Comparison Between Two Shock Wave Regimens for Treating Urinary Stones

NCT01222325 | Completed

• 1 other identifier: 1183/06
• Study Type: interventional
• Target: 302
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Urinary (Renal or Ureteral) Stones

Keywords

kidney calculi; urolithiasis; urologic surgical procedures; extracorporeal shockwave lithotripsy

Outcome Measures

Primary Outcomes (1)

• abdominal ultrasound and abdominal x rays (KUB)

  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.

  3 months

Secondary Outcomes (1)

• adverse effects of the two different regimens

  3 months

Study Arms (2)

swl 3000 impulses- 60 imp/min

ACTIVE COMPARATOR

patients in this group were submitted to extracorporeal shockwave lithotripsy (SWL) 3000 impulses at 60 impulses per minute under general anesthesia. Unique session

Procedure: extracorporeal shockwave lithotripsy (SWL)

swl- 4000 impulses - 90 impulses /min

ACTIVE COMPARATOR

patients in this group were submitted extracorporeal shockwave lithotripsy (swl) to 4000 impulses at 90 impulses per minute under general anesthesia- unique session

Procedure: extracorporeal shockwave lithotripsy (SWL)

Interventions

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.

Also known as: lithotripsy, shock waves

swl 3000 impulses- 60 imp/min; swl- 4000 impulses - 90 impulses /min

Eligibility Criteria

• Age: 6 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (1)

University of Sao Paulo General Hospital

São Paulo, São Paulo, 05403-000, Brazil

Location

MeSH Terms

Conditions

Calculi; Kidney Calculi; Urolithiasis

Interventions

Lithotripsy; High-Energy Shock Waves

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Nephrolithiasis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Calculi; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Ultrasonic Surgical Procedures; Surgical Procedures, Operative; Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena

Study Officials

• eduardo mazzucchi, md

  univesrity of sao paulo general hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 5, 2010
• First Posted: October 18, 2010
• Study Start: June 1, 2008
• Primary Completion: November 1, 2008
• Study Completion: August 1, 2009
• Last Updated: October 18, 2010

Record last verified: 2009-08

Locations

BR (1)