Premature EjaculationNCT03174470
Safety Demonstration of Increasing Intensities of Electrical Stimulation Delivered to The Bulbospongiosus Muscle
A study testing TENS Stimulator in people with Premature Ejaculation, run by Virility Medical Ltd. at 1 site in Israel.
Trial summary
The company suggests a new concept of treatment for PE: Transient inhibition of striated muscle contraction by a transcutaneous stimulation device. This study aim is to evaluate the safety of delivering increasing electrical stimulation intensities to the subject's perineum, using a TENS technique and equipment… Read more about this study
- Who is it for?
- Ages 18 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Premature Ejaculation
- What is being tested?
- TENS Stimulator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteIsrael
- Study dates
- 2 Nov 2016to 30 Jun 2017
- Phase
- Interventional
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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Generally healthy
- Ability to follow study instructions and complete study assessment tools
Who cannot join
- History of cardiovascular disorders
- Any type of implanted pacemaker/defibrillator
- Hypertension
- Diabetes Mellitus
- Local dermatological disease
- Local skin irritation/lesions
- Any neurological disorder
- Any psychiatric disease and/or psychiatric medications
Trial locations and contacts
1 site in 1 country.
About this study
The company suggests a new concept of treatment for PE: Transient inhibition of striated muscle contraction by a transcutaneous stimulation device. This study aim is to evaluate the safety of delivering increasing electrical stimulation intensities to the subject's perineum, using a TENS technique and equipment, followed by a 72-hour postoperative follow-up.
- Conditions
- Premature Ejaculation
- Being tested
- TENS Stimulator
- Medical subject headings
- Premature Ejaculation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TENS StimulatorDevice
Also called TensMed S82 ENRAF-NONIUS
Initial stimulation of arm (conditioning) followed by Increasing Intensities of Electrical Stimulation Delivered to The Bulbospongiosus Muscle
| Study group | Role | What they receive |
|---|---|---|
| TENS stimulator | Experimental | Single day Transcutaneous electrical nerve stimulations utilizing a commercial TENS stimulator (TensMed S82 ENRAF-NONIUS) Receives: Device: TENS Stimulator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events
Pain sensation score given by all subjects, as well as their verbal description of what they sensed during the various stimulations
Measured: Baseline
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 posted2 Jun 2017
- Study start2 Nov 2016
- Primary completion30 Jun 2017
- Study completion30 Jun 2017
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
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
- NCT03174470
- Sponsor's protocol ID
- VM-Rev-001
- Status last verified
- Oct 2019
- First submitted
- 28 May 2017
- Last updated
- 8 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No