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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | No preoperative phenazopyridine | |
| Phenazopyridine | Experimental | Preoperative phenazopyridine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Phenazopyridine | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day of surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | day of surgery (day 0) |
| Additional Interventions: Measured by Use of IV Fluids, IV Lasix, IV Methylene Blue, or Ureteral Stent Placement in OR |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hartford Hospital | Hartford | Connecticut | 06106 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27399998 | Derived | Propst K, Tunitsky-Bitton E, O'Sullivan DM, Steinberg AC, LaSala C. Phenazopyridine for Evaluation of Ureteral Patency: A Randomized Controlled Trial. Obstet Gynecol. 2016 Aug;128(2):348-355. doi: 10.1097/AOG.0000000000001472. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Control | No preoperative phenazopyridine |
| FG001 | Phenazopyridine | Preoperative oral phenazopyridine: two tablets 97.5 mg each (195 mg total) |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Control | No preoperative phenazopyridine |
| BG001 | Phenazopyridine | Preoperative phenazopyridine |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | seconds | Day of surgery |
|
From the time of surgery to 30 days post-surgery.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control | No preoperative phenazopyridine |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Katie Propst, MD | Hartford Hospital | 860-972-4338 | katie.propst@hhchealth.org |
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| ID | Term |
|---|---|
| D010621 | Phenazopyridine |
| ID | Term |
|---|---|
| D000631 | Aminopyridines |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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this is a composite measure and will be reported as a single value for each arm as number of additional interventions |
| day of surgery (day 0) |
| 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. | post operative day 1 |
| 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. | Day of hospital discharge |
| BG002 |
| Total |
Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Charlson comorbidity index | The Charlson co-morbidity index is a scale used in longitudinal studies to estimate relative risk of death from prognostic clinical covariates. Age and comorbidities are evaluated to produce a score. Minimum score is zero, there is no maximum score. Zero is predicts no risk of death based on age and comorbidities. | Mean | Standard Deviation | scale score |
|
| Serum creatinine | Mean | Standard Deviation | mg/dL |
|
| History or prolapse surgery | Number | participants |
|
| History of urinary tract surgery | Number | participants |
|
| Surgical indication: prolapse | Number | participants |
|
| Surgical indication: incontinence | Number | participants |
|
| Stage II or greater prolapse: anterior | Pelvic organ prolapse is assessed by physical exam using the Pelvic Organ Prolpase Quantification scale. The results of the exam findings are then classified into prolapse stages which range from 0 (no prolapse ) to IV (complete prolapse). Each compartment (anterior / bladder, apical / uterus / vaginal cuff, and posterior / rectum) is assigned a stage. | Number | participants |
|
| Stage II or greater prolapse: apical | Pelvic organ prolapse is assessed by physical exam using the Pelvic Organ Prolpase Quantification scale. The results of the exam findings are then classified into prolapse stages which range from 0 (no prolapse ) to IV (complete prolapse). Each compartment (anterior / bladder, apical / uterus / vaginal cuff, and posterior / rectum) is assigned a stage. | Number | participants |
|
| Stage II or greater prolapse: posterior | Pelvic organ prolapse is assessed by physical exam using the Pelvic Organ Prolpase Quantification scale. The results of the exam findings are then classified into prolapse stages which range from 0 (no prolapse ) to IV (complete prolapse). Each compartment (anterior / bladder, apical / uterus / vaginal cuff, and posterior / rectum) is assigned a stage. | Number | participants |
|
| Surgical procedure performed: concomitant incontinence procedure | Number of participants who underwent an incontinence procedure in addition to surgery for pelvic organ prolapse | Number | participants |
|
| Surgical procedure performed: prolapse repair without hysterectomy | Subjects who underwent surgical treatment of pelvic organ prolapse without a concomitant hysterectomy. | Number | participants |
|
| Surgical procedure performed: prolapse repair with vaginal hysterectomy | Number of study participants who underwent surgical repair of pelvic organ prolapse with a concomitant vaginal hysterectomy. | Number | participants |
|
| Surgical procedure performed: prolapse repair with abdominal hysterectomy | Number of study participants who underwent surgical repair of pelvic organ prolapse with a concomitant abdominal hysterectomy. | Number | participants |
|
| Surgical procedure performed: prolapse repair with laparoscopic hysterectomy | Number of study participants who underwent surgical repair of pelvic organ prolapse with a concomitant laparoscopic hysterectomy. | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| 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 | Posted | Mean | Standard Deviation | units on a scale | day of surgery (day 0) |
|
|
|
|
| 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 | Posted | Number | interventions | day of surgery (day 0) |
|
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | post operative day 1 |
|
|
|
|
| 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. | For this outcome, 96 participants were analyzed. Of the 104 participants that completed the study, only 96 underwent a trial of void. | Posted | Number | participants who failed trial of void | Day of hospital discharge |
|
|
|
|
| 0 |
| 52 |
| 0 |
| 52 |
| EG001 | Phenazopyridine | Preoperative phenazopyridine | 0 | 52 | 0 | 52 |
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