Use of Alfuzosin in Stone Treatment With ESWL

• ClinicalTrials.gov Identifier: NCT00388271
• Recruitment Status: Withdrawn
• First Posted: October 16, 2006
• Last Update Posted: February 10, 2017
• Sponsor: Singapore General Hospital
• Collaborator: Sanofi
• Information provided by (Responsible Party): Singapore General Hospital

Tracking Information

• First Submitted Date: October 13, 2006
• First Posted Date: October 16, 2006
• Last Update Posted Date: February 10, 2017
• Study Start Date: October 2006
• Actual Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 3, 2007)

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

Original Primary Outcome Measures (submitted: October 13, 2006)

• stone free rate
• Reduction in pain score
• Reduction in use of analgesics

• Current Secondary Outcome Measures (submitted: October 3, 2007): Severe giddiness as a side-effect [ Time Frame: 1 month ]
• Original Secondary Outcome Measures (submitted: October 13, 2006): Severe giddiness as a side-effect
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Use of Alfuzosin in Stone Treatment With ESWL
• 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.
• 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.

• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Urinary Calculi

Intervention

• Drug: Alfuzosin (Xatral)
  standard treatment plus alfuzosin
• Drug: standard treatment
  standard treatment

Study Arms

• Active Comparator: 1
  xatral
  Intervention: Drug: Alfuzosin (Xatral)
• Placebo Comparator: 2
  standard treatment
  Intervention: Drug: standard treatment

• Publications *: 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.

Recruitment Information

• Recruitment Status: Withdrawn
• Actual Enrollment (submitted: October 19, 2016): 0
• Original Enrollment (submitted: October 13, 2006): 200
• Actual Study Completion Date: December 2007
• Actual Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 21 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Singapore

Administrative Information

• NCT Number: NCT00388271
• Other Study ID Numbers: SGH/URO/XTR001
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Singapore General Hospital
• Study Sponsor: Singapore General Hospital
• Collaborators: Sanofi

Investigators

• Principal Investigator: Tsung Wen Chong, MBBS, FRCS; SGH Urology

• PRS Account: Singapore General Hospital
• Verification Date: February 2017