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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
William Beaumont Hospitals
ClinicalTrials.gov Identifier:
NCT00448123
First received: March 13, 2007
Last updated: October 1, 2012
Last verified: October 2012
History of Changes
  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)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: The Efficacy of Tamsulosin in the Treatment of Ureteral Stones in Emergency Department Patients

Resource links provided by NLM:

MedlinePlus related topics: Kidney Stones
U.S. FDA Resources

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.

Enrollment: 378
Study Start Date: February 2007
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
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

Locations
United States, Michigan
William Beaumont Hospital
Royal Oak, Michigan, United States, 48073
Sponsors and Collaborators
William Beaumont Hospitals
Investigators
Principal Investigator: Kelsea Lipe, MD William Beaumont Hospitals
  More Information

No publications provided

Responsible Party: William Beaumont Hospitals
ClinicalTrials.gov Identifier: NCT00448123     History of Changes
Other Study ID Numbers: 2005-107
Study First Received: March 13, 2007
Last Updated: October 1, 2012
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Calculi
Emergencies
Kidney Calculi
Nephrolithiasis
Ureteral Calculi
Ureterolithiasis
Pathological Conditions, Anatomical
Disease Attributes
Pathologic Processes
Kidney Diseases
Urologic Diseases
Urolithiasis
 Urinary Calculi
Ureteral Diseases
Tamsulosin
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 16, 2013