Alfuzosin Hydrochloride to Relieve Ureteral Stent Discomfort
Phase 3
Completed
- Conditions
- Ureteral Stent Discomfort
- Registration Number
- NCT00467467
- Lead Sponsor
- University of Minnesota
- Brief Summary
To assess the impact of alfuzosin vs. placebo on ureteral stent discomfort, urinary symptoms and quality of life.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method effect of study medication on urinary symptoms and quality of life usage of analgesics/narcotics
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University of Minnesota
🇺🇸Minneapolis, Minnesota, United States