Trial document




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  DRKS00008970

Trial Description

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Title

Combined prostatic Urethral lift and REmodelling of the bladder neck - a novel surgical treatment of benign prostatic syndrome with preservation of antegrade ejaculation

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Trial Acronym

CURE

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Transurethral resection of the Prostate (TUR-P) is the gold standard for the interventional therapy of benign prostate hyperplasia. Postoperative complications are urinary incontinence secondary to lesions of the sphincter, and (in almost all patients) retrograde ejaculation. Die implantation of prostatic retractors (or "Urolift®") is a new procedure for the treatment of benign prostate hyperplasia. It is less invasive, because no tissue is resected. The antegrade ejaculation is conserved. One restriction is that it can not be used in patients with a enlarged middle lobe or narrow bladder neck.
The newly developed CURE-Procedure is a combination of Urolift and TUR-P.
If there is a enlarged prostatic middle lobe it is resected and the lateral lobes are treated with Urolift.
We now investigate the outcomes of this new therapy.

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Brief Summary in Scientific Language

Transurethral resection of the Prostate (TUR-P) is the gold standard for the interventional therapy of benign prostate hyperplasia. Typical complications are intraoperative and postoperative blood loss and the need for blood transfusion in up to 5% of the patients. Postoperative complications are urinary incontinence secondary to lesions of the sphincter, and (in almost all patients) retrograde ejaculation. Die implantation of prostatic retractors (or "Urolift®") is a new procedure for the treatment of benign prostate hyperplasia. It is less invasive, because no tissue is resected. The efficacy could be shown in several publications. Furthermore, the antegrade ejaculation is conserved. One restriction is that it can not be used in up to 50% of the patients, because they have a middle lobe or narrow bladder neck which cannot be cured bei Urolift.
The newly developed CURE-Procedure is a combination of Urolift and TUR-P.
If there is a enlarged prostatic middle lobe it is resected and the lateral lobes are treated with Urolift.
We now investigate the outcomes of this new therapy.

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Organizational Data

  •   DRKS00008970
  •   2015/07/30
  •   [---]*
  •   yes
  •   Approved
  •   514/14, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

  •   U1111-1172-5471 
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Health Condition or Problem studied

  •   N40 -  Hyperplasia of prostate
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Interventions/Observational Groups

  •   CURE-procedure
    If there is a enlarged prostatic middle lobe it is resected and the lateral lobes are treated with Urolift. Patients who underwent this operation are now examined in a follow-up visit (questionnaires, postvoid residual urine, uroflow).
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Characteristics

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

Relief of obstructive lower urinary tzract symptoms, measured with the IPSS (International Prostate Symptom Score). Measurements will take place before the operation and 4 weeks / 6 months / 12 months later.

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Secondary Outcome

Protection of antegrade ejaculation

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2015/08/06
  •   30
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

Need for operative treatment of Lower urinary tract symptomes

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Exclusion Criteria

Acute urinary tract infection

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Universitätsklinikum FreiburgDepartment ChirurgieKlinik für Urologie
    • Mr.  PD Dr. med.  Martin  Schönthaler 
    • Hugstetterstr. 55
    • 79110  Freiburg
    • Germany
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    • Universtitätsklinikum FreiburgDepartment ChirurgieKlinik für Urologie
    • Mr.  Dr.  Konrad  Wilhelm 
    • Hugstetterstr. 55
    • 79106  Freiburg
    • Germany
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    • Universitätsklinikum FreiburgDepartment ChirurgieKlinik für Urologie
    • Mr.  PD Dr. med.  Martin  Schönthaler 
    • Hugstetterstr. 55
    • 79110  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinikum FreiburgDepartment ChirurgieKlinik für Urologie
    • Mr.  Prof. Dr.   Ulrich  Wetterauer 
    • Hugstetterstr. 55
    • 79110  Freiburg
    • Germany
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    •   0761/27028910
    •   0761/27028780
    •   [---]*
    •   [---]*
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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.