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

NCT00451061 | Unknown Phase 4

• 1 other identifier: sor449907ctil
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Renal Colic

Keywords

distal ureterolithiasis; α adrenoreceptors antagonist

Outcome Measures

Primary Outcomes (3)

• frequency of stone expulsion

• time to stone expulsion

• analgesics consumption

Interventions

Alfuzosin DRUG

Tamsulosin DRUG

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• renal colic due to radiologically proven distal ureteral stones

You may not qualify if:

• 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

Sponsors & Collaborators

• Soroka University Medical Center: lead

Study Sites (1)

Urology department, Soroka university medical center

Beer-Sheva, P,o,box 151, 84101, Israel

Location

Related Publications (12)

• 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. doi: 10.1089/end.2006.20.12.

  PMID: 16426124 BACKGROUND

• 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. doi: 10.1097/01.ju.0000161600.54732.86.

  PMID: 15947613 BACKGROUND

• 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. doi: 10.1097/01.ju.0000158453.60029.0a.

  PMID: 15879806 BACKGROUND

• 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. doi: 10.1097/01.ju.0000096050.22281.a7.

  PMID: 14634379 BACKGROUND

• 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. doi: 10.1007/s00240-005-0508-0. Epub 2005 Nov 29.

  PMID: 16317534 BACKGROUND

• 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.

  PMID: 15688769 BACKGROUND

• 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. doi: 10.1159/000076591.

  PMID: 15133333 BACKGROUND

• 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. doi: 10.1089/end.2006.20.841.

  PMID: 17144848 BACKGROUND

• 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. doi: 10.1016/j.eururo.2006.02.023. Epub 2006 Mar 3.

  PMID: 16574310 BACKGROUND

• Beach MA, Mauro LS. Pharmacologic expulsive treatment of ureteral calculi. Ann Pharmacother. 2006 Jul-Aug;40(7-8):1361-8. doi: 10.1345/aph.1G586. Epub 2006 Jul 18.

  PMID: 16849614 BACKGROUND

• Lipkin M, Shah O. The use of alpha-blockers for the treatment of nephrolithiasis. Rev Urol. 2006;8 Suppl 4(Suppl 4):S35-42.

  PMID: 17216000 BACKGROUND

• 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. doi: 10.1159/000076589.

  PMID: 15133331 BACKGROUND

Related Links

• Guidelines on benign prostatic hyperplasia,2004,p.36

MeSH Terms

Conditions

Renal Colic

Interventions

alfuzosin; Tamsulosin

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds

Study Officials

• Eran Rosenberg, M.D

  Soroka university medical center, Beer-Sheva, Israel

  PRINCIPAL INVESTIGATOR

• Igor Romanowski, M.D

  Soroka university medical center, Beer-Sheva, Israel

  STUDY DIRECTOR

Central Study Contacts

Eran Rosenberg, M.D

CONTACT

972-8-6400626; eranro@clalit.org.il

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 21, 2007
• First Posted: March 22, 2007
• Study Start: April 1, 2007
• Last Updated: July 12, 2012

Record last verified: 2007-02

Locations

IL (1)