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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

127 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-02-28

Study Completion Date

2011-09-30

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Kidney Stones Ureteral Stones

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

Tamsulosin

Intervention - Tamsulosin

Group Type ACTIVE_COMPARATOR

Tamsulosin

Intervention Type DRUG

Study Drug

Interventions

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Tamsulosin

Study Drug

Intervention Type DRUG

Placebo

Intervention Type DRUG

Other Intervention Names

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Flomax

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes