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

• Sponsor: Medical University of Warsaw (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02665182
• Collaborator: (none)
• Enrollment: 70
• Location: 1
• Arms: 2
• Duration (Months): 102
• Patients Per Site Per Month: 0.7

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Orchitis; Testicular Diseases	Behavioral: Up-positioning of the testes	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 70 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Treatment
• Official Title: Up-positioning of the Testes as Supportive Therapy in Patients With Acute Orchitis - a Randomized Controlled Trial
• Study Start Date: Jul 1, 2012
• Anticipated Primary Completion Date: Jan 1, 2020
• Anticipated Study Completion Date: Jan 1, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Time to alleviation of symptoms [10 days]

2. Time to clinical resolution of local symptoms [10 days]

Secondary Outcome Measures

1. Testicular pain [10 days]

2. Testicular swelling [10 days]

3. Testicular erythema [10 days]

4. Scrotal pain intensity [10 days]

5. Quality of life [10 days]

6. Body temperature [10 days]

7. Heart rate [10 days]

8. Duration of up-positioning of testes per day [10 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sławomir Poletajew	Warsaw		Poland	02005

Sponsors and Collaborators

• Medical University of Warsaw

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Medical University of Warsaw
• ClinicalTrials.gov Identifier: NCT02665182
• Other Study ID Numbers: SP12-1
• First Posted: Jan 27, 2016
• Last Update Posted: Dec 28, 2018
• Last Verified: Dec 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Medical University of Warsaw: orchitis; testicular diseases
• Additional relevant MeSH terms: Orchitis; Testicular Diseases

Study Results

No Results Posted as of Dec 28, 2018