Effect of Tamsulosin on Stone Expulsion and Pain Resolution in ED Patients With Ureterolithiasis

WellSpan Health53 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Kidney Stone

Interventions

FlowmaxDRUG

0.4 mg once a day until stone passage total = 9 tablets

placeboDRUG

cornstarch

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

York Hospital Emergency Department

York, Pennsylvania, United States

Outcomes

Primary Outcomes

Time of Stone Passage

Upon discharge, patient must be able to take the medication for 10 days and strain his/her urine. Patient must log the date and time of stone passage, if known.

Time frame: 10 Days

Data from ClinicalTrials.gov

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