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

Nephrolithiasis 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: NCT00600405
• Other study ID #: 2958
• Status: Completed
• Phase: N/A
• First received: January 14, 2008
• Last updated: January 14, 2008
• Start date: August 2006
• Est. completion date: November 2007

Study information

• Verified date: January 2008
• Source: Maine Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine the efficacy of the α-adrenergic antagonist tamsulosin in the treatment of adult emergency department (ED) patients with ureteral colic secondary to lower ureteral calculus. We hypothesize that there will be no difference in outcomes for subjects treated with and without tamsulosin.

Description:

This prospective, randomized controlled trial seeks to compare outcomes for adult emergency department patients with lower ureteral calculus. Subjects will be randomized to receive treatment with ibuprofen and oxycodone alone (standard therapy) or standard therapy plus tamsulosin 0.4mg orally once daily for ten days.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: November 2007
• Est. primary completion date: November 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years of age or older;

• able to read, write, and speak English;

• able to use the NRS pain scale; and

• computed tomography diagnosed single lower ureteral calculus

Exclusion Criteria:

• allergy or sensitivity to the study drug (tamsulosin hydrochloride [Flomax]);

• sulfa/sulfonamide allergy;

• inability to provide informed consent;

• lithiasis of the ureteral intramural tract;

• acute or chronic renal failure;

• fever;

• presence of multiple ureteral stones;

• peptic ulcer disease;

• liver failure;

• concomitant treatment with alpha-lytic drugs, calcium antagonists, nitrates, or vardenafil (Levitra);

• pregnancy;

• breastfeeding; or

• a history of urinary surgery or endoscopic treatment.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Calculi
• Nephrolithiasis
• Ureteral Calculi
• Ureterolithiasis

Intervention

Drug:
• tamsulosin
Tamsulosin 0.4 mg orally daily for ten days.
• Standard therapy with ibuprofen and oxycodone.
Oxycodone: 5mg, one to two tablets every four to six hours as needed for pain. Ibuprofen: 800 mg, one three times a day with food as needed for pain.

Locations

Country	Name	City	State
United States	Maine Medical Center	Portland	Maine

Sponsors (2)

Lead Sponsor	Collaborator
Maine Medical Center	Maine Medical Center Mentored Research Committee

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of spontaneous ureteral stone expulsion		48, 120, 336 hours	No
Secondary	Time to spontaneous ureteral stone expulsion.		48, 120, 336 hours	No
Secondary	Self-reported NRS-11 pain scores.		48, 120, 336 hours	No
Secondary	Number of colicky pain episodes.		48, 120, 336 hours	No
Secondary	Number of days missed work or usual functional ability.		48, 120, 336 hours	No
Secondary	Number of return ED visits or unscheduled PCP visits for continued pain.		48, 120, 336 hours	No
Secondary	Amount of narcotic pain medication used.		48, 120, 336 hours	Yes
Secondary	Adverse medication-related events.		48, 120, 336 hours	Yes