NCT01577823

Brief Summary

A study measuring utility of indwelling bladder catheter placement in orthopaedic surgical patients receiving spinal anesthesia. Study will track clinical outcomes, patient satisfaction and cost efficacy. Absence of indwelling bladder catheter may decrease urinary tract infection (UTI) incidence, increase patient satisfaction, and decrease cost burden without increasing postoperative urinary retention (POUR) incidence.

Trial Health

80
On Track

Trial Health Score

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

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

First Submitted

Initial submission to the registry

December 8, 2011

Completed
4 months until next milestone

First Posted

Study publicly available on registry

April 16, 2012

Completed
Last Updated

April 9, 2013

Status Verified

April 1, 2013

First QC Date

December 8, 2011

Last Update Submit

April 8, 2013

Conditions

Study Arms (2)

No foley catheter

NO INTERVENTION

Foley Catheter

ACTIVE COMPARATOR
Device: Foley Catheter

Interventions

Foley Catheter

Eligibility Criteria

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

You may qualify if:

  • Elective orthopaedic surgical patients of all ages undergoing lower extremity adult reconstructive surgery with spinal anesthesia will be interviewed.

You may not qualify if:

  • Patients are excluded from the study preoperatively with a history of prostate or urological surgery, renal failure, previous documented POUR, current indwelling catheter, or acute UTI.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rothman Institute

Philadelphia, Pennsylvania, 19107, United States

Location

Study Design

Study Type
interventional
Phase
not applicable
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 8, 2011

First Posted

April 16, 2012

Last Updated

April 9, 2013

Record last verified: 2013-04

Locations