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

Kidney Stone Clinical Trial

— Flowmax  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00762424
• Other study ID #: 0607030
• Status: Completed
• Phase: N/A
• First received: September 26, 2008
• Last updated: December 16, 2014
• Start date: June 2007
• Est. completion date: January 2011

Study information

• Verified date: December 2014
• Source: WellSpan Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Calculi
• Kidney Calculi
• Kidney Stone
• Nephrolithiasis
• Ureteral Calculi
• Ureterolithiasis

Intervention

Drug:
• Flowmax
0.4 mg once a day until stone passage total = 9 tablets
• placebo
cornstarch

Locations

Country	Name	City	State
United States	York Hospital Emergency Department	York	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
WellSpan Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No