Abstract
Non-neurogenic voiding dysfunction including dysfunctional voiding and detrusor underactivity caused by a spastic or non-relaxing external urethral sphincter can theoretically be treated by injections of botulinum A toxin into the external urethral sphincter. This randomized, double-blind, placebo-controlled trial was designed to determine the clinical efficacy of onabotulinumtoxinA urethral sphincter injections in patients with dysfunctional voiding or detrusor underactivity. Patients with medically refractory dysfunctional voiding (n = 31) or detrusor underactivity (n = 31) were randomly allocated in a 2:1 ratio to receive either onabotulinumtoxinA (100 U) (n = 38) or placebo (normal saline) (n = 24). There were no significant differences in subjective or objective parameters between patients who received onabotulinumtoxinA and those who received saline injection therapy, and the overall success rate was 43.5% (reduction in Patient perception of Bladder Condition by ≥2: onabotulinumtoxinA 36.8% vs placebo 54.2%, p = 0.114). The results were similar between the dysfunctional voiding and detrusor underactivity subgroups; however, a significant reduction in detrusor voiding pressure was only observed in dysfunctional voiding patients who received onabotulinumtoxinA. Repeat urethral sphincter onabotulinumtoxinA injections offered greater therapeutic effects in both dysfunctional voiding and detrusor underactivity patients. For patients with non-neurogenic voiding dysfunction, the success rate of onabotulinumtoxinA urethral sphincter injection was not superior to placebo.
Highlights
The urethral sphincter of a neurologically normal child with refractory dysfunctional voiding resulted in the resolution of urinary tract infections and incontinence episodes[8]
Franco et al reported that increasing the onabotulinumtoxinA dose to 200–300 U resulted in increased efficacy without increasing the morbidity rate[16]
Urethral sphincter onabotulinumtoxinA injection has been shown to be an effective therapy for patients with voiding dysfunction, its application for non-neurogenic voiding dysfunctions, including dysfunctional voiding and detrusor underactivity, is still off-label
Summary
The urethral sphincter of a neurologically normal child with refractory dysfunctional voiding resulted in the resolution of urinary tract infections and incontinence episodes[8]. Urethral sphincter onabotulinumtoxinA injection has been used to treat various types of neurogenic or non-neurogenic voiding dysfunction, including chronic urinary retention[9], detrusor underactivity[10,11], poor relaxation of urethral sphincter[12], and lower urinary tract symptoms in men with small prostates[13]. Urethral sphincter onabotulinumtoxinA injection has been shown to be an effective therapy for patients with voiding dysfunction, its application for non-neurogenic voiding dysfunctions, including dysfunctional voiding and detrusor underactivity, is still off-label. OnabotulinumtoxinA doses and the injection techniques varied widely among different study groups This prospective, randomized, double-blind, placebo-controlled trial was designed to demonstrate the actual therapeutic efficacy of urethral sphincter onabotulinumtoxinA injections for the treatment of non-neurogenic voiding dysfunctions, including dysfunctional voiding and detrusor underactivity
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