Up-positioning of the Testes as Supportive Therapy in Patients With Acute Orchitis (EleScro)
Primary Purpose
Orchitis, Testicular Diseases
Status
Unknown status
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Up-positioning of the testes
Sponsored by
About this trial
This is an interventional treatment trial for Orchitis focused on measuring orchitis, testicular diseases
Eligibility Criteria
Inclusion Criteria:
- acute orchitis confirmed clinically and in scrotal ultrasound
- age >=18 yrs
Exclusion Criteria:
- previous treatment of orchitis,
- need for exploration of the scrotum,
- need for hospitalization,
- physical and mental status not allowing for up-positioning of the testes during treatment
Sites / Locations
- Sławomir Poletajew
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Up-positioning of the testes
Medical therapy only
Arm Description
Patients receive standard medical therapy and supportive therapy
Patients receive standard medical therapy only
Outcomes
Primary Outcome Measures
Time to alleviation of symptoms
Time to clinical resolution of local symptoms
Secondary Outcome Measures
Testicular pain
Testicular swelling
Testicular erythema
Scrotal pain intensity
Quality of life
Body temperature
Heart rate
Duration of up-positioning of testes per day
Full Information
NCT ID
NCT02665182
First Posted
January 22, 2016
Last Updated
December 27, 2018
Sponsor
Medical University of Warsaw
1. Study Identification
Unique Protocol Identification Number
NCT02665182
Brief Title
Up-positioning of the Testes as Supportive Therapy in Patients With Acute Orchitis
Acronym
EleScro
Official Title
Up-positioning of the Testes as Supportive Therapy in Patients With Acute Orchitis - a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
December 2018
Overall Recruitment Status
Unknown status
Study Start Date
July 2012 (undefined)
Primary Completion Date
January 2020 (Anticipated)
Study Completion Date
January 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University of Warsaw
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a single-blinded RCT evaluating the value of up-positioning of the testes as supportive therapy in patients receiving antimicrobial treatment due to acute bacterial orchitis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Orchitis, Testicular Diseases
Keywords
orchitis, testicular diseases
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
70 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Up-positioning of the testes
Arm Type
Experimental
Arm Description
Patients receive standard medical therapy and supportive therapy
Arm Title
Medical therapy only
Arm Type
No Intervention
Arm Description
Patients receive standard medical therapy only
Intervention Type
Behavioral
Intervention Name(s)
Up-positioning of the testes
Intervention Description
Patients in the experimental arm are asked to elevate their testes during the treatment.
Primary Outcome Measure Information:
Title
Time to alleviation of symptoms
Time Frame
10 days
Title
Time to clinical resolution of local symptoms
Time Frame
10 days
Secondary Outcome Measure Information:
Title
Testicular pain
Time Frame
10 days
Title
Testicular swelling
Time Frame
10 days
Title
Testicular erythema
Time Frame
10 days
Title
Scrotal pain intensity
Time Frame
10 days
Title
Quality of life
Time Frame
10 days
Title
Body temperature
Time Frame
10 days
Title
Heart rate
Time Frame
10 days
Title
Duration of up-positioning of testes per day
Time Frame
10 days
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
acute orchitis confirmed clinically and in scrotal ultrasound
age >=18 yrs
Exclusion Criteria:
previous treatment of orchitis,
need for exploration of the scrotum,
need for hospitalization,
physical and mental status not allowing for up-positioning of the testes during treatment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sławomir Poletajew, MD PhD
Organizational Affiliation
Medical University of Warsaw
Official's Role
Study Director
Facility Information:
Facility Name
Sławomir Poletajew
City
Warsaw
ZIP/Postal Code
02005
Country
Poland
12. IPD Sharing Statement
Plan to Share IPD
No
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Up-positioning of the Testes as Supportive Therapy in Patients With Acute Orchitis
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