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

This study is currently recruiting participants.
Verified January 2012 by University of Zurich
Sponsor:
Information provided by (Responsible Party):
University of Zurich
ClinicalTrials.gov Identifier:
NCT01514032
First received: January 16, 2012
Last updated: January 19, 2012
Last verified: January 2012
History of Changes
  Purpose

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

Condition Intervention
Kidney Stones
 Procedure: Extracorporal shockwave lithotripsy
Procedure: Retrograde intrarenal surgery

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: TOP-Stone: Treatment of Patients With Small Kidney Stones - Randomized Head-to-head Trial Comparing Extracorporal Shockwave Lithotripsy With Retrograde Intrarenal Surgery

Resource links provided by NLM:

MedlinePlus related topics: Kidney Stones
U.S. FDA Resources

Further study details as provided by University of Zurich:

Primary Outcome Measures:
  • stonefree-rates 3month after therapy [ Time Frame: 3 month ] [ Designated as safety issue: No ]

Estimated Enrollment: 230
Study Start Date: October 2011
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Extracorporal shockwave lithotripsy Procedure: Extracorporal shockwave lithotripsy
Extracorporal shockwave lithotripsy
Active Comparator: Retrograde intrarenal surgery Procedure: Retrograde intrarenal surgery
Retrograde intrarenal surgery

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01514032

Contacts
Contact: Damian Weber, MD +41 44 2555407 damian.weber@usz.ch
Contact: Michael Muentener, MD +41 44 2555403 michael.muentener@usz.ch

Locations
Switzerland
University Hospital Zurich, Urology Recruiting
Zurich, Switzerland
Sponsors and Collaborators
University of Zurich
Investigators
Study Director: 01 Studienregister MasterAdmins UniversitaetsSpital Zuerich
Principal Investigator: Michael Muentener, MD University Hospital Zurich, Division of urology
  More Information

No publications provided

Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT01514032     History of Changes
Other Study ID Numbers: TOP-Stone
Study First Received: January 16, 2012
Last Updated: January 19, 2012
Health Authority: Switzerland: Swissmedic

Additional relevant MeSH terms:
Calculi
Kidney Calculi
Nephrolithiasis
Pathological Conditions, Anatomical
 Kidney Diseases
Urologic Diseases
Urolithiasis
Urinary Calculi

ClinicalTrials.gov processed this record on May 23, 2013