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

December 27, 2018 updated by: Medical University of Warsaw

Up-positioning of the Testes as Supportive Therapy in Patients With Acute Orchitis - a Randomized Controlled Trial

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
      • Warsaw, Poland, 02005
        • Sławomir Poletajew

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Up-positioning of the testes
Patients receive standard medical therapy and supportive therapy
Behavioral: Up-positioning of the testes
Patients in the experimental arm are asked to elevate their testes during the treatment.
No Intervention: Medical therapy only
Patients receive standard medical therapy only

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time to alleviation of symptoms
Time Frame: 10 days
10 days
Time to clinical resolution of local symptoms
Time Frame: 10 days
10 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Testicular pain
Time Frame: 10 days
10 days
Testicular swelling
Time Frame: 10 days
10 days
Testicular erythema
Time Frame: 10 days
10 days
Scrotal pain intensity
Time Frame: 10 days
10 days
Quality of life
Time Frame: 10 days
10 days
Body temperature
Time Frame: 10 days
10 days
Heart rate
Time Frame: 10 days
10 days
Duration of up-positioning of testes per day
Time Frame: 10 days
10 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Warsaw

Investigators

  • Study Director: Sławomir Poletajew, MD PhD, Medical University of Warsaw

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2012

Primary Completion (Anticipated)

January 1, 2020

Study Completion (Anticipated)

January 1, 2021

Study Registration Dates

First Submitted

January 22, 2016

First Submitted That Met QC Criteria

January 26, 2016

First Posted (Estimate)

January 27, 2016

Study Record Updates

Last Update Posted (Actual)

December 28, 2018

Last Update Submitted That Met QC Criteria

December 27, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SP12-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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