Back to resultsEffect of Tamsulosin on Stone Expulsion and Pain Resolution in ED Patients With Ureterolithiasis (Flowmax)
Primary Purpose
Kidney Stone
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Flowmax
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Kidney Stone focused on measuring Kidney stone, Ureterolithiasis, Tamsulosin, Flowmax, Emergency Department
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
Sites / Locations
- York Hospital Emergency Department
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Tamsulosin
Placebo
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00762424
Brief Title
Effect of Tamsulosin on Stone Expulsion and Pain Resolution in ED Patients With Ureterolithiasis
Acronym
Flowmax
Official Title
Effect of Tamsulosin on Stone Expulsion and Pain Resolution in ED Patients With Ureterolithiasis
Study Type
Interventional
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
June 2007 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
January 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
WellSpan Health
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Stone
Keywords
Kidney stone, Ureterolithiasis, Tamsulosin, Flowmax, Emergency Department
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
53 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tamsulosin
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Flowmax
Intervention Description
0.4 mg once a day until stone passage total = 9 tablets
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
cornstarch
Primary Outcome Measure Information:
Title
Time of Stone Passage
Description
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.
Time Frame
10 Days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc Pollack, MD, PhD
Organizational Affiliation
WellSpan Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
York Hospital Emergency Department
City
York
State/Province
Pennsylvania
ZIP/Postal Code
17405
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Effect of Tamsulosin on Stone Expulsion and Pain Resolution in ED Patients With Ureterolithiasis
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