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OpenTrials
Completed

NCT Number: NCT00467467

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.

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Key information

Conditions

Ureteral Stent Discomfort

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Alfuzosin Hydrochloride

Drug

Primary outcomes

  1. effect of study medication on urinary symptoms and quality of life

  2. usage of analgesics/narcotics

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Apr 30, 2007
Registry last updated
May 30, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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