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

Study Overview
=================
Brief Summary
-----------------
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.

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

Conditions
-----------------
Kidney Stone

Intervention / Treatment
-----------------
* Drug: Flowmax
* Drug: placebo


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Tamsulosin<br> | Drug: Flowmax<br>* 0.4 mg once a day until stone passage total = 9 tablets<br>|
| Placebo Comparator: Placebo<br> | Drug: placebo<br>* cornstarch<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 10 Days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Kidney stone, Ureterolithiasis, Tamsulosin, Flowmax, Emergency Department