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

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.
 
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

Tracking Information
First Submitted Date  ICMJE March 13, 2007
First Posted Date  ICMJE March 15, 2007
Results First Submitted Date  ICMJE December 24, 2013
Results First Posted Date  ICMJE October 12, 2016
Last Update Posted Date October 12, 2016
Study Start Date  ICMJE February 2007
Actual Primary Completion Date September 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 11, 2016)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: March 13, 2007)
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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 11, 2016)
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 13, 2007)
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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Efficacy of Tamsulosin in the Treatment of Ureteral Stones in Emergency Department Patients
Official Title  ICMJE The Efficacy of Tamsulosin in the Treatment of Ureteral Stones in Emergency Department Patients
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Kidney Stones
  • Ureteral Stones
Intervention  ICMJE
  • Drug: Tamsulosin
    Study Drug
    Other Name: Flomax
  • Drug: Placebo
    Placebo
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Placebo
    Intervention: Drug: Placebo
  • Active Comparator: Tamsulosin
    Intervention - Tamsulosin
    Intervention: Drug: Tamsulosin
Publications * Berger DA, Ross MA, Hollander JB, Ziadeh J, Chen C, Jackson RE, Swor RA. Tamsulosin does not increase 1-week passage rate of ureteral stones in ED patients. Am J Emerg Med. 2015 Dec;33(12):1721-4. doi: 10.1016/j.ajem.2015.08.006. Epub 2015 Aug 7.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 11, 2016)
127
Original Enrollment  ICMJE
 (submitted: March 13, 2007)
378
Actual Study Completion Date  ICMJE September 2011
Actual Primary Completion Date September 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00448123
Other Study ID Numbers  ICMJE 2005-107
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Robert Swor, William Beaumont Hospitals
Original Responsible Party Not Provided
Current Study Sponsor  ICMJE Robert Swor
Original Study Sponsor  ICMJE William Beaumont Hospitals
Collaborators  ICMJE William Beaumont Hospitals
Investigators  ICMJE
Principal Investigator: Swor Robert, DO William Beaumont Hospitals
PRS Account William Beaumont Hospitals
Verification Date October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP