The Efficacy of Tamsulosin in the Treatment of Ureteral Stones in Emergency Department Patients
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
|Official Title:||The Efficacy of Tamsulosin in the Treatment of Ureteral Stones in Emergency Department Patients|
- Stone Passage [ Time Frame: 1-7 days ] [ Designated as safety issue: No ]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.
- 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 ] [ Designated as safety issue: No ]
- High Pain Score by Treatment Group [ Time Frame: 7 Days ] [ Designated as safety issue: No ]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.
|Study Start Date:||February 2007|
|Study Completion Date:||September 2011|
|Primary Completion Date:||September 2011 (Final data collection date for primary outcome measure)|
Placebo Comparator: Placebo
Active Comparator: Tamsulosin
Intervention - Tamsulosin
Other Name: Flomax
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
- 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00448123
|United States, Michigan|
|William Beaumont Hospital|
|Royal Oak, Michigan, United States, 48073|
|Principal Investigator:||Swor Robert, DO||William Beaumont Hospitals|