NCT04506658

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 6, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 10, 2020

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

July 22, 2021

Status Verified

July 1, 2021

Enrollment Period

1.6 years

First QC Date

August 6, 2020

Last Update Submit

July 21, 2021

Conditions

Erectile Dysfunction

Keywords

high-frequency radio wave electrotherapyradio frequency448 kHz

Outcome Measures

Primary Outcomes (1)

  • A statistically significant increase in the number of points IIEF-5

    IIEF-5

    Through study completion, an average of 3 months after first procedure

Secondary Outcomes (2)

  • A statistically significant increase in penile blood flow.

    Through study completion, an average of 3 months after first procedure

  • Statistically significant increase in SEP scores (Sexual Encounter Profile)

    Through study completion, an average of 3 months after first procedure

Study Arms (2)

Intervention group

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

Control group

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

Interventions

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

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).

Intervention group

Eligibility Criteria

Age18 Years - 79 Years
Sexmale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients aged 18 to 79 years;
  • The diagnosis is confirmed by assessing the functional criteria of arterial factors of panel hemodynamics (dopplerography);
  • The diagnosis is confirmed by the assessment of the IIEF-5 questionnaire
  • Patients with organic erectile dysfunction lasting at least 6 months.
  • Patients with IIEF from 6 to 22 points.
  • Patients with a permanent sexual partner for more than 3 months;
  • Sexually Active Patients.
  • The use of other treatments for erectile dysfunction
  • Age under 18 and over 79 years old;
  • Anatomical deformation of the penis (angulation, cavernous fibrosis or Peyronie's disease);
  • The presence of diseases predisposing to the development of priapism (sickle cell anemia, multiple myeloma, leukemia, thrombocytopenia);
  • Running coagulation disorders;
  • The presence of tumors in the area of electrotherapy;
  • The presence of aneurysms in the propagation of radio frequency waves;
  • Angina pectoris;
  • +5 more criteria

You may not qualify if:

  • Serious unwanted phenomenons associated with exposure to the apparatus.
  • A marked deterioration in the patient's condition due to an increase in the severity of the disease or the attachment of another disease.
  • Serious deviation from the protocol.
  • The desire of the patient or his legal representative.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute for Urology and Reproductive Health, Sechenov University.

Moscow, 119991, Russia

RECRUITING

Related Links

MeSH Terms

Conditions

Erectile Dysfunction

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesSexual Dysfunction, PhysiologicalMale Urogenital DiseasesSexual Dysfunctions, PsychologicalMental Disorders

Study Officials

  • Dmitry Korolev, M.D.

    Sechenov University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dmitry Enikeev, M.D., Ph.D.

CONTACT

89267677873dvenikeev@gmail.com

Dmitry Korolev, M.D.

CONTACT

89267677873korolevdmitryo@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director for Research

Study Record Dates

First Submitted

August 6, 2020

First Posted

August 10, 2020

Study Start

June 1, 2020

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

July 22, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations

RU(1)