Clinical trial NCT00448123: 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
Overall status: COMPLETED
Phase: NA
Conditions: Kidney Stones
Ureteral Stones
Keywords: Kidney Stones
Ureteral Stones
Flomax
Emergency Medicine
Urology
Lead sponsor: William Beaumont Hospitals
Sponsor class: OTHER
Collaborators: name: William Beaumont Hospitals
First posted: 2007-03-15
Enrollment: 127
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility 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

Primary outcomes:
measure: Stone Passage
timeFrame: 1-7 days
Secondary outcomes:
measure: Amount (Mean Number of Tablets Taken) of Pain Medication Taken by Subjects up to Seven (7) Days Post Emergency Department Discharge
timeFrame: 1-7 days
measure: High Pain Score by Treatment Group
timeFrame: 7 Days
Other outcomes:
Locations:
city: Royal Oak
country: United States
facility: William Beaumont Hospital
state: Michigan
Study officials:
affiliation: William Beaumont Hospitals
name: Swor Robert, DO
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.