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

January 19, 2012 updated by: University of Zurich

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

230

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Switzerland
      • Zurich, Switzerland
        • Recruiting
        • University Hospital Zurich, Urology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
stonefree-rates 3month after therapy
Time Frame: 3 month
3 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Zurich

Investigators

  • Principal Investigator: Michael Muentener, MD, University Hospital Zurich, Division of urology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (Anticipated)

February 1, 2014

Study Completion (Anticipated)

February 1, 2014

Study Registration Dates

First Submitted

January 16, 2012

First Submitted That Met QC Criteria

January 19, 2012

First Posted (Estimate)

January 20, 2012

Study Record Updates

Last Update Posted (Estimate)

January 20, 2012

Last Update Submitted That Met QC Criteria

January 19, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TOP-Stone

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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