NCT04662398

Brief Summary

Using of testes' shocker in treating the sexual dysfunction.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
77

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2020

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 28, 2020

Completed
7 days until next milestone

Study Start

First participant enrolled

December 5, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 10, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 14, 2021

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2021

Completed
Last Updated

November 1, 2022

Status Verified

October 1, 2022

Enrollment Period

1 month

First QC Date

November 28, 2020

Last Update Submit

October 31, 2022

Conditions

Outcome Measures

Primary Outcomes (2)

  • Sexual desire

    improving the desire of sex by using the electric shocks directly on the testes and penis. This will be assessed by a questionnaire (validated and reliable) to assess their ability to have sex more actively or not.

    less than one month

  • Erectile dysfunction

    solving the problem of erectile dysfunction and this will be assessed by examination and experience to see if there is an effect for the electric shocks on erectile improvement.

    less than one month

Study Arms (2)

Case (Testes shocker device)

ACTIVE COMPARATOR

The shocker will be used in delivering the current gradually on the testes and penis to improve the blood flow and stimulates the sexual activity among males.

Device: JT Device

Control (non testes shocker device)

SHAM COMPARATOR

These groups will not given the shocks, shame device will be used instead and then compare the two results.

Device: JT Device

Interventions

JT DeviceDEVICE

Shocker giving electrical shocks on testes

Also known as: Testes shocker
Case (Testes shocker device)Control (non testes shocker device)

Eligibility Criteria

Age20 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All patients with sexual dysfunction or erectile dysfunction

You may not qualify if:

  • Patients with trauma or other causes that make them inactive sexually

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hashim Talib Talib Hashim

Nasiriyah, Thi Qar, 64001, Iraq

Location

MeSH Terms

Conditions

Sexual Dysfunction, PhysiologicalSexual AbstinenceErectile Dysfunction

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital DiseasesSexual BehaviorBehaviorGenital Diseases, MaleMale Urogenital DiseasesSexual Dysfunctions, PsychologicalMental Disorders

Study Officials

  • Ali Al Imam, MD

    University of Mosul

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Case control
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Student

Study Record Dates

First Submitted

November 28, 2020

First Posted

December 10, 2020

Study Start

December 5, 2020

Primary Completion

January 14, 2021

Study Completion

January 15, 2021

Last Updated

November 1, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations