Botulinum toxin type A injection for neurogenic detrusor overactivity: Clinical outcome in Japanese patients

Abstract

Abbreviations & Acronyms AE = adverse events BoNTA = botulinum toxin type A CIC = clean intermittent catheterization E = emotions GH = general health perception IDO = idiopathic detrusor II = incontinence impact IIG = incontinence impact questionnaire KHQ = King's Health Questionnaire MCC = maximum cystometric capacity MS = multiple sclerosis NDO = neurogenic detrusor overactivity P/S = physical and social limitations QOL = quality of life RL = role limitations SCL = spinal cord lesions S/E = sleep/energy SM = severity measures SNAP = soluble N-ethylmaleimide-sensitive factor attachment protein SNARE = soluble N-ethylmaleimide-sensitive factor attachment protein receptor SS = symptom severity UDI = urinary distress inventory UI = urinary incontinence UTI = urinary tract infection Objectives: To report our experience with intravesical injection of botulinum toxin type A into the detrusor muscle of patients with neurogenic detrusor overactivity secondary to suprasacral spinal cord lesions or multiple sclerosis. Methods: Between January 2003 and March 2011, 11 patients (aged 23-75 years) were treated with 40 injections of botulinum toxin type A 300 U. The patients were followed up for 4, 8 and 12 weeks after treatment. The King's Health Questionnaire was administered and cystometric studies were carried out at baseline and 8 weeks after treatment. Results: A total of six women and five men were treated. Analysis of the King's Health Questionnaire showed a significant improvement in eight of the nine domain scores at 8 weeks from baseline. On cystometric studies, the mean maximum cystometric capacity increased significantly in all patients at 8 weeks from baseline (P < 0.001). Bladder compliance also increased significantly (P < 0.001). The number of urinary incontinence episodes per day improved significantly from baseline after injection (4 weeks, P < 0.001; 8 weeks, P < 0.001; 12 weeks, P < 0.001). Lack of efficacy appeared 7.15 Ϯ 3.4 months after treatment. Conclusions: Injection of botulinum toxin type A into the detrusor muscle of patients with neurogenic detrusor overactivity secondary to suprasacral spinal cord lesions or multiple sclerosis consistently improves bladder control and quality of life.

Botulinum toxin injections for Japanese patients with urinary incontinence caused by neurogenic detrusor overactivity: Clinical evaluation of onabotulinumtoxinA in a randomized, placebo‐controlled, double‐blind trial with an open‐label extension

“…In the treatment of NDO, primary goals are to protect the upper urinary tract by lowering intravesical pressure and increasing bladder capacity, and improve QOL by reducing incontinence 14,15 . These parameters were improved by treatment with BoNTA 200 U in the present study.…”

Botulinum toxin A injection for the treatment of neurogenic detrusor overactivity secondary to spinal cord injury: Multi‐institutional experience in Japan

“…There are four articles reporting the efficacy of the BoNT‐A bladder wall injection in Japanese patients with DO so far . Hikita et al .…”

“…Hikita et al . reported the efficacy of 300 units BoNT‐A detrusor injection on NDO in 11 patients with SCI, spinal bifida or multiple sclerosis . A significant improvement was shown in UI episodes, quality of life, the bladder capacity and compliance in cystometry.…”

“…[14][15][16][17] Hikita et al reported the efficacy of 300 units BoNT-A detrusor injection on NDO in 11 patients with SCI, spinal bifida or multiple sclerosis. 16 A significant improvement was shown in UI episodes, quality of life, the bladder capacity and compliance in cystometry. Okamura et al reported the efficacy of 100 units BoNT-A submucosal injection on refractory nonneurogenic overactive bladder in 17 cases.…”

Editorial Comment to OnabotulinumtoxinA (botulinum toxin type A) for the treatment of Japanese patients with overactive bladder and urinary incontinence: Results of single‐dose treatment from a phase III, randomized, double‐blind, placebo‐controlled trial (interim analysis)

“…Based on subsequent trial data, the FDA expanded its botulinum toxin approval to include patients with non‐neurogenic OAB in 2013 5 . This manuscript presented only the Japanese phase 3 clinical trial data of idiopathic OAB; however, the treatment of neurogenic DO with onabotulinumtoxinA in Japan 6 is also necessary.…”