Premature EjaculationNCT03177226
Safety & Feasibility of Functional Electrical Stimulation for The Treatment of Premature Ejaculation
A study testing Functional TENS stimulation and Non-Functional TENS stimulation in people with Premature Ejaculation, run by Virility Medical Ltd. at 1 site in Israel.
Trial summary
Prospective, non-randomized, controlled, single-center study, to evaluate the efficacy of applied nominal electrical stimulation parameters given to premature ejaculation (PE) patients in order to prolong the ejaculatory latency time which will eventually increase the quality of their sexual life. Read more about this study
- Who is it for?
- Ages 18 to 60 years, men only
- Conditions the study is for
- Premature Ejaculation
- What is being tested?
- Functional TENS stimulation and Non-Functional TENS stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2017to Dec 2017
- 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 60 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Good general health
- Clinical history of premature ejaculation
- Familiar with self- stimulation
- Ability to follow study instructions and complete study assessment tools
- Washout period of two weeks
Who cannot join
- History of cardio-vascular disorders
- Any type of implanted pacemaker/defibrillator
- Hypertension
- Diabetes Mellitus
- Local dermatological disease
- Local skin irritation/ lesions
Show all 9Show fewer
- Any neurological disorder
- Any psychiatric disease and/or any psychiatric medications
- Any neoplastic disease in the past two years
Trial locations and contacts
1 site in 1 country.
Ilan Gruenwald, MD contact
Israel1 site, 1 recruiting
- Recruiting
Rambam Health Care Campus
Haifa
Ilan Gruenwald, MD, +972-4-777-2819
About this study
Prospective, non-randomized, controlled, single-center study, to evaluate the efficacy of applied nominal electrical stimulation parameters given to premature ejaculation (PE) patients in order to prolong the ejaculatory latency time which will eventually increase the quality of their sexual life.
- Conditions
- Premature Ejaculation
- Being tested
- Functional TENS stimulation, Non-Functional TENS stimulation
- Medical subject headings
- Premature Ejaculation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional TENS stimulationDevice
Also called 1427970 TensMed S82
A short continuous electrical stimulation, beginning at 0 mAmp and gradually increased by +0.5 mAmp every 2-10 sec to identifying Sensory Threshold (Is) and Motor Threshold (Imc), followed by continuous functional electrical stimulation, throughout the entire self-stimulation phase, equal to his Icm'
Non-Functional TENS stimulationDevice
A short continuous electrical stimulation, beginning at 0 mAmp and gradually increased by +0.5 mAmp every 2-10 sec to identifying Sensory Threshold (Is) and Motor Threshold (Imc), followed by continuous non-functional electrical stimulation, throughout the entire self-stimulation phase, equal to his Icm'
| Study group | Role | What they receive |
|---|---|---|
| Functional TENS stimulation | Experimental | Short stimulation to identifying Sensory Threshold and Motor Threshold, followed by continuous functional electrical stimulation, throughout the entire self-stimulation phase [from full erection to ejaculation] Receives: Device: Functional TENS stimulation |
| Non-stimulation treatment | Sham comparator | Short stimulation to identifying Sensory Threshold and Motor Threshold, followed by continuous non-functional electrical stimulation, throughout the entire self-stimulation phase [from full erection to ejaculation] Receives: Device: Non-Functional TENS stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events
All Self reported safety events (e.g. discomfort, pain, local irritation, local heat, noticeable changes in urination or bowl activity or any other complaint)
Measured: Procedure day
Change in ejaculation latency time
The difference between patient ejaculation latency time under perineal functional electrical stimulation during self-stimulation, and latency time during self-stimulation while no electrical stimulation is applied
Measured: Procedure day
Secondary outcomes (1)
Incidence of post-treatment Adverse Events
Post treatment safety evaluation completed by subjects (using safety questionnaire)
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2017
- Study startJan 2017
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature EjaculationStudies 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
- Device feasibility
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Virility Medical Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ilan Gruenwald, MD, Principal investigator, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03177226
- Sponsor's protocol ID
- VM II-Rev-001
- Status last verified
- Jun 2017
- First submitted
- 28 May 2017
- Last updated
- 6 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- 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 6 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety & Feasibility of Functional Electrical Stimulation for The Treatment of Premature Ejaculation
- ClinicalTrials.gov ID
- NCT03177226
- Acronym / sponsor ID
- VM II-Rev-001
- Conditions
- Premature Ejaculation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Virility Medical Ltd.Industry (pharma, biotech, devices)
- Study start
- Jan 2017 (actual)
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 6 Jun 2017 (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.
Prospective, non-randomized, controlled, single-center study, to evaluate the efficacy of applied nominal electrical stimulation parameters given to premature ejaculation (PE) patients in order to prolong the ejaculatory latency time which will eventually increase the quality of their sexual life.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Functional TENS stimulation | Experimental | Device: Functional TENS stimulationShort stimulation to identifying Sensory Threshold and Motor Threshold, followed by continuous functional electrical stimulation, throughout the entire self-stimulation phase [from full erection to ejaculation] |
| Non-stimulation treatment | Sham comparator | Device: Non-Functional TENS stimulationShort stimulation to identifying Sensory Threshold and Motor Threshold, followed by continuous non-functional electrical stimulation, throughout the entire self-stimulation phase [from full erection to ejaculation] |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Good general health
- Clinical history of premature ejaculation
- Familiar with self- stimulation
- Ability to follow study instructions and complete study assessment tools
- Washout period of two weeks
Key exclusion criteria (9 listed)
- History of cardio-vascular disorders
- Any type of implanted pacemaker/defibrillator
- Hypertension
- Diabetes Mellitus
- Local dermatological disease
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 |
|---|---|---|
| Functional TENS stimulationAlso: 1427970 TensMed S82A short continuous electrical stimulation, beginning at 0 mAmp and gradually increased by +0.5 mAmp every 2-10 sec to identifying Sensory Threshold (Is) and Motor Threshold (Imc), followed by continuous functional electrical stimulation, throughout the entire self-stimulation phase, equal to his Icm' | Device | Functional TENS stimulation |
| Non-Functional TENS stimulationA short continuous electrical stimulation, beginning at 0 mAmp and gradually increased by +0.5 mAmp every 2-10 sec to identifying Sensory Threshold (Is) and Motor Threshold (Imc), followed by continuous non-functional electrical stimulation, throughout the entire self-stimulation phase, equal to his Icm' | Device | Non-stimulation treatment |
Primary outcome
Incidence of Treatment-Emergent Adverse Events
Time frame: Procedure day
All Self reported safety events (e.g. discomfort, pain, local irritation, local heat, noticeable changes in urination or bowl activity or any other complaint)
Change in ejaculation latency time
Time frame: Procedure day
The difference between patient ejaculation latency time under perineal functional electrical stimulation during self-stimulation, and latency time during self-stimulation while no electrical stimulation is applied
1 secondary outcome
Incidence of post-treatment Adverse Events
Time frame: 72 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2017.
- 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.
Ilan Gruenwald, MD contact
Ilan Gruenwald, MD principal investigator
Rambam Health Care Campus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Functional TENS stimulation and Non-Functional TENS stimulation in people with Premature Ejaculation, run by Virility Medical Ltd. at 1 site in Israel.
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 5 inclusion and 9 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 6 Jun 2017. 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 Israel. 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 Ilan Gruenwald, MD (+972-4-777-2819), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-Emergent Adverse Events (time frame: Procedure day). The study lists 2 primary outcomes in all. 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 6 Jun 2017.