Phenazopyridine for Confirmation of Ureteral Patency

NCT02424149 | Completed Results DMC

• 1 other identifier: HHC-2015-0008
• Study Type: interventional
• Target: 107
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cystoscopy

Outcome Measures

Primary Outcomes (1)

• Time to Visualize Ureteral Urine Flow Intraoperatively Measured by Timing in the Operating Room

  Timing was performed in the operating room. Time to visualize urine efflux was started at insertion of the cystoscope into the bladder, the time was considered complete when both ureteral orifices had displayed urine efflux.

  Day of surgery

Secondary Outcomes (4)

• Physician Confidence Measured by a Survey

  day of surgery (day 0)

• Additional Interventions: Measured by Use of IV Fluids, IV Lasix, IV Methylene Blue, or Ureteral Stent Placement in OR

  day of surgery (day 0)

• Post-operative Urethral Discomfort Measured by Pain Scales

  post operative day 1

• Trial of Void Results

  Day of hospital discharge

Study Arms (2)

Control

NO INTERVENTION

No preoperative phenazopyridine

Phenazopyridine

EXPERIMENTAL

Preoperative phenazopyridine

Drug: Phenazopyridine

Interventions

Phenazopyridine DRUG

Also known as: Pyridium

Phenazopyridine

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hartford Hospital: lead

Study Sites (1)

Hartford Hospital

Hartford, Connecticut, 06106, United States

Location

Related Publications (1)

• Propst K, Tunitsky-Bitton E, O'Sullivan DM, Steinberg AC, LaSala C. Phenazopyridine for Evaluation of Ureteral Patency: A Randomized Controlled Trial. Obstet Gynecol. 2016 Aug;128(2):348-355. doi: 10.1097/AOG.0000000000001472.

  PMID: 27399998 DERIVED

MeSH Terms

Interventions

Phenazopyridine

Intervention Hierarchy (Ancestors)

Aminopyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Katie Propst, MD
• Organization: Hartford Hospital

katie.propst@hhchealth.org

860-972-4338

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Fellow

Study Record Dates

• First Submitted: April 8, 2015
• First Posted: April 22, 2015
• Study Start: April 1, 2015
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: December 5, 2016
• Results First Posted: December 5, 2016

Record last verified: 2016-10

Locations

US (1)