The Efficacy of Tamsulosin in the Treatment of Ureteral Stones in Emergency Department Patients - Tabular View

Tracking Information

First Received Date ^ICMJE

March 13, 2007

Last Updated Date

March 13, 2009

Start Date ^ICMJE

February 2007

Estimated Primary Completion Date

March 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00448123 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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.

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

The Efficacy of Tamsulosin in the Treatment of Ureteral Stones in Emergency Department Patients

Official Title ^ICMJE

The Efficacy of Tamsulosin in the Treatment of Ureteral Stones in Emergency Department Patients

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 (ED)and 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 (0.4mg 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 Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment

Condition ^ICMJE

Kidney Stones
Ureteral Stones

Intervention ^ICMJE

Drug: Tamsulosin (Flomax)

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

378

Completion Date

Estimated Primary Completion Date

March 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Emergency Department patients with acutely symptomatic renal colic pain
Confirmation of a symptomatic stone will be made by imaging (helical CT scan or intravenous pyelogram).

Exclusion Criteria:

Stones 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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00448123

Responsible Party

Kelsea Lipe, MD, WBH

Study ID Numbers ^ICMJE

2005-107

Study Sponsor ^ICMJE

William Beaumont Hospitals

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Kelsea Lipe, MD

William Beaumont Hospitals

Information Provided By

William Beaumont Hospitals

Verification Date

March 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP