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Completed

NCT Number: NCT01222325

Comparison Between Two Shock Wave Regimens for Treating Urinary Stones

In order to check if a reduction in the frequency and total number of shocks delivered during extracorporeal shockwave lithotripsy (SWL) results in a great number of stone-free patients,the investigators compared two different ways of treating urinary stones using SWL.

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Key information

About this study

Purpose: Two different regimens of SWL delivery for treating urinary stones were compared.

Methods: After informed consent, patients with previously untreated renal and ureteric stones were admitted for an initial treatment by SWL between June 2008 and May 2009. Patients were randomly divided into two groups; one group received 3000 impulses at a rate of 60 impulses per minute, and the other received 4000 impulses at a rate of 90 impulses per minute. Patients submitted to re-treatment of the same stone were excluded. All treatments were done using the Dornier Compact Delta lithotripter. Stones were located by x-ray or ultrasound. Prior to treatment, patients were submitted to laboratory tests and a cardiologic evaluation when indicated. Urinary infections were treated prior to the SWL session. All procedures were performed under general anesthesia. Briefly, Tramadol 1-2 mg/kg associated to Propofol 2.5-3.0 mg/kg and scopolamine were employed in the majority of the procedures. Patients received 50-100 mg of diluted Tramadol and 20 mg of scopolamine just before the beginning of the SWL session and Propofol was maintained on continuous bomb infusion during the treatment and interrupted three minutes before the end of the session. All patients were maintained under spontaneous breathing, and a facial or a laryngeal oxygen mask was used according to the anesthesiologist's judgment. The potency of the lithotripter was increased progressively by 300 shocks until reaching the final stage, which occurred at a mean of 1500 shocks. The maximum potency employed was level 4 (equivalent to 14 kV) for renal stones and level 6 (16 kV) for ureteric stones.

All patients were treated on an outpatient basis and were discharged from the hospital six hours after treatment. All patients received non-steroidal anti-inflammatory drugs (NSAIDs) and Dipyrone in combination with to Hyoscine for three days postoperatively unless contraindicated and were instructed to come to the emergency department in case of severe pain, fever or hematuria.

The final results for each patient were assessed with a kidney and urinary bladder scan (KUB) plus an abdominal ultrasound three months after the procedure. Success was defined as stone-free status or the detection of residual fragments ≤ 3 mm on final evaluation. Partial fragmentation was considered to have occurred if a significant reduction in the stone burden was observed but residual fragments bigger than 3 mm remained.

We evaluated overall stone-free rates, the incidence of unchanged stones and the occurrence of partial fragmentation as well as the occurrence of significant complications in both groups.

The sample size required was based on the assumption that the estimated success rate would be 70% in the 3000 impulses at 60 impulses per minute group and 50% in the 4000 impulses at 90 impulses per minute group, with a type I error of 0.05 and a type II error of 0.05 (power of 80%). This yielded a projected sample size of 93 stones in each group.

Data were analyzed using the Fischer's exact, Chi-square and Mann-Whitney tests; a level of significance of 5% was adopted.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients with renal or ureteral stones from 5 to 20 mm

Exclusion criteria

  • pregnancy
  • coagulation disturbs and antiplatelet treatment
  • urinary tract infection
  • aortic aneurism bigger than 2 cm
  • clinical contraindication to general anesthesia
  • refusal in participating of the protocol

Treatment and study plan

extracorporeal shockwave lithotripsy (SWL)

Procedure

patients were submitted to one session SWL at a Dornier Compact Delta lithotripter under general anesthesia under supervision of an anesthesiologist and an urologist.

Other names: lithotripsy, shock waves

Primary outcomes

  1. abdominal ultrasound and abdominal x rays (KUB)

    Time frame: 3 months

    patients submitted to SWL in two different regimens were submited to renal ultrasound and abdominal x rays (KUB) three months after procedure to check the occourrence of stone-free status, residual fragments or unmodified stone.

Secondary outcomes

  1. adverse effects of the two different regimens

    Time frame: 3 months

    patients submitted to two different SWL regimens were followed clinically and submited to renal ultrasound and abdominal x ray to check the occurrence of adverse effects like hematoma or peri renal collections.

Sponsors and collaborators

Lead sponsor

University of Sao Paulo General Hospital

Other

Registry information

Official study title

Comparison Between Two Shock Wave Regimens Using Frequencies of 60 and 90 Impulses Per Minute for Urinary Stones

Important dates

Study start
2008
Primary completion
2008
Study completion
2009
First posted
Oct 18, 2010
Registry last updated
Oct 18, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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