CompletedPhase 4ACTRN12610000434099

Comparison of 2 lithotripter regarding efficacy / complication rate of kidney and ureteral stones

Modified HM3 versus Modulith SLX-F2 lithotripter: A prospective randomized trial to compare the clinical efficacy and complication rate between the first and the latest lithotriptor generation in patients with kidney and/or ureteral stones.


Sponsor

Department of Urology

Enrollment

800 participants

Start Date

Apr 1, 2006

Study Type

Interventional

Conditions

Summary

The treatment of urinary stones with extracorporeal shock waves was first described in the early 80's and thereafter almost completely replaced open stone surgery. The first treatement device (lithotriptor) was the HM3 from Dornier. Since then, multiple successor models have been developped and are used worldwide. So far, only few direct comparisons between the first device and a following generation device have been conducted. Owing the last model of such a HM3 device in Switzerland and in addition, a third generation device, we intended to perform an internal quality control. within our department. Both devices are in daily use over years already. In our center, approximately 400 patients are treated per year. The HM3 requires regular technical workup but spare parts are increasingly hard to find. Being aware of the soner or later ending "career" of the legendary HM3, the performed internal quality control will enable us to compare treatment data, e.g. efficacy, complications etc. in the future. We therefore compared the stone free rates, size of residual stone fragments, side effects like hematoma around the kidney, stone clearance (urine was filtered to detect disintegrates), number of shock waves required and re-treatment rates between the two devices.


Eligibility

Sex: Both males and females

Plain Language Summary

Simplified for easier understanding

This study compares two different machines used for breaking up kidney and ureteral stones with shock waves (lithotripsy) to see which is more effective and causes fewer complications. It is for patients needing this procedure who do not have very large stones or blood clotting problems.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

Patients were stratified according to stone location and stone burden. All treatments with either lithotripter took place under anaesthesia (mostly spinal or epidural, few general) to eliminate pain a

Patients were stratified according to stone location and stone burden. All treatments with either lithotripter took place under anaesthesia (mostly spinal or epidural, few general) to eliminate pain as a limiting factor for optimal treatment and to keep respiratory movements regular for minimal stone movements. With either lithotripter, treatments were started with a series of 500 shock waves of moderate energy (HM3 with 19kV, SLX-F2 level 7). If the first fluoroscopic control showed no fragmentation, shock wave energy was increased to 21-22 kV or level 9 for HM3 and SLX-F2, respectively. In case of partial stone disintegration after 500 shocks, energy was maintaned in order to prevent unnecessary kidney trauma and progressively decreased (kV by kV / level by level) according to the size of the stone fragments. Treatment was stopped prematurely before the maximally allowed number of shock waves delivered (2500 for kidney stones, 3000 for ureteral stones off the kidney) if the x-ray snap shots didn't allow for the detection of residual fragments. Shocks were delivered heart beat triggered, usually at rates of 70-80 shock waves per minute. Modified lithotripter HM3, Dornier: The electro-hydraulic shock waves are generated between two electrodes in a water-bath. In an attempt to offer patients anaesthesia-free treatment, the original HM3 was modified in the early 90's. The elllipsoid aperture was increased from originally 15.0cm (aperture area of 176cm2) to 17.2cm (aperture area of 232 cm2) to have the shock wave energy distributed over a larger surface at the skin level. With this, shock waves became also more concentrated in the second focal area with higher peak pressures. Therefore, most modified HM3 with a wider ellipsoid were operated with a reduced generator capacity of 40nF, instead of 80nF as with the original ellipsoid. The HM3 lithotripter used for this trial has the bigger ellipsoid (17.2cm), but still the original generator (capacity =80nF). Exact energy measurements have never been performed for the "hybrid" model but it is estimated to deliver a total energy of at least 45mJ in the focal zone. Lithotripter Modulith SLX-F2, Storz Medial: The electro-magnetic shock waves are generated in analogy to a loud-speaker. The source aperture is 30cm (aperture area of 707cm2). Of the two focal zones available, we exclusively used the extended focus (F2). Working with a mean energy level 9, total energy in the focal zone is 150mJ. More than 3 times highter than that of the HM3. Treatment time depends on stone burden and localisation as well as fragmentation. Definitively after 2500 shock waves (kidney) and/or 3000 shock waves (ureter) the treatment has to be finished in order to avoid tissue trauma. The average treatment time is approximately 45-60 minutes. This does not include positioning/monitoring/targegint, which takes another 15-30 minutes.


Locations(1)

Switzerland

View Full Details on ANZCTR

For the most up-to-date information, visit the official listing.

Visit

ACTRN12610000434099