November 14, 2018
Last Update Posted : November 14, 2018
Sponsor:
Collaborators:
Pontificia Universidad Catolica de Chile
University of Chile
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Erectile Dysfunction Endothelial Dysfunction Device: Treatment Device: Sham Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized controlled trial
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Masking Description: Patients and who analyzes the data are blind to randomization.
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial to Test Low Intensity Shockwave Treatment in Patients With Mild and Moderate Erectile Dysfunction Using a Electromagnetic Emitter
Actual Study Start Date : January 17, 2018
Actual Primary Completion Date : November 2, 2018
Estimated Study Completion Date : January 2, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Treatment arm
Receives real treatment according to manufactures instructions. 6 sessions of low intensity shockwave treatment with an electromagnetic emitter.
Device: Treatment
Low intensity shockwave treatment in patients with mild/moderate ED using a electromagnetic emitter

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




Primary Outcome Measures :
  1. Changes in IIEF-5 [ Time Frame: 12 weeks ]
    We expect a change of 3.5 points in the IIEF-5 score



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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Only men because is for erectile dysfunction.
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03741439


Contacts
Contact: Marcelo Marconi, MD +56979685115 mmarconi@andro.cl
Contact: Marcelo Marconi, MD +56979685115

Locations
Chile
Unidad de Andrologia - Red Salud UC/Christus Recruiting
Santiago, Region Metropolitana, Chile, RM
Contact: Marcelo Marconi, MD    +56979685115    mmarconi@andro.cl   
Contact: Marcelo Marconi, MD    +56979685115    info@andro.cl   
Sponsors and Collaborators
IVI Santiago de Chile
Pontificia Universidad Catolica de Chile
University of Chile
Investigators
Principal Investigator: Marcelo Marconi, MD Asistant Professor Urology Department Universidad Catolica de Chile

Responsible Party: IVI Santiago de Chile
ClinicalTrials.gov Identifier: NCT03741439     History of Changes
Other Study ID Numbers: Marconi01
First Posted: November 14, 2018    Key Record Dates
Last Update Posted: November 14, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: We are evaluating is we decide to share all the protocol. All the protocol will be published with the results.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Erectile Dysfunction
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Mental Disorders