Urologic applications of botulinum toxin

King, Ashley; Quirouet, Adrienne; Moore, Courtenay

doi:10.3949/ccjm.82a.13166

Cited by 9 publications

(5 citation statements)

References 38 publications

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“…The faster onset and shorter effect duration of rBoNT-E compared with abobotulinumtoxinA is consistent with the literature [19,20]. Botulinum toxin serotype A (BoNT-A) has a 3-9-month duration of effect in human muscles [21,22], much longer than BoNT-E (< 60-day duration of effect in human skeletal muscles [23]). In rodent models of skeletal muscle function, BoNT-A has a half-life of around 10-20 days [24] (> 78 days in vitro [12,25]), compared with < 3 days with BoNT-E (5.8 days in vitro [12], in-house data).…”

Section: Tablesupporting

confidence: 85%

Safety and pharmacodynamics of a novel recombinant botulinum toxin E (rBoNT-E): Results of a phase 1 study in healthy male subjects compared with abobotulinumtoxinA (Dysport®)

Pons

Vilain

Volteau

et al. 2019

Journal of the Neurological Sciences

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Naturally occurring botulinum toxin (BoNT) serotypes have different pharmacological features of therapeutic and aesthetic interest. This phase 1, double-blind, placebo-controlled study (EudraCT: 2016-002609-20) assessed safety, tolerability and pharmacodynamics (PD) of the first recombinant BoNT serotype E (rBoNT-E) versus abobotulinumtoxinA (Dysport®), administered to extensor digitorum brevis (EDB) of healthy males. Subjects were randomised 3:1 (n = 28) to single ascending rBoNT-E (0.04-3.6 ng) doses or placebo. A further 24 subjects received abobotulinumtoxinA (20, 40, or 70 U) or placebo. PD were assessed using compound muscle action potential (CMAP) amplitude. Demographics were similar between groups. All rBoNT-E doses were well tolerated (no severe treatment-emergent adverse events [TEAEs], serious adverse events, or treatment-related toxicities). Most TEAEs were mild/moderate and treatment-unrelated. rBoNT-E had a faster onset of action (days 1-2 post-injection), greater peak effect (> 90% CMAP inhibition), and shorter duration of effect at highest tested doses versus abobotulinumtoxinA (onset of action ≤7 days post-injection; 70% maximal CMAP inhibition). rBoNT-E duration of effect was 2-7 weeks versus > 26 weeks for abobotulinumtoxinA. Dose-dependent effects were observed for magnitude and duration of EDB CMAP inhibition, plateauing at 0.9 and 3.6 ng. rBoNT-E demonstrated a good safety profile and a PD profile that may address unmet therapeutic and aesthetic patient needs. manufactured with recombinant technology (rBoNT-E) using the host Escherichia coli and containing genes encoding the natural sequence of BoNT-E, has been identified as a drug candidate [5]. Prior pre-clinical research using recombinant technology has been performed in various BoNT serotypes [6]; however, rBoNT-E is the first to reach clinical trials. Faster onset of action and shorter duration of effect, as well as a quick time to peak activity, have been reported in animal studies of rBoNT-E in comparison with established BoNT-A products, including abobotulinumtoxinA (Dysport®) [7,8]. This is likely to be due to differences between the exact mechanisms of action for the two different BoNT serotypes.rBoNT-E and BoNT-A both bind to synaptic vesicle protein 2 (SV2) [7,8], while BoNT-A can bind to all three isoforms (SV2A, SV2B, and

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Section: Tablesupporting

confidence: 85%

Safety and pharmacodynamics of a novel recombinant botulinum toxin E (rBoNT-E): Results of a phase 1 study in healthy male subjects compared with abobotulinumtoxinA (Dysport®)

Pons

Vilain

Volteau

et al. 2019

Journal of the Neurological Sciences

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“…The neuromuscular blocker botulinum toxin has a wide variety of medical applications and off-label use in urology, including detrusor external sphincter dyssynergia and pelvic pain syndromes [43, 44]. It was used by one gynecology clinic in 2018.…”

Section: Discussionmentioning

confidence: 99%

Treatment of Urethral Pain Syndrome (UPS) in Sweden

et al. 2019

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BackgroundUrethral Pain Syndrome (UPS) in women is a recurrent urethral pain without any proven infection or other obvious pathology. There are few studies on UPS, and evidence-based treatment is lacking. The primary aim was to study what treatments are used, and to compare the treatment tradition of UPS in Sweden in 2018, with what was used in 2006.MethodsA questionnaire on the treatment of women with UPS was sent to all public gynecology, urology, gynecologic oncology and venereology clinics, and one public general practice in each county in Sweden in 2018. Private practice clinics in gynecology responded to the survey in 2017. Comparisons were made with the same survey sent to gynecology and urology clinics in 2006.FindingsOf 137 invited clinics in 2018, 99 (72.3%) responded to the survey. Seventy-seven (77.8%) of them saw women with UPS and 79.2% (61/77) of these clinics treated the patients using 19 different treatment methods. Local corticosteroids and local estrogens were the methods most used. Treatments were similar in gynecology and urology clinics in 2006 and 2018, although strong corticosteroids had increased in use in the treatment regimens of 2018. More than half of the clinics used antibiotics.InterpretationSince there is no evidence-based treatment of UPS, a wide spectrum of treatments is used, and different specialties use different treatment strategies. Despite the lack of proven infection, a large number of clinics also treated the syndrome with antibiotics. There is thus a need for well-designed randomized controlled clinical trials to find evidence-based treatments of UPS.

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“…BoNTA has been found to be a safe and effective treatment for urological indications such as neurogenic detrusor overactivity and overactive bladder refractory to drug therapy. It has also been used off‐label for detrusor‐external sphincter dyssynergia and painful bladder syndrome/interstitial cystitis …”

Section: Outcome Of Botulinum Neurotoxin a Injections In Patients Witmentioning

confidence: 99%

Botulinum neurotoxin A is an effective treatment for irritant dermatitis caused by ostomy leaks in patients with retractile stomas

2019

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Urologic applications of botulinum toxin

Cited by 9 publications

References 38 publications

Safety and pharmacodynamics of a novel recombinant botulinum toxin E (rBoNT-E): Results of a phase 1 study in healthy male subjects compared with abobotulinumtoxinA (Dysport®)

Safety and pharmacodynamics of a novel recombinant botulinum toxin E (rBoNT-E): Results of a phase 1 study in healthy male subjects compared with abobotulinumtoxinA (Dysport®)

Treatment of Urethral Pain Syndrome (UPS) in Sweden

Botulinum neurotoxin A is an effective treatment for irritant dermatitis caused by ostomy leaks in patients with retractile stomas

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