Use of Alfuzosin in Stone Treatment With ESWL

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2007 by Singapore General Hospital.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Sanofi-Synthelabo
Information provided by:
Singapore General Hospital
ClinicalTrials.gov Identifier:
NCT00388271
First received: October 13, 2006
Last updated: October 3, 2007
Last verified: October 2007
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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.

Resource links provided by NLM:


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
Active Comparator: 1
xatral
Drug: Alfuzosin (Xatral)
standard treatment plus alfuzosin
Placebo Comparator: 2
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

Additional relevant MeSH terms:
Urinary Calculi
Urolithiasis
Urologic Diseases
Calculi
Pathological Conditions, Anatomical
Alfuzosin
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Urological Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 18, 2014