Use of Alfuzosin in Stone Treatment With ESWL

NCT ID: NCT00388271

Last Updated: 2017-02-10

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-10-31
• Study Completion Date: 2007-12-31

Brief Summary

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

Detailed Description

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. Alpha1-adrenergic blockers have been shown to improve stone free rates in renal stones and lower ureteric stones. Tamsulosin has been the agent most commonly investigated. There have been no studies done to study the effectiveness of Alfuzosin in stone treatment. Alfuzosin has been shown to be effective in treating benign prostatic hypertrophy, and has a good safety profile. Deliveliotis et al has shown that alfuzosin improves symptoms and quality of life in patients with double-J stents.

This is a prospective, randomised, double-blind, placebo-controlled study involving patients undergoing ESWL for renal and ureteric stones. Exclusion criteria applies (please see below). The patients will be randomised into 2 groups: study VS control. Randomisation is done by using a computer generated list with block randomisation, assigning consecutive patients to either treatment arms. Our standard treatment is intravenous pethidine 50mg and intravenous maxolon 10mg at the onset of the ESWL session, followed by oral analgesics- NSAIDs with a gastroprotective agent. For this study, we will standardise all to oral naproxen 550mg BD with oral omeprazole 20mg BD. The study group will receive the standard treatment, with oral alfuzosin 10mg ON for 1 month, while the control group will receive a placebo. Patients will be given a diary in which to chart their pain scores, use of analgesics, episodes of pain, passage of stones, side-effects of the medications and complications of treatment. At the end of one month, all patients will be called back for review. Stone free status is ascertained with an X-ray, and the diary will be collected for further analysis.

Conditions

Urinary Calculi

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

1

xatral

Group Type: ACTIVE_COMPARATOR

Alfuzosin (Xatral)

Intervention Type: DRUG

standard treatment plus alfuzosin

2

standard treatment

Group Type: PLACEBO_COMPARATOR

standard treatment

Intervention Type: DRUG

standard treatment

Interventions

Alfuzosin (Xatral)

standard treatment plus alfuzosin

Intervention Type: DRUG

standard treatment

standard treatment

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: collaborator

Singapore General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tsung Wen Chong, MBBS, FRCS

Role: PRINCIPAL_INVESTIGATOR

SGH Urology

Locations

Urology Centre

Singapore, , Singapore

Countries

Singapore

References

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. doi: 10.1016/j.urology.2005.01.013.

Reference Type: BACKGROUND

PMID: 15992885 (View on PubMed)

Other Identifiers

SGH/URO/XTR001

Identifier Type: -

Identifier Source: org_study_id