Alfuzosin Hydrochloride to Relieve Ureteral Stent Discomfort

University of Minnesota (UMN)

Status and phase: Completed; Phase 3

Conditions: Ureteral Stent Discomfort

Treatments: Drug: Alfuzosin Hydrochloride

Study type: Interventional

Funder types: Other

Identifiers

NCT00467467

0512M78807

Details and patient eligibility

About

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

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.