Neurourology and Urodynamics 35:267–270 (2016)
Preliminary Results of Botulinum Toxin A Switch After First Detrusor Injection Failure as a Treatment of Neurogenic Detrusor Overactivity ,1 Evelyne Castel-Lacanal,2 Julien Guillotreau,1 Bernard Malavaud,1 Benoit Peyronnet,1 Mathieu Roumiguie 1* Philippe Marque,2 Pascal Rischmann,1 and Xavier Game 1
Departement d’Urologie, Transplantation Renale et Andrologie, CHU Rangueil, Toulouse, France 2 Service de Medecine Physique et Readaptation, CHU Rangueil, Toulouse, France
Aims: To assess the results of onabotulinum toxin detrusor injections when abobotulinum toxin detrusor injection failed. Methods: Twenty-six patients, 15 women and 11 men, mean age 40.8 12.7 years old, in whom a first injection of 750 U abobotulinum toxin in 20 sites failed in treating neurogenic detrusor overactivity, received onabotulinum toxin 300 U detrusor injections in 30 sites. Neurologic conditions were spinal cord injury in 14 cases, multiple sclerosis in nine, myelomeningocele in two and myelitis in one. Mean time between the two injections was 5.6 1.4 months. Before and 6 weeks after each injection, patients carried out a 3-day bladder diary and had urodynamics. The success was defined as the combination of a clean intermittent self-catheterization number under 8 per 24 hr, urgency, urinary incontinence and detrusor overactivity relief. Results: Out of 26 patients, the second injection was successful in 15 (57.7%). While the first injection of 750 U abobotulinum toxin had no impact at all, after 300 U onabotulinum toxin injection, the number of clean intermittent self-catheterization decreased significantly (11.3 2.1 vs. 6.4 1.9, P ¼ 0.01), 17/26 (65.4%) patients achieved continence, urgency was relieved in 18/26 (69.2%) and detrusor overactivity in 15/26 (57.7%). Conclusions: In case of failure after a first detrusor injection of abobotulinum toxin, switching for onabotulinum toxin is efficient. Further investigations should be performed to assess whether the replacement of onabotulinum toxin by abobotulinum toxin provides the same results. Neurourol. Urodynam. 35:267–270, 2016. # 2014 Wiley Periodicals, Inc. Key words: botulinum toxin; detrusor overactivity; neurogenic bladder; urinary incontinence INTRODUCTION
Detrusor injection of botulinum toxin is recommended as the second-line therapy in patients with neurogenic detrusor overactivity (NDO) when anticholinergic therapy is ineffective or poorly tolerated.1 Onabotulinumtoxin-A (BOTOX1, Allergan, Inc., Irvine, CA) is the only botulinum toxin that’s use is based on large multicenter randomized controlled trials2–5 and is therefore the only one to be licensed in the US and Europe for the management of NDO.6 However, the use of abobotulinumtoxin A (Dysport1, Ipsen Biopharmaceuticals, Inc., Basking Ridge, NJ) for NDO is also supported by high level of evidence studies7–10 and is used in several centers for detrusor injections. Failure of botulinum toxin detrusor injections has been reported in up to 32% of cases.10 Nevertheless, current guidelines do not address the issue of neurogenic patients who have failed a first detrusor injection of botulinum toxin for NDO.11,12 There is very little data on the management of these patients in the literature and bladder augmentation appears to be the only option universally approved to date.11,12 To our knowledge, no data has been published on the efficacy of a new detrusor injection using another botulinum toxin A in this situation. The aim of this study was to assess the results of onabotulinum toxin detrusor injections in case of abobotulinum toxin failure. POPULATION AND METHODS Population
A prospective nonrandomized open-labeled cohort singlecenter study was carried out in neurological patients in whom a #
2014 Wiley Periodicals, Inc.
single 750 U abobotulinum toxin intradetrusor injection in 20 sites failed to treat neurogenic detrusor overactivity, who received onabotulinum toxin injections. The study received approval by the local ethics committee. Patients were included between 2007 and 2011. During the study period, abobotulinum toxin was the only first-line botulinum toxin used to treat NDO in our department, and onabotulinum toxin was only given in the case of failure of the first injection. Onabotulinum toxin was administered at a dose of 300 U because the study took place until 2011 and prior to this date, due to the lack of high level of evidence studies, it was the dose typically used in our department as initially reported by Schurch et al.2 Failure after abobotulinum toxin injection was defined as the persistence of both urinary incontinence and detrusor overactivity 6 weeks after the injection. The inclusion criteria for patients were as follows: patients with NDO who failed to respond to oral antimuscarinics and to abobotulinum toxin intradetrusor injection, aged >18 years, able and willing to do clean intermittent self-catheterization (CISC) and a sterile urine culture 7 days before the injections. Patients were excluded if they were unable or unwilling to do CISC, were aged
Preliminary Results of Botulinum Toxin A Switch After First Detrusor Injection Failure as a Treatment of Neurogenic Detrusor Overactivity ,1 Evelyne Castel-Lacanal,2 Julien Guillotreau,1 Bernard Malavaud,1 Benoit Peyronnet,1 Mathieu Roumiguie 1* Philippe Marque,2 Pascal Rischmann,1 and Xavier Game 1
Departement d’Urologie, Transplantation Renale et Andrologie, CHU Rangueil, Toulouse, France 2 Service de Medecine Physique et Readaptation, CHU Rangueil, Toulouse, France
Aims: To assess the results of onabotulinum toxin detrusor injections when abobotulinum toxin detrusor injection failed. Methods: Twenty-six patients, 15 women and 11 men, mean age 40.8 12.7 years old, in whom a first injection of 750 U abobotulinum toxin in 20 sites failed in treating neurogenic detrusor overactivity, received onabotulinum toxin 300 U detrusor injections in 30 sites. Neurologic conditions were spinal cord injury in 14 cases, multiple sclerosis in nine, myelomeningocele in two and myelitis in one. Mean time between the two injections was 5.6 1.4 months. Before and 6 weeks after each injection, patients carried out a 3-day bladder diary and had urodynamics. The success was defined as the combination of a clean intermittent self-catheterization number under 8 per 24 hr, urgency, urinary incontinence and detrusor overactivity relief. Results: Out of 26 patients, the second injection was successful in 15 (57.7%). While the first injection of 750 U abobotulinum toxin had no impact at all, after 300 U onabotulinum toxin injection, the number of clean intermittent self-catheterization decreased significantly (11.3 2.1 vs. 6.4 1.9, P ¼ 0.01), 17/26 (65.4%) patients achieved continence, urgency was relieved in 18/26 (69.2%) and detrusor overactivity in 15/26 (57.7%). Conclusions: In case of failure after a first detrusor injection of abobotulinum toxin, switching for onabotulinum toxin is efficient. Further investigations should be performed to assess whether the replacement of onabotulinum toxin by abobotulinum toxin provides the same results. Neurourol. Urodynam. 35:267–270, 2016. # 2014 Wiley Periodicals, Inc. Key words: botulinum toxin; detrusor overactivity; neurogenic bladder; urinary incontinence INTRODUCTION
Detrusor injection of botulinum toxin is recommended as the second-line therapy in patients with neurogenic detrusor overactivity (NDO) when anticholinergic therapy is ineffective or poorly tolerated.1 Onabotulinumtoxin-A (BOTOX1, Allergan, Inc., Irvine, CA) is the only botulinum toxin that’s use is based on large multicenter randomized controlled trials2–5 and is therefore the only one to be licensed in the US and Europe for the management of NDO.6 However, the use of abobotulinumtoxin A (Dysport1, Ipsen Biopharmaceuticals, Inc., Basking Ridge, NJ) for NDO is also supported by high level of evidence studies7–10 and is used in several centers for detrusor injections. Failure of botulinum toxin detrusor injections has been reported in up to 32% of cases.10 Nevertheless, current guidelines do not address the issue of neurogenic patients who have failed a first detrusor injection of botulinum toxin for NDO.11,12 There is very little data on the management of these patients in the literature and bladder augmentation appears to be the only option universally approved to date.11,12 To our knowledge, no data has been published on the efficacy of a new detrusor injection using another botulinum toxin A in this situation. The aim of this study was to assess the results of onabotulinum toxin detrusor injections in case of abobotulinum toxin failure. POPULATION AND METHODS Population
A prospective nonrandomized open-labeled cohort singlecenter study was carried out in neurological patients in whom a #
2014 Wiley Periodicals, Inc.
single 750 U abobotulinum toxin intradetrusor injection in 20 sites failed to treat neurogenic detrusor overactivity, who received onabotulinum toxin injections. The study received approval by the local ethics committee. Patients were included between 2007 and 2011. During the study period, abobotulinum toxin was the only first-line botulinum toxin used to treat NDO in our department, and onabotulinum toxin was only given in the case of failure of the first injection. Onabotulinum toxin was administered at a dose of 300 U because the study took place until 2011 and prior to this date, due to the lack of high level of evidence studies, it was the dose typically used in our department as initially reported by Schurch et al.2 Failure after abobotulinum toxin injection was defined as the persistence of both urinary incontinence and detrusor overactivity 6 weeks after the injection. The inclusion criteria for patients were as follows: patients with NDO who failed to respond to oral antimuscarinics and to abobotulinum toxin intradetrusor injection, aged >18 years, able and willing to do clean intermittent self-catheterization (CISC) and a sterile urine culture 7 days before the injections. Patients were excluded if they were unable or unwilling to do CISC, were aged
