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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00448123
First Posted: March 15, 2007
Last Update Posted: October 12, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
William Beaumont Hospitals
Information provided by (Responsible Party):
Robert Swor, William Beaumont Hospitals
  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 Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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:


Further study details as provided by Robert Swor, William Beaumont Hospitals:

Primary Outcome Measures:
  • Stone Passage [ Time Frame: 1-7 days ]
    Participants were asked during the follow-up phone call to indicate if their stone had passed within seven days. Phone calls were conducted at days 1, 2, 3, 7, 10 and 30 days after the emergency department discharge. Data is reported based on the information obtained up to the 7th day.


Secondary Outcome Measures:
  • Amount (Mean Number of Tablets Taken) of Pain Medication Taken by Subjects up to Seven (7) Days Post Emergency Department Discharge [ Time Frame: 1-7 days ]
  • High Pain Score by Treatment Group [ Time Frame: 7 Days ]
    Severity of Patient Pain at 7 days Post Emergency Department Visit. Patients were asked to describe their pain severity at each followup phone call, using a numerical scale, ranging from 0 (no pain) to 10 (worst possible pain). We report this measure at 7 days.


Enrollment: 127
Study Start Date: February 2007
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Placebo
Drug: Placebo
Placebo
Active Comparator: Tamsulosin
Intervention - Tamsulosin
Drug: Tamsulosin
Study Drug
Other Name: Flomax

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

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00448123


Locations
United States, Michigan
William Beaumont Hospital
Royal Oak, Michigan, United States, 48073
Sponsors and Collaborators
Robert Swor
William Beaumont Hospitals
Investigators
Principal Investigator: Swor Robert, DO William Beaumont Hospitals
  More Information

Publications:
Responsible Party: Robert Swor, Principal Investigator, William Beaumont Hospitals
ClinicalTrials.gov Identifier: NCT00448123     History of Changes
Other Study ID Numbers: 2005-107
First Submitted: March 13, 2007
First Posted: March 15, 2007
Results First Submitted: December 24, 2013
Results First Posted: October 12, 2016
Last Update Posted: October 12, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Additional relevant MeSH terms:
Emergencies
Calculi
Kidney Calculi
Nephrolithiasis
Ureteral Calculi
Ureterolithiasis
Disease Attributes
Pathologic Processes
Pathological Conditions, Anatomical
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
Physiological Effects of Drugs
Urological Agents