NCT03177226

Brief 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2017

Geographic Reach
1 country

1 active site

Status
unknown

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

January 1, 2017

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 28, 2017

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 6, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

June 6, 2017

Status Verified

June 1, 2017

Enrollment Period

11 months

First QC Date

May 28, 2017

Last Update Submit

June 1, 2017

Conditions

Premature Ejaculation

Outcome Measures

Primary Outcomes (2)

  • 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)

    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

    Procedure day

Secondary Outcomes (1)

  • Incidence of post-treatment Adverse Events

    72 hours

Other Outcomes (1)

  • Effects of applied electrical stimulation on Erection using Self Reported - User Questionnaire

    Procedure day

Study Arms (2)

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 \[from full erection to ejaculation\]

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 \[from full erection to ejaculation\]

Device: Non-Functional TENS stimulation

Interventions

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 functional electrical stimulation, throughout the entire self-stimulation phase, equal to his Icm'

Also known as: 1427970 TensMed S82
Functional TENS stimulation
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'

Non-stimulation treatment

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rambam Health Care Campus

Haifa, Israel

RECRUITING

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

Central Study Contacts

Ilan Gruenwald, MD

CONTACT

+972-4-777-2819

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DEVICE FEASIBILITY
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 28, 2017

First Posted

June 6, 2017

Study Start

January 1, 2017

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

June 6, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)