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Use of Alfuzosin in Stone Treatment With ESWL

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Recruitment Status : Withdrawn (lack of funding)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

Tracking Information
First Submitted Date  ICMJE October 13, 2006
First Posted Date  ICMJE October 16, 2006
Last Update Posted Date February 10, 2017
Study Start Date  ICMJE October 2006
Actual Primary Completion Date December 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE
 (submitted: October 13, 2006)
  • stone free rate
  • Reduction in pain score
  • Reduction in use of analgesics
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 3, 2007)
Severe giddiness as a side-effect [ Time Frame: 1 month ]
Original Secondary Outcome Measures  ICMJE
 (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  ICMJE Use of Alfuzosin in Stone Treatment With ESWL
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Urinary Calculi
Intervention  ICMJE
  • Drug: Alfuzosin (Xatral)
    standard treatment plus alfuzosin
  • Drug: standard treatment
    standard treatment
Study Arms  ICMJE
  • 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: October 19, 2016)
0
Original Enrollment  ICMJE
 (submitted: October 13, 2006)
200
Actual Study Completion Date  ICMJE December 2007
Actual Primary Completion Date December 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Singapore
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00388271
Other Study ID Numbers  ICMJE SGH/URO/XTR001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Singapore General Hospital
Study Sponsor  ICMJE Singapore General Hospital
Collaborators  ICMJE Sanofi
Investigators  ICMJE
Principal Investigator: Tsung Wen Chong, MBBS, FRCS SGH Urology
PRS Account Singapore General Hospital
Verification Date February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP