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| Sponsor: | Singapore General Hospital |
|---|---|
| Collaborator: |
Sanofi-Synthelabo |
| Information provided by: | Singapore General Hospital |
| ClinicalTrials.gov Identifier: | NCT00388271 |
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 III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
| 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. |
| Estimated Enrollment: | 200 |
| Study Start Date: | October 2006 |
| Estimated Study Completion Date: | December 2007 |
| Arms | Assigned Interventions |
|---|---|
|
1: Active Comparator
xatral
|
Drug: Alfuzosin (Xatral)
standard treatment plus alfuzosin
|
|
2: Placebo Comparator
standard treatment
|
Drug: standard treatment
standard treatment
|
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Yia Swam Tan, MBBS | ungesellig@hotmail.com | |
| Contact: Tsung Wen Chong, MBBS, FRCS | chong.tsung.wen@sgh.com.sg |
| Singapore | |
| Urology Centre | Recruiting |
| Singapore, Singapore | |
| Contact: Tsung Wen Chong, MBBS, FRCS chong.tsung.wen@sgh.com.sg | |
| Principal Investigator: | Tsung Wen Chong, MBBS, FRCS | SGH Urology |
More Information
| Study ID Numbers: | SGH/URO/XTR001 |
| Study First Received: | October 13, 2006 |
| Last Updated: | October 3, 2007 |
| ClinicalTrials.gov Identifier: | NCT00388271 History of Changes |
| Health Authority: | Singapore: Health Sciences Authority |
|
Alpha-blocker Alfuzosin Xatral ESWL |
|
Pathological Conditions, Anatomical Urinary Calculi Neurotransmitter Agents Adrenergic Agents Molecular Mechanisms of Pharmacological Action Urolithiasis Physiological Effects of Drugs Cardiovascular Agents |
Adrenergic alpha-Antagonists Antihypertensive Agents Calculi Pharmacologic Actions Alfuzosin Urologic Diseases Therapeutic Uses Adrenergic Antagonists |