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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2007 by Soroka University Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Soroka University Medical Center
ClinicalTrials.gov Identifier:
NCT00451061
First received: March 21, 2007
Last updated: July 11, 2012
Last verified: February 2007
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: March 21, 2007
Last Updated: July 11, 2012
Health Authority: Israel: Ministry of Health

Keywords provided by Soroka University Medical Center:
distal ureterolithiasis
α adrenoreceptors antagonist

Additional relevant MeSH terms:
Renal Colic
Abdominal Pain
Colic
Pain
Signs and Symptoms
Signs and Symptoms, Digestive

ClinicalTrials.gov processed this record on November 27, 2014