NCT03174470

Brief 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, followed by a 72-hour postoperative follow-up.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 2, 2016

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

May 28, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 2, 2017

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2017

Completed
Last Updated

October 8, 2019

Status Verified

October 1, 2019

Enrollment Period

8 months

First QC Date

May 28, 2017

Last Update Submit

October 7, 2019

Conditions

Premature Ejaculation

Outcome Measures

Primary Outcomes (1)

  • 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

    Baseline

Secondary Outcomes (1)

  • Incidence of post-treatment Adverse Events

    72 hours

Study Arms (1)

TENS stimulator

EXPERIMENTAL

Single day Transcutaneous electrical nerve stimulations utilizing a commercial TENS stimulator (TensMed S82 ENRAF-NONIUS)

Device: TENS Stimulator

Interventions

TENS StimulatorDEVICE

Initial stimulation of arm (conditioning) followed by Increasing Intensities of Electrical Stimulation Delivered to The Bulbospongiosus Muscle

Also known as: TensMed S82 ENRAF-NONIUS
TENS stimulator

Eligibility Criteria

Age18 Years - 60 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Generally healthy
  • Ability to follow study instructions and complete study assessment tools

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rambam Health Care Campus

Haifa, Israel

Location

MeSH Terms

Conditions

Premature Ejaculation

Condition Hierarchy (Ancestors)

Ejaculatory DysfunctionGenital Diseases, MaleGenital DiseasesUrogenital DiseasesSexual Dysfunction, PhysiologicalMale Urogenital DiseasesSexual Dysfunctions, PsychologicalMental Disorders

Study Officials

  • Ilan Gruenwald, MD

    Rambam Health Care Campus

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 28, 2017

First Posted

June 2, 2017

Study Start

November 2, 2016

Primary Completion

June 30, 2017

Study Completion

June 30, 2017

Last Updated

October 8, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)