Botulinum-A toxin detrusor and sphincter injection in treatment of overactive bladder syndrome: objective outcome and patient satisfaction. Preliminary results of a dose-finding study for botulinum toxin-A in patients with idiopathic overactive bladder: 100 versus 150 units. Botulinum toxin type a is a safe and effective treatment for neurogenic urinary incontinence: results of a single treatment, randomized, placebo controlled 6-month study. Patient-Reported Side Effects of Intradetrusor Botulinum Toxin Type A for Idiopathic Overactive Bladder Syndrome Botulinum toxin type A injections for treating neurogenic detrusor overactivity combined with low-compliance bladder in patients with spinal cord lesions. Botulinum A toxin injections into the detrusor: an effective treatment in idiopathic and neurogenic detrusor overactivity? Repeated botulinum toxin type A injections for refractory overactive bladder: medium-term outcomes, safety profile, and discontinuation rates. Refractory idiopathic urge urinary incontinence and botulinum A injection. Experience with 100 cases treated with botulinum-A toxin injections in the detrusor muscle for idiopathic overactive bladder syndrome refractory to anticholinergics. Outcome of a randomized, double-blind, placebo controlled trial of botulinum A toxin for refractory overactive bladder. Safety and tolerability of sedation-free flexible cystoscopy for intradetrusor botulinum toxin-A injection. Clinical effects of suburothelial injection of botulinum A toxin on patients with nonneurogenic detrusor overactivity refractory to anticholinergics. Efficacy of botulinum toxin-A for treating idiopathic detrusor overactivity: results from a single center, randomized, double-blind, placebo controlled trial. Comparing botulinum toxin A with casting for treatment of dynamic equinus in children with cerebral palsy. The Role of Kinesiotaping Combined With Botulinum Toxin to Reduce Plantar Flexors Spasticity After Stroke The safety and efficacy of botulinum toxin type B in the treatment of patients with cervical dystonia: summary of three controlled clinical trials. Botulinum toxin a has antinociceptive effects in treating interstitial cystitis. Clinico-immunologic aspects of botulinum toxin type B treatment of cervical dystonia Botulinum toxin type A for the treatment of trigeminal neuralgia: results from a randomized, double-blind, placebo-controlled trial Botulinum toxin-type A: could it be an effective treatment option in intractable trigeminal neuralgia? Distant effects of locally injected botulinum toxin: a double-blind study of single fiber EMG changes. Botulinum Toxin A in Postherpetic Neuralgia: A Parallel, Randomized, Double-Blind, Single-Dose, Placebo-controlled Trial Effects of flexible-dose fesoterodine on overactive bladder symptoms and treatment satisfaction: an open-label study
OBJECTIVE We investigated the effect of botulinum-a toxin injections into the detrusor and external sphincter muscle in patients with overactive bladder ( OAB ) symptoms . METHODS We included 44 patients - 41 women and three men with a mean age of 66.1 years - who were suffering from OAB symptoms that were refractory to anticholinergic treatment . We injected 200 - 300 U of BTX-A ( Botox ) into the detrusor muscle ; 22 patients also received external sphincter injections . For outcome analysis , we used a bladder diary , a urodynamic examination , and a question naire that consisted of 27 vali date d questions . RESULTS Changes in the bladder diary 4 weeks and 3 , 6 , and 9 months after BTX-A injection were as follows : Micturition frequency was reduced by 12 % , 16 % , 13 % and 9 % , respectively . Average pad use decreased from 4.2 pads per day to at most 2.4 pads per day after 6 months . Urodynamic changes were most distinct after 4 weeks : the volume when the first uninhibited detrusor contraction occurred increased from 149+/-18.2 mL to 263 + /- 24.2 mL , and maximum cystometric bladder capacity increased from 228 + /- 19.2 mL to 305 + /- 19.0 mL. Subjectively , 86 % of the patients would choose this procedure for their bladder condition again . Residua 4 weeks after additional injection into the sphincter muscle were distinctly smaller than in the " only detrusor " group . CONCLUSIONS BTX-A detrusor and sphincter injection is very effective in treating OAB symptoms . For patients who might be expected to have residual urine after injection only into the detrusor , additional injection of low doses of BTX-A into the external sphincter muscle could be one option to reduce that risk AIMS To evaluate the clinical outcomes of two different doses of BTX-A in patients with I-OAB . METHODS This investigator initiated , r and omized trial was design ed to evaluate clinical differences in outcomes for 100 versus 150 U BTX-A in patients with I-OAB . Patients with OAB-Wet and OAB-Dry were r and omized to receive 100 or 150 U BTX-A intra-detrusor injection . For patients with OAB-Wet , the primary outcome of interest was change in daily UUI episodes , and for those with OAB-Dry the primary outcome measure was change in number of daily voids as determined by 3-VD . Statistical comparisons were made both pre- and post-injection and also between different treatment groups to assess the superiority of one dose versus the other . RESULTS Forty-four patients enrolled in the study ; 10 OAB-Dry and 12 OAB-Wet patients received 100 U and another 10 OAB-Dry and 12 OAB-Wet patients received 150 U. No significant differences in outcome measure were noted between those receiving 100 versus 150 U. Patients with OAB-Wet tended to be completely dry more frequently if they received the 150 U dose , but this was not statistically significant . No differences in urodynamics outcomes were noted between the groups . QOL was significantly improved in both groups with no difference between the different doses . CONCLUSIONS In patients with I-OAB , preliminary results indicate that 100 U BTX-A and 150 U BTX-A are equivalent in terms of symptom reduction and QOL improvement PURPOSE We determined the safety and efficacy of each of 2 doses of botulinum toxin type A ( BTX-A ) ( 200 or 300 U BOTOX ) injected into the detrusor for urinary incontinence caused by neurogenic detrusor overactivity of predominantly spinal cord origin . MATERIAL S AND METHODS A total of 59 patients with urinary incontinence caused by neurogenic detrusor overactivity ( due to spinal cord injury in 53 and multiple sclerosis in 6 ) requiring clean intermittent self-catheterization were r and omized to receive a single dose into the detrusor of BTX-A ( 200 U or 300 U ) or placebo . Changes in daily frequency of urinary incontinence episodes were monitored via a patient bladder diary during 24 weeks . Key urodynamic assessment s ( maximum cystometric capacity , reflex detrusor volume and maximum detrusor pressure during bladder contraction ) were used to provide objective measures of the treatment effect on bladder function . The impact of treatment on quality of life was assessed using the Incontinence Quality of Life question naire . RESULTS There were significant posttreatment decreases in incontinence episodes from baseline in the 2 BTX-A groups ( p < /=0.05 ) but not in the placebo group . In addition , more patients who received BTX-A reported no incontinence episodes during at least 1 posttreatment evaluation period . Positive treatment effects were also reflected by significant improvements in bladder function in the BTX-A groups , as assessed by urodynamics and in patient quality of life . Benefits were observed from the first evaluation at week 2 to the end of the 24-week study . No safety concerns were raised . CONCLUSIONS Intramuscular injections of BTX-A into the detrusor can provide rapid , well tolerated , clinical ly significant decreases in the signs and symptoms of urinary incontinence caused by neurogenic detrusor overactivity during a 24-week study period Objective : The aim of the study was a prospect i ve assessment of patient-reported side effects in an open-label study after intradetrusor botulinum toxin injections for idiopathic overactive bladder ( OAB ) . Patients and Methods : Botulinum toxin A injection was performed in 56 patients with idiopathic OAB . Patients were followed up for 6 months concerning side effects and patients ’ satisfaction . Results : Different types of side effects were assessed such as dry mouth ( 19.6 % ) , arm weakness ( 8.9 % ) , eyelid weakness ( 8.9 % ) , leg weakness ( 7.1 % ) , torso weakness ( 5.4 % ) , impaired vision ( 5.4 % ) and dysphagia ( 5.4 % ) . In all cases , symptoms were mild and transient . Urological complications such as gross hematuria ( 17.9 % ) , acute urinary retention ( 8.9 % ) and acute urinary tract infection ( 7.1 % ) were noticed . In all cases , acute urinary retention was transient and treated with temporary intermittent self-catheterization . There was no statistically significant correlation between dosage and observed side effects . Patients ’ satisfaction rate was high ( 71.4 % ) . Conclusion : Intradetrusor injection of botulinum toxin was associated with a high rate of neurourological side effects . In general , side effects were transient , mild and did not require special treatment OBJECTIVE To evaluate botulinum toxin type A ( BTX-A ) for treating neurogenic detrusor overactivity in patients with spinal cord lesions , including those with abnormally low bladder compliance . DESIGN Nonr and omized , before-after trial ( 9-mo follow-up ) . SETTING Hospitalized care . PARTICIPANTS Ten patients with high detrusor contraction pressure and /or poor response to oxyphencyclimine with incontinence selected as a consecutive sample . INTERVENTION BTX-A ( Botox ; 300U ) was injected into the detrusor muscle . MAIN OUTCOME MEASURES Urinary continence , functional bladder capacity , bladder compliance , detrusor contraction pressure , and volume at first reflex voiding . Measurements were taken before and 6 , 16 , and 36 weeks posttreatment . RESULTS Six weeks after treatment , complete continence was restored in 7 patients without oxyphencyclimine .  Mean functional bladder capacity ( P=.008 ) , compliance ( P=.012 ) , and reflex volume ( P=.045 ) significantly increased , whereas maximal detrusor contraction pressure significantly decreased ( P<.001 ) . Urodynamic variables remained significantly improved at 16 weeks , but values were returning toward baseline levels by 36 weeks . The procedure was generally uneventful , without any serious side effects . CONCLUSIONS BTX-A injections are an effective , well-tolerated treatment for neurogenic detrusor overactivity in patients with spinal cord lesions , even in patients with abnormally low bladder compliance . Patients may require repeat injections after 16 weeks to remain continent AIMS To assess and compare the effect of botulinum A toxin ( BTX-A ) injections into the detrusor in idiopathic and neurogenic detrusor overactivity resistant to anticholinergic treatment . PATIENTS AND METHODS In a prospect i ve study , 11 patients with idiopathic and 11 with neurogenic detrusor overactivity resistant to anticholinergic treatment were injected with 300 U of BTX-A ( Botox ) into the detrusor . Clinical and urodynamic parameters were assessed before and after BTX-A injections . RESULTS In idiopathic as well as in neurogenic detrusor overactivity , median daytime frequency decreased significantly from 11 to 4 ( P = 0.004 ) and 12 to 5 ( P = 0.001 ) , median nocturia from 3 to 1 ( P = 0.004 ) and 3 to 1 ( P = 0.001 ) , and median number of used pads from 5 to 0 ( P = 0.001 ) and 5 to 0 ( P = 0.002 ) , respectively . There was a significant increase in median maximum cystometric capacity from 220 to 340 ml ( P = 0.001 ) and 190 to 410 ml ( to instead of ) ( P = 0.001 ) , median bladder compliance from 20 to 55 ml/cm H(2)O ( P = 0.001 ) and 23 to 60 ml/cm H(2)O ( P = 0.004 ) and median post void residual from 10 to 140 ml ( P = 0.002 ) and 30 to 240 ml ( P = 0.002 ) , respectively . Median maximum detrusor pressure decreased significantly from 45 to 29 cm H(2)O ( P = 0.002 ) and 40 to 24 cm H(2)O ( P = 0.002 ) , and median detrusor pressure at maximum flow rate from 30 to 14 ml/sec ( P = 0.001 ) and 38 to 21 ml/sec ( P = 0.016 ) , respectively . Due to post void residuals > 150 ml following BTX-A injections , de novo clean intermittent self-catheterization was necessary in nine patients ( four with idiopathic and five with neurogenic detrusor overactivity ) and in one patient ( with idiopathic detrusor overactivity ) a suprapubic catheter was placed . The effect of BTX-A injections lasted for a median time of 5 months in both idiopathic and neurogenic detrusor overactivity . There was no significant difference in idiopathic compared to neurogenic detrusor overactivity in regard to clinical and urodynamic parameters assessed before and after BTX-A injections . CONCLUSIONS BTX-A injections into the detrusor have a significant and comparable but temporally limited effect in idiopathic and neurogenic detrusor overactivity resistant to anticholinergic treatment BACKGROUND Efficacy and safety of botulinum toxin type A ( BoNTA ) injection is supported by level 1 evidence , but data regarding repeated injections are limited in patients with refractory overactive bladder ( OAB ) and idiopathic detrusor overactivity ( IDO ) . OBJECTIVES Describe medium-term outcomes and discontinuation rates for patients adopting repeated BoNTA as a management strategy for IDO . DESIGN , SETTING , AND PARTICIPANTS Prospect i ve data from a single centre were collected from the first 100 patients . INTERVENTION Bladder injection of BoNTA ( predominantly 200 U onabotulinumtoxinA ; Allergan Ltd. , Marlow , Buckinghamshire , UK ) in an outpatient setting . MEASUREMENTS OAB symptoms , quality of life , discontinuation rates , interinjection interval , and adverse events were recorded . Data comparisons were performed using a generalised linear model or a chi-square test where appropriate . RESULTS AND LIMITATIONS Two hundred seven injections were performed in 100 patients . All patients had 1 injection , 53 had a total of 2 , 20 had 3 , 13 had 4 , 10 had 5 , 5 had 6 , 3 had 7 , 1 had 8 , 1 had 9 , and 1 had 10 injections . Statistics were applied up to five repeated injections . A statistically significant reduction in frequency , urgency , and urge urinary incontinence were seen following the first BoNTA injection compared to baseline . This improvement was maintained after repeated injections and was not statistically different when comparing differences between injections . Thirty-seven patients stopped treatment after the first two injections ; thereafter , dropouts were rare . The most common reasons for discontinuing treatment were poor efficacy ( 13 % ) and clean intermittent self-catheterisation (CISC)-related issues ( 11 % ) . The incidence of CISC after the first injection was 35 % . Bacteriuria was detected in 21 % of patients . The mean interinjection interval was 322 d. Limitations included the concurrent use of antimuscarinic drugs in some patients . CONCLUSIONS BoNTA can provide a safe and effective medium-term management option for patients with refractory IDO . The most common reasons cited for stopping treatment were poor efficacy and CISC-related issues PURPOSE We compared 200 U intradetrusor botulinum toxin A vs placebo in women with refractory idiopathic urge incontinence . MATERIAL S AND METHODS This institutional review board approved , multicenter registered trial r and omized women with refractory urge incontinence , detrusor overactivity incontinence and 6 or greater urge incontinence episodes in 3 days to botulinum toxin A or placebo at a 2:1 ratio . Refractory was defined as inadequate symptom control after 2 or more attempts at pharmacotherapy and 1 or more other first line therapies for detrusor overactivity incontinence . The primary outcome measure was time to failure , as evidence d by a Patient Global Impression of Improvement score of 4 or greater at least 2 months after injection , or changes in treatment ( initiation or increase ) at any time after injection . Safety data , including increased post-void residual volume , defined as more than 200 ml irrespective of symptoms , was obtained at specified time points . RESULTS Approximately 60 % of the women who received botulinum toxin A had a clinical response based on the Patient Global Impression of Improvement . The median duration of their responses was 373 days , significantly longer than the 62 days or less for placebo ( p < 0.0001 ) . In the botulinum toxin A group increased post-void residual urine ( 12 of 28 women or 43 % ) and urinary tract infection in those with increased post-void residual urine ( 9 of 12 or 75 % ) exceeded expected ranges . Further injections were stopped after 43 patients were r and omized , including 28 to botulinum toxin A and 15 to placebo . CONCLUSIONS Local injection of 200 U botulinum toxin A was an effective and durable treatment for refractory overactive bladder . However , a transient post-void residual urine increase was experienced in 43 % of patients . Botulinum toxin A for idiopathic overactive bladder is still under investigation PURPOSE In this prospect i ve , nonr and omized , ongoing study we evaluated the efficacy and safety of botulinum-A toxin injections in the detrusor muscle to treat patients with idiopathic overactive bladder resistant to conventional treatment , such as anticholinergic drugs . MATERIAL S AND METHODS A total of 23 men and 77 women with a mean age of 63 years ( range 24 to 89 ) with nonneurogenic overactive bladder , including urgency-frequency syndrome , and incontinence despite the administration of maximal doses of anticholinergics were consecutively treated with injections of 100 U botulinum-A toxin in the detrusor muscle at 30 sites under cystoscopic guidance . Micturition diary , full urodynamics , neurological status and urine probes were performed in all participants before treatment . Bladder biopsies were done only in cases of suspected bladder fibrosis or unclear findings . Special attention was given to reflex volume , maximal bladder capacity , detrusor compliance , post-void residual urine , urgency and frequency/nocturia . Clinical , urodynamic and quality of life assessment s were performed at baseline , and 4 , 12 and 36 weeks after botulinum-A toxin treatment . RESULTS Overall after 4 and 12 weeks 88 % of our patients showed significant improvement in bladder function in regard to subjective symptoms , quality of life and urodynamic parameters ( p < 0.001 ) . Urgency disappeared in 82 % of the patients and incontinence resolved in 86 % within 1 to 2 weeks after botulinum-A toxin injections . Mean frequency decreased from 14 to 7 micturitions daily ( -50 % ) and nocturia decreased from 4 to 1.5 micturitions . Mean maximal bladder capacity increased 56 % from 246 to 381 ml , mean detrusor compliance increased from 24 to 41 ml/cm H(2)O and pretreatment detrusor instability ( mean reflex volume 169 ml ) resolved in 74 % of patients . Mean volume at first desire to void increased from 126 to 212 ml and mean urge volume increased from 214 to 309 ml . There were no severe side effects except temporary urine retention in 4 cases . Only in 8 patients was the clinical benefit poor and analysis revealed preoperative low detrusor compliance . Mean efficacy duration + /- SD was at least approximately 6 + /- 2 months and then symptoms began to increase . CONCLUSIONS Our results show that intradetrusor botulinum-A toxin injections may be an efficient and safe treatment option in patients with severe overactive bladder resistant to all conventional treatments PURPOSE We determined the effectiveness of cystoscopic administration of botulinum-A toxin compared to placebo for the treatment of urinary incontinence in subjects with idiopathic overactive bladder . MATERIAL S AND METHODS Subjects were recruited from the Division of Urogynecology at the University of Rochester . Inclusion criteria were overactive bladder refractory to anticholinergic medications , multiple daily incontinence episodes and a 24-hour pad weight of 100 gm or greater . Subjects with low leak point pressures , increased post-void residual volume or neurological etiologies were excluded from study . Subjects were r and omized to placebo or to 1 of 2 doses of botulinum-A toxin . The detrusor was injected at 8 to 10 sites above the trigone . Evaluations were performed at baseline , and at 3 and 6 weeks after injection , and included bladder diaries , pad weights , quality of life question naires and urodynamic studies . RESULTS A total of 22 subjects participated in stage 1 of this 2-stage study . We report on the outcomes of stage 1 of this study . Because stage 2 is still ongoing and investigators remain blind to the doses of botulinum-A toxin , the 2 botulinum-A toxin groups were combined for this report . There were no differences in mean baseline measurements between the 2 groups . Statistically significant improvements in daily incontinence episodes , pads changed per day and quality of life question naires were seen in the botulinum-A toxin group with no changes in the placebo group . No change in nocturia , daily voiding frequency , peak flow or detrusor pressure was seen in either group . Of 15 subjects 4 ( 26 % ) receiving botulinum-A toxin had a post-void residual volume of 200 cc or greater and 1 subject required intermittent catheterization . Four subjects experienced a urinary tract infection , 2 ( 13 % ) in the botulinum-A toxin group and 2 ( 28 % ) in the placebo group ( not significant ) . CONCLUSIONS Botulinum-A toxin can significantly reduce urge urinary incontinence due to overactive bladder at 6 weeks . However , there is a risk of urinary retention requiring self-catheterization PURPOSE Intradetrusor botulinum toxin-A injection is a promising emerging therapy for neurogenic and idiopathic overactive bladder that is refractory to current antimuscarinic agents . We evaluated a sedation-free procedure using flexible endoscopy to perform intradetrusor botulinum toxin-A injection using a vali date d pain score to assess the tolerability of this technique . MATERIAL S AND METHODS Five men and 22 women with idiopathic overactive bladder refractory to antimuscarinics were prospect ively evaluated and r and omized to 100 U ( 14 ) or 150 U botulinum toxin-A ( 13 ) . Subjects underwent BTA injection with intravesical lidocaine using a 14Fr Olympus flexible cystoscope , which accommo date s a 27 gauge flexible Olympus injection needle . Patients were evaluated with the visual analog scale to evaluate discomfort during and 15 minutes after the procedure . Procedure time was recorded . RESULTS In 22 female patients the mean pain score was 3.1 ( range 0 to 10 ) during the procedure and 0.7 ( range 0 to 7 ) 15 minutes after the procedure . In 5 male patients the mean pain score was 1.6 ( range 0 to 3.5 ) during the procedure and 0.0 with all reporting no pain 15 minutes after the procedure . Mean procedure time was 4.5 minutes ( range 4 to 6 ) . Only 1 of the 27 patients requested sedation before any subsequent injections . CONCLUSIONS Sedation-free intradetrusor botulinum toxin-A injection using intravesical lidocaine and flexible endoscopy is a well tolerated and safe procedure to perform in an office setting OBJECTIVES To investigate the clinical and urodynamic effects of suburothelial injection of botulinum A toxin on patients with nonneurogenic detrusor overactivity . Intradetrusor injection of botulinum A toxin has been used to treat patients with detrusor overactivity .  Suburothelial injection of botulinum A toxin might effectively inhibit the occurrence of detrusor overactivity mediated by sensory nerves . METHODS Twenty patients with nonneurogenic detrusor overactivity refractory to anticholinergics were enrolled and treated with injection of 200 U botulinum A toxin into the suburothelial space . The clinical effects on the lower urinary tract symptoms and urodynamic parameters were assessed . RESULTS At 3 months after treatment , 9 patients had regained continence ( 45 % ) , 8 had improvement ( 40 % ) , and treatment had failed in 3 ( 15 % ) . At 6 months after treatment , 7 patients remained continent , but treatment had failed in 5 . Hematuria developed in 1 patient , urinary tract infection in 7 ( 35 % ) , and a large postvoid residual urine volume requiring catheterization in 6 ( 30 % ) . Hesitancy in initiation and difficult urination was also noted in 15 patients ( 75 % ) . The volume of the first sensation of bladder filling and bladder capacity increased about two times ; however , the voiding efficiency was reduced by 50 % at 2 weeks after treatment . The postvoid residual urine volume was increased by seven times the baseline value at 2 weeks and had decreased to three times greater at 3 and 6 months after treatment . CONCLUSIONS The results of this study have shown that suburothelial injection of 200 U botulinum A toxin impairs bladder sensation and voiding efficiency , but is effective in the treatment of nonneurogenic detrusor overactivity . Transient urinary retention and the development of urinary tract infection should be carefully monitored PURPOSE We evaluated the use of botulinum toxin-A in treating patients with idiopathic detrusor overactivity refractory to anticholinergics . MATERIAL S AND METHODS This double-blind , placebo controlled trial r and omized participants to intradetrusor injections of 200 U botulinum toxin-A ( 16 patients ) or placebo ( 18 patients ) . The primary outcome measure was change in maximum cystometric capacity . Secondary outcome measures included changes in overactive bladder symptoms , post-void residual , maximum detrusor pressure during filling cystometry and reflex detrusor volume . Quality of life was assessed using the Incontinence Impact Question naire short form 7 and Urogenital Distress Inventory short form 6 . Followup occurred at 4 and 12 weeks after injection , at which point the study was unblinded . Further followup in the botulinum toxin-A group occurred at 24 weeks . RESULTS Significant increases in maximum cystometric capacity were observed at 4 weeks ( difference 144.69 ml , 95 % CI 100.95 to 215.75 , p < 0.0001 ) and 12 weeks ( difference 95.71 ml , 95 % CI 47.47 to 172.45 , p = 0.001 ) in patients treated with botulinum toxin-A compared to placebo . Botulinum toxin-A reduced frequency ( p < 0.001 , p = 0.003 ) and urgency urinary incontinence ( p = 0.03 , p = 0.008 ) episodes at 4 and 12 weeks , respectively . Urgency was reduced at 4 weeks ( p = 0.005 ) in the botulinum toxin-A group . In patients receiving botulinum toxin-A , post-void residual increased at 4 weeks ( p = 0.024 ) but became insignificant by 12 weeks ( p = 0.406 ) . Of these patients 6 required intermittent self-catheterization . Significant improvements in quality of life were observed following botulinum toxin-A. The extension study suggests that the beneficial effects of botulinum toxin-A are maintained for at least 24 weeks . CONCLUSIONS Botulinum toxin-A at 200 U is safe and effective for idiopathic detrusor overactivity and the beneficial effects persist for at least 24 weeks The purpose of this study was to compare the cumulative efficacy ( three treatment sessions ) of botulinum toxin A ( BTX-A ) alone , casting alone , and the combination of BTX-A and casting in the management of dynamic equinus in ambulatory children with spastic cerebral palsy ( CP ) . Thirty-nine children with spastic CP ( mean age 5y 10mo , range 3 to 9y ) were enrolled in the study . A multicenter , r and omized , double blind , placebo-controlled prospect i ve study was used . Children were r and omly assigned to one of three treatment groups : BTX-A only ( B ) , placebo injection plus casting ( C ) , or BTX-A plus casting ( B+C ) . The dosage for the BTX-A injections was 4U/kg per extremity . Assessment s were performed at baseline , 3 , 6 , 7.5 , and 12 months with a total of three treatments administered after the evaluations at baseline , 3 , and 6 months . Primary outcome measures were ankle kinematics , velocity , and stride length . Secondary outcome measures were ankle spasticity , strength , range of motion , and ankle kinetics . Group B made no significant change in any variable at any time . Groups C and B+C demonstrated significant improvements in ankle kinematics , spasticity , passive range of motion , and dorsiflexor strength . Results of this 1-year study indicate that BTX-A alone provided no improvement in the parameters measured in this study , while casting and BTX-A/casting were effective in the short- and long-term management of dynamic equinus in children with spastic CP Abstract Purpose : To evaluate the effect of kinesiotaping as an adjuvant therapy to botulinum toxin A ( BTX-A ) injection in lower extremity spasticity . Methods : This is a single-center , r and omized , and double-blind study . Twenty hemiplegic patients with spastic equinus foot were enrolled into the study and r and omized into 2 groups . The first group ( n=10 ) received BTX-A injection and kinesiotaping , and the second group ( n=10 ) received BTX-A injection and sham-taping . Clinical assessment was done before injection and at 2 weeks and 1 , 3 , and 6 months . Outcome measures were modified Ashworth scale ( MAS ) , passive ankle dorsiflexion , gait velocity , and step length . Results : Improvement was recorded in both kinesiotaping and sham groups for all outcome variables . No significant difference was found between groups other than passive range of motion ( ROM ) , which was found to have increased more in the kinesiotaping group at 2 weeks . Conclusion : There is no clear benefit in adjuvant kinesiotaping application with botulinum toxin for correction of spastic equinus in stroke Cervical dystonia ( CD ) is characterized by abnormal , involuntary contractions of the cervical and /or shoulder muscles . Direct injection of Botulinum toxin type A ( BTX-A ) into the affected muscles has been used successfully to treat this condition . However , clinical resistance to BTX-A therapy develops in a limited number of patients . Moreover , an unknown proportion of treated patients have a suboptimal response to their present therapy . BTX-B is antigenically distinct from BTX-A and possesses a different mechanism of action . Three r and omized , double-blind , placebo-controlled clinical trials evaluated the safety and efficacy of BTX-B ( Elan 's BTX-B evaluated as NeuroBloc ) as a treatment for patients with CD . Patients received a single dose of BTX-B ranging from 2,500 to 10,000 U. The primary efficacy evaluation for each of these studies used the Toronto Western Spasmodic Torticollis Rating Scale ( TWSTRS ) total score . Additional efficacy measures included the TWSTRS severity , disability , and pain subscale scores , as well as the Patient Analog Pain Assessment and Patient 's and Physician 's Global Assessment s of Change . In all three studies , groups receiving BTX-B displayed statistically significant improvements in TWSTRS total score and other efficacy end points compared with those who received placebo treatment . The clinical benefits after BTX-B treatment lasted 12 to 16 weeks and were observed in both BTX-A-responsive and BTX-A-resistant patients . In general , treatment with BTX-B was well tolerated and most of the reported adverse events were of short duration , mild to moderate in severity , and anticipated . The results from the three controlled clinical trials demonstrate the safety and efficacy of BTX-B in the treatment of patients with CD , including those who are resistant to BTX-A treatment OBJECTIVES To present clinical evidence with botulinum toxin A ( BTX-A ) suggesting an antinociceptive role in patients with interstitial cystitis ( IC ) . Intriguing evidence in a somatic pain model has suggested that BTX-A injection may have an antinociceptive effect on both acute and chronic ( inflammatory ) pain . METHODS Thirteen female patients ( 6 in the United States and 7 in Pol and ) with IC according to the criteria of the National Institute of Diabetes , Digestive and Kidney Disease were included . Under short general anesthesia or sedation , 100 to 200 U of Dysport ( Polish patients ) or Botox ( U.S. patients ) was injected through a cystoscope into 20 to 30 sites submucosally in the trigone and floor of the bladder . Patients were evaluated with the O'Leary-Sant vali date d IC question naire or with voiding charts and a visual analog pain scale 1 month postoperatively and at subsequent 3-month intervals . The Polish patients also underwent pretreatment and post-treatment urodynamic evaluations . RESULTS Overall , 9 ( 69 % ) of 13 patients noted subjective improvement after BTX-A treatment . The Interstitial Cystitis Symptom Index and Interstitial Cystitis Problem Index mean scores improved by 71 % and 69 % , respectively ( P < 0.05 ) . Daytime frequency , nocturia , and pain by visual analog scale decreased by 44 % , 45 % , and 79 % , respectively ( P < 0.01 ) . The first desire to void and maximal cystometric capacity increased by 58 % and 57 % , respectively ( P < 0.01 ) . CONCLUSIONS Our results suggest that BTX-A has an antinociceptive effect on bladder afferent pathways in patients with IC , producing both symptomatic and functional ( ie , urodynamic ) improvements In this multicenter study of 100 patients with cervical dystonia , we examined the immunogenicity of botulinum toxin type B ( BTX-B ) and correlated the clinical response with the presence of blocking antibodies ( Abs ) using a novel mouse protection assay . One-third of the patients who were negative for BTX-B Abs at baseline became positive for BTX-B Abs at last visit . Thus , the high antigenicity of BTX-B limits its long-term efficacy Aim : To investigate the efficacy , safety and tolerability of intradermal and /or submucosal administration of botulinum toxin type A ( BTX-A ) for patients with trigeminal neuralgia ( TN ) . Methods : In this r and omized , double-blind , placebo-controlled study , 42 TN patients were r and omly allocated into two groups , namely , intradermal and /or submucosal injection of BTX-A ( 75 U/1.5 mL ; n = 22 ) or saline ( 1.5 mL ; n = 20 ) in the skin and /or mucosa where pain was experienced . The primary endpoints were pain severity ( assessed by the visual analogue scale ) and pain attack frequency per day . The secondary endpoint was the patient ’s overall response to treatment , assessed using the Patient Global Impression of Change scale . Patients with ≥ 50 % reduction in mean pain score at week 12 were defined as responders . Results : A total of 40 patients completed the study .  BTX-A significantly reduced pain intensity at week 2 and pain attack frequency at week 1 . The efficacy was maintained throughout the course of the study . More BTX-A treated patients reported that pain had improved by the end of the study . Significantly more responders were present in the BTX-A group ( 68.18 % ) than in the placebo group ( 15.00 % ) . BTX-A was well tolerated , with few treatment-related adverse events . Conclusions : BTX-A may be an efficient , safe and novel strategy for TN treatment Background Botulinum toxin type A ( BTX-A ) has been reported to have analgesic effects independent of its action on muscle tone , mostly by acting on neurogenic inflammatory mediators and controlling the neurotransmitter release of sensory and autonomic nerve terminals that are involved in many chronic painful conditions as chronic intractable trigeminal neuralgia (TN).The aim of our work was evaluating the efficacy , safety , and tolerability of BTX-A for the treatment of intractable idiopathic TN . Methods This was a r and omized , single-blinded , placebo-control study carried out on 20 Egyptian patients with intractable TN . Patients received a one-time subcutaneous administration of BTX-A using “ follow the pain ” method . The primary efficacy measure was reduction in pain severity on the 10-cm VAS score as well as in paroxysms frequency from the baseline to week 12 ( endpoint last observation carried forward [ LOCF ] ) . Secondary efficacy measures included QoL assessment and number of acute medications received from baseline to the endpoint . Results Pain reduction at the 12-week endpoint was significant in BTX-A group ( p<0.0001 ) ; VAS scores at endpoint LOCF relative to baseline for BTX-A group showed a decrease of 6.5 compared with a decrease of 0.3 for placebo , also there was a significant decrease in the number of acute medications and an increase in QoL functioning scale . Conclusion These results indicate that BTX-A has a direct analgesic effect in patients with TN and can represent a therapeutic option for intractable cases We used single fiber electromyography ( SFEMG ) to study 42 patients who had enrolled in a double-blind , placebo-controlled trial undertaken to assess the efficacy of botulinum toxin ( BTX ) injection of neck muscles to treat torticollis . SFEMG in a limb muscle was performed before treatment , 2 , and 12 weeks after injection of placebo or BTX . Before treatment , the mean jitter was 26.8 microsec in patients who were to receive BTX , and 25.7 microsec in the placebo group . Two weeks after injection , mean jitter in the group receiving BTX was 43.6 microsec . In the placebo group , it was 26.5 microsec ( P = less than .05 ) . Twelve weeks after injection , mean jitter in the BTX group was 35.5 ; for the placebo group it was 24.5 . Fiber density did not change in any patient during the study . There were no remote clinical effects of BTX . Injection of BTX into muscles affected with focal dystonia is a promising and safe treatment , but there are sub clinical effects on uninjected muscles Objectives : Cumulative evidence support a beneficial effect of botulinum toxin A ( BTX-A ) in postherpetic neuralgia ( PHN ) . We aim ed to assess efficacy , safety , and tolerability of BTX-A in the management of PHN , performing a r and omized , double-blind , single-dose , placebo-controlled trial . Methods : Thirty adults with PHN were r and omized either to BTX-A or placebo .  Severity of pain was evaluated by patients using a visual analogue scale ( VAS ) and quality of sleep was assessed using a 5-item question naire . Primary outcome was reduction in VAS score , with a greater than 50 % reduction being considered clinical ly significant . Secondary outcomes were reduction in sleep score and maintenance of VAS score after treatment , with over 50 % maintenance considered clinical ly meaningful . Results : Thirteen patients from the experimental arm achieved an at least 50 % reduction in VAS score , compared with none of the placebo patients ( NNT=1.2 , 95 % CI , 2 - 1 ; ARR=0.87 , 95 % CI , 055 - 096 ; P<0.001 ) . BTX-A patients showed significant reduction in VAS pain scores between baseline and week 2 , which persisted for a median period of 16 weeks . BTX-A patients showed significant reduction in sleep scores between baseline and week 2 , which remained unchanged until 16th week ( P<0.001 ) . Treatment was well tolerated . Discussion : Data confirm that BTX-A is effective and well tolerated in the treatment of PHN Aims : To evaluate the efficacy and tolerability of flexible-dose fesoterodine in subjects with overactive bladder ( OAB ) who were dissatisfied with previous tolterodine treatment . Methods : This was a 12-week , open-label , flexible-dose study of adults with OAB ( ≥ 8 micturitions and ≥ 3 urgency episodes per 24 h ) who had been treated with tolterodine ( immediate- or extended-release ) for OAB within 2 years of screening and reported dissatisfaction with tolterodine treatment . Subjects received fesoterodine 4 mg once daily for 4 weeks ; thereafter , daily dosage was maintained at 4 mg or increased to 8 mg based on the subject ’s and physician ’s subjective assessment of efficacy and tolerability . Subjects completed 5-day diaries , the Patient Perception of Bladder Condition ( PPBC ) and the Overactive Bladder Question naire ( OAB-q ) at baseline and week 12 and rated treatment satisfaction at week 12 using the Treatment Satisfaction Question ( TSQ ) . Safety and tolerability were assessed . Results : Among 516 subjects treated , approximately 50 % opted for dose escalation to 8 mg at week 4 . Significant improvements from baseline to week 12 were observed in micturitions , urgency urinary incontinence episodes , micturition-related urgency episodes and severe micturition-related urgency episodes per 24 h ( all p < 0.0001 ) . Approximately 80 % of subjects who responded to the TSQ at week 12 reported satisfaction with treatment ; 38 % reported being very satisfied . Using the PPBC , 83 % of subjects reported improvement at week 12 with 59 % reporting improvement ≥ 2 points . Significant improvements from baseline ( p < 0.0001 ) exceeding the minimally important difference ( 10 points ) were observed in OAB-q Symptom Bother and Health-Related Quality of Life ( HRQL ) scales and all four HRQL domains . Dry mouth ( 23 % ) and constipation ( 5 % ) were the most common adverse events ; no safety issues were identified . Conclusion : Flexible-dose fesoterodine  significantly improved OAB symptoms , HRQL , and rates of treatment satisfaction and was well tolerated in subjects with OAB who were dissatisfied with prior tolterodine therapy
These and other outcomes for effectiveness of BTX-A at different dosages in two observation periods indicate that a dose greater than 50 U is significantly more effective for certain symptoms of OAB compared with placebo .
However , there were no significant differences between some dosages .
Compared with placebo , the outcomes of total adverse events for NDO and for IDO show that doses of 300 U and 200 U for NDO are associated with more complications .
Conclusions In consideration that the treatments of BTX-A were with minimal , local , and manageable adverse effects , this meta- analysis demonstrates that BTX-A 200 U is recommended for management of NDO for short-term treatment for there was no significant difference from the larger dose of 300U .
Purpose To assess the effectiveness and safety of botulinum toxin A ( BTX-A ) at different dosages for overactive bladder ( OAB ) .