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

This study is currently recruiting participants.
Verified by William Beaumont Hospitals, June 2008

Sponsored by: William Beaumont Hospitals
Information provided by: William Beaumont Hospitals
ClinicalTrials.gov Identifier: NCT00448123
  Purpose

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.


Condition Intervention
Kidney Stones
Ureteral Stones
Drug: Tamsulosin (Flomax)

Drug Information available for:   Tamsulosin    Tamsulosin hydrochloride   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment
Official Title:   The Efficacy of Tamsulosin in the Treatment of Ureteral Stones in Emergency Department Patients

Further study details as provided by William Beaumont Hospitals:

Primary Outcome 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 Outcome 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.

Estimated Enrollment:   378
Study Start Date:   February 2007

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
  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

Criteria

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00448123

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

Locations
United States, Michigan
William Beaumont Hospital     Recruiting
      Royal Oak, Michigan, United States, 48073
      Principal Investigator: Kelsea Lipe, MD            
      Sub-Investigator: Andrew Bernstein, MD            
      Sub-Investigator: Jay Hollander, Md            
      Sub-Investigator: Raymond Jackson, MD            
      Sub-Investigator: Brian Seifman, MD            
      Sub-Investigator: Nathan Pickering, MD            

Sponsors and Collaborators
William Beaumont Hospitals

Investigators
Principal Investigator:     Kelsea Lipe, MD     William Beaumont Hospital    
  More Information


Study ID Numbers:   2005-107
First Received:   March 13, 2007
Last Updated:   June 3, 2008
ClinicalTrials.gov Identifier:   NCT00448123
Health Authority:   United States: Institutional Review Board

Keywords provided by William Beaumont Hospitals:
Kidney Stones  
Ureteral Stones  
Flomax  
Emergency Medicine  
Urology  

Study placed in the following topic categories:
Pathological Conditions, Anatomical
Urinary Calculi
Urolithiasis
Ureteral Calculi
Ureteral Diseases
Calculi
Ureterolithiasis
Urologic Diseases
Tamsulosin
Emergencies
Kidney Diseases
Nephrolithiasis
Kidney Calculi

Additional relevant MeSH terms:
Neurotransmitter Agents
Disease Attributes
Pathologic Processes
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Antineoplastic Agents
Therapeutic Uses
Physiological Effects of Drugs
Adrenergic Antagonists
Adrenergic alpha-Antagonists
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 31, 2008




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