Colic, Kidney Calculi, Ureteral Calculi
Conditions
Brief summary
This study will assess improvement in the percentage of spontaneous stone passage for distal ureteral calculi for alfuzosin compared to placebo, decrease of pain and narcotic/analgesic use associated with stone passage, decrease of the time to spontaneous stone passage, shift in the size distribution of stones passed towards larger sizes.
Interventions
One tablet every day for 4 weeks
Sponsors
Manoj, Monga, M.D.
University of Minnesota
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age =\>18 * \<8mm ureteral calculus below the pelvic brim identified by non-contrast CT scan and/or intravenous pyelogram
Exclusion criteria
* Subject with know hypersensitivity to Alfuzosin hydrochloride or any component of Alfuzosin hydrochloride tablets * Pregnant/Nursing females * Solitary kidney * Renal insufficiency (Creatinine\>1.8) * Urinary infection (fever \>101, positive urine culture, many bacteria on urinalysis) * Moderate or severe hepatic insufficiency (Childs-Pugh categories B and C) * Potent CYP3A4 inhibitors such as ketoconazole, itraconazole, and ritonavir, since Alfuzosin blood levels are increased * Other alpha-blockers * Phosphodiesterase type 5 inhibitors for erectile dysfunction * Any subject for whom the principal investigator feels it would not be in his or her best interest to participate in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Spontaneous stone passage for distal ureteral calculi | increased |
Secondary
| Measure | Time frame |
|---|---|
| Decrease the pain and narcotic use associated with stone passage | decrease |
| Decrease the time to spontaneous passage | decrease |
| Shift the size distribution of stones passed towards larger sizes | — |
Countries
United States
Outcome results
None listed