Alfuzosin Hydrochloride to Relieve Ureteral Stent Discomfort

• Status: Completed
• Trial end date: 2007-10-01
• Target enrollment: 0
• Participant gender: All

Summary

To assess the impact of alfuzosin vs. placebo on ureteral stent discomfort, urinary symptoms and quality of life.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Minnesota; University of Minnesota - Clinical and Translational Science Institute
• Treatments: Alfuzosin

Criteria

Inclusion Criteria:

• Age >18

• Undergoing unilateral retrograde ureteroscopy with ureteral stent placement

Exclusion Criteria:

• 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.