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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
Medical University of Warsaw
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Orchitis focused on measuring orchitis, testicular diseases

Eligibility Criteria

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

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

First Posted
January 22, 2016
Last Updated
December 27, 2018
Sponsor
Medical University of Warsaw
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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

Learn more about this trial

Up-positioning of the Testes as Supportive Therapy in Patients With Acute Orchitis

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