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Completed

NCT Number: NCT00600405

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

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.

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Key information

Conditions

Nephrolithiasis Calculi Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Ureteral Calculi Ureteral Diseases Ureterolithiasis Urinary Calculi Urogenital Diseases Urolithiasis Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Maine Medical Center

Portland, Maine, 04102, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tamsulosin

Drug

Tamsulosin 0.4 mg orally daily for ten days.

Other names: Flomax

Standard therapy with ibuprofen and oxycodone.

Drug

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.

Primary outcomes

  1. Rate of spontaneous ureteral stone expulsion

    Time frame: 48, 120, 336 hours

Secondary outcomes

  1. Time to spontaneous ureteral stone expulsion.

    Time frame: 48, 120, 336 hours

  2. Self-reported NRS-11 pain scores.

    Time frame: 48, 120, 336 hours

  3. Number of colicky pain episodes.

    Time frame: 48, 120, 336 hours

  4. Number of days missed work or usual functional ability.

    Time frame: 48, 120, 336 hours

  5. Number of return ED visits or unscheduled PCP visits for continued pain.

    Time frame: 48, 120, 336 hours

  6. Amount of narcotic pain medication used.

    Time frame: 48, 120, 336 hours

  7. Adverse medication-related events.

    Time frame: 48, 120, 336 hours

Sponsors and collaborators

Lead sponsor

MaineHealth

Other

Collaborators

  • Maine Medical Center Mentored Research Committee

Registry information

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Jan 25, 2008
Registry last updated
Jan 25, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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