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

Study Overview
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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.

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

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

Conditions
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Kidney Stones, Ureteral Stones

Intervention / Treatment
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* Drug: Tamsulosin
* Drug: Placebo


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Placebo | Drug: Placebo<br>* Placebo<br>|
| Active Comparator: Tamsulosin<br>Intervention - Tamsulosin | Drug: Tamsulosin<br>* Study Drug<br>* Other names: Flomax;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stone Passage | 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. | 1-7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amount (Mean Number of Tablets Taken) of Pain Medication Taken by Subjects up to Seven (7) Days Post Emergency Department Discharge |  | 1-7 days | 
| High Pain Score by Treatment Group | 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. | 7 Days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Kidney Stones, Ureteral Stones, Flomax, Emergency Medicine, Urology