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

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ClinicalTrials.gov Identifier: NCT00762424
Recruitment Status : Completed
First Posted : September 30, 2008
Results First Posted : December 17, 2014
Last Update Posted : December 17, 2014
Sponsor:
Information provided by (Responsible Party):
WellSpan Health

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.

Condition or disease Intervention/treatment Phase
Kidney Stone Drug: Flowmax Drug: placebo Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 53 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Effect of Tamsulosin on Stone Expulsion and Pain Resolution in ED Patients With Ureterolithiasis
Study Start Date : June 2007
Actual Primary Completion Date : January 2011
Actual Study Completion Date : January 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Stones

Arm Intervention/treatment
Active Comparator: Tamsulosin Drug: Flowmax
0.4 mg once a day until stone passage total = 9 tablets

Placebo Comparator: Placebo Drug: placebo
cornstarch




Primary Outcome Measures :
  1. Time of Stone Passage [ Time Frame: 10 Days ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: WellSpan Health
ClinicalTrials.gov Identifier: NCT00762424     History of Changes
Other Study ID Numbers: 0607030
First Posted: September 30, 2008    Key Record Dates
Results First Posted: December 17, 2014
Last Update Posted: December 17, 2014
Last Verified: December 2014

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
Physiological Effects of Drugs
Urological Agents