Efficacy and Tolerability of Botulinum Toxin Type A in Patients with Neurogenic Detrusor Overactivity and Without Concomitant Anticholinergic Therapy: Comparison of Two Doses

Grise, P.; Ruffion, A.; Denys, Pierre; Egon, G.; Kastler, E. Chartier

doi:10.1016/j.eururo.2010.06.035

Cited by 47 publications

(35 citation statements)

References 22 publications

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“…No neutralizing antibodies were detected after 12 weeks of treatment in 180 patients receiving either 200 or 300 U of onabotulinumtoxinA in a pivotal Phase III trial in this condition (Cruz et al 2011). Antigenicity rates have not been reported in the trials of abobotulinumtoxinA for the treatment of urinary incontinence that have been conducted to date (Ehren et al 2007; Grise et al 2010; Grosse et al 2009); incobotulinumtoxinA and rimabotulinumtoxinB have not been studied for this indication.…”

Section: Urinary Incontinence Due To Neurogenic Detrusor Overactivitymentioning

confidence: 99%

Immunogenicity of botulinum toxins

et al. 2012

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Botulinum neurotoxins are formulated biologic pharmaceuticals used therapeutically to treat a wide variety of chronic conditions, with varying governmental approvals by country. Some of these disorders include cervical dystonia, post-stroke spasticity, blepharospasm, migraine, and hyperhidrosis. Botulinum neurotoxins also have varying governmental approvals for cosmetic applications. As botulinum neurotoxin therapy is often continued over many years, some patients may develop detectable antibodies that may or may not affect their biological activity. Although botulinum neurotoxins are considered “lower risk” biologics since antibodies that may develop are not likely to cross react with endogenous proteins, it is possible that patients may lose their therapeutic response. Various factors impact the immunogenicity of botulinum neurotoxins, including product-related factors such as the manufacturing process, the antigenic protein load, and the presence of accessory proteins, as well as treatment-related factors such as the overall toxin dose, booster injections, and prior vaccination or exposure. Detection of antibodies by laboratory tests does not necessarily predict the clinical success or failure of treatment. Overall, botulinum neurotoxin type A products exhibit low clinically detectable levels of antibodies when compared with other approved biologic products. This review provides an overview of all current botulinum neurotoxin products available commercially, with respect to the development of neutralizing antibodies and clinical response.

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Section: Urinary Incontinence Due To Neurogenic Detrusor Overactivitymentioning

confidence: 99%

Immunogenicity of botulinum toxins

et al. 2012

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“…Most trials reporting ABO injections in neurogenic OAB have considered 500 U as the starting dose . Grosse et al have found no clear dose‐related effect for 500, 750, and 1000 U of ABO; Ghalayini et al have shown equivalent results in terms of duration and efficacy with repeated injections of 500 and 1000 U of ABO; Grise et al have compared 500 and 750 U of ABO in 77 patients with NDO and both doses seem to be effective and well tolerated as monotherapy . Better results using higher doses of ABO were observed.…”

Section: Discussionmentioning

confidence: 99%

“…In urology, onabotulinumtoxinA and abobotulinumtoxinA are the two most commonly used formulations, the first one being the only licensed one in the USA and Europe for NDO and IDO management . However, randomized clinical trials support the use of ABO for NDO, and small uncontrolled studies have reported its use in IDO/OAB …”

Section: Introductionmentioning

confidence: 99%

A prospective randomized clinical trial comparing two doses of AbobotulinumtoxinA for idiopathic overactive bladder

Bezerra

Toledo

Carramão

et al. 2018

Neurourology and Urodynamics

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Aims To compare 300 U versus 500 U of abobotulinumtoxinA (ABO) intravesical injections for the treatment of idiopathic overactive bladder (OAB) refractory to first and second‐line treatments. Methods A prospective, randomized, single blind study was performed in female patients with symptoms of OAB, who had failed conservative treatment. Patients were treated with 300 or 500 U of ABO injected into 30 sites, avoiding the trigone. All treatments were evaluated by voiding diary, ICIQ‐OAB questionnaire, urodynamic test, visual analogue scale (VAS) for treatment satisfaction and patient global impression of improvement (PGI‐I). The primary outcome was change in maximum cistometric capacity (MCC). Secondary outcome included changes in urgency, complete continence, subjective success (VAS and PGI‐I), and adverse events (urinary retention, UTI, and CIC). Results Twenty‐one patients were included. MCC has increased from 185.0 to 270.9 mL (300 U) and from 240.8 to 311.7 mL (500 U), comparing the baseline with 12 weeks, without statistical difference between the groups (P = 0.270). At 12 weeks, 91% of patients were dry in both groups. At 24 weeks, episodes of incontinence had returned in 50% (300 U) and 0% (500 U) (P = 0.013). Patients were better or much better (PGI‐I) in70% (300 U) and 88.9% (500 U) at 12 w; and 50% (300 U) and 100% (500 U), at 24 w (P = 0.027). The peak of PVR was at 4 w, being 71.7 mL (300 U) and 96.5 mL (500 U). General UTI incidence was 35.7%. One patient (500 U) required CIC for 2 weeks. Conclusions Intravesical ABO injection at 500 U improves symptoms and quality of life for longer period of time than 300 U for idiopathic OAB.

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“…These patients frequently struggle with urinary incontinence that may severely affect their QoL [2]. Spinal cord injury (SCI), one of the most frequent causes of neurogenic detrusor dysfunction in young adults, is often associated with neurogenic detrusor overactivity (NDO).…”

Section: Introductionmentioning

confidence: 99%

Botulinum Toxin in Neurogenic Detrusor Overactivity

2012

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PurposeTo evaluate the effects of botulinum toxin on urodynamic parameters and quality of life in patients with neurogenic detrusor overactivity.MethodsThirty four adult patients with spinal cord injury and detrusor overactivity were selected. The patients received 300 units of botulinum toxin type A. The endpoints evaluated with the episodes of urinary incontinence and measured the maximum cystometric capacity, maximum amplitude of detrusor pressure and bladder compliance at the beginning and end of the study (24 weeks) and evaluated the quality of life by applying the Qualiveen questionnaire.ResultsA significant decrease in the episodes of urinary incontinence was observed. All urodynamic parameters presented a significant improvement. The same was observed in the quality of life index and the specific impact of urinary problems scores from the Qualiveen questionnaire. Six patients did not complete the study, two due to incomplete follow-up, and four violated protocol and were excluded from the analyses. No systemic adverse events of botulinum toxin type A were reported.ConclusionsA botulinum toxin type A showed a significantly improved response in urodynamics parameters and specific and general quality of life.

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Efficacy and Tolerability of Botulinum Toxin Type A in Patients with Neurogenic Detrusor Overactivity and Without Concomitant Anticholinergic Therapy: Comparison of Two Doses

Cited by 47 publications

References 22 publications

Immunogenicity of botulinum toxins

Immunogenicity of botulinum toxins

A prospective randomized clinical trial comparing two doses of AbobotulinumtoxinA for idiopathic overactive bladder

Botulinum Toxin in Neurogenic Detrusor Overactivity

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