We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Efficacy of Alpha-blockers for Expulsion of Distal Ureteral Stones

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2007 by Soroka University Medical Center.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00451061
First Posted: March 22, 2007
Last Update Posted: July 12, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Soroka University Medical Center
  Purpose

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 Intervention Phase
Renal Colic Drug: Alfuzosin Drug: Tamsulosin Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Soroka University Medical Center:

Primary Outcome Measures:
  • frequency of stone expulsion
  • time to stone expulsion
  • analgesics consumption

Estimated Enrollment: 120
Study Start Date: April 2007
  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (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
  Contacts and Locations
Information from the National Library of Medicine

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
  More Information

Additional Information:
Publications:

ClinicalTrials.gov Identifier: NCT00451061     History of Changes
Other Study ID Numbers: sor449907ctil
First Submitted: March 21, 2007
First Posted: March 22, 2007
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