Alfuzosin Hydrochloride to Relieve Ureteral Stent Discomfort

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-06-30

Study Completion Date

2007-10-31

Brief Summary

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

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Detailed Description

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Conditions

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Ureteral Stent Discomfort

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Blinding Strategy

DOUBLE

Interventions

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Alfuzosin Hydrochloride

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No