Cystoscopy
Conditions
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.
Interventions
DRUGPhenazopyridine
Sponsors
Hartford Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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. |
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control No preoperative phenazopyridine | 52 |
| Phenazopyridine Preoperative phenazopyridine | 52 |
| Total | 104 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | surgery cancelled | 2 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Control | Phenazopyridine | Total |
|---|---|---|---|
| Age, Continuous | 57.6 years STANDARD_DEVIATION 11.3 | 62.7 years STANDARD_DEVIATION 9.8 | 60.19 years STANDARD_DEVIATION 10.89 |
| Charlson comorbidity index | 1.96 scale score STANDARD_DEVIATION 1.5 | 2.31 scale score STANDARD_DEVIATION 1.1 | 2.13 scale score STANDARD_DEVIATION 1.3 |
| History of urinary tract surgery | 6 participants | 9 participants | 15 participants |
| History or prolapse surgery | 7 participants | 12 participants | 19 participants |
| Region of Enrollment United States | 52 participants | 52 participants | 104 participants |
| Serum creatinine | 0.66 mg/dL STANDARD_DEVIATION 0.28 | 0.63 mg/dL STANDARD_DEVIATION 0.35 | 0.65 mg/dL STANDARD_DEVIATION 0.32 |
| Sex: Female, Male Female | 52 Participants | 52 Participants | 104 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| Stage II or greater prolapse: anterior | 46 participants | 46 participants | 92 participants |
| Stage II or greater prolapse: apical | 19 participants | 24 participants | 43 participants |
| Stage II or greater prolapse: posterior | 38 participants | 34 participants | 72 participants |
| Surgical indication: incontinence | 21 participants | 14 participants | 35 participants |
| Surgical indication: prolapse | 51 participants | 49 participants | 100 participants |
| Surgical procedure performed: concomitant incontinence procedure | 21 participants | 21 participants | 42 participants |
| Surgical procedure performed: prolapse repair with abdominal hysterectomy | 1 participants | 1 participants | 2 participants |
| Surgical procedure performed: prolapse repair with laparoscopic hysterectomy | 7 participants | 6 participants | 13 participants |
| Surgical procedure performed: prolapse repair without hysterectomy | 16 participants | 25 participants | 41 participants |
| Surgical procedure performed: prolapse repair with vaginal hysterectomy | 27 participants | 18 participants | 45 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 52 | 0 / 52 |
| serious Total, serious adverse events | 0 / 52 | 0 / 52 |
Outcome results
Primary
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.
Time frame: Day of surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Time to Visualize Ureteral Urine Flow Intraoperatively Measured by Timing in the Operating Room | 160 seconds | Standard Deviation 158 |
| Phenazopyridine | Time to Visualize Ureteral Urine Flow Intraoperatively Measured by Timing in the Operating Room | 173 seconds | Standard Deviation 275 |
p-value: 0.77t-test, 2 sided
Secondary
Additional Interventions: Measured by Use of IV Fluids, IV Lasix, IV Methylene Blue, or Ureteral Stent Placement in OR
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)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Control | Additional Interventions: Measured by Use of IV Fluids, IV Lasix, IV Methylene Blue, or Ureteral Stent Placement in OR | 4 interventions |
| Phenazopyridine | Additional Interventions: Measured by Use of IV Fluids, IV Lasix, IV Methylene Blue, or Ureteral Stent Placement in OR | 3 interventions |
p-value: 1Fisher Exact
Secondary
Physician Confidence Measured by a Survey
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)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Physician Confidence Measured by a Survey | 4.6 units on a scale | Standard Deviation 0.49 |
| Phenazopyridine | Physician Confidence Measured by a Survey | 4.5 units on a scale | Standard Deviation 0.61 |
p-value: 0.73t-test, 2 sided
Secondary
Post-operative Urethral Discomfort Measured by Pain Scales
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Post-operative Urethral Discomfort Measured by Pain Scales | 2.3 units on a scale | Standard Deviation 2.8 |
| Phenazopyridine | Post-operative Urethral Discomfort Measured by Pain Scales | 2.1 units on a scale | Standard Deviation 2.4 |
p-value: 0.78t-test, 2 sided
Secondary
Trial of Void Results
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
Population: For this outcome, 96 participants were analyzed. Of the 104 participants that completed the study, only 96 underwent a trial of void.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Control | Trial of Void Results | 19 participants who failed trial of void |
| Phenazopyridine | Trial of Void Results | 9 participants who failed trial of void |
p-value: 0.04Fisher Exact