Official Title: “The Efficacy of Tamsulosin in the Treatment of Ureteral Stones in Emergency Department Patients”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment

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

Intervention(s) in this Clinical Trial

• Drug: Tamsulosin (Flomax)

Primary Measures

• 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.

Secondary Measures

• 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.

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 Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: William Beaumont Hospitals

Overall Clinical Trial Officials and Contacts

Kelsea Lipe, MD Principal Investigator William Beaumont Hospital  

Overall Contact: Patrick B Medado, BS 248-898-0124 pmedado@beaumonthospitals.com

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00448123

Study ID Number: 2005-107

ClinicalTrials.gov Identifier: NCT00448123

Health Authority: United States: Institutional Review Board