BACKGROUND: Cystoscopic intradetrusor injection of botulinum toxin has helped patients with refractory overactive bladder (OAB), but with increased risks of urinary tract infection and urinary retention.
We assessed whether catheter instillation of onabotulinumtoxinA 200 U formulated with liposomes (lipo-BoNT) is safe and effective for the treatment of OAB.
METHODS: This two-center, double-blind, randomized, placebo-controlled study enrolled patients with OAB who were inadequately managed by antimuscarinics. Patients were assigned to intravesical instillation of lipo-BoNT (n=31) or normal saline (n=31). The primary end-point was the mean change in micturition events per three days at four weeks post-treatment. Additional end-points included mean changes of urgency event, frequency and urinary urge incontinence (UUI), as well as changes in OAB symptom scores (OABSS) and urgency severity scores (USS).
RESULTS: At four weeks post-treatment, lipo-BoNT instillation was associated with a statistically significantly decrease in micturition events per three-days (-4.64 for lipo-BoNT versus -0.19 for placebo; p = 0.0252). Lipo-BoNT instillation was also associated with a statistically significant decrease in urinary urgency event with respect to baseline but not placebo. However, lipo-BoNT instillation was associated with a statistically significant decrease in USS scores versus those of placebo (p = 0.0181). These observed benefits of lipo-BoNT instillation were not accompanied by an increased risk of urinary retention. Effects of lipo-BoNT on UUI were inconclusive.
CONCLUSION: A single intravesical instillation of lipo-BoNT was associated with decreases of OAB symptoms without side effects. Intravesical instillation of liposomal botulinum toxin may be a promising approach for treatment of refractory OAB.
Written by:
Chuang YC, Kaufmann JH, Chancellor D, Chancellor M, Kuo HC. Are you the author?
Department of Urology, Kaohsiung Chang Gang Memorial Hospital, Chang Gung University, College of Medicine, Taiwan; Lipella pharmaceutical company, Pittsburgh, PA; Oakland University-William Beaumont School of Medicine, Royal Oak MI 48073 USA; Department of Urology, Buddhist Tzu Chi General Hospital and Tzu Chi University, Hualien, Taiwan.
Reference: J Urol. 2014 Jul 18. pii: S0022-5347(14)03955-X.
doi: 10.1016/j.juro.2014.07.008
PubMed Abstract
PMID: 25046622
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