Ignite Creation Date:
2025-12-24 @ 12:16 PM
Ignite Modification Date:
2026-01-04 @ 1:12 PM
Study NCT ID:
NCT00451061
Status:
UNKNOWN
Last Update Posted:
2012-07-12
First Post:
2007-03-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Efficacy of Alpha-blockers for Expulsion of Distal Ureteral Stones
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D056844', 'term': 'Renal Colic'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C047638', 'term': 'alfuzosin'}, {'id': 'D000077409', 'term': 'Tamsulosin'}], 'ancestors': [{'id': 'D000096926', 'term': 'Benzenesulfonamides'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2007-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-02', 'lastUpdateSubmitDate': '2012-07-11', 'studyFirstSubmitDate': '2007-03-21', 'studyFirstSubmitQcDate': '2007-03-21', 'lastUpdatePostDateStruct': {'date': '2012-07-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-03-22', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'frequency of stone expulsion'}, {'measure': 'time to stone expulsion'}, {'measure': 'analgesics consumption'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['distal ureterolithiasis', 'α adrenoreceptors antagonist'], 'conditions': ['Renal Colic']}, 'referencesModule': {'references': [{'pmid': '16426124', 'type': 'BACKGROUND', '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. doi: 10.1089/end.2006.20.12."}, {'pmid': '15947613', 'type': 'BACKGROUND', '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. doi: 10.1097/01.ju.0000161600.54732.86.'}, {'pmid': '15879806', 'type': 'BACKGROUND', '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. doi: 10.1097/01.ju.0000158453.60029.0a.'}, {'pmid': '14634379', 'type': 'BACKGROUND', '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. doi: 10.1097/01.ju.0000096050.22281.a7.'}, {'pmid': '16317534', 'type': 'BACKGROUND', 'citation': "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': '15688769', 'type': 'BACKGROUND', '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.'}, {'pmid': '15133333', 'type': 'BACKGROUND', '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. doi: 10.1159/000076591.'}, {'pmid': '17144848', 'type': 'BACKGROUND', '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. doi: 10.1089/end.2006.20.841.'}, {'pmid': '16574310', 'type': 'BACKGROUND', '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. doi: 10.1016/j.eururo.2006.02.023. Epub 2006 Mar 3.'}, {'pmid': '16849614', 'type': 'BACKGROUND', 'citation': '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': '17216000', 'type': 'BACKGROUND', 'citation': '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': '15133331', 'type': 'BACKGROUND', '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. doi: 10.1159/000076589.'}], 'seeAlsoLinks': [{'url': 'http://www.berlin.uroweb.org/', 'label': 'Guidelines on benign prostatic hyperplasia,2004,p.36'}]}, 'descriptionModule': {'briefSummary': '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)\n\nOnly 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.\n\nThe 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.', 'detailedDescription': "The efficacy of alpha-blockers for expulsion of distal ureteral stones\n\nUrolithiasis is estimated among 8%-15% of the population in Europe and North America.1-5 Patient who suffer from renal colic represent a very common reason for visiting the emergency room or for hospitalization. The stones are usually located in the ureter, mostly in its lower third.\n\nSome of the distal ureteral stone would pass spontaneously, depending on a few factors such as the stone's size, location, shape, smooth muscle spasm, submucosal edema and anatomy.\n\nSince renal colic is one of the most painful conditions, the time until expulsion of the stone should be reduced as much as possible. In case the stone obstructs and does'nt pass, damage to the kidney might occur, and surgical intervention should be considered. However, surgery and anesthesia are not risk free.\n\nThe local reaction to obstructing ureterolithiasis manifests in ureteric smooth muscle contraction, edema, inflammation and pain. The ureter contains α -adrenergic receptors in the smooth muscle layer, along it's entire length. Since these receptors play an important role in ureteric contraction during renal colic, several studies were performed in order to evaluate the effect of α receptors blockade. These studies had demonstrated that different α blockers had increased the frequency of stone expulsion rate among patients with renal colic, reduced the time to expulsion and reduced analgesics consumption.\n\nMost 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.\n\nA common treatment these days to obstructive uropathy due to benign prostatic hypertrophy (BPH) is Alfuzosin. Despite the fact that it is an α adrenergic receptor blocker and not selective for any α 1 adrenergic receptor subtypes, it 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, and side effects were similar.\n\nOnly one study these days describes the use of Alfuzosin for expulsion of distal ureteric stones.\n\nThe 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.\n\nMaterials and methods:\n\nParticipants - Individuals who will be referred to the emergency room or be admitted to the urology department in Soroka hospital, (Beer-Sheva, Israel) because of acute renal colic. The patient would be considered for the study only if the stone would be located in the distal ureter.\n\nThis study is estimated to include 120 patients and last 6 months. The patients would be divided randomly to three groups:\n\nA. Patients with renal colic that would receive Abitren and Rowatinex B. Same therapy plus Tamsulosin (0.4 mg/daily) C. Same therapy as A plus Alfuzosin (10 mg/daily)\n\nThe treatment would last up to 4 weeks.\n\nThe duration of the trial would be until expulsion of the stone, but not longer than 4 weeks. Patients who would not pass the stone spontaneously, would be referred to intervention (ESWL, ureteric stent insertion, ureteroscopy)\n\nTreatment discontinuation would be due to hospitalization (intractable pain, fever, the need for an intervention)\n\nThe α blockers treatment would be once daily, until stone expulsion, or up to four weeks.\n\nThe initial treatment protocol would be the standard treatment - I.V fluids and analgesics\n\nEach patient would be initially evaluated by:\n\n* physical examination\n* abdominal radiography\n* serum creatinine and leukocytes measurement\n* urinalysis\n* renal ultrasonography\n* blood pressure measurement\n\nThe follow up:\n\nThe blood pressure measurements would be taken by the family physician, two days and one week after the beginning of the treatment. Four weeks after the treatment begins, each patient would be checked in the out patient clinic. Unenhanced CT scan, serum creatinine and blood pressure measurement would be taken. In case the patient would not pass the stone, intervention would be scheduled."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n• renal colic due to radiologically proven distal ureteral stones\n\nExclusion Criteria:\n\n* stone larger than 10 mm\n* fever\n* urinary tract infection\n* additional stones, that might be the reason for the renal colic\n* severe hydronephrosis\n* known sensitivity to α blockers\n* concomitant treatment with α blockers, β blockers, calcium antagonists, and nitrates\n* pregnancy\n* inability to provide informed consent\n* a history of surgery or endoscopic procedures in the urinary tract\n* history of spontaneous stone expulsion\n* known ureteral stricture\n* diabetes\n* blood pressure values lower than 100/70 mm hg'}, 'identificationModule': {'nctId': 'NCT00451061', 'briefTitle': 'The Efficacy of Alpha-blockers for Expulsion of Distal Ureteral Stones', 'organization': {'class': 'OTHER', 'fullName': 'Soroka University Medical Center'}, 'orgStudyIdInfo': {'id': 'sor449907ctil'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Alfuzosin', 'type': 'DRUG'}, {'name': 'Tamsulosin', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '84101', 'city': 'Beer-Sheva, P,o,box 151', 'country': 'Israel', 'facility': 'Urology department, Soroka university medical center', 'geoPoint': {'lat': 31.25181, 'lon': 34.7913}}], 'centralContacts': [{'name': 'Eran Rosenberg, M.D', 'role': 'CONTACT', 'email': 'eranro@clalit.org.il', 'phone': '972-8-6400626'}], 'overallOfficials': [{'name': 'Eran Rosenberg, M.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Soroka university medical center, Beer-Sheva, Israel'}, {'name': 'Igor Romanowski, M.D', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Soroka university medical center, Beer-Sheva, Israel'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Soroka University Medical Center', 'class': 'OTHER'}}}}