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Use of Alfuzosin in Stone Treatment With ESWL

This study is currently recruiting participants.
Verified by Singapore General Hospital, October 2007

Sponsors and Collaborators: Singapore General Hospital
Sanofi-Synthelabo
Information provided by: Singapore General Hospital
ClinicalTrials.gov Identifier: NCT00388271
  Purpose

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


Condition Intervention Phase
Urinary Calculi
Drug: Alfuzosin (Xatral)
Drug: standard treatment
Phase III

ChemIDplus related topics:   Alfuzosin    Alfuzosin hydrochloride   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:   To Investigate if Alpha-Blocker Therapy (Alfuzosin) Increases Stone Free Rates and Improves Pain Control After ESWL (Extra-Corporeal Shock Wave Lithotripsy) for Renal and Ureteric Stones.

Further study details as provided by Singapore General Hospital:

Primary Outcome Measures:
  • Reduction in pain score [ Time Frame: 1 month ]
  • Reduction in use of analgesics [ Time Frame: 1 month ]
  • stone free rate [ Time Frame: 1 month ]

Secondary Outcome Measures:
  • Severe giddiness as a side-effect [ Time Frame: 1 month ]

Estimated Enrollment:   200
Study Start Date:   October 2006
Estimated Study Completion Date:   December 2007

Arms Assigned Interventions
1: Active Comparator
xatral
Drug: Alfuzosin (Xatral)
standard treatment plus alfuzosin
2: Placebo Comparator
standard treatment
Drug: standard treatment
standard treatment

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.

  Eligibility
Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00388271

Contacts
Contact: Yia Swam Tan, MBBS     ungesellig@hotmail.com    
Contact: Tsung Wen Chong, MBBS, FRCS     chong.tsung.wen@sgh.com.sg    

Locations
Singapore
Urology Centre     Recruiting
      Singapore, Singapore
      Contact: Tsung Wen Chong, MBBS, FRCS         chong.tsung.wen@sgh.com.sg    

Sponsors and Collaborators
Singapore General Hospital
Sanofi-Synthelabo

Investigators
Principal Investigator:     Tsung Wen Chong, MBBS, FRCS     SGH Urology    
  More Information


Publications:

Study ID Numbers:   SGH/URO/XTR001
First Received:   October 13, 2006
Last Updated:   October 3, 2007
ClinicalTrials.gov Identifier:   NCT00388271
Health Authority:   Singapore: Health Sciences Authority

Keywords provided by Singapore General Hospital:
Alpha-blocker  
Alfuzosin  
Xatral  
ESWL  

Study placed in the following topic categories:
Pathological Conditions, Anatomical
Urinary Calculi
Ureterolithiasis
Alfuzosin
Urologic Diseases
Shock
Urolithiasis
Ureteral Calculi
Pain
Calculi

Additional relevant MeSH terms:
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Therapeutic Uses
Physiological Effects of Drugs
Adrenergic Antagonists
Cardiovascular Agents
Adrenergic alpha-Antagonists
Antihypertensive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 15, 2008




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