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Alfuzosin Hydrochloride to Relieve Ureteral Stent Discomfort

Alfuzosin Hydrochloride to Relieve Ureteral Stent Discomfort

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00467467
Enrollment
60
Registered
2007-04-30
Start date
2006-06-30
Completion date
2007-10-31
Last updated
2013-05-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ureteral Stent Discomfort

Brief summary

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

Interventions

Sponsors

University of Minnesota
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026