NCT02665182

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2012

Completed
3.6 years until next milestone

First Submitted

Initial submission to the registry

January 22, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 27, 2016

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2021

Completed
Last Updated

December 28, 2018

Status Verified

December 1, 2018

Enrollment Period

7.5 years

First QC Date

January 22, 2016

Last Update Submit

December 27, 2018

Conditions

OrchitisTesticular Diseases

Keywords

orchitistesticular diseases

Outcome Measures

Primary Outcomes (2)

  • Time to alleviation of symptoms

    10 days

  • Time to clinical resolution of local symptoms

    10 days

Secondary Outcomes (8)

  • Testicular pain

    10 days

  • Testicular swelling

    10 days

  • Testicular erythema

    10 days

  • Scrotal pain intensity

    10 days

  • Quality of life

    10 days

  • +3 more secondary outcomes

Study Arms (2)

Up-positioning of the testes

EXPERIMENTAL

Patients receive standard medical therapy and supportive therapy

Behavioral: Up-positioning of the testes

Medical therapy only

NO INTERVENTION

Patients receive standard medical therapy only

Interventions

Up-positioning of the testesBEHAVIORAL

Patients in the experimental arm are asked to elevate their testes during the treatment.

Up-positioning of the testes

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • acute orchitis confirmed clinically and in scrotal ultrasound
  • age \>=18 yrs

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sławomir Poletajew

Warsaw, 02005, Poland

Location

MeSH Terms

Conditions

OrchitisTesticular Diseases

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital DiseasesGonadal DisordersEndocrine System Diseases

Study Officials

  • Sławomir Poletajew, MD PhD

    Medical University of Warsaw

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 22, 2016

First Posted

January 27, 2016

Study Start

July 1, 2012

Primary Completion

January 1, 2020

Study Completion

January 1, 2021

Last Updated

December 28, 2018

Record last verified: 2018-12

Data Sharing

IPD Sharing
Will not share

Locations

PL(1)