Extracorporal Shockwave Lithotripsy Versus Retrograde Intrarenal Surgery for the Treatment of Kidney Stones
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ClinicalTrials.gov 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
|
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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 or disease | Intervention/treatment | Phase |
---|---|---|
Kidney Stones | Procedure: Extracorporal shockwave lithotripsy Procedure: Retrograde intrarenal surgery | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 230 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (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 |
Study Start Date : | October 2011 |
Estimated Primary Completion Date : | February 2014 |
Estimated Study Completion Date : | February 2014 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Extracorporal shockwave lithotripsy |
Procedure: Extracorporal shockwave lithotripsy
Extracorporal shockwave lithotripsy
|
Active Comparator: Retrograde intrarenal surgery |
Procedure: Retrograde intrarenal surgery
Retrograde intrarenal surgery
|
- stonefree-rates 3month after therapy [ Time Frame: 3 month ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01514032
Contact: Damian Weber, MD | +41 44 2555407 | damian.weber@usz.ch | |
Contact: Michael Muentener, MD | +41 44 2555403 | michael.muentener@usz.ch |
Switzerland | |
University Hospital Zurich, Urology | Recruiting |
Zurich, Switzerland |
Study Director: | 01 Studienregister MasterAdmins | UniversitaetsSpital Zuerich | |
Principal Investigator: | Michael Muentener, MD | University Hospital Zurich, Division of urology |
Responsible Party: | University of Zurich |
ClinicalTrials.gov Identifier: | NCT01514032 History of Changes |
Other Study ID Numbers: |
TOP-Stone |
First Posted: | January 20, 2012 Key Record Dates |
Last Update Posted: | January 20, 2012 |
Last Verified: | January 2012 |
Additional relevant MeSH terms:
Kidney Calculi Nephrolithiasis Kidney Diseases Urologic Diseases |
Urolithiasis Urinary Calculi Calculi Pathological Conditions, Anatomical |