The Efficacy of Tamsulosin in the Treatment of Ureteral Stones in Emergency Department Patients - Full Text View

Sponsors and Collaborators:	Maine Medical Center Maine Medical Center Mentored Research Committee
Information provided by:	Maine Medical Center
ClinicalTrials.gov Identifier:	NCT00600405

Purpose

The purpose of this study is to determine the efficacy of the α-adrenergic antagonist tamsulosin in the treatment of adult emergency department (ED) patients with ureteral colic secondary to lower ureteral calculus. We hypothesize that there will be no difference in outcomes for subjects treated with and without tamsulosin.

Condition	Intervention
Nephrolithiasis Ureteral Calculi	Drug: tamsulosin Drug: Standard therapy with ibuprofen and oxycodone.

MedlinePlus related topics: Kidney Stones

Drug Information available for: Ibuprofen Dexibuprofen Oxycodone Tamsulosin Tamsulosin hydrochloride Oxycodone hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title:	The Efficacy of Tamsulosin in the Treatment of Ureteral Stones in Emergency Department Patients

Further study details as provided by Maine Medical Center:

Primary Outcome Measures:

Rate of spontaneous ureteral stone expulsion [ Time Frame: 48, 120, 336 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Time to spontaneous ureteral stone expulsion. [ Time Frame: 48, 120, 336 hours ] [ Designated as safety issue: No ]
Self-reported NRS-11 pain scores. [ Time Frame: 48, 120, 336 hours ] [ Designated as safety issue: No ]
Number of colicky pain episodes. [ Time Frame: 48, 120, 336 hours ] [ Designated as safety issue: No ]
Number of days missed work or usual functional ability. [ Time Frame: 48, 120, 336 hours ] [ Designated as safety issue: No ]
Number of return ED visits or unscheduled PCP visits for continued pain. [ Time Frame: 48, 120, 336 hours ] [ Designated as safety issue: No ]
Amount of narcotic pain medication used. [ Time Frame: 48, 120, 336 hours ] [ Designated as safety issue: Yes ]
Adverse medication-related events. [ Time Frame: 48, 120, 336 hours ] [ Designated as safety issue: Yes ]

Enrollment:	81
Study Start Date:	August 2006
Study Completion Date:	November 2007
Primary Completion Date:	November 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
I: Experimental Subjects randomized to the experimental group receive ibuprofen, oxycodone, and tamsulosin 0.4 mg orally daily for ten days.	Drug: tamsulosin Tamsulosin 0.4 mg orally daily for ten days.
II Standard therapy arm: subjects randomized to standard therapy receive ibuprofen and oxycodone alone.	Drug: Standard therapy with ibuprofen and oxycodone. Oxycodone: 5mg, one to two tablets every four to six hours as needed for pain. Ibuprofen: 800 mg, one three times a day with food as needed for pain.

Detailed Description:

This prospective, randomized controlled trial seeks to compare outcomes for adult emergency department patients with lower ureteral calculus. Subjects will be randomized to receive treatment with ibuprofen and oxycodone alone (standard therapy) or standard therapy plus tamsulosin 0.4mg orally once daily for ten days.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

18 years of age or older;
able to read, write, and speak English;
able to use the NRS pain scale; and
computed tomography diagnosed single lower ureteral calculus

Exclusion Criteria:

allergy or sensitivity to the study drug (tamsulosin hydrochloride [Flomax]);
sulfa/sulfonamide allergy;
inability to provide informed consent;
lithiasis of the ureteral intramural tract;
acute or chronic renal failure;
fever;
presence of multiple ureteral stones;
peptic ulcer disease;
liver failure;
concomitant treatment with alpha-lytic drugs, calcium antagonists, nitrates, or vardenafil (Levitra);
pregnancy;
breastfeeding; or
a history of urinary surgery or endoscopic treatment.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00600405

Locations

United States, Maine
Maine Medical Center
Portland, Maine, United States, 04102

Sponsors and Collaborators

Maine Medical Center

Maine Medical Center Mentored Research Committee

Investigators

Principal Investigator:

Andrew D Perron, MD

Maine Medical Center

More Information

No publications provided

Responsible Party:	Maine Medical Center ( Andrew Perron, MD )
Study ID Numbers:	2958
Study First Received:	January 14, 2008
Last Updated:	January 14, 2008
ClinicalTrials.gov Identifier:	NCT00600405 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Maine Medical Center:

Nephrolithiasis
Ureteral Calculi

Study placed in the following topic categories:

Pathological Conditions, Anatomical
Anti-Inflammatory Agents
Urinary Calculi
Neurotransmitter Agents
Adrenergic Agents
Urolithiasis
Oxycodone
Ureteral Diseases
Calculi
Urologic Diseases
Tamsulosin
Anti-Inflammatory Agents, Non-Steroidal
Kidney Diseases
Analgesics

Analgesics, Opioid
Ibuprofen
Cyclooxygenase Inhibitors
Ureteral Calculi
Central Nervous System Depressants
Narcotics
Adrenergic alpha-Antagonists
Ureterolithiasis
Analgesics, Non-Narcotic
Emergencies
Adrenergic Antagonists
Peripheral Nervous System Agents
Antirheumatic Agents
Nephrolithiasis

Additional relevant MeSH terms:

Pathological Conditions, Anatomical
Anti-Inflammatory Agents
Urinary Calculi
Neurotransmitter Agents
Disease Attributes
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Urolithiasis
Oxycodone
Physiological Effects of Drugs
Ureteral Diseases
Calculi
Pathologic Processes
Urologic Diseases

Sensory System Agents
Therapeutic Uses
Tamsulosin
Anti-Inflammatory Agents, Non-Steroidal
Kidney Diseases
Analgesics
Analgesics, Opioid
Ibuprofen
Cyclooxygenase Inhibitors
Central Nervous System Depressants
Ureteral Calculi
Narcotics
Enzyme Inhibitors
Adrenergic alpha-Antagonists
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 06, 2009