OrchitisEleScroNCT02665182
Up-positioning of the Testes as Supportive Therapy in Patients With Acute Orchitis
A study testing Up-positioning of the testes in people with Orchitis and Testicular Diseases, run by Medical University of Warsaw at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Orchitis, Testicular Diseases
- What is being tested?
- Up-positioning of the testes
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 sitePoland
- Study dates
- Jul 2012to Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- acute orchitis confirmed clinically and in scrotal ultrasound
- age >=18 yrs
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Orchitis, Testicular Diseases
- Being tested
- Up-positioning of the testes
- Keywords
- orchitis, testicular diseases
- Medical subject headings
- Orchitis, Testicular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Up-positioning of the testesBehavioural
Patients in the experimental arm are asked to elevate their testes during the treatment.
| Study group | Role | What they receive |
|---|---|---|
| Up-positioning of the testes | Experimental | Patients receive standard medical therapy and supportive therapy Receives: Behavioral: Up-positioning of the testes |
| Medical therapy only | No intervention | Patients receive standard medical therapy only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to alleviation of symptoms
Measured: 10 days
Time to clinical resolution of local symptoms
Measured: 10 days
Secondary outcomes (8)
Testicular pain
Measured: 10 days
Testicular swelling
Measured: 10 days
Testicular erythema
Measured: 10 days
Scrotal pain intensity
Measured: 10 days
Quality of life
Measured: 10 days
Body temperature
Measured: 10 days
Heart rate
Measured: 10 days
Duration of up-positioning of testes per day
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2016 (estimated)
- Study startJul 2012
- Primary completionJan 2020 (estimated)
- Study completionJan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OrchitisStudies of the same condition, open and under way.
- More trials run by Medical University of WarsawThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sławomir Poletajew, MD PhD, Study director, Medical University of Warsaw
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02665182
- Sponsor's protocol ID
- SP12-1
- Acronym
- EleScro
- Status last verified
- Dec 2018
- First submitted
- 22 Jan 2016
- Last updated
- 28 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Up-positioning of the Testes as Supportive Therapy in Patients With Acute Orchitis - a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02665182
- Acronym / sponsor ID
- EleScro / SP12-1
- Conditions
- Orchitis, Testicular Diseases
- Keywords
- orchitis, testicular diseases
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Jan 2020 (estimated)
- Study completion
- Jan 2021 (estimated)
- First posted
- 27 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Up-positioning of the testes | Experimental | Behavioral: Up-positioning of the testesPatients receive standard medical therapy and supportive therapy |
| Medical therapy only | No intervention | –Patients receive standard medical therapy only |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- acute orchitis confirmed clinically and in scrotal ultrasound
- age >=18 yrs
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Up-positioning of the testesPatients in the experimental arm are asked to elevate their testes during the treatment. | Behavioural | Up-positioning of the testes |
Primary outcome
Time to alleviation of symptoms
Time frame: 10 days
Time to clinical resolution of local symptoms
Time frame: 10 days
8 secondary outcomes
Testicular pain
Time frame: 10 days
Testicular swelling
Time frame: 10 days
Testicular erythema
Time frame: 10 days
Scrotal pain intensity
Time frame: 10 days
Quality of life
Time frame: 10 days
Body temperature
Time frame: 10 days
Heart rate
Time frame: 10 days
Duration of up-positioning of testes per day
Time frame: 10 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2018.
- Individual participant dataSharing planned: No
Related trials for Orchitis
RecruitingObservational study
Prospective Observational Study on SEBBIN Silicone Gel-filled Testicular Implants
Testicular Cancer, Testicular Torsion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sławomir Poletajew, MD PhD study director
Medical University of Warsaw
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Up-positioning of the testes in people with Orchitis and Testicular Diseases, run by Medical University of Warsaw at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to alleviation of symptoms (time frame: 10 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Dec 2018.