search
Back to results

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.

Primary Purpose

Erectile Dysfunction

Status
Unknown status
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
high-frequency radio wave electrotherapy with a frequency of 448 kHz on the penis structures.
high-frequency radio wave electrotherapy with a frequency of 448 kHz on the penis structures.
Sponsored by
I.M. Sechenov First Moscow State Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Erectile Dysfunction focused on measuring high-frequency radio wave electrotherapy, radio frequency, 448 kHz

Eligibility Criteria

18 Years - 79 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  1. Patients aged 18 to 79 years;
  2. The diagnosis is confirmed by assessing the functional criteria of arterial factors of panel hemodynamics (dopplerography);
  3. The diagnosis is confirmed by the assessment of the IIEF-5 questionnaire
  4. Patients with organic erectile dysfunction lasting at least 6 months.
  5. Patients with IIEF from 6 to 22 points.
  6. Patients with a permanent sexual partner for more than 3 months;
  7. Sexually Active Patients.

Non-inclusion criteria:

  1. The use of other treatments for erectile dysfunction
  2. Age under 18 and over 79 years old;
  3. Anatomical deformation of the penis (angulation, cavernous fibrosis or Peyronie's disease);
  4. The presence of diseases predisposing to the development of priapism (sickle cell anemia, multiple myeloma, leukemia, thrombocytopenia);
  5. Running coagulation disorders;
  6. The presence of tumors in the area of electrotherapy;
  7. The presence of aneurysms in the propagation of radio frequency waves;
  8. Angina pectoris;
  9. Myocardial infarction, stroke, life-threatening arrhythmias;
  10. Thrombosis, thromboembolic disease;
  11. Arterial hypertension (blood pressure ≥ 170/90 mm Hg) or hypotension (blood pressure ≤ 90/50 mm Hg.);
  12. The patient has a mental illness that does not allow an assessment of the effectiveness of therapy; history of alcoholism and drug addiction;

14. Active tuberculosis, chronic somatic diseases in the acute stage; 15. Condition after coronary artery bypass grafting (CABG); 16. Patient's involvement in another clinical trial in the last 3 months;

Exclusion Criteria:

  1. Serious unwanted phenomenons associated with exposure to the apparatus.
  2. Incorrect inclusion in the study.
  3. A marked deterioration in the patient's condition due to an increase in the severity of the disease or the attachment of another disease.
  4. The patient's appearance of non-inclusion criteria during the study.
  5. Serious deviation from the protocol.
  6. The desire of the patient or his legal representative.

Sites / Locations

  • Institute for Urology and Reproductive Health, Sechenov University.Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Intervention group

Control group

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

A statistically significant increase in penile blood flow.
According to Doppler
Statistically significant increase in SEP scores (Sexual Encounter Profile)
Schramek grading system score for assessing penile rigidity

Full Information

First Posted
August 6, 2020
Last Updated
July 21, 2021
Sponsor
I.M. Sechenov First Moscow State Medical University
search

1. Study Identification

Unique Protocol Identification Number
NCT04506658
Brief Title
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.
Official Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2020 (Actual)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
I.M. Sechenov First Moscow State Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
The objectives of this study are: To evaluate the effectiveness of the course treatment with the apparatus for continuous capacitive resistive monopolar electrotherapy with a radio frequency of 448 kHz in patients with organic erectile dysfunction. Assess the safety and tolerability of continuous capacitive resistive monopolar electrotherapy with a radio frequency of 448 kHz in patients with organic erectile dysfunction. To evaluate the duration of the effect of continuous capacitive resistive monopolar electrotherapy with a radio frequency of 448 kHz.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Erectile Dysfunction
Keywords
high-frequency radio wave electrotherapy, radio frequency, 448 kHz

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Title
Control group
Arm Type
Sham Comparator
Intervention Type
Device
Intervention Name(s)
high-frequency radio wave electrotherapy with a frequency of 448 kHz on the penis structures.
Intervention Description
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 Type
Device
Intervention Name(s)
high-frequency radio wave electrotherapy with a frequency of 448 kHz on the penis structures.
Intervention Description
Doctor uses sham sensor to reduce efficiency to zero.
Primary Outcome Measure Information:
Title
A statistically significant increase in the number of points IIEF-5
Description
IIEF-5
Time Frame
Through study completion, an average of 3 months after first procedure
Secondary Outcome Measure Information:
Title
A statistically significant increase in penile blood flow.
Description
According to Doppler
Time Frame
Through study completion, an average of 3 months after first procedure
Title
Statistically significant increase in SEP scores (Sexual Encounter Profile)
Description
Schramek grading system score for assessing penile rigidity
Time Frame
Through study completion, an average of 3 months after first procedure

10. Eligibility

Sex
Male
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Non-inclusion criteria: 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; Myocardial infarction, stroke, life-threatening arrhythmias; Thrombosis, thromboembolic disease; Arterial hypertension (blood pressure ≥ 170/90 mm Hg) or hypotension (blood pressure ≤ 90/50 mm Hg.); The patient has a mental illness that does not allow an assessment of the effectiveness of therapy; history of alcoholism and drug addiction; 14. Active tuberculosis, chronic somatic diseases in the acute stage; 15. Condition after coronary artery bypass grafting (CABG); 16. Patient's involvement in another clinical trial in the last 3 months; Exclusion Criteria: Serious unwanted phenomenons associated with exposure to the apparatus. Incorrect inclusion in the study. A marked deterioration in the patient's condition due to an increase in the severity of the disease or the attachment of another disease. The patient's appearance of non-inclusion criteria during the study. Serious deviation from the protocol. The desire of the patient or his legal representative.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dmitry Enikeev, M.D., Ph.D.
Phone
89267677873
Email
dvenikeev@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Dmitry Korolev, M.D.
Phone
89267677873
Email
korolevdmitryo@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dmitry Korolev, M.D.
Organizational Affiliation
Sechenov University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute for Urology and Reproductive Health, Sechenov University.
City
Moscow
ZIP/Postal Code
119991
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dmitry Enikeev, M.D., Ph.D
Phone
+79267677873
Email
enikeev-dv@1msmu.ru
First Name & Middle Initial & Last Name & Degree
Dmitry Korolev, MD
Phone
+79267677873
Email
marktaratkin@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://www.sechenov.ru
Description
Related Info
URL
http://www.urologypro.ru
Description
Related Info

Learn more about this trial

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.

We'll reach out to this number within 24 hrs