Extracorporal Shockwave Lithotripsy Versus Retrograde Intrarenal Surgery for the Treatment of Kidney Stones

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01514032
Recruitment Status : Unknown
Verified January 2012 by University of Zurich.
Recruitment status was:  Recruiting
First Posted : January 20, 2012
Last Update Posted : January 20, 2012
Information provided by (Responsible Party):
University of Zurich

January 16, 2012
January 20, 2012
January 20, 2012
October 2011
February 2014   (Final data collection date for primary outcome measure)
stonefree-rates 3month after therapy [ Time Frame: 3 month ]
Same as current
No Changes Posted
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Extracorporal Shockwave Lithotripsy Versus Retrograde Intrarenal Surgery for the Treatment of Kidney Stones
TOP-Stone: Treatment of Patients With Small Kidney Stones - Randomized Head-to-head Trial Comparing Extracorporal Shockwave Lithotripsy With Retrograde Intrarenal Surgery

The purpose of this study is to compare two established modalities for the treatment of kidneystones: ESWL (extracorporal shockwave-lithotripsy) vs. URS (uretero-reno-scopy with stone-extraction). Comparison of the stone-free rates 3month postoperative.

  • Trial with surgical intervention
Not Provided
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Kidney Stones
  • Procedure: Extracorporal shockwave lithotripsy
    Extracorporal shockwave lithotripsy
  • Procedure: Retrograde intrarenal surgery
    Retrograde intrarenal surgery
  • Active Comparator: Extracorporal shockwave lithotripsy
    Intervention: Procedure: Extracorporal shockwave lithotripsy
  • Active Comparator: Retrograde intrarenal surgery
    Intervention: Procedure: Retrograde intrarenal surgery
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
Same as current
February 2014
February 2014   (Final data collection date for primary outcome measure)

Inclusion criteria: - kidneystones requiring treatment up to an maximal size of 15mm (singular or multiple kidneystones with at least one stone with min. 5mm of size)

  • male and female patients between 18 and 99 years
  • informed consent signed by patient after explanation of the both treatment-modalities

Exclusion criteria: - age < 18 or > 99

  • pregnancy
  • breastfeeding mother
  • disorders of blood clotting
  • kidneystones > 15mm
  • aneurysms of the aorta or renal artery
  • severe skeletal deformations which hamper one of the treatment modalities
  • synchronous stones of the ipsilateral ureter
  • stones which can not visualized which X-ray or sonography
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
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University of Zurich
University of Zurich
Not Provided
Study Director: 01 Studienregister MasterAdmins UniversitaetsSpital Zuerich
Principal Investigator: Michael Muentener, MD University Hospital Zurich, Division of urology
University of Zurich
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP