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

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WellSpan Health

Status

Completed

Conditions

Kidney Stone

Treatments

Drug: placebo
Drug: Flowmax

Study type

Interventional

Funder types

Other

Identifiers

NCT00762424
0607030

Details and patient eligibility

About

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.

Enrollment

53 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

53 participants in 2 patient groups, including a placebo group

Tamsulosin
Active Comparator group
Treatment:
Drug: Flowmax
Placebo
Placebo Comparator group
Treatment:
Drug: placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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