Trial document




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  DRKS00006527

Trial Description

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Title

Outcome of transurethral resection of the prostate in patients with glands > 70ccm

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Trial Acronym

[---]*

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URL of the Trial

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Brief Summary in Lay Language

The Transurethral resection of the prostate (TUR-P) is the most common surgical treatment option of benign prostate enlargement.

For patients with prostatic glands > 70 ccm most clinic perform open adenomectomy. In our clinic we use the TUR-P for every patient regardless the gland volume.

We hypothesise that the TUR-P is a safe treatment option with good long-term outcome for patients with every size of prostatic gland.

Therefor we analyse the clinical course of patients who have been operated approximately 5 years ago and compare the results of patients with prostatic volume < 70 ccm and > 80 ccm.

Besides the analysis of existing data we will reassess the patients with questionnaires, urine flow measurement and ultrasound.

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Brief Summary in Scientific Language

Treatment options of BPH are TUR-P, open adenomectomy and different laser methods.

For gland sizes > 70 ccm most clinics still prefere the open adenomectomy.
We perform the TUR-P in all of our patients (with gland sizes up to 150 - 200 ccm). This is possible due to the use of a suprapubic suction system and consequent low pressure resection.

This study will investigate the clinical course of patients during the operation and after 5 years.

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Organizational Data

  •   DRKS00006527
  •   2014/07/25
  •   [---]*
  •   yes
  •   Approved
  •   309/14, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

  •   U1111-1159-5422 
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Health Condition or Problem studied

  •   N40 -  Hyperplasia of prostate
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Interventions/Observational Groups

  •   Outcome Analysis 5 years after TUR-P with questionnaires, sonographic estimation of post-void residual urine and peak flow Analysis. Comparison of results of patients with prostatic Gland < and > 70 ccm
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Characteristics

  •   Non-interventional
  •   Other
  •   Other
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Other
  •   Other
  •   N/A
  •   N/A
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Primary Outcome

Comparison of perioperative and Long-term outcome (perioperative: blood transfusion rate, bleeding, revision, urinary retention, other complications. Long-term outcome: IPSS (International Prostate Symptom Score), ICIQ (International Consultation on Incontinence Questionnaire), IIEF (International Index of Erectile Function), post-void residual urine, Peak flow, Re-operation).
Comparison of the results for patients with prostatic gland size < and > 70 ccm

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Secondary Outcome

Comparison of complications

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Planned
  •   2014/08/01
  •   200
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Male
  •   18   Years
  •   100   Years
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Additional Inclusion Criteria

TUR-P in our clinic between 2009 and 2011

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Exclusion Criteria

Denial of participation by individual

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Addresses

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    • Universitätsklinikum FreiburgKlinik für Urologie
    • Mr.  Prof. Dr.  Ulrich  Wetterauer 
    • Hugstetterstr. 55
    • 79106  Freiburg
    • Germany
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    • Universitätsklinikum FreiburgKlinik für Urologie
    • Mr.  Dr.  Konrad  Wilhelm 
    • Hugstetterstr. 55
    • 79106  Freiburg
    • Germany
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    • Universitätsklinikum FreiburgKlinik für Urologie
    • Mr.  Dr.  Konrad  Wilhelm 
    • Hugstetterstr. 55
    • 79106  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinikum FreiburgKlinik für Urologie
    • Mr.  Prof. Dr.  Ulrich  Wetterauer 
    • Hugstetterstr. 55
    • 79106  Freiburg
    • Germany
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Status

  •   Recruiting planned
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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.