Ignite Creation Date:
2024-05-05 @ 5:22 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00448123
Status:
COMPLETED
Last Update Posted:
2016-10-12
First Post:
2007-03-13
Brief Title:
The Efficacy of Tamsulosin in the Treatment of Ureteral Stones in Emergency Department Patients
Sponsor:
Robert Swor
Organization:
William Beaumont Hospitals
Study Overview
Official Title:
The Efficacy of Tamsulosin in the Treatment of Ureteral Stones in Emergency Department Patients
Status:
COMPLETED
Status Verified Date:
2016-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To determine if emergency department patients with acute ureteral colic pain due to a ureteral stone who are treated with tamsulosin versus placebo will experience a shorter time to passage of their stone or resolution of their pain A secondary study objective will be to determine if there is a relationship between response to tamsulosin and stone size or position in the ureter
Detailed Description:
This is a prospective randomized placebo controlled study of tamsulosin alone vs placebo to determine its effect on the rates of stone passage and resolution of pain in patients with acute renal colic pain that present to the emergency department The study will be conducted in the Emergency Department EDand Emergency Department Observation Unit EDOU of William Beaumont Hospital a high volume university affiliated 952 bed suburban teaching hospital
Patients will be given a seven-day supply of tamsulosin 04mg daily or placebo They will also be given a prescription for Vicodin 30 pills and Ibuprofen 600mg 30 pills They will be called on days 1 2 3 7 and 10 following the index visit regarding passage of stone or 48 hours without pain Patients will be asked to call in if they pass their stone or are without pain for 48 hours Related return visits to Royal Oak or Troy Beaumont within 30 days of their index visit will be followed by chart review
The study will be limited to patients presenting to the emergency department with acutely symptomatic renal colic pain Confirmation of a symptomatic stone will be made by imaging helical CT scan or intravenous pyelogram
Study exclusion criteria
Stone not documented on imaging
Stones 10mm
Pregnancy
Age 18 years
Evidence of infection with an obstructing stone
Obstructing stone in a solitary kidney
Currently taking tamsulosin vardenafil nifedipine or steroids
Contraindications or allergy to tamsulosin
Ureteral surgery
Patients that are unable to understand consent
Patients that are unable to comply with follow-up
Patients will be given a seven-day supply of tamsulosin 04mg daily or placebo They will also be given a prescription for Vicodin 30 pills and Ibuprofen 600mg 30 pills They will be called on days 1 2 3 7 and 10 following the index visit regarding passage of stone or 48 hours without pain Patients will be asked to call in if they pass their stone or are without pain for 48 hours Related return visits to Royal Oak or Troy Beaumont within 30 days of their index visit will be followed by chart review
The study will be limited to patients presenting to the emergency department with acutely symptomatic renal colic pain Confirmation of a symptomatic stone will be made by imaging helical CT scan or intravenous pyelogram
Study exclusion criteria
Stone not documented on imaging
Stones 10mm
Pregnancy
Age 18 years
Evidence of infection with an obstructing stone
Obstructing stone in a solitary kidney
Currently taking tamsulosin vardenafil nifedipine or steroids
Contraindications or allergy to tamsulosin
Ureteral surgery
Patients that are unable to understand consent
Patients that are unable to comply with follow-up
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None