Effect of Tamsulosin on Stone Expulsion and Pain Resolution in ED Patients With Ureterolithiasis
Information source: WellSpan Health
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Kidney Stone
Intervention: Flowmax (Drug); placebo (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: WellSpan Health Official(s) and/or principal investigator(s):
Marc Pollack, MD, PhD, Principal Investigator, Affiliation: WellSpan Health
Overall contact:
Marc Pollack, MD, PhD, Phone: 717-851-2450, Email: mpollack@wellspan.org
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.
Clinical Details
Official title: Effect of Tamsulosin on Stone Expulsion and Pain Resolution in ED Patients With Ureterolithiasis
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Rate and time of stone passage
Secondary outcome: Level of pain
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Marc Pollack, MD, PhD, Phone: 717-851-2450, Email: mpollack@wellspan.org
York Hospital Emergency Department, York, Pennsylvania 17405, United States; Recruiting
Marc Pollack, MD, PhD, Phone: 717-851-2450, Email: mpollack@wellspan.org
Barbie Stahlman, MS, Phone: 717-851-4104, Email: bstahlman@wellspan.org
Additional Information
Starting date: June 2007
Last updated: September 29, 2008
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