The Effect of Oral PhenazopyrIdine on Perioperative Voiding After Mid-urethral sliNg (EPIPhANy Study) (EPIPhANy)

The Effect of Oral phenazopyrIdine on Perioperative Voiding After Mid-urethral Sling

Randomized clinical trial using phenazopyridine to decrease voiding dysfunction after a retropubic midurethral sling operation.

Study Overview

• Status: Completed
• Conditions: Postoperative Pain; Dysfunctional Voiding
• Intervention / Treatment: Drug: Phenazopyridine; Other: no Phenazopyridine

Detailed Description

Study design and randomization This study is a randomized controlled trial. Randomization will be performed using software and a block randomization scheme. Study assignment will be completed using sequentially numbered sealed opaque envelopes. All the research procedures described other than the use or not of phenazopyridine will be applicable to both arms of the study. Subjects will have a 50% chances of getting either phenazopyridine or nothing.

Because pyridium turns the urine orange, it is impossible to blind the patients and researchers to the study assignment. Because there is no known placebo that turns the urine orange, there is no value to using an actual placebo tablet. Subjects will be assigned to either receive pyridium or not receive pyridium preoperatively.

Screening potential subjects: Investigators will screen potential subjects for contraindications to methylene blue. Prior obtaining the routine surgical consent for the potential subject's surgical procedure, the patient's medical history in the UMass Electronic Medical Record is routinely reviewed. The medical record will be reviewed for a diagnosis of G6PD and if found, the potential subject will be excluded.

Once written consent has been obtained, subject number will be assigned and the appropriate randomization envelope will be opened. The study assignment will not be formally shared with the subject. Those assigned to the "pyridium" arm will have orders written for the standard 200 mg dose of pyridium to be given on arrival to the Surgical Admissions Care Unit (SACU). Those assigned to the "NO pyridium" arm with have their routine preoperative orders written along with an order for "No preoperative pyridium".

Subjects will then follow the routine perioperative care for their procedures with the only study interventions being the gathering of PHI and performing postoperative pain assessments.

PHI will be obtained at the time of the surgical consent with the purpose to evaluate for possible confounders affecting the postoperative bladder function.

Surgical procedure:

The Mid Urethral Sling will be performed in standard fashion based on manufacturer's recommendations and instructions to minimize inter-observer variations. We will perform the procedure according to our usual and customary techniques. The subject will receive the same technique and interventions that a routine patient on the Urogyn service would expect to undergo. There will be no changes to the technique for the purpose of the study.

Bladder challenge:

Patient will undergo voiding trial at same day surgery per our usual and customary protocol. This is the same protocol the subject would undergo as a patient on the Urogyn service. The bladder challenge will be interpreted in our usual manner and the subject managed according to our routine clinical protocols.

Postoperative care:

Subjects will undergo routine postoperative care and followup. Subjects failing their bladder challenge will be seen in the Urogyn clinic according to routine clinical protocols and data concerning their void trials collected. Subjects will undergo routine followup evaluation 6 weeks postoperatively in the order to assess any potential long-term voiding dysfunction. Information on any postoperative complications will be collected

Administration of Visual analog scale:

(1) Visual analog scale for assessment of pain will be administered at two- time intervals.

1. VAS #1) Preoperative VAS will be done by the principal investigator or any of the study assistants. The VAS form will be part of subject's packet.
2. VAS#2) VAS will be administered by one of the study investigators 2 to 3 hours after the surgical procedure in the SACU.

• Study Type: Interventional
• Enrollment (Actual): 92
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Worcester, Massachusetts, United States, 01605
      • UMass Memorial

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

1. Any female subjects scheduled to undergo Mid-Urethral Sling (MUS) through the UMass urogynecology service for incontinence.

Exclusion Criteria:

1. Planned concurrent prolapse or other procedure besides cystoscopy
2. Using intermittent self catheterization preoperatively
3. Undergoing spinal anesthesia for the procedure
4. Known allergy to phenazopyridine (AKA Pyridium)
5. Renal insufficiency
6. Any condition or situation that in the attending physician's opinion would contra-indicate the use of phenazopyridine
7. Subjects not competent to give consent
8. Prisoners
9. Non-English speaking patients
10. Age <18
11. Pregnant patients

12. Contraindications to the use of IV methylene blue including

    1. Patients with known hypersensitivity reactions
    2. Severe renal insufficiency
    3. Patients with G6PD deficiency

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: no phenazopyridine; Patients not receiving phenazopyridine (standard of care)	Other: no Phenazopyridine; Because the obvious effects on the urine coloration of pyridium no placebo or dummy are provided
Experimental: phenazopyridine; Patients receiving phenazopyridine	Drug: Phenazopyridine; Other Names: Pyridium

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With a Failed Voiding Trial	Number of participants with a failed postoperative voiding trial. A failed voiding trial is defined as not voiding all urine in 20 minutes or voiding less than 1/3 of total volume (voided volume + post void residual). Patients will undergo voiding trial at same day surgery per the following protocol. Participants who do not pass the voiding trial the same day of their surgical procedure return to the clinic in 3 days to repeat it, following the same protocol described above.	Postoperatively, up to 3 days after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Participant-reported Pain From Pre to Post Procedure Using the Visual Analog Scale (VAS)	To determine if the phenazopyridine has an analgesic effect after the retropubic midurethral slings, participants will be asked to self-report pain intensity preoperatively and then postoperatively (2 to 3 hours post procedure) using the Visual Analog Scale (VAS). The scale of the VAS is from 0 meaning "no pain" to 10 indicating the "worst pain." The resulting change is measured as the difference between the self-reported preoperative pain score and the postoperative pain score.	Preoperatively and then 2 to 3 hours after surgery

Collaborators and Investigators

• Sponsor: University of Massachusetts, Worcester
• Investigators: Principal Investigator: Michael K Flynn, MD, MHS, University of Massachusetts, Worcester

Publications and helpful links

General Publications

• Nilsson CG, Palva K, Rezapour M, Falconer C. Eleven years prospective follow-up of the tension-free vaginal tape procedure for treatment of stress urinary incontinence. Int Urogynecol J Pelvic Floor Dysfunct. 2008 Aug;19(8):1043-7. doi: 10.1007/s00192-008-0666-z. Epub 2008 Jun 6.
• Nilsson CG, Kuuva N, Falconer C, Rezapour M, Ulmsten U. Long-term results of the tension-free vaginal tape (TVT) procedure for surgical treatment of female stress urinary incontinence. Int Urogynecol J Pelvic Floor Dysfunct. 2001;12 Suppl 2:S5-8. doi: 10.1007/s001920170003.

Study record dates

Study Major Dates

• Study Start: February 1, 2016
• Primary Completion (Actual): August 1, 2017
• Study Completion (Actual): August 1, 2017

Study Registration Dates

• First Submitted: April 29, 2016
• First Submitted That Met QC Criteria: June 15, 2016
• First Posted (Estimate): June 21, 2016

Study Record Updates

• Last Update Posted (Actual): February 5, 2019
• Last Update Submitted That Met QC Criteria: January 11, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: H00008816

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes