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Urinary Calculi | Use of Alfuzosin in Stone Treatment With ESWL

Urinary Calculi research study

What is the primary objective of this study?

Urinary tract stones may form in the kidneys or along the ureteric tracts and when left untreated, may result in complications such as pain, bleeding, infection and obstruction. ESWL (extra-corporeal shock wave lithotripsy) has been shown to be an effective and safe method of treatment for kidney and ureteric stones in-situ. In our centre, ESWL is done on an outpatient basis with oral pain killers in the weeks following treatment. Patients are also instructed to increase their fluid intake during this period to expedite the clearance of stone fragments. There have been studies to show that pain caused by stones is due to smooth muscle spasm along the ureters, possibly mediated by alpha-receptors. Alpha-blockers have been shown to improve the expulsion of stones and also improve pain relief when used alone, or together with ESWL treatment. In our study, we seek to investigate if alpha-blocker therapy (Alfuzosin) increases stone free rates and improves pain control after ESWL for renal and ureteric stones. The potential benefits include a higher rate of stone clearance and better pain control

Who is eligible to participate?

Inclusion Criteria: - All adult patients referred to our centre for ESWL treatment of renal or ureteric stones who give their informed consent. Exclusion Criteria: - Documented allergy or severe side effects to opioids/ NSAIDs/ Alfuzosin Severe hydronephrosis (on ultrasound or IVU) Radiolucent stones Urinary tract infections Previous pyeloureteral surgery Lower pole stones DJ stents in situ for stones Known renal/hepatic impairment or coagulopathy Pregnant Severe skeletal disease

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Urinary Calculi

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:Alfuzosin (Xatral)standard treatment plus alfuzosin

Drug:standard treatmentstandard treatment

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

1xatral

2standard treatment

Study Status

Withdrawn

Start Date: October 2006

Completed Date: December 2007

Phase: Phase 3

Type: Interventional

Design:

Primary Outcome: Reduction in pain score

Secondary Outcome: Severe giddiness as a side-effect

Study sponsors, principal investigator, and references

Principal Investigator: Tsung Wen Chong, MBBS, FRCS

Lead Sponsor: Singapore General Hospital

Collaborator: Sanofi

More information:https://clinicaltrials.gov/show/NCT00388271

Gravina GL, Costa AM, Ronchi P, Galatioto GP, Angelucci A, Castellani D, Narcisi F, Vicentini C. Tamsulosin treatment increases clinical success rate of single extracorporeal shock wave lithotripsy of renal stones. Urology. 2005 Jul;66(1):24-8.

Discuss Xatral