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

University of Zurich (UZH)

Status: Unknown

Conditions: Kidney Stones

Treatments: Procedure: Extracorporal shockwave lithotripsy; Procedure: Retrograde intrarenal surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT01514032

TOP-Stone

Details and patient eligibility

About

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

Enrollment: 230 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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230 participants in 2 patient groups

Extracorporal shockwave lithotripsy

Active Comparator group

Treatment:

Procedure: Extracorporal shockwave lithotripsy

Retrograde intrarenal surgery

Active Comparator group

Treatment:

Procedure: Retrograde intrarenal surgery