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

Kidney Stones Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00448123
• Other study ID #: 2005-107
• Status: Completed
• Phase: N/A
• First received: March 13, 2007
• Last updated: October 11, 2016
• Start date: February 2007
• Est. completion date: September 2011

Study information

• Verified date: October 2016
• Source: William Beaumont Hospitals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 127
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Calculi
• Emergencies
• Kidney Calculi
• Kidney Stones
• Nephrolithiasis
• Ureteral Calculi
• Ureteral Stones
• Ureterolithiasis

Intervention

Drug:
• Tamsulosin
Study Drug
• Placebo
Placebo

Locations

Country	Name	City	State
United States	William Beaumont Hospital	Royal Oak	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
Robert Swor	William Beaumont Hospitals

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Amount (Mean Number of Tablets Taken) of Pain Medication Taken by Subjects up to Seven (7) Days Post Emergency Department Discharge		1-7 days	No
Secondary	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	No