Journal article
Randomized Controlled Trial of Oxybutynin Extended Release Versus Placebo for Urinary Symptoms During Intravesical Bacillus Calmette-Guérin Treatment
The Journal of urology, Vol.189(4), pp.1268-1274
04/2013
DOI: 10.1016/j.juro.2012.10.070
PMCID: PMC4150693
PMID: 23123375
Abstract
Intravesical bacillus Calmette-Guérin is used to decrease recurrence rates of nonmuscle invasive urothelial carcinoma. Irritative urinary symptoms are a common side effect of treatment and frequently limit treatment tolerance. While anticholinergic medications may be used for symptom prophylaxis, to our knowledge they have not been evaluated in a randomized controlled trial.
A total of 50 bacillus Calmette-Guérin naïve patients were randomized to 10 mg extended release oxybutynin daily or placebo starting the day before 6 weekly bacillus Calmette-Guérin treatments. A questionnaire assessing urinary symptoms (frequency, burning on urination, urgency, bladder pain, hematuria), systemic symptoms (flu-like symptoms, fever, arthralgia) and medication side effects (constipation, blurred vision, dry mouth) was recorded daily throughout the therapeutic course. A linear mixed repeated measures model tested the differences between each point and baseline score.
The treatment group had a greater increase in urinary frequency and burning on urination compared to placebo (p = 0.004 and p = 0.04, respectively). There were no significant differences between groups for other urinary symptoms, which increased in severity after bacillus Calmette-Guérin but concomitantly returned to baseline in both groups. The treatment group experienced increases in fever, flu-like symptoms, dry mouth and constipation compared to placebo (p <0.0001, p = 0.0008, p = 0.045 and p = 0.001, respectively). There were otherwise no significant differences in nonurinary symptoms or medication adverse reactions.
Oxybutynin increased urinary frequency and burning on urination compared to placebo in patients receiving intravesical bacillus Calmette-Guérin treatment. Our results do not support the routine use of oxybutynin as prophylaxis against urinary symptoms during bacillus Calmette-Guérin therapy.
Details
- Title: Subtitle
- Randomized Controlled Trial of Oxybutynin Extended Release Versus Placebo for Urinary Symptoms During Intravesical Bacillus Calmette-Guérin Treatment
- Creators
- Michael H Johnson - Division of Urologic Surgery, Washington University School of Medicine, Saint Louis, MissouriKenneth G Nepple - Division of Urologic Surgery, Washington University School of Medicine, Saint Louis, MissouriVicky Peck - Division of Urologic Surgery, Washington University School of Medicine, Saint Louis, MissouriKathryn Trinkaus - Division of Biostatistics, Washington University School of Medicine, Saint Louis, MissouriAleksandra Klim - Division of Urologic Surgery, Washington University School of Medicine, Saint Louis, MissouriGurdarshan S Sandhu - Division of Urologic Surgery, Washington University School of Medicine, Saint Louis, MissouriAdam S Kibel - Division of Urologic Surgery, Washington University School of Medicine, Saint Louis, Missouri
- Resource Type
- Journal article
- Publication Details
- The Journal of urology, Vol.189(4), pp.1268-1274
- DOI
- 10.1016/j.juro.2012.10.070
- PMID
- 23123375
- PMCID
- PMC4150693
- NLM abbreviation
- J Urol
- ISSN
- 0022-5347
- eISSN
- 1527-3792
- Publisher
- Elsevier Inc
- Grant note
- 1KM1CA156708-01 / National Institutes of Health
- Language
- English
- Date published
- 04/2013
- Academic Unit
- Urology
- Record Identifier
- 9984051763902771
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