N/A
N=127
The Efficacy of Tamsulosin in the Treatment of Ureteral Stones in Emergency Department Patients
Kidney Stones · Ureteral Stones
Bottom Line
View on ClinicalTrials.gov: NCT00448123 ↗Enrolled (actual)
127
Serious AEs
0.0%
Results posted
Oct 2016
Primary outcome: Primary: Stone Passage — 18; 21 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Tamsulosin (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Robert Swor
- Primary completion
- Sep 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Stone Passage |
18; 21 | — |
| SECONDARY Amount (Mean Number of Tablets Taken) of Pain Medication Taken by Subjects up to Seven (7) Days Post Emergency Department Discharge |
0.4; 0.6 | — |
| SECONDARY High Pain Score by Treatment Group |
1.69; 2.4 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00448123). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.