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 minutesSurgeons 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 minsA 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
Satisfied
|
14 Participants
|
12 Participants
|
15 Participants
|
13 Participants
|
|
Surgeon Satisfaction
Somewhat Satisfied
|
13 Participants
|
5 Participants
|
12 Participants
|
4 Participants
|
|
Surgeon Satisfaction
Very Satisfied
|
12 Participants
|
27 Participants
|
12 Participants
|
26 Participants
|
|
Surgeon Satisfaction
Unacceptable
|
5 Participants
|
0 Participants
|
5 Participants
|
1 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 weeksMedical 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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place