Renal Colic Clinical Trial
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.
Status | Not yet recruiting |
Enrollment | 120 |
Est. completion date | |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
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 a blockers - concomitant treatment with a blockers, ß 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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Israel | Urology department, Soroka university medical center | Beer-Sheva, p,o,box 151 |
Lead Sponsor | Collaborator |
---|---|
Soroka University Medical Center |
Israel,
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Lipkin M, Shah O. The use of alpha-blockers for the treatment of nephrolithiasis. Rev Urol. 2006;8 Suppl 4:S35-42. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
* Note: There are 12 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | frequency of stone expulsion | |||
Primary | time to stone expulsion | |||
Primary | analgesics consumption |
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