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
About this trial
This is an interventional treatment trial for Sexual Dysfunction
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
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
NCT ID
NCT04662398
First Posted
November 28, 2020
Last Updated
October 31, 2022
Sponsor
University of Baghdad
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
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Using of Testes' Shocker in Improving Sexual Activity
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