SGS Papers| Volume 227, ISSUE 2, P308.e1-308.e8, August 2022

Oral phenazopyridine vs intravesical lidocaine for bladder onabotulinumtoxinA analgesia: a randomized controlled trial


      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.


      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.


      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).


      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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        • Coyne K.S.
        • Sexton C.C.
        • Bell J.A.
        • et al.
        The prevalence of lower urinary tract symptoms (LUTS) and overactive bladder (OAB) by racial/ethnic group and age: results from OAB-POLL.
        Neurourol Urodyn. 2013; 32: 230-237
        • Powell L.C.
        • Szabo S.M.
        • Walker D.
        • Gooch K.
        The economic burden of overactive bladder in the United States: a systematic literature review.
        Neurourol Urodyn. 2018; 37: 1241-1249
        • Stewart W.F.
        • Van Rooyen J.B.
        • Cundiff G.W.
        • et al.
        Prevalence and burden of overactive bladder in the United States.
        World J Urol. 2003; 20: 327-336
        • Gormley E.A.
        • Lightner D.J.
        • Faraday M.
        • Vasavada S.P.
        • American Urological Association, Society of Urodynamics, Female Pelvic Medicine
        Diagnosis and treatment of overactive bladder (non-neurogenic) in adults: AUA/SUFU guideline amendment.
        J Urol. 2015; 193: 1572-1580
        • Brubaker L.
        • Richter H.E.
        • Visco A.
        • et al.
        Refractory idiopathic urge urinary incontinence and botulinum A injection.
        J Urol. 2008; 180: 217-222
        • Pode D.
        • Zylber-Katz E.
        • Shapiro A.
        Intravesical lidocaine: topical anesthesia for bladder mucosal biopsies.
        J Urol. 1992; 148: 795-796
        • Thrasher J.B.
        • Kreder K.J.
        • Peterson N.E.
        • Donatucci C.F.
        Lidocaine as topical anesthesia for bladder mappings and cold-cup biopsies.
        J Urol. 1993; 150: 335-336
        • Henry R.
        • Patterson L.
        • Avery N.
        • et al.
        Absorption of alkalized intravesical lidocaine in normal and inflamed bladders: a simple method for improving bladder anesthesia.
        J Urol. 2001; 165: 1900-1903
        • Pereira e Silva R.
        • Ponte C.
        • Lopes F.
        • Palma dos Reis J.
        Alkalinized lidocaine solution as a first-line local anesthesia protocol for intradetrusor injection of Onabotulinum toxin A: results from a double-blinded randomized controlled trial.
        Neurourol Urodyn. 2020; 39: 2471-2479
        • Aizawa N.
        • Wyndaele J.J.
        Effects of phenazopyridine on rat bladder primary afferent activity, and comparison with lidocaine and acetaminophen.
        Neurourol Urodyn. 2010; 29: 1445-1450
        • Younger J.
        • McCue R.
        • Mackey S.
        Pain outcomes: a brief review of instruments and techniques.
        Curr Pain Headache Rep. 2009; 13: 39-43
        • Hjermstad M.J.
        • Fayers P.M.
        • Haugen D.F.
        • et al.
        Studies comparing Numerical Rating Scales, Verbal Rating Scales, and Visual Analogue Scales for assessment of pain intensity in adults: a systematic literature review.
        J Pain Symptom Manage. 2011; 41: 1073-1093
        • Cicinelli E.
        • Didonna T.
        • Ambrosi G.
        • Schönauer L.M.
        • Fiore G.
        • Matteo M.G.
        Topical anaesthesia for diagnostic hysteroscopy and endometrial biopsy in postmenopausal women: a randomised placebo-controlled double-blind study.
        Br J Obstet Gynaecol. 1997; 104: 316-319
        • Olsen M.F.
        • Bjerre E.
        • Hansen M.D.
        • et al.
        Pain relief that matters to patients: systematic review of empirical studies assessing the minimum clinically important difference in acute pain.
        BMC Med. 2017; 15: 35
        • Cohen B.L.
        • Rivera R.
        • Barboglio P.
        • Gousse A.
        Safety and tolerability of sedation-free flexible cystoscopy for intradetrusor botulinum toxin-A injection.
        J Urol. 2007; 177: 1006-1010
        • Nambiar A.K.
        • Younis A.
        • Khan Z.A.
        • Hildrup I.
        • Emery S.J.
        • Lucas M.G.
        Alkalinized lidocaine versus lidocaine gel as local anesthesia prior to intra-vesical botulinum toxin (BoNTA) injections: a prospective, single center, randomized, double-blind, parallel group trial of efficacy and morbidity.
        Neurourol Urodyn. 2016; 35: 522-527
        • LeClaire E.L.
        • Duong J.
        • Wykes R.M.
        • Miller K.E.
        • Winterton T.L.
        • Bimali M.
        Randomized controlled trial of belladonna and opiate suppository during intravesical Onabotulinum toxin A injection.
        Am J Obstet Gynecol. 2018; 219: 488.e1-488.e7