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Effectiveness And Safety Of Two Protocols For The Treatment Of Erectile Dysfunction With Low-Density Shock Waves

NCT02683044 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 206

Last updated 2016-07-18

No results posted yet for this study

Summary

Randomized, experimental, non-inferiority clinical trial to determine the comparative effectiveness and safety of two protocols used in the treatment of Erectile Dysfunction (ED) with Low-Density Shock Waves (Li-ESWT), for patients seen at the Boston Medical Group's Bogota center. Protocol 1: Consists of five sessions, one per week, with 3000 pulses at 0,15 mg/mm2, at a frequency of 4 Hz. The distribution of the shocks will be 2000 pulses to the body of the penis and 1000 pulses at its base. Total duration: 5 weeks. Protocol 2: Consists of six sessions, two per week, with 1500 pulses each one at 0.1 mJ/mm2, at a frequency of 4 Hz. The distribution of the shocks will be 900 pulses to the body of the penis and 600 pulses at its base. Total duration: 3 weeks.

Outcome variables: Erection Hardness Score (EHS). International Index of Erectile Function, 5-item version (IIEF-5). Penile blood flow.

Evaluation at 1, 3 and 6 months after completing each of the Li-ESWT protocols.

Conditions

Interventions

PROCEDURE

Low-Intensity Extracorporeal Shock Wave Therapy (Li-ESWT)

Sessions of shocks to the body of the penis

Sponsors & Collaborators

  • Boston Medical Group

    collaborator INDUSTRY

  • Instituto para la Evaluación de la Calidad y Atención en Salud

    lead OTHER

Principal Investigators

  • Jose P Saffon, MD · Boston Medical Group

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-02-29
Primary Completion
2017-08-31
Completion
2017-12-31

Countries

  • Colombia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02683044 on ClinicalTrials.gov