Status:
COMPLETED
Alfuzosin Hydrochloride to Relieve Ureteral Stent Discomfort
Lead Sponsor:
University of Minnesota
Conditions:
Ureteral Stent Discomfort
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
To assess the impact of alfuzosin vs. placebo on ureteral stent discomfort, urinary symptoms and quality of life.
Eligibility Criteria
Inclusion
- Age \>18
- Undergoing unilateral retrograde ureteroscopy with ureteral stent placement
Exclusion
- Significant ureteral trauma
- Concomitant ESWL or other secondary surgical procedure than may impact patient comfort
- Subject with know hypersensitivity to alfuzosin hydrochloride or any component of alfuzosin hydrochloride tablets.
- Pregnancy, nursing mother, or woman of child-bearing age unwilling to take contraception for the duration of the study
- Undergoing bilateral ureteral stenting
- Undergoing antegrade ureteral stenting
- Undergoing simultaneous extracorporeal shockwave lithotripsy
- Urinary infection (fever \>101, positive urine culture, many bacteria on urinalysis)
- Primary bladder dysfunction that would impact ability to void without a catheter
- Neurologic dysfunction that would impair pain sensation
- History of chronic pain or substance abuse
- Potent CYP3A4 inhibitors such as ketoconazole, itraconazole, and ritonavir, since alfuzosin blood levels are increased
- Other alpha-blockers
- Phosphodiesterase type 5 inhibitors for erectile function Any subject for whom the principal investigator feels it would not be in his or her best interest to participate in the study.
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2007
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00467467
Start Date
June 1 2006
End Date
October 1 2007
Last Update
May 30 2013
Active Locations (1)
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1
University of Minnesota
Minneapolis, Minnesota, United States, 55455