Trial document




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  DRKS00008079

Trial Description

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Title

Prospektive randomised interventional single-center study to evaluate pre-operative transarterial embolisation of the prostate before prostatectomy

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Trial Acronym

PIEMONTE

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Patients with symptomatic benign hyperplasia of the prostate (BPH) designated for open prostatectomy are randomized 1:1 for prostatectomy or preoperative catheter-directed transarterial embolization of the prostate. Embolization of the prostate is aimed to reduce the size of the prostate. Instead of open prostatadenomectomie, transurethral prostatadenomresection (TURP) should be possible. In case of symptomatic BPH >80 ml open prostatadenomectomie is planned. In case of symptomatic BPH <80 ml TURP is planned. In case of clinically absent symptoms conservative management is planned.

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Brief Summary in Scientific Language

Aim of the study is the evaluation of pre-operative embolization before open prostatectomy (PAE). If symptoms are present after 3 months PAE or in case of appropriate volumen reduction transurethral resection (TURP) are performed.

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Organizational Data

  •   DRKS00008079
  •   2015/06/01
  •   [---]*
  •   yes
  •   Approved
  •   25/14, Ethik-Kommission bei der Ärztekammer des Saarlandes
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Secondary IDs

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

  •   N40 -  Hyperplasia of prostate
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Interventions/Observational Groups

  •   Prostatectomie without preoperative embolization
  •   Embolisation of the prostate before prostatectomy. If symptoms are present after 3 months PAE or in case of appropriate volumen reduction transurethral resection (TURP) are performed.
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

conversion of patients primarily planned for open prostatectomy to TURP or conservative management

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Secondary Outcome

• volume reduction of the prostate after embolization
• uro-flow, urinary retention volume
• hospital stay
• duration of operation
• peri-operative/interventional complications

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2015/05/31
  •   100
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Male
  •   no minimum age
  •   no maximum age
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Additional Inclusion Criteria

Symptomatic BPH
Prostate >80 ml
IPSS >18
quality of life score >3
peak urinary flow <12 ml/s
informed consent

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Exclusion Criteria

prostate cancer
operative pre-treatment of the prostate
neurogene prostate
Prostatic arteries inaccessible due to vascular occlusions

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Addresses

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    • Universität des Saarlandes
    • 66123  Saarbrücken
    • Germany
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    • Universitätsklinikum des Saarlandes, Klinik für Diagnostische und Interventionelle Radiologie
    • Mr.  Dr. med.  Alexander  Massmann 
    • Kirrberger Straße
    • 66421  Homburg
    • Germany
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    • Universitätsklinikum des Saarlandes, Klinik für Diagnostische und Interventionelle Radiologie
    • Mr.  Dr. med.  Alexander  Massmann 
    • Kirrberger Straße
    • 66421  Homburg
    • Germany
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Sources of Monetary or Material Support

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    • Universität des Saarlandes
    • 66123  Saarbrücken
    • 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.