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

Study Description

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

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Study Design


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

Resource links provided by the National Library of Medicine

Drug Information available for: Alfuzosin Tamsulosin

U.S. FDA Resources

Arms and Interventions

Outcome Measures

Primary Outcome Measures :

frequency of stone expulsion
time to stone expulsion
analgesics consumption

Eligibility Criteria

Information from the National Library of Medicine

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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

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:

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, Perdonà 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, Tănase 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.


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

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