BACKGROUND: This randomized phase 3 study with double-blind main period (MP) and open-label extension (OLEX; NCT02002884) assessed incobotulinumtoxinA safety and efficacy for pediatric upper-limb spasticity treatment in ambulant/nonambulant (Gross Motor Function Classification System [GMFCS] I-V) patients, with the option of combined upper- and lower-limb treatment. METHODS: Patients were aged two to 17 years with unilateral or bilateral spastic cerebral palsy (CP) and Ashworth Scale (AS) score ≥2 in treatment-selected clinical patterns. In the MP, patients were randomized (2:1:1) to incobotulinumtoxinA 8, 6, or 2 U/kg body weight (maximum 200, 150, 50 U/upper limb), with optional lower-limb injections in one of five topographical distributions (total body dose ≤16 to 20 U/kg, maximum 400 to 500 U, depending on body weight and GMFCS level). In the OLEX, patients received three further treatment cycles, at the highest MP doses (8 U/kg/upper limb group). Outcomes included AS, Global Impression of Change Scale (GICS), and adverse events (AEs). RESULTS: AS scores improved from baseline to week 4 in all MP dose groups (n = 350); patients in the incobotulinumtoxinA 8 U/kg group had significantly greater spasticity improvements versus the 2 U/kg group (least-squares mean [standard error] for upper-limb main clinical target pattern -1.15 [0.06] versus -0.93 [0.08]; P = 0.017). Investigator's, child/adolescent's, and parent/caregiver's GICS scores showed improvements in all groups. Treatment benefits were sustained over further treatment cycles. AE incidence did not increase with dose or repeated treatment across GMFCS levels. CONCLUSIONS: Data provide evidence for sustained efficacy and safety of multipattern incobotulinumtoxinA treatment in children and adolescents with upper-limb spasticity.

• Klíčová slova
• Botulinum neurotoxin A, Cerebral palsy, IncobotulinumtoxinA, Multipattern treatment, Pediatric, Spasticity,
• MeSH
• botulotoxiny typ A aplikace a dávkování   škodlivé účinky   farmakologie   MeSH
• dítě MeSH
• dvojitá slepá metoda MeSH
• hodnocení výsledků zdravotní péče MeSH
• horní končetina patofyziologie   MeSH
• lidé MeSH
• mladiství MeSH
• mozková obrna komplikace   farmakoterapie   MeSH
• nervosvalové látky aplikace a dávkování   škodlivé účinky   farmakologie   MeSH
• předškolní dítě MeSH
• svalová spasticita farmakoterapie   etiologie   patofyziologie   MeSH
• Check Tag
• dítě MeSH
• lidé MeSH
• mladiství MeSH
• mužské pohlaví MeSH
• předškolní dítě MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• klinické zkoušky, fáze III MeSH
• práce podpořená grantem MeSH
• randomizované kontrolované studie MeSH
• Názvy látek
• botulotoxiny typ A MeSH
• incobotulinumtoxinA MeSH Prohlížeč
• nervosvalové látky MeSH

In dystonic and spastic movement disorders, abnormalities of motor control and somatosensory processing as well as cortical modulations associated with clinical improvement after botulinum toxin A (BoNT-A) treatment have been reported, but electrophysiological evidence remains controversial. In the present observational study, we aimed to uncover central correlates of post-stroke spasticity (PSS) and BoNT-A-related changes in the sensorimotor cortex by investigating the cortical components of somatosensory evoked potentials (SEPs). Thirty-one chronic stroke patients with PSS of the upper limb were treated with BoNT-A application into the affected muscles and physiotherapy. Clinical and electrophysiological evaluations were performed just before BoNT-A application (W0), then 4 weeks (W4) and 11 weeks (W11) later. PSS was evaluated with the modified Ashworth scale (MAS). Median nerve SEPs were examined in both upper limbs with subsequent statistical analysis of the peak-to-peak amplitudes of precentral P22/N30 and postcentral N20/P23 components. At baseline (W0), postcentral SEPs were significantly lower over the affected cortex. At follow up, cortical SEPs did not show any significant changes attributable to BoNT-A and/or physiotherapy, despite clear clinical improvement. Our results imply that conventional SEPs are of limited value in evaluating cortical changes after BoNT-A treatment and further studies are needed to elucidate its central actions.

• MeSH
• botulotoxiny typ A aplikace a dávkování   MeSH
• cévní mozková příhoda komplikace   patofyziologie   MeSH
• dospělí MeSH
• horní končetina inervace   MeSH
• lidé středního věku MeSH
• lidé MeSH
• mladý dospělý MeSH
• následné studie MeSH
• nervosvalové látky aplikace a dávkování   MeSH
• nervus medianus účinky léků   patofyziologie   MeSH
• rehabilitace po cévní mozkové příhodě metody   MeSH
• senioři MeSH
• somatosenzorické evokované potenciály účinky léků   MeSH
• somatosenzorické korové centrum účinky léků   patofyziologie   MeSH
• svalová spasticita diagnóza   farmakoterapie   etiologie   patofyziologie   MeSH
• terapie cvičením metody   MeSH
• výsledek terapie MeSH
• Check Tag
• dospělí MeSH
• lidé středního věku MeSH
• lidé MeSH
• mladý dospělý MeSH
• mužské pohlaví MeSH
• senioři MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• pozorovací studie MeSH
• Názvy látek
• botulotoxiny typ A MeSH
• nervosvalové látky MeSH

In cervical dystonia, functional MRI (fMRI) evidence indicates changes in several resting state networks, which revert in part following the botulinum neurotoxin A (BoNT) therapy. Recently, the involvement of the cerebellum in dystonia has gained attention. The aim of our study was to compare connectivity between cerebellar subdivisions and the rest of the brain before and after BoNT treatment. Seventeen patients with cervical dystonia indicated for treatment with BoNT were enrolled (14 female, aged 50.2 ± 8.5 years, range 38-63 years). Clinical and fMRI examinations were carried out before and 4 weeks after BoNT injection. Clinical severity was evaluated using TWSTRS. Functional MRI data were acquired on a 1.5 T scanner during 8 min rest. Seed-based functional connectivity analysis was performed using data extracted from atlas-defined cerebellar areas in both datasets. Clinical scores demonstrated satisfactory BoNT effect. After treatment, connectivity decreased between the vermis lobule VIIIa and the left dorsal mesial frontal cortex. Positive correlations between the connectivity differences and the clinical improvement were detected for the right lobule VI, right crus II, vermis VIIIb and the right lobule IX. Our data provide evidence for modulation of cerebello-cortical connectivity resulting from successful treatment by botulinum neurotoxin.

• MeSH
• botulotoxiny typ A aplikace a dávkování   MeSH
• dospělí MeSH
• injekce do léze MeSH
• kognice fyziologie   MeSH
• lidé středního věku MeSH
• lidé MeSH
• magnetická rezonanční tomografie MeSH
• mozeček patofyziologie   MeSH
• mozková kůra patofyziologie   MeSH
• odpočinek fyziologie   MeSH
• stupeň závažnosti nemoci MeSH
• tortikolis diagnostické zobrazování   farmakoterapie   patofyziologie   psychologie   MeSH
• výsledek terapie MeSH
• Check Tag
• dospělí MeSH
• lidé středního věku MeSH
• lidé MeSH
• mužské pohlaví MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• práce podpořená grantem MeSH
• Názvy látek
• botulotoxiny typ A MeSH

BACKGROUND: Although the short- and long-term effectiveness of abobotulinumtoxinA (Dysport®/Azzalure®) for glabellar line (GL) treatment is well established, reporting of subject satisfaction over repeat treatment cycles is limited. The APPEAL study aimed to assess subject satisfaction with long-term GL treatment with abobotulinumtoxinA in a real-life setting. METHODS: APPEAL was a noninterventional, prospective, longitudinal study in subjects administered ≥ 3 abobotulinumtoxinA injection cycles for moderate-to-severe GL, according to routine clinical practice. Subjects completed a satisfaction questionnaire at 3 weeks (± 7 days) after each cycle. Primary endpoint included subjects' overall satisfaction with GL after three injection cycles. Secondary endpoints included satisfaction after Cycles 1 and 2 and factors associated with satisfaction after each cycle. Physician satisfaction was also assessed after Cycles 1 and 3. RESULTS: Of 150 subjects enrolled, 135 completed the overall subject satisfaction questionnaire after Cycle 3. At 3 weeks after Cycle 3, 99.3% of subjects were 'very satisfied' (74.1%) or 'satisfied' (25.2%) with GL. Levels of subject satisfaction and associated factors after Cycles 1 and 2 were as large and significant as after Cycle 3 (83-100%, depending on question). Physicians' satisfaction with GL appearance, facial expression, and overall satisfaction was almost complete after the first injection (≥ 97.4%) and unanimous after the third (100%). CONCLUSIONS: In the APPEAL study, overall satisfaction was high after three abobotulinumtoxinA injection cycles for GL based on both subjects' (99.3%) and physicians' (100.0%) assessments. High levels of subject satisfaction reported after Cycle 1 were maintained with repeated injections. No new safety signals were observed. LEVEL OF EVIDENCE IV: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 . Trial registration NCT02353897.

• Klíčová slova
• AbobotulinumtoxinA, Dysport®, Glabellar lines, Physician satisfaction, Subject satisfaction,
• MeSH
• botulotoxiny typ A aplikace a dávkování   MeSH
• čelo MeSH
• dospělí MeSH
• estetika MeSH
• injekce subkutánní MeSH
• lékaři * MeSH
• lidé středního věku MeSH
• lidé MeSH
• longitudinální studie MeSH
• mladý dospělý MeSH
• omlazení fyziologie   MeSH
• osobní uspokojení MeSH
• prognóza MeSH
• prospektivní studie MeSH
• průzkumy a dotazníky MeSH
• rozvrh dávkování léků MeSH
• spokojenost pacientů statistika a číselné údaje   MeSH
• stárnutí kůže MeSH
• výsledek terapie MeSH
• Check Tag
• dospělí MeSH
• lidé středního věku MeSH
• lidé MeSH
• mladý dospělý MeSH
• mužské pohlaví MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• hodnotící studie MeSH
• Názvy látek
• abobotulinumtoxinA MeSH Prohlížeč
• botulotoxiny typ A MeSH

BACKGROUND: AbobotulinumtoxinA has beneficial effects on spasticity and active movements in hemiparetic adults with upper limb spasticity (ULS). However, evidence-based information on optimal dosing for clinical use is limited. OBJECTIVE: To describe joint-specific dose effects of abobotulinumtoxinA in adults with ULS. DESIGN: Secondary analysis of a phase 3 study (NCT01313299). SETTING: Multicenter, international, double-blind, placebo-controlled clinical trial. PARTICIPANTS: A total of 243 adults with ULS >6 months after stroke or traumatic brain injury, aged 52.8 (13.5) years and 64.3% male, randomized 1:1:1 to receive a single-injection cycle of placebo or abobotulinumtoxinA 500 U or 1000 U (total dose). METHODS: The overall effects of injected doses were assessed in the primary analysis, which showed improvement of angles of catch in finger, wrist, and elbow flexors and of active range of motion against these muscle groups. This secondary analysis was performed at each of the possible doses received by finger, wrist, and elbow flexors to establish possible dose effects. MAIN OUTCOME MEASURES: Angle of arrest (XV1) and angle of catch (XV3) were assessed with the Tardieu Scale, and active range of motion (XA). RESULTS: At each muscle group level (finger, wrist, and elbow flexors) improvements in all outcome measures assessed (XV1, XV3, XA) were observed. In each muscle group, increases in abobotulinumtoxinA dose were associated with greater improvements in XV3 and XA, suggesting a dose-dependent effect. CONCLUSIONS: Previous clinical trials have established the clinical efficacy of abobotulinumtoxinA by total dose only. The wide range of abobotulinumtoxinA doses per muscle groups used in this study allowed observation of dose-dependent improvements in spasticity and active movement. This information provides a basis for future abobotulinumtoxinA dosing recommendations for health care professionals based on treatment objectives and quantitative assessment of spasticity and active range of motion at individual joints. LEVEL OF EVIDENCE: I.

• MeSH
• botulotoxiny typ A aplikace a dávkování   MeSH
• časové faktory MeSH
• dospělí MeSH
• dvojitá slepá metoda MeSH
• horní končetina patofyziologie   MeSH
• inhibitory uvolňování acetylcholinu aplikace a dávkování   MeSH
• injekce intramuskulární MeSH
• kosterní svaly patofyziologie   MeSH
• lidé středního věku MeSH
• lidé MeSH
• mladiství MeSH
• mladý dospělý MeSH
• následné studie MeSH
• pohyb fyziologie   MeSH
• senioři nad 80 let MeSH
• senioři MeSH
• svalová spasticita farmakoterapie   patofyziologie   MeSH
• výsledek terapie MeSH
• vztah mezi dávkou a účinkem léčiva MeSH
• Check Tag
• dospělí MeSH
• lidé středního věku MeSH
• lidé MeSH
• mladiství MeSH
• mladý dospělý MeSH
• mužské pohlaví MeSH
• senioři nad 80 let MeSH
• senioři MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• klinické zkoušky, fáze III MeSH
• multicentrická studie MeSH
• práce podpořená grantem MeSH
• randomizované kontrolované studie MeSH
• Názvy látek
• abobotulinumtoxinA MeSH Prohlížeč
• botulotoxiny typ A MeSH
• inhibitory uvolňování acetylcholinu MeSH

BACKGROUND: Approved botulinum toxin A products require reconstitution. AbobotulinumtoxinA solution for injection is a ready-to-use liquid formulation of abobotulinumtoxinA. OBJECTIVES: The objective of this study was to demonstrate the superior efficacy of abobotulinumtoxinA solution for injection to placebo and to test the noninferior efficacy of abobotulinumtoxinA solution for injection versus abobotulinumtoxinA (dry formulation) in cervical dystonia. METHODS: This was a phase-3, multicenter, prospective, double-blind, randomized, active, and placebo-controlled study (N = 369). Patients with cervical dystonia were randomized (3:3:1) to abobotulinumtoxinA solution for injection 500 U, abobotulinumtoxinA 500 U, or placebo. Following the double-blind phase, patients received abobotulinumtoxinA solution for injection, open-label, for up to 4 cycles. The primary outcome was change from baseline at week 4 of the Toronto Western Spasmodic Torticollis Rating Scale total score. Secondary measures included change from baseline or cycle baseline in Toronto Western Spasmodic Torticollis Rating Scale scores. RESULTS: At week 4, both products were superior to placebo (Toronto Western Spasmodic Torticollis Rating Scale total score least square mean decrease from baseline, abobotulinumtoxinA solution for injection 500 U -12.5, abobotulinumtoxinA 500 U -14.0, placebo -3.9; P < .0001 vs placebo). The noninferiority limit of 3 points in the Toronto Western Spasmodic Torticollis Rating Scale total score at week 4 was not met for abobotulinumtoxinA solution for injection versus abobotulinumtoxinA. Toronto Western Spasmodic Torticollis Rating Scale total score reductions were maintained for up to 4 cycles of abobotulinumtoxinA solution for injection open-label follow-up treatment. Safety profiles of abobotulinumtoxinA solution for injection and abobotulinumtoxinA were similar, with dysphagia and injection-site pain the most frequent drug-related adverse events. CONCLUSIONS: Although the predefined noninferiority criterion was not met, abobotulinumtoxinA solution for injection was similarly effective to freeze-dried abobotulinumtoxinA in reducing Toronto Western Spasmodic Torticollis Rating Scale total scores with a similar safety profile. AbobotulinumtoxinA solution for injection efficacy was maintained with chronic open-label treatment, and this novel formulation may add convenience as well as dosing accuracy to treatment with abobotulinumtoxinA. © 2016 International Parkinson and Movement Disorder Society.

• Klíčová slova
• Toronto Western Spasmodic Torticollis Rating Scale, abobotulinumtoxinA solution for injection, cervical dystonia,
• MeSH
• botulotoxiny typ A aplikace a dávkování   škodlivé účinky   farmakologie   MeSH
• dospělí MeSH
• dvojitá slepá metoda MeSH
• hodnocení výsledků zdravotní péče metody   MeSH
• inhibitory uvolňování acetylcholinu aplikace a dávkování   škodlivé účinky   farmakologie   MeSH
• lidé středního věku MeSH
• lidé MeSH
• prospektivní studie MeSH
• stupeň závažnosti nemoci MeSH
• tortikolis farmakoterapie   MeSH
• Check Tag
• dospělí MeSH
• lidé středního věku MeSH
• lidé MeSH
• mužské pohlaví MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• klinické zkoušky, fáze III MeSH
• multicentrická studie MeSH
• randomizované kontrolované studie MeSH
• srovnávací studie MeSH
• Názvy látek
• abobotulinumtoxinA MeSH Prohlížeč
• botulotoxiny typ A MeSH
• inhibitory uvolňování acetylcholinu MeSH

OBJECTIVE: It was hypothesized that increasing the time for which onabotulinum toxin A (OnabotA) is exposed to the urothelium following intravesical instillation will augment its effect. TC-3 is an inert heat-sensitive hydrogel, which creates an intravesical bulk providing a slow release of the embedded drug after instillation. The aim of this study was to evaluate the effect of OnabotA, embedded in inert TC-3 hydrogel, in patients with idiopathic overactive bladder (OAB). METHODS: In total, 39 female patients (age 30-65, average 53.8 years) with OAB symptoms were randomized for the study into four groups, each receiving 50 ml of the following intravesical instillations: Group A, 0.9% NaCl (placebo, n = 11); Group B, TC-3 gel + 200 U OnabotA (n = 9); Group C, TC-3 gel + 200 U OnabotA + dimethyl sulfoxide (DMSO) (n = 10); and Group D, DMSO (n = 9). The parameters were compared before and 1 month after treatment. RESULTS: When comparing parameters using conventional statistical methods (Kruskal-Wallis test), no statistically significant changes were observed within the groups. Comparison of the medians using an analysis based on the mathematical gnostics showed the superiority of the method used in Group B over the other groups in the following parameters: number of urgency grade 3 + 4 episodes/72 h, number of leakage episodes/72 h, Overactive Bladder Questionnaire total score and Patient Perception of Bladder Condition total score. Group D showed its superiority over the other groups in respect to the number of nocturia episodes/72 h. CONCLUSIONS: The results indicate that intravesical instillation of OnabotA, embedded in TC-3 gel, could become an alternative to intramural injection for a well-selected subgroup of patients.

• Klíčová slova
• Intravesical instillation, TC-3 hydrogel, onabotulinum A, overactive bladder, urothelium,
• MeSH
• aplikace intravezikální MeSH
• botulotoxiny typ A aplikace a dávkování   MeSH
• dospělí MeSH
• dvojitá slepá metoda MeSH
• hyperaktivní močový měchýř farmakoterapie   MeSH
• inhibitory uvolňování acetylcholinu aplikace a dávkování   MeSH
• lidé středního věku MeSH
• lidé MeSH
• nosiče léků MeSH
• PEG-DMA hydrogel MeSH
• pilotní projekty MeSH
• prospektivní studie MeSH
• senioři MeSH
• Check Tag
• dospělí MeSH
• lidé středního věku MeSH
• lidé MeSH
• senioři MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• randomizované kontrolované studie MeSH
• srovnávací studie MeSH
• Názvy látek
• botulotoxiny typ A MeSH
• inhibitory uvolňování acetylcholinu MeSH
• nosiče léků MeSH
• PEG-DMA hydrogel MeSH

BACKGROUND: Resistance from antagonistic muscle groups might be a crucial factor reducing function in chronic hemiparesis. The resistance due to spastic co-contraction might be reduced by botulinum toxin injections. We assessed the effects of abobotulinumtoxinA injection in the upper limb muscles on muscle tone, spasticity, active movement, and function. METHODS: In this randomised, placebo-controlled, double-blind study, we enrolled adults (aged 18-80 years) at least 6 months after stroke or brain trauma from 34 neurology or rehabilitation clinics in Europe and the USA. Eligible participants were randomly allocated in a 1:1:1 ratio with a computer-generated list to receive a single injection session of abobotulinumtoxinA 500 U or 1000 U or placebo into the most hypertonic muscle group among the elbow, wrist, or finger flexors (primary target muscle group [PTMG]), and into at least two additional muscle groups from the elbow, wrist, or finger flexors or shoulder extensors. Patients and investigators were masked to treatment allocation. The primary endpoint was the change in muscle tone (Modified Ashworth Scale [MAS]) in the PTMG from baseline to 4 weeks. Secondary endpoints were Physician Global Assessment (PGA) at week 4 and change from baseline to 4 weeks in the perceived function (Disability Assessment Scale [DAS]) in the principal target of treatment, selected by the patient together with physician from four functional domains (dressing, hygiene, limb position, and pain). Analysis was by intention to treat. This study is registered with ClinicalTrials.gov, number NCT01313299. FINDINGS: 243 patients were randomly allocated to placebo (n=81), abobotulinumtoxinA 500 U (n=81), or abobotulinumtoxinA 1000 U (n=81). Mean change in MAS score from baseline at week 4 in the PTMG was -0·3 (SD 0·6) in the placebo group (n=79), -1·2 (1·0) in the abobotulinumtoxinA 500 U group (n=80; difference -0·9, 95% CI -1·2 to -0·6; p<0·0001 vs placebo), and -1·4 (1·1) in the abobotulinumtoxinA 1000 U group (n=79; -1·1, -1·4 to -0·8; p<0·0001 vs placebo). Mean PGA score at week 4 was 0·6 (SD 1·0) in the placebo group (n=78), 1·4 (1·1) in the abobotulinumtoxinA 500 U group (n=80; p=0·0003 vs placebo), and 1·8 (1·1) in the abobotulinumtoxinA 1000 U group (n=78; p<0·0001 vs placebo). Mean change from baseline at week 4 in DAS score for the principal target of treatment was -0·5 (0·7) in the placebo group (n=79), -0·7 (0·8) in the abobotulinumtoxinA 500 U group (n=80; p=0·2560 vs placebo), and -0·7 (0·7) in the abobotulinumtoxinA 1000 U group (n=78; p=0·0772 vs placebo). Three serious adverse events occurred in each group and none were treatment related; two resulted in death (from pulmonary oedema in the placebo group and a pre-existing unspecified cardiovascular disorder in the abobotulinumtoxinA 500 U group). Adverse events that were thought to be treatment related occurred in two (2%), six (7%), and seven (9%) patients in the placebo, abobotulinumtoxinA 500 U, and abobotulinumtoxinA 1000 U groups, respectively. The most common treatment-related adverse event was mild muscle weakness. All adverse events were mild or moderate. INTERPRETATION: AbobotulinumtoxinA at doses of 500 U or 1000 U injected into upper limb muscles provided tone reduction and clinical benefit in hemiparesis. Future research into the treatment of spastic paresis with botulinum toxin should use active movement and function as primary outcome measures. FUNDING: Ipsen.

• MeSH
• botulotoxiny typ A aplikace a dávkování   škodlivé účinky   farmakologie   MeSH
• cévní mozková příhoda komplikace   MeSH
• dospělí MeSH
• dvojitá slepá metoda MeSH
• horní končetina patofyziologie   MeSH
• inhibitory uvolňování acetylcholinu aplikace a dávkování   škodlivé účinky   farmakologie   MeSH
• injekce intramuskulární MeSH
• lidé středního věku MeSH
• lidé MeSH
• paréza farmakoterapie   etiologie   MeSH
• poranění mozku komplikace   MeSH
• svalová spasticita farmakoterapie   etiologie   MeSH
• výsledek terapie MeSH
• Check Tag
• dospělí MeSH
• lidé středního věku MeSH
• lidé MeSH
• mužské pohlaví MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• multicentrická studie MeSH
• práce podpořená grantem MeSH
• randomizované kontrolované studie MeSH
• Názvy látek
• abobotulinumtoxinA MeSH Prohlížeč
• botulotoxiny typ A MeSH
• inhibitory uvolňování acetylcholinu MeSH

INTRODUCTION: Apart from the standard intramural administration of botulinum neurotoxin A (BoNT/A) to the detrusor, intense research is taking place into new means of administration in view of the complex mechanism of action of BoNT/A. METHODS: An open, randomised, prospective study was performed on a total of 23 patients with neurogenic detrusor overactivity. Following randomisation, patients were treated with 300 U of onabotulinumtoxinA (onaBoNT/A) in either the submucosa or the detrusor. Urodynamic examinations were carried out, and a bladder diary was kept both prior to and 12 weeks after the treatment. All patients stopped taking anticholinergics 1 week prior to the treatment. RESULTS: In both the submucosa and detrusor groups, we recorded a significant improvement in the monitored urodynamic parameters and significant decreases in the frequency of urinary incontinence episodes following the treatment. A comparison of the two groups showed no significant difference between the two forms of application, with the exception of voided volume (p = 0.007). CONCLUSION: A comparison of the two administration methods did not show any significant difference between onaBoNT/A administration to the submucosa and to the detrusor. Thus, the submucosal injection of onaBoNT/A represents an equally effective approach for its administration to patients.

• MeSH
• botulotoxiny typ A aplikace a dávkování   MeSH
• dospělí MeSH
• endoskopie MeSH
• hladké svalstvo účinky léků   MeSH
• injekce intramuskulární MeSH
• inkontinence moči terapie   MeSH
• kvalita života MeSH
• lidé středního věku MeSH
• lidé MeSH
• mladý dospělý MeSH
• močový měchýř účinky léků   MeSH
• neurogenní močový měchýř farmakoterapie   MeSH
• pilotní projekty MeSH
• poranění míchy prevence a kontrola   MeSH
• prospektivní studie MeSH
• sliznice účinky léků   MeSH
• urodynamika MeSH
• výsledek terapie MeSH
• Check Tag
• dospělí MeSH
• lidé středního věku MeSH
• lidé MeSH
• mladý dospělý MeSH
• mužské pohlaví MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• práce podpořená grantem MeSH
• randomizované kontrolované studie MeSH
• srovnávací studie MeSH
• Názvy látek
• botulotoxiny typ A MeSH

STUDY DESIGN: This was a multicentre, prospective, randomised study. OBJECTIVES: To compare the outcomes of intradetrusor and suburothelial onabotulinumtoxinA injections in patients with spinal cord injury and refractory neurogenic detrusor overactivity (NDO). SETTING: Urology departments of two tertiary hospitals in the Czech Republic. METHODS: A total of 32 spinal cord injury patients with severe NDO refractory to the standard anticholinergic treatment were randomised to receive either intradetrusor or suburothelial 300 IU onabotulinumtoxinA injections. Subjective satisfaction, bladder diary data and urodynamic data were compared in both groups before treatment and at 3 months post treatment. RESULTS: In all, 64.3% patients in the intradetrusor group and 88.8% patients in the suburothelial group were subjectively satisfied with the treatment. There was a significant post-treatment improvement in both groups regarding the number of catheterisations over 24 h, number of incontinence episodes over 24 h, catheterised volume, cystometric capacity, volume at first involuntary detrusor contraction, maximal detrusor pressure during filling and detrusor compliance. No significant differences between the groups were observed, with the exception of improvement of detrusor compliance, which was better in the intradetrusor group. There was one adverse effect comprising transient muscle weakness that was reported by one patient in the intradetrusor group. CONCLUSION: Results in both groups were comparable. The authors favour suburothelial onabotulinumtoxinA injection because this method allows more precise toxin localisation.

• MeSH
• botulotoxiny typ A aplikace a dávkování   škodlivé účinky   terapeutické užití   MeSH
• dospělí MeSH
• injekce MeSH
• inkontinence moči farmakoterapie   MeSH
• lidé středního věku MeSH
• lidé MeSH
• mladý dospělý MeSH
• močový měchýř MeSH
• nervosvalové látky aplikace a dávkování   škodlivé účinky   terapeutické užití   MeSH
• neurogenní močový měchýř farmakoterapie   etiologie   MeSH
• pilotní projekty MeSH
• poranění míchy komplikace   MeSH
• prospektivní studie MeSH
• spokojenost pacientů MeSH
• urodynamika fyziologie   MeSH
• urotel MeSH
• Check Tag
• dospělí MeSH
• lidé středního věku MeSH
• lidé MeSH
• mladý dospělý MeSH
• mužské pohlaví MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• multicentrická studie MeSH
• randomizované kontrolované studie MeSH
• srovnávací studie MeSH
• Názvy látek
• botulotoxiny typ A MeSH
• nervosvalové látky MeSH