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

Not Applicable

Completed

• Conditions: Kidney Stones; Ureteral Stones
• Interventions: Drug: Placebo; Drug: Tamsulosin

• Registration Number: NCT00448123
• Lead Sponsor: Robert Swor

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

Study Timeline

• Study Start: 2007-02
• Study First Submitted: 2007-03-13
• Study First Submitted QC: 2007-03-13
• Study First Posted: 2007-03-15
• Primary Completion: 2011-09
• Study Completion: 2011-09
• Results First Submitted: 2013-12-24
• Status Verified: 2016-10
• Results First Submitted QC: 2016-10-11
• Last Update Submitted: 2016-10-11
• Results First Posted: 2016-10-12
• Last Update Posted: 2016-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 127

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).

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo
Tamsulosin	Tamsulosin	Intervention - Tamsulosin

Primary Outcome Measures

Name	Time	Method
Stone Passage	1-7 days	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.

Secondary Outcome Measures

Name	Time	Method
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	7 Days	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.

Trial Locations

Locations (1)

William Beaumont Hospital; 🇺🇸 Royal Oak, Michigan, United States