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

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ClinicalTrials.gov Identifier: NCT00448123
Recruitment Status : Completed
First Posted : March 15, 2007
Results First Posted : October 12, 2016
Last Update Posted : October 12, 2016
Sponsor:
Collaborator:
William Beaumont Hospitals
Information provided by (Responsible Party):
Robert Swor, William Beaumont Hospitals

Study Description
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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.

Condition or disease Intervention/treatment Phase
Kidney Stones Ureteral Stones Drug: Tamsulosin Drug: Placebo Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 127 participants
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
Study Start Date : February 2007
Actual Primary Completion Date : September 2011
Actual Study Completion Date : September 2011

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Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Placebo
Placebo
 Drug: Placebo
Placebo
Active Comparator: Tamsulosin
Intervention - Tamsulosin
 Drug: Tamsulosin
Study Drug
Other Name: Flomax


Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. 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 ]
  2. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Responsible Party: Robert Swor, Principal Investigator, William Beaumont Hospitals
ClinicalTrials.gov Identifier: NCT00448123    
Other Study ID Numbers: 2005-107
First Posted: March 15, 2007    Key Record Dates
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:
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Kidney Calculi
Nephrolithiasis
Ureteral Calculi
Ureterolithiasis
Emergencies
Calculi
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