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

Primary Purpose

Nephrolithiasis, Ureteral Calculi

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
tamsulosin
Standard therapy with ibuprofen and oxycodone.
Sponsored by
MaineHealth
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nephrolithiasis focused on measuring Nephrolithiasis, Ureteral Calculi

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 18 years of age or older;
  • able to read, write, and speak English;
  • able to use the NRS pain scale; and
  • computed tomography diagnosed single lower ureteral calculus

Exclusion Criteria:

  • allergy or sensitivity to the study drug (tamsulosin hydrochloride [Flomax]);
  • sulfa/sulfonamide allergy;
  • inability to provide informed consent;
  • lithiasis of the ureteral intramural tract;
  • acute or chronic renal failure;
  • fever;
  • presence of multiple ureteral stones;
  • peptic ulcer disease;
  • liver failure;
  • concomitant treatment with alpha-lytic drugs, calcium antagonists, nitrates, or vardenafil (Levitra);
  • pregnancy;
  • breastfeeding; or
  • a history of urinary surgery or endoscopic treatment.

Sites / Locations

  • Maine Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

I

II

Arm Description

Subjects randomized to the experimental group receive ibuprofen, oxycodone, and tamsulosin 0.4 mg orally daily for ten days.

Standard therapy arm: subjects randomized to standard therapy receive ibuprofen and oxycodone alone.

Outcomes

Primary Outcome Measures

Rate of spontaneous ureteral stone expulsion

Secondary Outcome Measures

Time to spontaneous ureteral stone expulsion.
Self-reported NRS-11 pain scores.
Number of colicky pain episodes.
Number of days missed work or usual functional ability.
Number of return ED visits or unscheduled PCP visits for continued pain.
Amount of narcotic pain medication used.
Adverse medication-related events.

Full Information

First Posted
January 14, 2008
Last Updated
January 14, 2008
Sponsor
MaineHealth
Collaborators
Maine Medical Center Mentored Research Committee
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1. Study Identification

Unique Protocol Identification Number
NCT00600405
Brief Title
The Efficacy of Tamsulosin in the Treatment of Ureteral Stones in Emergency Department Patients
Official Title
The Efficacy of Tamsulosin in the Treatment of Ureteral Stones in Emergency Department Patients
Study Type
Interventional

2. Study Status

Record Verification Date
January 2008
Overall Recruitment Status
Completed
Study Start Date
August 2006 (undefined)
Primary Completion Date
November 2007 (Actual)
Study Completion Date
November 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
MaineHealth
Collaborators
Maine Medical Center Mentored Research Committee

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to determine the efficacy of the α-adrenergic antagonist tamsulosin in the treatment of adult emergency department (ED) patients with ureteral colic secondary to lower ureteral calculus. We hypothesize that there will be no difference in outcomes for subjects treated with and without tamsulosin.
Detailed Description
This prospective, randomized controlled trial seeks to compare outcomes for adult emergency department patients with lower ureteral calculus. Subjects will be randomized to receive treatment with ibuprofen and oxycodone alone (standard therapy) or standard therapy plus tamsulosin 0.4mg orally once daily for ten days.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nephrolithiasis, Ureteral Calculi
Keywords
Nephrolithiasis, Ureteral Calculi

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
81 (Actual)

8. Arms, Groups, and Interventions

Arm Title
I
Arm Type
Experimental
Arm Description
Subjects randomized to the experimental group receive ibuprofen, oxycodone, and tamsulosin 0.4 mg orally daily for ten days.
Arm Title
II
Arm Type
Other
Arm Description
Standard therapy arm: subjects randomized to standard therapy receive ibuprofen and oxycodone alone.
Intervention Type
Drug
Intervention Name(s)
tamsulosin
Other Intervention Name(s)
Flomax
Intervention Description
Tamsulosin 0.4 mg orally daily for ten days.
Intervention Type
Drug
Intervention Name(s)
Standard therapy with ibuprofen and oxycodone.
Intervention Description
Oxycodone: 5mg, one to two tablets every four to six hours as needed for pain. Ibuprofen: 800 mg, one three times a day with food as needed for pain.
Primary Outcome Measure Information:
Title
Rate of spontaneous ureteral stone expulsion
Time Frame
48, 120, 336 hours
Secondary Outcome Measure Information:
Title
Time to spontaneous ureteral stone expulsion.
Time Frame
48, 120, 336 hours
Title
Self-reported NRS-11 pain scores.
Time Frame
48, 120, 336 hours
Title
Number of colicky pain episodes.
Time Frame
48, 120, 336 hours
Title
Number of days missed work or usual functional ability.
Time Frame
48, 120, 336 hours
Title
Number of return ED visits or unscheduled PCP visits for continued pain.
Time Frame
48, 120, 336 hours
Title
Amount of narcotic pain medication used.
Time Frame
48, 120, 336 hours
Title
Adverse medication-related events.
Time Frame
48, 120, 336 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18 years of age or older; able to read, write, and speak English; able to use the NRS pain scale; and computed tomography diagnosed single lower ureteral calculus Exclusion Criteria: allergy or sensitivity to the study drug (tamsulosin hydrochloride [Flomax]); sulfa/sulfonamide allergy; inability to provide informed consent; lithiasis of the ureteral intramural tract; acute or chronic renal failure; fever; presence of multiple ureteral stones; peptic ulcer disease; liver failure; concomitant treatment with alpha-lytic drugs, calcium antagonists, nitrates, or vardenafil (Levitra); pregnancy; breastfeeding; or a history of urinary surgery or endoscopic treatment.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew D Perron, MD
Organizational Affiliation
MaineHealth
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maine Medical Center
City
Portland
State/Province
Maine
ZIP/Postal Code
04102
Country
United States

12. IPD Sharing Statement

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

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