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Alfuzosin Hydrochloride to Relieve Ureteral Stent Discomfort

This study has been completed.
Sponsor:
Information provided by:
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT00467467
First received: April 27, 2007
Last updated: January 31, 2008
Last verified: January 2008
History of Changes
  Purpose

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


Condition Intervention Phase
Ureteral Stent Discomfort
 Drug: Alfuzosin Hydrochloride
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Official Title: Alfuzosin Hydrochloride to Relieve Ureteral Stent Discomfort

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Minnesota - Clinical and Translational Science Institute:

Primary Outcome Measures:
  • effect of study medication on urinary symptoms and quality of life
  • usage of analgesics/narcotics

Estimated Enrollment: 60
Study Start Date: June 2006
Study Completion Date: October 2007
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00467467

Locations
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Investigators
Principal Investigator: Manoj Monga, MD University of Minnesota - Clinical and Translational Science Institute
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00467467     History of Changes
Other Study ID Numbers: 0512M78807
Study First Received: April 27, 2007
Last Updated: January 31, 2008
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Alfuzosin
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Adrenergic alpha-1 Receptor Antagonists
 Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 23, 2013