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

Postoperative Pain Clinical Trial

— EPIPhANy  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02806713
• Other study ID #: H00008816
• Status: Completed
• Phase: Phase 3
• Start date: February 2016
• Est. completion date: August 2017

Study information

• Verified date: January 2019
• Source: University of Massachusetts, Worcester
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: August 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dysfunctional Voiding
• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• Phenazopyridine

Other:
• no Phenazopyridine
Because the obvious effects on the urine coloration of pyridium no placebo or dummy are provided

Locations

Country	Name	City	State
United States	Umass Memorial	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
University of Massachusetts, Worcester

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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