Trial document





This trial has been registered retrospectively.
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  DRKS00003325

Trial Description

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Title

Epididymo-orchitis: Etiology, Inflammation, Impact on Fertility, and Clinical Course

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Trial Acronym

Giessen Epididymitis Study

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URL of the Trial

[---]*

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Brief Summary in Lay Language

The study deals with a combined inflammation of the testicle and the epididymis. The causes for the disease and the causative factors, the inflammation and whether it thereby affecting the ability to breed there will be research. Study participants may be male persons who are older than 18 years and present with an acute inflammation of the epididymis. The study includes a detailes medical history inlcuding questionnaires, a clinical investigation, and the investigation of urine, blood and semen at first presentation and subsequent visits on days 14 and 84. Afterwards a continuous follow-up is performed by telephone or personal presentation of the patient.

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Brief Summary in Scientific Language

The study deals with the Epididymoorchitis. Should be investigated, the etiology, inflammation, the effects on fertility and the clinical course. Study participants are male, older than 18 and have an acute epididymitis.

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Organizational Data

  •   DRKS00003325
  •   2011/11/10
  •   [---]*
  •   yes
  •   Approved
  •   100/07, Ethik-Kommission des Fachbereichs Medizin der Justus-Liebig-Universität Gießen
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   N45 -  Orchitis and epididymitis
  •   acute epididymitis
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Interventions/Observational Groups

  •   Therapy according to the guidelines
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Characteristics

  •   Non-interventional
  •   Epidemiological study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Other
  •   Single (group)
  •   N/A
  •   [---]*
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Primary Outcome

• investigate the etiology of acute epididymo-orchitis (bacterial and viral investigation of urine, p.r.n. blood, semen, testicular and epididymal tissue)

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Secondary Outcome

• determine the pathogen in correspondence to sexual activity/age (IIEF-questionnaire)
• determine systemic inflammatory parameters (CRP, White blood cell count, procalcitonin, cytokines)
• Documentation of markers for testicular cancer (AFP, HCG, LDH)
• determine the impact on seminal parameters and sperm (semen analysis according to WHO 1999 and WHO 2010)
• determine inflammatory parameters in the male genitourinary tract (2 resp. 4-glas test, leukocytes in urine, PSA in blood, inflammatory parameters in sement: leukocytes, elastase, cytokines)
• determine the impact on fertility (semen analysis and future paternity)
• determine comorbidities associated with acute epididymo-orchitis (anamnesis, clinical investigation, laboratory parameters, medical reports)
• determine the impact of analgetic and antimicrobial premedication on the clinical course (documentation of type and duration of premedication)
• determine the impact of previous antimicrobial therapy on the etiology
• determine the interval between onset of symptoms and seeking medical help
• determine ultrasonographic features associated with acute epididymo-orchitis
• (testicular size, epididymal size, perfusion oft he spermatic cord, testis and epididymis, concomitant hydrocele, abscess formation).
• determine a possible side-specific distribution
• determine urinary flow parameters and bladder function (uroflowmetry, residual urine, urodynamic bladder investigation, IPSS questionnaire)
• determine the impact of the infection on quality of life using questionnaires (NIH-CPSI, CESI)
• determine the need for surgical intervention
• determine risk factors to suffer epididymo-orchitis
• determine percentage of patients with epididymitis and epididymo-orchitis (clinical and ultrasound assessment)
• determine the clinical course (ambulatory visits, follow-up by telephone)
• determine the benefit of 16 S rRNA gene sequencing
• determine the possibility of recurrent and the development of chronic epididymo-orchitis

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • [---]*
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Recruitment

  •   Actual
  •   2007/07/16
  •   250
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Male
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

- Male, at least 18 years of age
- Suffer acute epididymitis, defined as a) enlarged epididymis and b) epididymal hypervascularity in ultrasonography

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Exclusion Criteria

- Testicular torsion
- Other primary scrotal diseases than epididymo-orchitis
- Any condition that, in the opinion of the investigator, would comprise the study

NOTE: Subjects may be enrolled in this study regardless of whether previous antimicrobial therapy was initiated.

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Addresses

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    • Klinik und Poliklinik für Urologie, Kinderurologie und Andrologie Universitätsklinikum Gießen und Marburg GmbH, Standort Gießen
    • Mr.  Dr. med.  Adrian  Pilatz 
    • Rudolf-Buchheim-Str. 7
    • 35392  Gießen
    • Germany
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    • Klinik und Poliklinik für Urologie, Kinderurologie und Andrologie Universitätsklinikum Gießen und Marburg GmbH, Standort Gießen
    • Mr.  Dr. med.  Adrian  Pilatz 
    • Rudolf-Buchheim-Str. 7
    • 35392  Gießen
    • Germany
    end of 1:1-Block address scientific-contact
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    end of 1:1-Block address contact scientific-contact
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    • Klinik und Poliklinik für Urologie, Kinderurologie und Andrologie Universitätsklinikum Gießen und Marburg GmbH, Standort Gießen
    • Mr.  Dr. med.  Adrian  Pilatz 
    • Rudolf-Buchheim-Str. 7
    • 35392  Gießen
    • Germany
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Sources of Monetary or Material Support

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    • Justus Liebig Universität Klinik und Poliklinik für Urologie, Kinderurologie und Andrologie
    • Mr.  Dr. med.  Adrian  Pilatz 
    • Rudolf-Buchcheim-Str.7
    • 35392  Gießen
    • Germany
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Status

  •   Recruiting ongoing
  •   [---]*
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Trial Publications, Results and other Documents

  • [---]*
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* This entry means the parameter is not applicable or has not been set.