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Using of Testes' Shocker in Improving Sexual Activity

Primary Purpose

Sexual Dysfunction, Sexual Abstinence, Sexual Desire Disorder

Status
Completed
Phase
Not Applicable
Locations
Iraq
Study Type
Interventional
Intervention
JT Device
Sponsored by
University of Baghdad
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sexual Dysfunction

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • All patients with sexual dysfunction or erectile dysfunction

Exclusion Criteria:

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

Sites / Locations

  • Hashim Talib Talib Hashim

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Case (Testes shocker device)

Control (non testes shocker device)

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
November 28, 2020
Last Updated
October 31, 2022
Sponsor
University of Baghdad
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1. Study Identification

Unique Protocol Identification Number
NCT04662398
Brief Title
Using of Testes' Shocker in Improving Sexual Activity
Official Title
Using of Testes' Shocker in Treating Sexual Disease and Dysfunction
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
December 5, 2020 (Actual)
Primary Completion Date
January 14, 2021 (Actual)
Study Completion Date
January 15, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Baghdad

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Using of testes' shocker in treating the sexual dysfunction.
Detailed Description
Using of electrical shocks in treating sexual dysfunction in males, rectile dysfunction and inability to perform sexually good.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sexual Dysfunction, Sexual Abstinence, Sexual Desire Disorder, Erectile Dysfunction, Erectile Dysfunction Following Radical Prostatectomy, Erectile Dysfunction Following Cryotherapy, Erectile Dysfunction With Diabetes Mellitus, Erectile Dysfunction Following Radiation Therapy, Erectile Dysfunction Following Urethral Surgery, Erectile Dysfunction With Type 2 Diabetes Mellitus

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Case control
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
77 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Case (Testes shocker device)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Control (non testes shocker device)
Arm Type
Sham Comparator
Arm Description
These groups will not given the shocks, shame device will be used instead and then compare the two results.
Intervention Type
Device
Intervention Name(s)
JT Device
Other Intervention Name(s)
Testes shocker
Intervention Description
Shocker giving electrical shocks on testes
Primary Outcome Measure Information:
Title
Sexual desire
Description
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.
Time Frame
less than one month
Title
Erectile dysfunction
Description
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.
Time Frame
less than one month

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All patients with sexual dysfunction or erectile dysfunction Exclusion Criteria: Patients with trauma or other causes that make them inactive sexually
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ali Al Imam, MD
Organizational Affiliation
University of Mosul
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hashim Talib Talib Hashim
City
Nasiriyah
State/Province
Thi Qar
ZIP/Postal Code
64001
Country
Iraq

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Using of Testes' Shocker in Improving Sexual Activity

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