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Completed

NCT Number: NCT00448123

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

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.

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Key information

Conditions

Kidney Stones Calculi Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Calculi Kidney Diseases Male Urogenital Diseases Nephrolithiasis Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Ureteral Stones 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

William Beaumont Hospital

Royal Oak, Michigan, 48073, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Tamsulosin

Drug

Study Drug

Other names: Flomax

Placebo

Drug

Placebo

Primary outcomes

  1. Stone Passage

    Time frame: 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 outcomes

  1. Amount (Mean Number of Tablets Taken) of Pain Medication Taken by Subjects up to Seven (7) Days Post Emergency Department Discharge

    Time frame: 1-7 days

  2. High Pain Score by Treatment Group

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Robert Swor

Other

Collaborators

  • Corewell Health East

Registry information

Important dates

Study start
2007
Primary completion
2011
Study completion
2011
First posted
Mar 15, 2007
Registry last updated
Oct 12, 2016

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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