Injury of Ureter
Conditions
Keywords
ureteral jet, pelvic surgery, cystoscopy
Brief summary
This study evaluates 4 different methods to aid surgeons to visualize ureteral jets on cystoscopy.
Detailed description
This study proposes to test and compare the surgeon's impression/confidence in identifying ureteral jets using 3 other methods in contrast to standard diagnostic cystoscopy: 1) cystoscopy with Dextrose 10% solution, 2) cystoscopy with phenazopyridine and 3) IV sodium fluorescein 4) standard cystoscopy with saline.
Interventions
DRUGNormal saline
Used to distend the bladder for cystoscopic evaluation
DRUGPhenazopyridine
Administered orally preoperatively and assessed during cystoscopy
DRUGDextrose 10%
Used to distend the bladder for cystoscopic evaluation
Administered intravenously and assessed during cystoscopy
Sponsors
The Cleveland Clinic
Cecilia Calvo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* adult * undergoing a cystoscopy or as part of their planned procedure
Exclusion criteria
* Chronic kidney disease * known prior surgical removal of kidney or ureteral obstruction * Current ureteral stent placed * Allergy to any of the interventions
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ureteral Jet Visibility | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Surgeon Satisfaction | 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Urinary Tract Infections | 6 weeks | Medical records will be followed prospectively for 6 weeks to assess for incidence of urinary tract infections within different groups. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 44 |
| 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 | 44 |
| Phenazopyridine Will be administered (PO) preoperatively and will be evaluated for its colorization properties during cystoscopy.
Phenazopyridine: Administered orally preoperatively and assessed during cystoscopy | 44 |
| 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 | 44 |
| Total | 176 |
Baseline characteristics
| Characteristic | Normal Saline | Dextrose 10% | Phenazopyridine | Sodium Fluorescein | Total |
|---|---|---|---|---|---|
| Age, Continuous | 63.2 years STANDARD_DEVIATION 13.8 | 59.3 years STANDARD_DEVIATION 12.1 | 60 years STANDARD_DEVIATION 9.7 | 60.3 years STANDARD_DEVIATION 13.9 | 60.7 years STANDARD_DEVIATION 12.4 |
| BMI | 26.4 kg/m^2 | 26.9 kg/m^2 | 30.3 kg/m^2 | 26.7 kg/m^2 | 27.6 kg/m^2 |
| Race and Ethnicity Not Collected | — | — | — | — | 0 Participants |
| Sex: Female, Male Female | 44 Participants | 44 Participants | 44 Participants | 44 Participants | 176 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 44 | 0 / 44 | 0 / 44 | 0 / 44 |
| other Total, other adverse events | 0 / 44 | 0 / 44 | 0 / 44 | 0 / 44 |
| serious Total, serious adverse events | 2 / 44 | 1 / 44 | 0 / 44 | 1 / 44 |
Outcome results
Primary
Ureteral Jet Visibility
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
Time frame: 5 minutes
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Normal Saline | Ureteral Jet Visibility | Clearly Visible | 22 Participants |
| Normal Saline | Ureteral Jet Visibility | Somewhat Visible | 17 Participants |
| Normal Saline | Ureteral Jet Visibility | Not Visible | 5 Participants |
| Dextrose 10% | Ureteral Jet Visibility | Somewhat Visible | 9 Participants |
| Dextrose 10% | Ureteral Jet Visibility | Not Visible | 0 Participants |
| Dextrose 10% | Ureteral Jet Visibility | Clearly Visible | 35 Participants |
| Phenazopyridine | Ureteral Jet Visibility | Clearly Visible | 27 Participants |
| Phenazopyridine | Ureteral Jet Visibility | Somewhat Visible | 16 Participants |
| Phenazopyridine | Ureteral Jet Visibility | Not Visible | 1 Participants |
| Sodium Fluorescein | Ureteral Jet Visibility | Not Visible | 0 Participants |
| Sodium Fluorescein | Ureteral Jet Visibility | Somewhat Visible | 3 Participants |
| Sodium Fluorescein | Ureteral Jet Visibility | Clearly Visible | 41 Participants |
Secondary
Surgeon Satisfaction
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
Time frame: 5 mins
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Normal Saline | Surgeon Satisfaction | Very Satisfied | 12 Participants |
| Normal Saline | Surgeon Satisfaction | Satisfied | 14 Participants |
| Normal Saline | Surgeon Satisfaction | Somewhat Satisfied | 13 Participants |
| Normal Saline | Surgeon Satisfaction | Unacceptable | 5 Participants |
| Dextrose 10% | Surgeon Satisfaction | Satisfied | 12 Participants |
| Dextrose 10% | Surgeon Satisfaction | Somewhat Satisfied | 5 Participants |
| Dextrose 10% | Surgeon Satisfaction | Unacceptable | 0 Participants |
| Dextrose 10% | Surgeon Satisfaction | Very Satisfied | 27 Participants |
| Phenazopyridine | Surgeon Satisfaction | Somewhat Satisfied | 12 Participants |
| Phenazopyridine | Surgeon Satisfaction | Satisfied | 15 Participants |
| Phenazopyridine | Surgeon Satisfaction | Unacceptable | 5 Participants |
| Phenazopyridine | Surgeon Satisfaction | Very Satisfied | 12 Participants |
| Sodium Fluorescein | Surgeon Satisfaction | Unacceptable | 1 Participants |
| Sodium Fluorescein | Surgeon Satisfaction | Satisfied | 13 Participants |
| Sodium Fluorescein | Surgeon Satisfaction | Very Satisfied | 26 Participants |
| Sodium Fluorescein | Surgeon Satisfaction | Somewhat Satisfied | 4 Participants |
Other Pre-specified
Number of Participants With Urinary Tract Infections
Medical records will be followed prospectively for 6 weeks to assess for incidence of urinary tract infections within different groups.
Time frame: 6 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Normal Saline | Number of Participants With Urinary Tract Infections | 10 Participants |
| Dextrose 10% | Number of Participants With Urinary Tract Infections | 13 Participants |
| Phenazopyridine | Number of Participants With Urinary Tract Infections | 9 Participants |
| Sodium Fluorescein | Number of Participants With Urinary Tract Infections | 10 Participants |