Outcome of a Randomized, Double-Blind, Placebo Controlled Trial of Botulinum A Toxin for Refractory Overactive Bladder

Content Provider	Scilit
Author	Flynn, Michael K. Amundsen, Cindy L. Perevich, Maryann Liu, Fan Webster, George D.
Copyright Year	2009
Description	Journal: Journal of Urology Purpose: We determined the effectiveness of cystoscopic administration of botulinum-A toxin compared to placebo for the treatment of urinary incontinence in subjects with idiopathic overactive bladder. Materials and Methods: Subjects were recruited from the Division of Urogynecology at the University of Rochester. Inclusion criteria were overactive bladder refractory to anticholinergic medications, multiple daily incontinence episodes and a 24-hour pad weight of 100 gm or greater. Subjects with low leak point pressures, increased post-void residual volume or neurological etiologies were excluded from study. Subjects were randomized to placebo or to 1 of 2 doses of botulinum-A toxin. The detrusor was injected at 8 to 10 sites above the trigone. Evaluations were performed at baseline, and at 3 and 6 weeks after injection, and included bladder diaries, pad weights, quality of life questionnaires and urodynamic studies. Results: A total of 22 subjects participated in stage 1 of this 2-stage study. We report on the outcomes of stage 1 of this study. Because stage 2 is still ongoing and investigators remain blind to the doses of botulinum-A toxin, the 2 botulinum-A toxin groups were combined for this report. There were no differences in mean baseline measurements between the 2 groups. Statistically significant improvements in daily incontinence episodes, pads changed per day and quality of life questionnaires were seen in the botulinum-A toxin group with no changes in the placebo group. No change in nocturia, daily voiding frequency, peak flow or detrusor pressure was seen in either group. Of 15 subjects 4 (26%) receiving botulinum-A toxin had a post-void residual volume of 200 cc or greater and 1 subject required intermittent catheterization. Four subjects experienced a urinary tract infection, 2 (13%) in the botulinum-A toxin group and 2 (28%) in the placebo group (not significant). Conclusions: Botulinum-A toxin can significantly reduce urge urinary incontinence due to overactive bladder at 6 weeks. However, there is a risk of urinary retention requiring self- catheterization.
Related Links	http://europepmc.org/articles/pmc2730562?pdf=render https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2730562/pdf
Ending Page	2615
Page Count	8
Starting Page	2608
ISSN	00225347
e-ISSN	15273792
DOI	10.1016/j.juro.2009.01.117
Journal	Journal of Urology
Issue Number	6
Volume Number	181
Language	English
Publisher	Ovid Technologies (Wolters Kluwer Health)
Publisher Date	2009-06-30
Access Restriction	Open
Subject Keyword	Journal: Journal of Urology Womens Studies Botulinum Toxins Urinary Bladder Urinary Incontinence
Content Type	Text
Resource Type	Article
Subject	Urology