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Efficiency and Safety of High-frequency Radio Wave Electrotherapy With a Radio Frequency of 448 kHz in the Treatment of Patients With Organic Erectile Dysfunction.

NCT04506658 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2021-07-22

No results posted yet for this study

Summary

Efficiency and safety of high-frequency radio wave electrotherapy with a radio frequency of 448 kHz in the treatment of patients with organic erectile dysfunction. Sham comparator, parallel study including both the main and control group to demonstrate the efficiency of the device to treat erectile dysfunction.

Conditions

Interventions

DEVICE

high-frequency radio wave electrotherapy with a frequency of 448 kHz on the penis structures.

Patient in lithotomy position (supine) with return plate at lumbar level. Start with high power (within the allowed range) to get a faster hyperthermia and slowly decrease this percentage as the current builds up in the patient's body. Patients are undergoing high-frequency radio wave electrotherapy 2 times a week (12 procedures at all).

DEVICE

high-frequency radio wave electrotherapy with a frequency of 448 kHz on the penis structures.

Doctor uses sham sensor to reduce efficiency to zero.

Sponsors & Collaborators

  • I.M. Sechenov First Moscow State Medical University

    lead OTHER

Principal Investigators

  • Dmitry Korolev, M.D. · Sechenov University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2020-06-01
Primary Completion
2021-12-31
Completion
2021-12-31

Countries

  • Russia

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 NCT04506658 on ClinicalTrials.gov