NCT00467467

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jun 2006

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2006

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

April 27, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 30, 2007

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
Last Updated

May 30, 2013

Status Verified

May 1, 2013

Enrollment Period

1.3 years

First QC Date

April 27, 2007

Last Update Submit

May 28, 2013

Conditions

Ureteral Stent Discomfort

Outcome Measures

Primary Outcomes (2)

  • effect of study medication on urinary symptoms and quality of life

  • usage of analgesics/narcotics

Interventions

Alfuzosin HydrochlorideDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \>18
  • Undergoing unilateral retrograde ureteroscopy with ureteral stent placement

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Interventions

alfuzosin

Study Officials

  • Manoj Monga, MD

    University of Minnesota

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 27, 2007

First Posted

April 30, 2007

Study Start

June 1, 2006

Primary Completion

October 1, 2007

Study Completion

October 1, 2007

Last Updated

May 30, 2013

Record last verified: 2013-05

Locations

US(1)