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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
Sponsor:
Information provided by:
Soroka University Medical Center

Brief Summary:

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

  Show Detailed Description

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

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Primary Outcome Measures :
  1. frequency of stone expulsion
  2. time to stone expulsion
  3. analgesics consumption


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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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


Contacts
Contact: Eran Rosenberg, M.D 972-8-6400626 eranro@clalit.org.il

Locations
Israel
Urology department, Soroka university medical center Not yet recruiting
Beer-Sheva, p,o,box 151, Israel, 84101
Sponsors and Collaborators
Soroka University Medical Center
Investigators
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