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Withdrawn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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Urinary Calculi | Drug: Alfuzosin (Xatral) Drug: standard treatment | Phase 3 |
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 (Clinical Trial) |
Actual Enrollment : | 0 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, 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. |
Study Start Date : | October 2006 |
Actual Primary Completion Date : | December 2007 |
Actual Study Completion Date : | December 2007 |

Arm | Intervention/treatment |
---|---|
Active Comparator: 1
xatral
|
Drug: Alfuzosin (Xatral)
standard treatment plus alfuzosin |
Placebo Comparator: 2
standard treatment
|
Drug: standard treatment
standard treatment |
- Reduction in pain score [ Time Frame: 1 month ]
- Reduction in use of analgesics [ Time Frame: 1 month ]
- stone free rate [ Time Frame: 1 month ]
- Severe giddiness as a side-effect [ Time Frame: 1 month ]

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Ages Eligible for Study: | 21 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00388271
Singapore | |
Urology Centre | |
Singapore, Singapore |
Principal Investigator: | Tsung Wen Chong, MBBS, FRCS | SGH Urology |
Responsible Party: | Singapore General Hospital |
ClinicalTrials.gov Identifier: | NCT00388271 |
Other Study ID Numbers: |
SGH/URO/XTR001 |
First Posted: | October 16, 2006 Key Record Dates |
Last Update Posted: | February 10, 2017 |
Last Verified: | February 2017 |
Alpha-blocker Alfuzosin Xatral ESWL |
Urinary Calculi Calculi Pathological Conditions, Anatomical Urolithiasis Urologic Diseases Alfuzosin Adrenergic alpha-1 Receptor Antagonists |
Adrenergic alpha-Antagonists Adrenergic Antagonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Urological Agents |