Phenazopyridine for Confirmation of Ureteral Patency

• Sponsor: Hartford Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT02424149
• Collaborator: (none)
• Enrollment: 107
• Location: 1
• Arms: 2
• Duration (Months): 9
• Patients Per Site Per Month: 11.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cystoscopy	Drug: Phenazopyridine	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 107 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Use of Phenazopyridine for Confirmation of Ureteral Patency During Intraoperative Cystoscopy
• Study Start Date: Apr 1, 2015
• Actual Primary Completion Date: Jan 1, 2016
• Actual Study Completion Date: Jan 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Control No preoperative phenazopyridine
Experimental: Phenazopyridine Preoperative phenazopyridine	Drug: Phenazopyridine; Other Names: Pyridium

Outcome Measures

Primary Outcome Measures

1. Time to Visualize Ureteral Urine Flow Intraoperatively Measured by Timing in the Operating Room [Day of surgery]

   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.

Secondary Outcome Measures

1. Physician Confidence Measured by a Survey [day of surgery (day 0)]

   Surgeon response to the question: "I am confident that ureteral injury was ruled out in this patient" on a 5-point Likert scale where 1 = strongly disagree, 2 = disagree, 3 = neither agree nor disagree, 4 = agree, 5 = strongly agree

2. Additional Interventions: Measured by Use of IV Fluids, IV Lasix, IV Methylene Blue, or Ureteral Stent Placement in OR [day of surgery (day 0)]

   this is a composite measure and will be reported as a single value for each arm as number of additional interventions

3. Post-operative Urethral Discomfort Measured by Pain Scales [post operative day 1]

   Measured prior to catheter removal using a 10 point visual analog pain scale: Zero represented no pain, Ten represented the most severe pain.

4. Trial of Void Results [Day of hospital discharge]

   Number of subjects that failed a back-filled trial of void on the day of hospital discharge, up to 2 days after surgery.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hartford Hospital	Hartford	Connecticut	United States	06106

Sponsors and Collaborators

• Hartford Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Katie Propst, Fellow, Hartford Hospital
• ClinicalTrials.gov Identifier: NCT02424149
• Other Study ID Numbers: HHC-2015-0008
• First Posted: Apr 22, 2015
• Last Update Posted: Dec 5, 2016
• Last Verified: Oct 1, 2016

Study Results

Participant Flow

Arm/Group Title	Control	Phenazopyridine
Arm/Group Description	No preoperative phenazopyridine	Preoperative oral phenazopyridine: two tablets 97.5 mg each (195 mg total)
Period Title: Overall Study
STARTED	54	53
COMPLETED	52	52
NOT COMPLETED	2	1

Baseline Characteristics

Arm/Group Title	Control	Phenazopyridine	Total
Arm/Group Description	No preoperative phenazopyridine	Preoperative phenazopyridine	Total of all reporting groups
Overall Participants	52	52	104
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	57.6 (11.3)	62.7 (9.8)	60.19 (10.89)
Sex: Female, Male (Count of Participants)
Female	52 100%	52 100%	104 100%
Male	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	52 100%	52 100%	104 100%
Charlson comorbidity index (scale score) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [scale score]	1.96 (1.5)	2.31 (1.1)	2.13 (1.3)
Serum creatinine (mg/dL) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mg/dL]	0.66 (0.28)	0.63 (0.35)	0.65 (0.32)
History or prolapse surgery (participants) [Number]
Number [participants]	7 13.5%	12 23.1%	19 18.3%
History of urinary tract surgery (participants) [Number]
Number [participants]	6 11.5%	9 17.3%	15 14.4%
Surgical indication: prolapse (participants) [Number]
Number [participants]	51 98.1%	49 94.2%	100 96.2%
Surgical indication: incontinence (participants) [Number]
Number [participants]	21 40.4%	14 26.9%	35 33.7%
Stage II or greater prolapse: anterior (participants) [Number]
Number [participants]	46 88.5%	46 88.5%	92 88.5%
Stage II or greater prolapse: apical (participants) [Number]
Number [participants]	19 36.5%	24 46.2%	43 41.3%
Stage II or greater prolapse: posterior (participants) [Number]
Number [participants]	38 73.1%	34 65.4%	72 69.2%
Surgical procedure performed: concomitant incontinence procedure (participants) [Number]
Number [participants]	21 40.4%	21 40.4%	42 40.4%
Surgical procedure performed: prolapse repair without hysterectomy (participants) [Number]
Number [participants]	16 30.8%	25 48.1%	41 39.4%
Surgical procedure performed: prolapse repair with vaginal hysterectomy (participants) [Number]
Number [participants]	27 51.9%	18 34.6%	45 43.3%
Surgical procedure performed: prolapse repair with abdominal hysterectomy (participants) [Number]
Number [participants]	1 1.9%	1 1.9%	2 1.9%
Surgical procedure performed: prolapse repair with laparoscopic hysterectomy (participants) [Number]
Number [participants]	7 13.5%	6 11.5%	13 12.5%

Outcome Measures

1. Primary Outcome

Title	Time to Visualize Ureteral Urine Flow Intraoperatively Measured by Timing in the Operating Room
Description	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.
Time Frame	Day of surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control	Phenazopyridine
Arm/Group Description	No preoperative phenazopyridine	Preoperative oral phenazopyridine: two tablets 97.5 mg each (195 mg total)
Measure Participants	52	52
Mean (Standard Deviation) [seconds]	160 (158)	173 (275)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Control, Phenazopyridine
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.77
	Comments
	Method	t-test, 2 sided
	Comments

2. Secondary Outcome

Title	Physician Confidence Measured by a Survey
Description	Surgeon response to the question: "I am confident that ureteral injury was ruled out in this patient" on a 5-point Likert scale where 1 = strongly disagree, 2 = disagree, 3 = neither agree nor disagree, 4 = agree, 5 = strongly agree
Time Frame	day of surgery (day 0)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control	Phenazopyridine
Arm/Group Description	No preoperative phenazopyridine	Preoperative oral phenazopyridine: two tablets 97.5 mg each (195 mg total)
Measure Participants	52	52
Mean (Standard Deviation) [units on a scale]	4.6 (0.49)	4.5 (0.61)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Control, Phenazopyridine
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.73
	Comments
	Method	t-test, 2 sided
	Comments

3. Secondary Outcome

Title	Additional Interventions: Measured by Use of IV Fluids, IV Lasix, IV Methylene Blue, or Ureteral Stent Placement in OR
Description	this is a composite measure and will be reported as a single value for each arm as number of additional interventions
Time Frame	day of surgery (day 0)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control	Phenazopyridine
Arm/Group Description	No preoperative phenazopyridine	Preoperative oral phenazopyridine: two tablets 97.5 mg each (195 mg total)
Measure Participants	52	52
Number [interventions]	4	3

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Control, Phenazopyridine
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	1.0
	Comments
	Method	Fisher Exact
	Comments

4. Secondary Outcome

Title	Post-operative Urethral Discomfort Measured by Pain Scales
Description	Measured prior to catheter removal using a 10 point visual analog pain scale: Zero represented no pain, Ten represented the most severe pain.
Time Frame	post operative day 1

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control	Phenazopyridine
Arm/Group Description	No preoperative phenazopyridine	Preoperative oral phenazopyridine: two tablets 97.5 mg each (195 mg total)
Measure Participants	52	52
Mean (Standard Deviation) [units on a scale]	2.3 (2.8)	2.1 (2.4)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Control, Phenazopyridine
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.78
	Comments
	Method	t-test, 2 sided
	Comments

5. Secondary Outcome

Title	Trial of Void Results
Description	Number of subjects that failed a back-filled trial of void on the day of hospital discharge, up to 2 days after surgery.
Time Frame	Day of hospital discharge

Outcome Measure Data

Analysis Population Description

For this outcome, 96 participants were analyzed. Of the 104 participants that completed the study, only 96 underwent a trial of void.

Arm/Group Title	Control	Phenazopyridine
Arm/Group Description	No preoperative phenazopyridine	Preoperative oral phenazopyridine: two tablets 97.5 mg each (195 mg total)
Measure Participants	49	47
Number [participants who failed trial of void]	19 36.5%	9 17.3%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Control, Phenazopyridine
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.04
	Comments
	Method	Fisher Exact
	Comments

Adverse Events

Time Frame	From the time of surgery to 30 days post-surgery.
Arm/Group Title	Control		Phenazopyridine
Arm/Group Description	No preoperative phenazopyridine		Preoperative phenazopyridine
All Cause Mortality
	Control		Phenazopyridine
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Control		Phenazopyridine
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/52 (0%)		0/52 (0%)
Other (Not Including Serious) Adverse Events
	Control		Phenazopyridine
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/52 (0%)		0/52 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.