Phenazopyridine for Confirmation of Ureteral Patency
Information source: Hartford Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cystoscopy
Intervention: Phenazopyridine (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Hartford Hospital Overall contact:
Katie Propst, MD, Phone: 860-972-1908, Email: katie.propst@hhchealth.gov
Summary
In this prospective, randomized trial subjects will be randomized to receive phenazopyridine
or no medication prior to pelvic reconstructive procedures that use cystoscopy to confirm
ureteral patency intraoperatively.
Clinical Details
Official title: Use of Phenazopyridine for Confirmation of Ureteral Patency During Intraoperative Cystoscopy
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Primary outcome: Time to visualize ureteral urine flow intraoperatively measured by timing in the operating room
Secondary outcome: Physician confidence measured by a surveyAdditional interventions: measured by use of IV fluids, IV lasix, IV methylene blue, or ureteral stent placement in OR Post-operative urethral discomfort measured by pain scales Cost measured by case duration and standard operating room cost
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Female.
Criteria:
Inclusion Criteria:
- Females only
- Planned surgical procedure where cystoscopy will be used to document ureteral urine
flow
- Age > or = 18 years, no upper age limit
- Able and willing to consent
Exclusion Criteria:
- Planned surgical procedure where cystoscopy will not be used
- Planned surgical procedure where cystoscopy is used for a purpose other than
documenting ureteral urine flow
- age <18 years
- pregnancy
- unable/unwilling to participate
- history of allergy or adverse reaction to phenazopyridine
- hepatic dysfunction
- known phenazopyridine hypersensitivity
- history of urologic surgery
- presence of ureteral stents prior to the planned surgical procedure
- concomitant suprapubic catheter placement
Locations and Contacts
Katie Propst, MD, Phone: 860-972-1908, Email: katie.propst@hhchealth.gov
Hartford Hospital, Hartford, Connecticut 06106, United States; Recruiting
Katie Propst, MD, Phone: 860-972-1908
Additional Information
Starting date: April 2015
Last updated: April 17, 2015
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