Use of Alfuzosin in Stone Treatment With ESWL
Primary Purpose
Urinary Calculi
Status
Withdrawn
Phase
Phase 3
Locations
Singapore
Study Type
Interventional
Intervention
Alfuzosin (Xatral)
standard treatment
Sponsored by
About this trial
This is an interventional treatment trial for Urinary Calculi focused on measuring Alpha-blocker, Alfuzosin, Xatral, ESWL
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
Sites / Locations
- Urology Centre
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
1
2
Arm Description
xatral
standard treatment
Outcomes
Primary Outcome Measures
Reduction in pain score
Reduction in use of analgesics
stone free rate
Secondary Outcome Measures
Severe giddiness as a side-effect
Full Information
NCT ID
NCT00388271
First Posted
October 13, 2006
Last Updated
February 8, 2017
Sponsor
Singapore General Hospital
Collaborators
Sanofi
1. Study Identification
Unique Protocol Identification Number
NCT00388271
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.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Withdrawn
Why Stopped
lack of funding
Study Start Date
October 2006 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
December 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Singapore General Hospital
Collaborators
Sanofi
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Calculi
Keywords
Alpha-blocker, Alfuzosin, Xatral, ESWL
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
xatral
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
standard treatment
Intervention Type
Drug
Intervention Name(s)
Alfuzosin (Xatral)
Intervention Description
standard treatment plus alfuzosin
Intervention Type
Drug
Intervention Name(s)
standard treatment
Intervention Description
standard treatment
Primary Outcome Measure Information:
Title
Reduction in pain score
Time Frame
1 month
Title
Reduction in use of analgesics
Time Frame
1 month
Title
stone free rate
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Severe giddiness as a side-effect
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tsung Wen Chong, MBBS, FRCS
Organizational Affiliation
SGH Urology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Urology Centre
City
Singapore
Country
Singapore
12. IPD Sharing Statement
Citations:
PubMed Identifier
15992885
Citation
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.
Results Reference
background
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Use of Alfuzosin in Stone Treatment With ESWL
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