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

This study is not yet open for participant recruitment.
Verified by Soroka University Medical Center, February 2007

Sponsored by: Soroka University Medical Center
Information provided by: Soroka University Medical Center
ClinicalTrials.gov Identifier: NCT00451061
  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 IV

ChemIDplus related topics:   Alfuzosin    Alfuzosin hydrochloride    Tamsulosin    Tamsulosin hydrochloride   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

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  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

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

Guidelines on benign prostatic hyperplasia,2004,p.36  This link exits the ClinicalTrials.gov site
 

Publications:
De Sio M, Autorino R, Di Lorenzo G, Damiano R, Giordano D, Cosentino L, Pane U, Di Giacomo F, Mordente S, D'Armiento M. Medical expulsive treatment of distal-ureteral stones using tamsulosin: a single-center experience. J Endourol. 2006 Jan;20(1):12-6.
 
Dellabella M, Milanese G, Muzzonigro G. Randomized trial of the efficacy of tamsulosin, nifedipine and phloroglucinol in medical expulsive therapy for distal ureteral calculi. J Urol. 2005 Jul;174(1):167-72.
 
Yilmaz E, Batislam E, Basar MM, Tuglu D, Ferhat M, Basar H. The comparison and efficacy of 3 different alpha1-adrenergic blockers for distal ureteral stones. J Urol. 2005 Jun;173(6):2010-2.
 
Dellabella M, Milanese G, Muzzonigro G. Efficacy of tamsulosin in the medical management of juxtavesical ureteral stones. J Urol. 2003 Dec;170(6 Pt 1):2202-5.
 
Autorino R, De Sio M, Damiano R, Di Lorenzo G, Perdona S, Russo A, Quarto G, Cosentino L, D'Armiento M. The use of tamsulosin in the medical treatment of ureteral calculi: where do we stand? Urol Res. 2005 Dec;33(6):460-4. Epub 2005 Nov 29.
 
Pricop C, Novac C, Negru D, Ilie C, Pricop A, Tanase V. [Can selective alpha-blockers help the spontaneous passage of the stones located in the uretero-bladder junction?] Rev Med Chir Soc Med Nat Iasi. 2004 Jan-Mar;108(1):128-33. Romanian.
 
Saita A, Bonaccorsi A, Marchese F, Condorelli SV, Motta M. Our experience with nifedipine and prednisolone as expulsive therapy for ureteral stones. Urol Int. 2004;72 Suppl 1:43-5.
 
Micali S, Grande M, Sighinolfi MC, De Carne C, De Stefani S, Bianchi G. Medical therapy of urolithiasis. J Endourol. 2006 Nov;20(11):841-7. Review.
 
Porpiglia F, Vaccino D, Billia M, Renard J, Cracco C, Ghignone G, Scoffone C, Terrone C, Scarpa RM. Corticosteroids and tamsulosin in the medical expulsive therapy for symptomatic distal ureter stones: single drug or association? Eur Urol. 2006 Aug;50(2):339-44. Epub 2006 Mar 3.
 
Beach MA, Mauro LS. Pharmacologic expulsive treatment of ureteral calculi. Ann Pharmacother. 2006 Jul-Aug;40(7-8):1361-8. Epub 2006 Jul 18. Review.
 
Lipkin M, Shah O. The use of alpha-blockers for the treatment of nephrolithiasis. Rev Urol. 2006;8 Suppl 4:S35-42.
 
Porena M, Guiggi P, Balestra A, Micheli C. Pain killers and antibacterial therapy for kidney colic and stones. Urol Int. 2004;72 Suppl 1:34-9. Review.
 

Study ID Numbers:   sor449907ctil
First Received:   March 21, 2007
Last Updated:   April 26, 2007
ClinicalTrials.gov Identifier:   NCT00451061
Health Authority:   Israel: Ministry of Health

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

Study placed in the following topic categories:
Ureterolithiasis
Alfuzosin
Colic
Tamsulosin
Ureteral Calculi
Calculi

Additional relevant MeSH terms:
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Antineoplastic Agents
Therapeutic Uses
Physiological Effects of Drugs
Adrenergic Antagonists
Adrenergic alpha-Antagonists
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 05, 2008




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