Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00004058

Trial Description

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Title

BPH-6: A UroLift® System Post Market Multi-Center Randomized Study

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Trial Acronym

BPH-6

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URL of the Trial

[---]*

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Brief Summary in Lay Language

The purpose of this study is to compare the UroLift System Treatment to Transurethral
Resection of the Prostate (TURP) in improving a patient's overall quality of life, while
evaluating healthcare expenditures associated with each therapy.

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Brief Summary in Scientific Language

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Organizational Data

  •   DRKS00004058
  •   2012/08/01
  •   2012/02/10
  •   no
  •   [---]*
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Secondary IDs

  •   NCT01533038  (ClinicalTrials.gov)
  •   CP12317  (NeoTract, Inc.)
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Health Condition or Problem studied

  •   Benign Prostatic Hyperplasia
  •   N40 -  Hyperplasia of prostate
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Interventions/Observational Groups

  •   Device: UroLift System
  •   Procedure: Transurethral Resection of the Prostate
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   IV
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Primary Outcome

- Responder Analysis: A Subject is a Responder at the 12 Month Follow-up Time Point if All 6 Thresholds of the BPH-6 Endpoint Are Met; time frame: Month 12; LUTS: ≥ 30% reduction in IPSS compared to baseline
Recovery Experience: Return to pre-operative activity levels by 1 month
Erectile function: Less than 6-point reduction in SHIM compared to baseline.
Ejaculatory function: Response on MSHQ-EjD that indicates emission of semen. This excludes the response "Could not ejaculate"
Continence: ISI score of 4 points or less at all follow-up time points
Safety: No procedure-related adverse event greater than Grade I on the Clavien-Dindo classification system modified for TURP at any time during procedure or follow up.

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Secondary Outcome

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Countries of Recruitment

  •   Denmark
  •   Germany
  •   United Kingdom
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Locations of Recruitment

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Recruitment

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  •   2012/02/27
  •   100
  •   Multicenter trial
  •   International
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Inclusion Criteria

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

• Men >50 years old with moderate-severe BPH

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Exclusion Criteria

- Size, width of prostate

- Other medical condition or co-morbidity contraindicative for TURP or UroLift

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Addresses

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    • NeoTract, Inc.
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    • University Vita Salute San Raffaele
    • Francesco Montorsi, MD 
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    • University Vita Salute San Raffaele
    • Francesco Montorsi, MD 
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    •   [---]*
    •   [---]*
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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    •   [---]*
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Status

  •   Recruiting complete, follow-up continuing
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   7
  •   2016/01/14


* This entry means the parameter is not applicable or has not been set.