N/A N=53 Randomized Double-blind Treatment

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

Kidney Stone

Bottom Line

View on ClinicalTrials.gov: NCT00762424 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Dec 2014

Primary outcome: Primary: Time of Stone Passage — 68.8; 19.0 hours

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Flowmax (Drug); placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: WellSpan Health
Primary completion: Jan 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Time of Stone Passage	68.8; 19.0	—

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.

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

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Data sourced from ClinicalTrials.gov (NCT00762424). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.