Safety & Feasibility of Functional Electrical Stimulation for The Treatment of Premature Ejaculation

NCT ID: NCT03177226

Last Updated: 2017-06-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-31

Study Completion Date

2017-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Premature Ejaculation

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

SINGLE

Participants

Study Groups

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Functional TENS stimulation

Short stimulation to identifying Sensory Threshold and Motor Threshold, followed by continuous functional electrical stimulation, throughout the entire self-stimulation phase \[from full erection to ejaculation\]

Group Type EXPERIMENTAL

Functional TENS stimulation

Intervention Type DEVICE

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-stimulation treatment

Short stimulation to identifying Sensory Threshold and Motor Threshold, followed by continuous non-functional electrical stimulation, throughout the entire self-stimulation phase \[from full erection to ejaculation\]

Group Type SHAM_COMPARATOR

Non-Functional TENS stimulation

Intervention Type DEVICE

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'

Interventions

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Functional TENS stimulation

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'

Intervention Type DEVICE

Non-Functional TENS stimulation

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'

Intervention Type DEVICE

Other Intervention Names

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1427970 TensMed S82

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* History of cardio-vascular 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 any psychiatric medications
* Any neoplastic disease in the past two years
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Virility Medical Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ilan Gruenwald, MD

Role: PRINCIPAL_INVESTIGATOR

Rambam Health Care Campus

Locations

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Rambam Health Care Campus

Haifa, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Ilan Gruenwald, MD

Role: CONTACT

+972-4-777-2819

Facility Contacts

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Ilan Gruenwald, MD

Role: primary

+972-4-777-2819

Other Identifiers

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VM II-Rev-001

Identifier Type: -

Identifier Source: org_study_id

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