Background
The efficacy of intradetrusor onabotulinumtoxinA injections for the management of
idiopathic overactive bladder has been well-established. The injections are typically
performed in the office setting using local analgesia, most commonly a 20 to 30-minute
intravesical instillation of lidocaine. There are limited data evaluating alternative
bladder analgesics.
Objective
To compare pain scores with preprocedure oral phenazopyridine vs intravesical lidocaine
in women undergoing intradetrusor onabotulinumtoxinA injections for idiopathic overactive
bladder.
Study Design
Nonpregnant adult females with idiopathic overactive bladder, scheduled for office
injection of 100 units of intradetrusor onabotulinumtoxinA were randomized to either
200 mg of oral phenazopyridine taken 1 to 2 hours preprocedure or a 20-minute preprocedure
intravesical instillation of 50 mL of 2% lidocaine. We excluded participants with
neurogenic bladders, and those who had received intradetrusor onabotulinumtoxinA injections
in the previous 12 months. The primary outcome was pain measured by a 100-mm visual
analog scale. Demographic characteristics and overall satisfaction with the procedure
were also recorded. Providers answered questions about cystoscopic visualization,
ease of procedure, and perception of participant comfort. Prespecified noninferiority
margin was set to equal the anticipated minimum clinically important difference of
14 mm. A planned sample of 100 participants, 50 in each treatment arm, provided 80%
power to detect noninferiority at a significance level of.05. We performed a modified
intention-to-treat analysis and compared variables with the t test or the Fisher exact test.
Results
A total of 111 participants were enrolled, and complete data were obtained for 100
participants; 47 participants were randomized to phenazopyridine and 53 to lidocaine.
Baseline characteristics did not differ between groups. There were 19.6% and 20.8%
of participants in the phenazopyridine and lidocaine groups, respectively, who previously
underwent intradetrusor onabotulinumtoxinA injections. The mean postprocedure pain
was 2.7 mm lower in the phenazopyridine group than in the lidocaine group (95% confidence
interval, −11.3 to 10.7), demonstrating noninferiority. More than 90% of participants
in both groups stated that the pain was tolerable. Slightly more participants reported
being “very satisfied” in the lidocaine group, although this was not statistically
significant (50.0% vs 40.4%; P=.34). Providers reported clear visualization in 89.4% of participants in the phenazopyridine
group and in 100% of participants in the lidocaine group (P=.02). Provider perception of participant comfort and overall ease of procedure were
not different between groups. Length of time in the exam room was significantly shorter
in the phenazopyridine than in the lidocaine group (44.4 vs 57.5 minutes; P=.0003).
Conclusion
In women receiving intradetrusor onabotulinumtoxinA injections for idiopathic overactive
bladder, oral phenazopyridine was noninferior to intravesical lidocaine for procedural
pain control. Phenazopyridine is well-tolerated by participants, allows for the procedure
to be performed with similar ease, and is associated with shorter appointment times.
Key words
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Article info
Publication history
Published online: May 13, 2022
Accepted:
May 10,
2022
Received in revised form:
May 2,
2022
Received:
January 3,
2022
Footnotes
The authors report no conflict of interest.
The authors report no funding for this study.
Clinical Trial Identifier: NCT03755089.
Registration URL: https://clinicaltrials.gov/ct2/show/NCT03755089?cond=Overactive+Bladder&cntry=US&state=US%3ARI&city=Providence&draw=2&rank=2
This was presented at the 48th annual scientific meeting of the Society of Gynecologic Surgeons, San Antonio, TX, March 27–30, 2022.
Data Sharing Statement:
1. Will individual participant data be available (including data dictionaries)?
a. No
2. What data in particular will be shared?
a. Not applicable
3. What other documents will be available (eg, study protocol, statistical analysis plan, etc.)?
a. Study Protocol, Statistical Analysis Plan, Informed Consent Form, Analytic Code
4. When will data be available (start and end dates)?
a. Beginning at the time of and ending 5 years following article publication.
5. How will data be shared (including with whom, for what types of analyses, and by what mechanism)?
a. Proposals should be directed to [email protected] To gain access, data requestors will need to sign a data access agreement.
Cite this article as: Stewart LE, Siddique M, Jacobs KM, et al. Oral phenazopyridine vs intravesical lidocaine for bladder onabotulinumtoxinA analgesia: a randomized controlled trial (OPIL). Am J Obstet Gynecol 2022;227:308.e1-8.
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