Erectile DysfunctionNCT04506658
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.
A study testing high-frequency radio wave electrotherapy with a frequency of 448 kHz on the penis structures. in people with Erectile Dysfunction, run by I.M. Sechenov First Moscow State Medical University at 1 site in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 79 years, men only
- Conditions the study is for
- Erectile Dysfunction
- What is being tested?
- high-frequency radio wave electrotherapy with a frequency of 448 kHz on the penis structures.
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteRussia
- Study dates
- 1 Jun 2020to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 79 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Show all 21Show fewer
- 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;
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Russia1 site, 1 recruiting
- Recruiting
Institute for Urology and Reproductive Health, Sechenov University.
Moscow, 119991
Dmitry Enikeev, M.D., Ph.D, +79267677873, enikeev-dv@1msmu.ru
Dmitry Korolev, MD, +79267677873, marktaratkin@gmail.com
About this study
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.
Read the 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.
- Conditions
- Erectile Dysfunction
- Being tested
- high-frequency radio wave electrotherapy with a frequency of 448 kHz on the penis structures.
- Keywords
- high-frequency radio wave electrotherapy, radio frequency, 448 kHz
- Medical subject headings
- Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
high-frequency radio wave electrotherapy with a frequency of 448 kHz on the penis structures.Device
Doctor uses sham sensor to reduce efficiency to zero.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Not described Receives: Device: high-frequency radio wave electrotherapy with a frequency of 448 kHz on the penis structures. |
| Control group | Sham comparator | Not described Receives: Device: high-frequency radio wave electrotherapy with a frequency of 448 kHz on the penis structures. |
What is being measured
The primary outcome is the main question the study is designed to answer.
A statistically significant increase in the number of points IIEF-5
IIEF-5
Measured: Through study completion, an average of 3 months after first procedure
Secondary outcomes (2)
A statistically significant increase in penile blood flow.
According to Doppler
Measured: Through study completion, an average of 3 months after first procedure
Statistically significant increase in SEP scores (Sexual Encounter Profile)
Schramek grading system score for assessing penile rigidity
Measured: Through study completion, an average of 3 months after first procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2020
- Study start1 Jun 2020
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erectile DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- I.M. Sechenov First Moscow State Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dmitry Enikeev, MD, PhD, I.M. Sechenov First Moscow State Medical University
- Investigators
- Dmitry Korolev, M.D., Principal investigator, Sechenov University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04506658
- Sponsor's protocol ID
- 07-20 from 15.04.2020
- Status last verified
- Jul 2021
- First submitted
- 6 Aug 2020
- Last updated
- 22 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04506658
- Acronym / sponsor ID
- 07-20 from 15.04.2020
- Conditions
- Erectile Dysfunction
- Keywords
- high-frequency radio wave electrotherapy, radio frequency, 448 kHz
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- I.M. Sechenov First Moscow State Medical UniversityUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 10 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Intervention group |
| high-frequency radio wave electrotherapy with a frequency of 448 kHz on the penis structures.Doctor uses sham sensor to reduce efficiency to zero. | Device | Control group |
Primary outcome
A statistically significant increase in the number of points IIEF-5
Time frame: Through study completion, an average of 3 months after first procedure
IIEF-5
2 secondary outcomes
A statistically significant increase in penile blood flow.
Time frame: Through study completion, an average of 3 months after first procedure
Statistically significant increase in SEP scores (Sexual Encounter Profile)
Time frame: Through study completion, an average of 3 months after first procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2021.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dmitry Korolev, M.D. principal investigator
Sechenov University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing high-frequency radio wave electrotherapy with a frequency of 448 kHz on the penis structures. in people with Erectile Dysfunction, run by I.M. Sechenov First Moscow State Medical University at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dmitry Enikeev, M.D., Ph.D. (89267677873, dvenikeev@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A statistically significant increase in the number of points IIEF-5 (time frame: Through study completion, an average of 3 months after first procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2021.