Effect of Tamsulosin on Stone Expulsion and Pain Resolution in ED Patients With Ureterolithiasis - Full Text View

Sponsor:	WellSpan Health
Information provided by:	WellSpan Health
ClinicalTrials.gov Identifier:	NCT00762424

Purpose

Tamsulosin (Flowmax)is approved by the FDA for the treatment for enlarged prostate. Several studies regarding the use of Tamsulosin for the treatment of lower kidney stones have been carried out in the non-Emergency Department setting. This study will compare Tamsulosin 0.4 mg with placebo in regards to rate and time of stone passing and will also look at amount of pain. The purpose of this study is to compare the usefulness of Tamsulosin versus placebo on time to stone passage and pain relief in Emergency Department patients with kidney stones.

Condition	Intervention
Kidney Stone	Drug: Flowmax Drug: placebo

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver) Primary Purpose: Treatment
Official Title:	Effect of Tamsulosin on Stone Expulsion and Pain Resolution in ED Patients With Ureterolithiasis

Resource links provided by NLM:

MedlinePlus related topics: Kidney Stones

Drug Information available for: Tamsulosin Tamsulosin hydrochloride

U.S. FDA Resources

Further study details as provided by WellSpan Health:

Primary Outcome Measures:

Rate and time of stone passage [ Time Frame: 10 Days ] [ Designated as safety issue: No ]
Physician made the determination that the patient will be discharged at home. Patient must be able to take the medication for 10 days and strain his/her urine. Patient must be available for telephone follow-up. Patient must be able to keep a log of number of analgesic pills taken and complete a 0-10 Likert pain scale

Secondary Outcome Measures:

Level of pain [ Time Frame: up to 10 days ] [ Designated as safety issue: No ]
Physician made the determination that the patient will be discharged at home. Patient must be able to take the medication for 10 days and strain his/her urine. Patient must be available for telephone follow-up. Patient must be able to keep a log of number of analgesic pills taken and complete a 0-10 Likert pain scale

Enrollment:	84
Study Start Date:	June 2007
Primary Completion Date:	January 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Tamsulosin	Drug: Flowmax 0.4 mg once a day until stone passage total = 9 tablets Other Name: Flowmax
Placebo Comparator: Placebo	Drug: placebo cornstarch

Eligibility

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

Criteria

Inclusion Criteria:

18 y.o. or older
diagnosed with a kidney stone less than or equal to 10 mm determined by CT scan
physician has made the decision that you will be discharged to home
must be able to take study medication for up to 10 days and strain your urine
must be able to keep a record of pain medication taken and complete a pain scale rating

Exclusion Criteria:

patients currently taking: Tamsulosin (Flowmax), calcium channel blockers, beta blockers, alpha blockers, Sildenaphil (Viagara), Tadalaphil (Cilias), Warfarin (Coumadin, Jantoven), Cimetidine (Tagamet, Tagamet HB)
patients with a clinical and laboratory signs of: urinary tract infection, multiple kidney stones, diabetes, kidney failure, hypotension, pregnancy, fever
patient known to have hypersensitivity to Tamsulosin
patient history of cataract surgery
inability of patient to perform visual pain scale
allergy or intolerance to acetaminophen/oxycodone
patient is unable to understand informed consent
prisoners

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00762424

Locations

United States, Pennsylvania
York Hospital Emergency Department
York, Pennsylvania, United States, 17405

Sponsors and Collaborators

WellSpan Health

Investigators

Principal Investigator:

Marc Pollack, MD, PhD

WellSpan Health

More Information

No publications provided

Responsible Party:	Marc Pollack, MD, PhD Director of Emergency Medicine Research, WellSpan Health
ClinicalTrials.gov Identifier:	NCT00762424 History of Changes
Other Study ID Numbers:	0607030
Study First Received:	September 26, 2008
Last Updated:	March 2, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by WellSpan Health:

Kidney stone
Ureterolithiasis
Tamsulosin
Flowmax
Emergency Department

Additional relevant MeSH terms:

Calculi
Kidney Calculi
Nephrolithiasis
Ureterolithiasis
Ureteral Calculi
Pathological Conditions, Anatomical
Kidney Diseases
Urologic Diseases
Urolithiasis
Urinary Calculi

Ureteral Diseases
Tamsulosin
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 09, 2012