The Efficacy of Tamsulosin in the Treatment of Ureteral Stones in Emergency Department Patients
Information source: William Beaumont Hospitals
Information obtained from ClinicalTrials.gov on February 12, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Kidney Stones; Ureteral Stones
Intervention: Tamsulosin (Flomax) (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: William Beaumont Hospitals Official(s) and/or principal investigator(s):
Kelsea Lipe, MD, Principal Investigator, Affiliation: William Beaumont Hospitals
Overall contact:
Patrick B Medado, BS, Phone: 248-898-0124, Email: pmedado@beaumonthospitals.com
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.
Clinical Details
Official title: The Efficacy of Tamsulosin in the Treatment of Ureteral Stones in Emergency Department Patients
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment
Primary outcome: 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.
Secondary outcome: 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
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Patrick B Medado, BS, Phone: 248-898-0124, Email: pmedado@beaumonthospitals.com
William Beaumont Hospital, Royal Oak, Michigan 48073, United States; Recruiting
Kelsea Lipe, MD, Principal Investigator
Andrew Bernstein, MD, Sub-Investigator
Jay Hollander, Md, Sub-Investigator
Raymond Jackson, MD, Sub-Investigator
Brian Seifman, MD, Sub-Investigator
Nathan Pickering, MD, Sub-Investigator
Additional Information
Starting date: February 2007
Last updated: June 3, 2008
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