An updated systematic review and statistical comparison of standardised mean outcomes for the use of botulinum toxin in the management of lower urinary tract disorders.
BACKGROUND
Botulinum toxin A (BoNTA) has received regulatory approval for use in neurogenic detrusor overactivity (NDO) and overactive bladder (OAB), but it remains unlicensed in other lower urinary tract symptoms (LUTS) indications such as nonneurogenic LUTS in men with benign prostatic enlargement (LUTS/BPE), bladder pain syndrome (BPS), and detrusor sphincter dyssynergia (DSD).


OBJECTIVE
To compare statistically the outcomes of high level of evidence (LE) studies with placebo using BoNTA for LUTS indications; NDO, OAB, LUTS/BPE, BPS and DSD.


METHODS
We conducted a systematic review of the published literature on PubMed, Scopus, and Embase reporting on BoNTA use in LUTS dysfunction. Statistical comparison was made between high LE studies with placebo and low LE studies.


RESULTS
In adult NDO, there are significantly greater improvements with BoNTA in daily incontinence and catheterisation episodes (-63% and -18%, respectively; p<0.01), and the urodynamic parameters of maximum cystometric capacity (MCC), reflex volume, and maximum detrusor pressure (MDP) (68%, 61%, and -42%, respectively; all p<0.01). In OAB, BoNTA leads to significant improvements in bladder diary parameters such as daily frequency (-29%), daily urgency (-38%), and daily incontinence (-59%) (all p<0.02). The urodynamic parameters of MCC and MDP improved by 58% (p=0.04) and -29% (p=0.002), respectively. The risk of urinary tract infection was significantly increased from placebo at 21% versus 7% (p<0.001), respectively; the risk of intermittent self-catherisation increased from 0% to 12% (p<0.001). Men with LUTS/BPE showed no significant improvements in International Prostate Symptom Score, maximum flow rate, or prostate volume. There were insufficient data for statistical analysis in DSD, BPS, and paediatric studies. Low LE studies were found to overestimate the effects of BoNTA in all indications, but differences from high LE studies were significant in only a few parameters.


CONCLUSIONS
BoNTA significantly improves all symptoms and urodynamic parameters in NDO and OAB. The effect of BoNTA in treating LUTS dysfunction appears to be overestimated in lower as opposed to higher LE studies.
Sheffield Teaching Hospitals NHS Trust, Sheffield, UK. Electronic address: mangeraaltaf@hotmail.com.
Altaf
A
Mangera
Aristotle University of Thessaloniki, Thessaloniki, Greece.
Apostolos
A
Apostolidis
Wake Forest University School of Medicine, Winston Salem, NC, USA.
Karl Eric
KE
Andersson
Medical Research Council Centre for Transplantation, Urology Department, NIHR Biomedical Centre, King's College London, King's Health Partners, Guy's Hospital, London, UK.
Prokar
P
Dasgupta
Department of Urology and Andrology, University of Perugia, Perugia, Italy.
Antonella
A
Giannantoni
Department of Urology, Southwestern Medical Center, Dallas, TX, USA.
Claus
C
Roehrborn
Department of Surgery, Oncology, and Gastroenterology-Urology Clinic, University of Padua, Padua, Italy.
Giacomo
G
Novara
Sheffield Teaching Hospitals NHS Trust, Sheffield, UK.
Christopher
C
Chapple
D001259:Ataxia / Q000188:drug therapy*; D019274:Botulinum Toxins, Type A / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D009465:Neuromuscular Agents / Q000009:adverse effects / Q000627:therapeutic use*; D053448:Prostatism / Q000188:drug therapy*; D001745:Urinary Bladder Diseases / Q000188:drug therapy*; D001750:Urinary Bladder, Neurogenic / Q000188:drug therapy; D053201:Urinary Bladder, Overactive / Q000188:drug therapy; D014552:Urinary Tract Infections / Q000139:chemically induced; D014563:Urodynamics / Q000187:drug effects
D009465:Neuromuscular Agents; D019274:Botulinum Toxins, Type A
AbobotulinumtoxinA; Benign prostatic obstruction; Bladder outflow obstruction; Bladder pain syndrome; Botox; Botulinum toxin; Detrusor sphincter dyssynergia; Dysport; Idiopathic detrusor overactivity; Interstitial cystitis; Neurogenic detrusor overactivity; OnabotulinumtoxinA; Overactive bladder; Systematic review