Official Title: “Alfuzosin Hydrochloride to Relieve Ureteral Stent Discomfort”

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

Study Type: Interventional

Study Design: Randomized, Double-Blind, Placebo Control, Single Group Assignment, Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: Alfuzosin Hydrochloride

Primary Measures

• effect of study medication on urinary symptoms and quality of life
• usage of analgesics/narcotics

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: University of Minnesota

Overall Clinical Trial Officials and Contacts

Manoj Monga, MD Principal Investigator University of Minnesota  

Information obtained from ClinicalTrials.gov on November 20, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00467467

Study ID Number: 0512M78807

ClinicalTrials.gov Identifier: NCT00467467

Health Authority: United States: Food and Drug Administration