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

• Sponsor: University of Zurich (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01514032
• Collaborator: (none)
• Enrollment: 230
• Location: 1
• Arms: 2
• Duration (Months): 28.1
• Patients Per Site Per Month: 8.2

Study Details

Study Description

Brief Summary

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	N/A

Study Design

• Study Type: Interventional
• Anticipated 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: Oct 1, 2011
• Anticipated Primary Completion Date: Feb 1, 2014
• Anticipated Study Completion Date: Feb 1, 2014

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. stonefree-rates 3month after therapy [3 month]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital Zurich, Urology	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Zurich
• ClinicalTrials.gov Identifier: NCT01514032
• Other Study ID Numbers: TOP-Stone
• First Posted: Jan 20, 2012
• Last Update Posted: Jan 20, 2012
• Last Verified: Jan 1, 2012

• Additional relevant MeSH terms: Kidney Calculi; Nephrolithiasis

Study Results

No Results Posted as of Jan 20, 2012