Trial Outcomes & Findings for Evaluation of Ureteral Jets on Cystoscopy (NCT NCT02476448)

NCT ID: NCT02476448

Last Updated: 2019-10-23

Results Overview

Surgeons will chose from a likert scales as either: 1. not visible 2. Somewhat visible 3. clearly visible This will be completed during the cystoscopic evaluation

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 176 participants
• Primary outcome timeframe: 5 minutes
• Results posted on: 2019-10-23

Participant Flow

Participant milestones

Measure	Normal Saline Infused into the bladder to allow for visualization of bladder walls and urine jets. Normal saline: Used to distend the bladder for cystoscopic evaluation	Dextrose 10% Infused into the bladder to allow for visualization of bladder walls and colored urine jets. Dextrose 10%: Used to distend the bladder for cystoscopic evaluation	Phenazopyridine Will be administered (PO) preoperatively and will be evaluated for its colorization properties during cystoscopy. Phenazopyridine: Administered orally preoperatively and assessed during cystoscopy	Sodium Fluorescein Will be administered (IV) prior to the cystoscopy and will be evaluated for its colorization properties during cystoscopy. Sodium Fluorescein: Administered intravenously and assessed during cystoscopy
Overall Study STARTED	44	44	44	44
Overall Study COMPLETED	44	44	44	44
Overall Study NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Normal Saline n=44 Participants Infused into the bladder to allow for visualization of bladder walls and urine jets. Normal saline: Used to distend the bladder for cystoscopic evaluation	Dextrose 10% n=44 Participants Infused into the bladder to allow for visualization of bladder walls and colored urine jets. Dextrose 10%: Used to distend the bladder for cystoscopic evaluation	Phenazopyridine n=44 Participants Will be administered (PO) preoperatively and will be evaluated for its colorization properties during cystoscopy. Phenazopyridine: Administered orally preoperatively and assessed during cystoscopy	Sodium Fluorescein n=44 Participants Will be administered (IV) prior to the cystoscopy and will be evaluated for its colorization properties during cystoscopy. Sodium Fluorescein: Administered intravenously and assessed during cystoscopy	Total n=176 Participants Total of all reporting groups
Age, Continuous	63.2 years STANDARD_DEVIATION 13.8 • n=44 Participants	59.3 years STANDARD_DEVIATION 12.1 • n=44 Participants	60 years STANDARD_DEVIATION 9.7 • n=44 Participants	60.3 years STANDARD_DEVIATION 13.9 • n=44 Participants	60.7 years STANDARD_DEVIATION 12.4 • n=176 Participants
Sex: Female, Male Female	44 Participants n=44 Participants	44 Participants n=44 Participants	44 Participants n=44 Participants	44 Participants n=44 Participants	176 Participants n=176 Participants
Sex: Female, Male Male	0 Participants n=44 Participants	0 Participants n=44 Participants	0 Participants n=44 Participants	0 Participants n=44 Participants	0 Participants n=176 Participants
Race and Ethnicity Not Collected	—	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.
BMI	26.4 kg/m^2 n=44 Participants	26.9 kg/m^2 n=44 Participants	30.3 kg/m^2 n=44 Participants	26.7 kg/m^2 n=44 Participants	27.6 kg/m^2 n=176 Participants

PRIMARY outcome

Timeframe: 5 minutes

Surgeons will chose from a likert scales as either:

1. not visible

2. Somewhat visible

3. clearly visible This will be completed during the cystoscopic evaluation

Outcome measures

Measure	Normal Saline n=44 Participants Infused into the bladder to allow for visualization of bladder walls and urine jets. Normal saline: Used to distend the bladder for cystoscopic evaluation	Dextrose 10% n=44 Participants Infused into the bladder to allow for visualization of bladder walls and colored urine jets. Dextrose 10%: Used to distend the bladder for cystoscopic evaluation	Phenazopyridine n=44 Participants Will be administered (PO) preoperatively and will be evaluated for its colorization properties during cystoscopy. Phenazopyridine: Administered orally preoperatively and assessed during cystoscopy	Sodium Fluorescein n=44 Participants Will be administered (IV) prior to the cystoscopy and will be evaluated for its colorization properties during cystoscopy. Sodium Fluorescein: Administered intravenously and assessed during cystoscopy
Ureteral Jet Visibility Clearly Visible	22 Participants	35 Participants	27 Participants	41 Participants
Ureteral Jet Visibility Somewhat Visible	17 Participants	9 Participants	16 Participants	3 Participants
Ureteral Jet Visibility Not Visible	5 Participants	0 Participants	1 Participants	0 Participants

SECONDARY outcome

Timeframe: 5 mins

A 4 point likert scale will be completed during the procedure to assess satisfaction as follows:

1. very satisfied

2. satisfied

3. somewhat satisfied

4. unacceptable

Outcome measures

Measure	Normal Saline n=44 Participants Infused into the bladder to allow for visualization of bladder walls and urine jets. Normal saline: Used to distend the bladder for cystoscopic evaluation	Dextrose 10% n=44 Participants Infused into the bladder to allow for visualization of bladder walls and colored urine jets. Dextrose 10%: Used to distend the bladder for cystoscopic evaluation	Phenazopyridine n=44 Participants Will be administered (PO) preoperatively and will be evaluated for its colorization properties during cystoscopy. Phenazopyridine: Administered orally preoperatively and assessed during cystoscopy	Sodium Fluorescein n=44 Participants Will be administered (IV) prior to the cystoscopy and will be evaluated for its colorization properties during cystoscopy. Sodium Fluorescein: Administered intravenously and assessed during cystoscopy
Surgeon Satisfaction Very Satisfied	12 Participants	27 Participants	12 Participants	26 Participants
Surgeon Satisfaction Satisfied	14 Participants	12 Participants	15 Participants	13 Participants
Surgeon Satisfaction Somewhat Satisfied	13 Participants	5 Participants	12 Participants	4 Participants
Surgeon Satisfaction Unacceptable	5 Participants	0 Participants	5 Participants	1 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 weeks

Medical records will be followed prospectively for 6 weeks to assess for incidence of urinary tract infections within different groups.

Outcome measures

Measure	Normal Saline n=44 Participants Infused into the bladder to allow for visualization of bladder walls and urine jets. Normal saline: Used to distend the bladder for cystoscopic evaluation	Dextrose 10% n=44 Participants Infused into the bladder to allow for visualization of bladder walls and colored urine jets. Dextrose 10%: Used to distend the bladder for cystoscopic evaluation	Phenazopyridine n=44 Participants Will be administered (PO) preoperatively and will be evaluated for its colorization properties during cystoscopy. Phenazopyridine: Administered orally preoperatively and assessed during cystoscopy	Sodium Fluorescein n=44 Participants Will be administered (IV) prior to the cystoscopy and will be evaluated for its colorization properties during cystoscopy. Sodium Fluorescein: Administered intravenously and assessed during cystoscopy
Number of Participants With Urinary Tract Infections	10 Participants	13 Participants	9 Participants	10 Participants

Adverse Events

Normal Saline

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Dextrose 10%

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Phenazopyridine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Sodium Fluorescein

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Normal Saline n=44 participants at risk Infused into the bladder to allow for visualization of bladder walls and urine jets. Normal saline: Used to distend the bladder for cystoscopic evaluation	Dextrose 10% n=44 participants at risk Infused into the bladder to allow for visualization of bladder walls and colored urine jets. Dextrose 10%: Used to distend the bladder for cystoscopic evaluation	Phenazopyridine n=44 participants at risk Will be administered (PO) preoperatively and will be evaluated for its colorization properties during cystoscopy. Phenazopyridine: Administered orally preoperatively and assessed during cystoscopy	Sodium Fluorescein n=44 participants at risk Will be administered (IV) prior to the cystoscopy and will be evaluated for its colorization properties during cystoscopy. Sodium Fluorescein: Administered intravenously and assessed during cystoscopy
Cardiac disorders Elevated blood pressure	2.3% 1/44	0.00% 0/44	0.00% 0/44	0.00% 0/44
Nervous system disorders parathesia	2.3% 1/44	0.00% 0/44	0.00% 0/44	0.00% 0/44
Cardiac disorders chest pain	0.00% 0/44	2.3% 1/44	0.00% 0/44	0.00% 0/44
Renal and urinary disorders Post-op retention	0.00% 0/44	0.00% 0/44	0.00% 0/44	2.3% 1/44

Other adverse events

Adverse event data not reported

Additional Information

Dr. Eric Hurtado

Cleveland Clinic Florida

Phone: 954-659-5559

Email: hurtade@ccf.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place