The Efficacy of Alpha-blockers for Expulsion of Distal Ureteral Stones
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ClinicalTrials.gov Identifier: NCT00451061 |
Recruitment Status
: Unknown
Verified February 2007 by Soroka University Medical Center.
Recruitment status was: Not yet recruiting
First Posted
: March 22, 2007
Last Update Posted
: July 12, 2012
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Most of the patients suffering from renal colic have a distal ureterolithiasis. It had been demonstrated that α adrenoreceptors antagonists, given to patients suffering from renal colic, due to distal ureterolithiasis, had increased the frequency of stone expulsion rate , reduced the time to expulsion and reduced analgesics consumption.Most of the studies evaluated the efficacy of Tamsulosin, which is a selective α 1A and α 1D adrenoreceptors antagonist.(The lower intramural portion of the ureter, where it passes through the detrusor muscle contains mostly α 1D and α 1A adrenergic receptors)
Only one study these days describes the use of Alfuzosin, which is an α adrenergic receptor blocker and not selective for any α 1 adrenergic receptor, for expulsion of distal ureteric stones.Alfuzosin is a drug with a proven efficacy and considered uroselective with high specificity and sensitivity, for the treatment of BPH. There was no significant difference in efficacy between the two α blockers (Alfuzosin vs. Tamsulosin) concerning symptoms relief or flow improvement.
The objective of this study is to compare patient who would receive the standard treatment for distal ureterolithiasis (analgesics, Rowatinex) to patients who would receive also a non selective α blocker (Alfuzosin) or a selective α blocker (Tamsulosin). This in order to evaluate the efficacy of treatment with α blockers for expulsion of distal ureterolithiasis.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Renal Colic | Drug: Alfuzosin Drug: Tamsulosin | Phase 4 |

Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 120 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Study Start Date : | April 2007 |
- frequency of stone expulsion
- time to stone expulsion
- analgesics consumption

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Ages Eligible for Study: | 18 Years to 65 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
• renal colic due to radiologically proven distal ureteral stones
Exclusion Criteria:
- stone larger than 10 mm
- fever
- urinary tract infection
- additional stones, that might be the reason for the renal colic
- severe hydronephrosis
- known sensitivity to α blockers
- concomitant treatment with α blockers, β blockers, calcium antagonists, and nitrates
- pregnancy
- inability to provide informed consent
- a history of surgery or endoscopic procedures in the urinary tract
- history of spontaneous stone expulsion
- known ureteral stricture
- diabetes
- blood pressure values lower than 100/70 mm hg

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): NCT00451061
Contact: Eran Rosenberg, M.D | 972-8-6400626 | eranro@clalit.org.il |
Israel | |
Urology department, Soroka university medical center | Not yet recruiting |
Beer-Sheva, p,o,box 151, Israel, 84101 |
Principal Investigator: | Eran Rosenberg, M.D | Soroka university medical center, Beer-Sheva, Israel | |
Study Director: | Igor Romanowski, M.D | Soroka university medical center, Beer-Sheva, Israel |
Additional Information:
Publications:
ClinicalTrials.gov Identifier: | NCT00451061 History of Changes |
Other Study ID Numbers: |
sor449907ctil |
First Posted: | March 22, 2007 Key Record Dates |
Last Update Posted: | July 12, 2012 |
Last Verified: | February 2007 |
Keywords provided by Soroka University Medical Center:
distal ureterolithiasis α adrenoreceptors antagonist |
Additional relevant MeSH terms:
Renal Colic Pain Neurologic Manifestations Nervous System Diseases Signs and Symptoms Tamsulosin 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 |