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 injections for treating neurogenic detrusor overactivity combined with low-compliance bladder in patients with spinal cord lesions. 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. A prospective study to evaluate the safety, tolerability, efficacy and durability of response of intravesical injection of botulinum toxin type A into detrusor muscle in patients with refractory idiopathic detrusor overactivity Efficacy and safety of onabotulinumtoxinA for idiopathic overactive bladder: a double-blind, placebo controlled, randomized, dose ranging trial. Botulinum-A toxin detrusor and sphincter injection in treatment of overactive bladder syndrome: objective outcome and patient satisfaction. Prospective randomized trial of 100u vs 200u botox in the treatment of idiopathic overactive bladder Efficacy of botulinum toxin type A 100 units versus 200 units for treatment of refractory idiopathic overactive bladder OnabotulinumtoxinA 100 U significantly improves all idiopathic overactive bladder symptoms and quality of life in patients with overactive bladder and urinary incontinence: a randomised, double-blind, placebo-controlled trial. Botulinum toxin A and upper limb functional skills in hemiparetic cerebral palsy: a randomized trial in children receiving intensive therapy. Functional outcomes of intramuscular botulinum toxin type a and occupational therapy in the upper limbs of children with cerebral palsy: a randomized controlled trial. Botulinum A toxin injections into the detrusor: an effective treatment in idiopathic and neurogenic detrusor overactivity? The safety and efficacy of botulinum toxin type B in the treatment of patients with cervical dystonia: summary of three controlled clinical trials. Patient-Reported Side Effects of Intradetrusor Botulinum Toxin Type A for Idiopathic Overactive Bladder Syndrome Repeated botulinum toxin type A injections for refractory overactive bladder: medium-term outcomes, safety profile, and discontinuation rates. Botulinum toxin type A for upper limb spasticity following stroke: an open-label study with individualised, flexible injection regimens Outcome of a randomized, double-blind, placebo controlled trial of botulinum A toxin for refractory overactive bladder.
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 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 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 To assess , in a prospect i ve study , whether botulinum toxin A ( BTXA ) injected into the detrusor muscle is safe and well tolerated , produces significant changes in urodynamic variables , if the effect is durable , as measured by the Bristol Female Lower Urinary Tract Symptom Question naire ( BFLUTS ) , and to assess changes in quality of life , as measured by the Kings Health Question naire ( KHQ ) , when it is used to manage idiopathic detrusor overactivity PURPOSE Treatment options for patients with overactive bladder refractory to anticholinergics are limited . We assessed the dose response across a range of doses of onabotulinumtoxinA ( BOTOX ® ) in patients with idiopathic overactive bladder and urinary urgency incontinence whose symptoms were not adequately managed with anticholinergics .  MATERIAL S AND METHODS In a phase 2 , multicenter , r and omized , double-blind study , 313 patients with idiopathic overactive bladder and urinary urgency incontinence experiencing 8 or more urinary urgency incontinence episodes a week and 8 or more micturitions daily at baseline received 50 , 100 , 150 , 200 or 300 U intradetrusor onabotulinumtoxinA , or placebo . Symptoms were recorded using a 7-day bladder diary . The primary efficacy variable was weekly urinary urgency incontinence episodes and the primary end point was week 12 . RESULTS Demographics and baseline characteristics were balanced across the treatment groups . Durable efficacy was observed for all onabotulinumtoxinA dose groups of 100 U or greater for primary and secondary efficacy measures , including the proportion of incontinence-free patients . When the dose response curves were analyzed , doses greater than 150 U contributed minimal additional or clinical ly relevant improvement in symptoms . This finding was also reflected in health related quality of life assessment s. Dose dependent changes in post-void residual urine volume were observed and the use of clean intermittent catheterization was also dose dependent . The only adverse events significantly greater with onabotulinumtoxinA than with placebo were urinary tract infection and urinary retention . CONCLUSIONS OnabotulinumtoxinA at doses of 100 U or greater demonstrated durable efficacy in the management of idiopathic overactive bladder and urinary urgency incontinence . A dose of 100 U may be the dose that appropriately balances the symptom benefits with the post-void residual urine volume related safety profile 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 Aim : To evaluate the clinical outcomes of two different doses of BTX-A in patients with refractory idiopathic overactive bladder . Patients and Methods : Thirty nine patients with refractory idiopathic overactive bladder from 1/1/2008 till 30/3/2009 were evaluated in a tertiary care hospital . Patients were evaluated using urodynamic studies , voiding diary , UDI-6 and IIQ-7 question naires prior to being prospect ively r and omized ( alternate r and omization ) to the BTX-A applications and three months after treatment . Voiding diary and residual volume were followed two weeks later . All patients received intradetrusorial injections of BTX-A ( Botox , Allergan , Irvine , CA ) of 100u or 200u under cystoscopic control on an outpatient basis . The primary endpoint was assessed for the improvement of urodynamic parameters and adverse events at three months after the initial treatment . Secondary end points included urinary frequency , urgency and UUI episodes as assessed by voiding diary and QoL. Results : Eleven patients were enrolled to each arm of the study . There were no significant differences in demographic characteristics between the two groups . Urodynamic assessment at the end of the third month showed significant improvement in urodynamic variables in both groups . There was no statistically significant difference in urodynamic parameters and in the voiding diary between the two groups . QOL was significantly improved in both groups with no statistically significant difference between the different doses . Only three patients developed acute urinary retention . Conclusion : BTX-A at 100u and 200u appears to improve symptoms , urodynamic parameters and QoL with no statistical significance between the two groups ABSTRACT Objective : To evaluate the efficacy and safety of a single intra detrusor injection of BoNTA comparing two different doses ( 100 U or 200 U ) in patients with idiopathic overactive bladder . Material s and Methods : A r and omized prospect i ve study evaluated the efficacy of BoNTA in management of refractory idiopathic overactive bladder and included 80 patients . All patients were assessed initially by taking a history , a physical examination , overactive bladder symptom score , urine analysis , routine laboratory investigations , KUB and pelviabdominal . OABSS was adjusted on all patients postoperative at 1,3,6,9 months also Urodynamic was done for all patients preoperative and postoperative at 3 , 6 , 9 months . Results : The mean age was 30.22±8.37 and 31.35±7.61 in group I and II respectively . There was no statistically difference between both groups in all parameters all over the study except at 9 months after treatment . Hematuria was observed 6 and 9 patients in group I and II respectively . Dysuria was observed in 6 and 15 patients in group I and II respectively . UTI was detected in 3 and 7 patients in group I and II respectively . Conclusion : A single-injection procedure of 100 U or 200 U BoNTA is an effective and safe treatment for patients with IOAB who failed anticholinergic regimens . OABSS and QoL were improved for 6 months ; 100 U injections seemed to have comparable results with 200 U. There was a significant difference at month 9 towards 200 U with more incidences of adverse events BACKGROUND Overactive bladder ( OAB ) syndrome with urinary incontinence ( UI ) is prevalent in the population and impairs health-related quality of life ( HRQOL ) . OBJECTIVE To assess the impact on efficacy , safety , and HRQOL of onabotulinumtoxinA ( BOTOX ( ® ) , Allergan , Inc. ) treatment in patients with OAB with UI . DESIGN , SETTING , AND PARTICIPANTS This pivotal , multicentre , double-blind , r and omised , placebo-controlled , phase 3 study enrolled patients with idiopathic OAB with ≥ 3 urgency UI episodes over 3 d and ≥ 8 micturitions per day who were inadequately managed by anticholinergics . INTERVENTION OnabotulinumtoxinA at a 100U dose ( n=277 ) or placebo ( n=271 ) , administered as 20 intradetrusor injections of 0.5 ml . OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS Co- primary end points were change from baseline in the number of UI episodes per day and proportion of patients reporting positive treatment response on the treatment benefit scale ( TBS ) at week 12 . Additional end points included other OAB symptoms ( episodes of urinary urgency incontinence , micturition , urgency , and nocturia ) and HRQOL ( Incontinence Quality of Life [ I-QOL ] , King 's Health Question naire [ KHQ ] ) . Safety assessment s included adverse events ( AEs ) , postvoid residual ( PVR ) urine volume , and initiation of clean intermittent catheterisation ( CIC ) . RESULTS AND LIMITATIONS OnabotulinumtoxinA significantly decreased UI episodes per day at week 12 ( -2.95 for onabotulinumtoxinA versus -1.03 for placebo ; p<0.001 ) . Reductions from baseline in all other OAB symptoms were also significantly greater following onabotulinumtoxinA compared with placebo ( p ≤ 0.01 ) . Patients perceived a significant improvement in their condition , as measured by patients with a positive treatment response on the TBS ( 62.8 % for onabotulinumtoxinA versus 26.8 % for placebo ; p<0.001 ) . Clinical ly meaningful improvements from baseline in all I-QOL and KHQ multi-item domains ( p<0.001 versus placebo ) indicated positive impact on HRQOL . AEs were mainly localised to the urinary tract . Mean PVR was higher in the onabotulinumtoxinA group ( 46.9 ml versus 10.1 ml at week 2 ; p<0.001 ) ; 6.9 % of onabotulinumtoxinA patients versus 0.7 % of placebo patients initiated CIC . CONCLUSIONS OnabotulinumtoxinA 100 U was well tolerated and demonstrated significant and clinical ly relevant improvements in all OAB symptoms , patient-reported benefit , and HRQOL in patients inadequately managed by anticholinergics . TRIAL REGISTRATION Clinical Trials.gov : NCT00910520 The objective of this study was to determine whether the use of intramuscular botulinum toxin A ( BTX-A ) increases upper limb function and skills in the context of a specific therapy programme in children with hemiparetic cerebral palsy . Twenty children ( nine females , 11 males ) aged 4 to 16 years who were thought likely to benefit from BTX-A treatment were included . After matched pairs were made , on the basis of Zancolli grade and age , r and omization took place . All patients were given structured rehabilitation ( physiotherapy and occupational therapy three times a week for 6 months ) , and half of the patients received intramuscular BTX-A. No placebo injections were given in the control group . Participants were assessed at baseline , at 2 and 6 weeks , and at 3 , 6 , and 9 months after injection . The Ashworth scale , active range of motion of arm joints , the Melbourne assessment of upper limb function , the Pediatric Evaluation of Disability Inventory , and the nine-hole peg test were used for outcome measurement . Observers were blinded for treatment allocation only for scoring the Melbourne test . The children in the treatment group showed a clinical ly relevant increase in active dorsal flexion , and tone reduction of the wrist . For the functional outcome measures , no statistically significant differences between the groups could be demonstrated . Intramuscular BTX-A added to an intensive therapy programme reduces impairment for at least 9 months ; the effect on activity level is still uncertain OBJECTIVE To investigate the functional outcomes of botulinum toxin type A ( BTX-A ) injections to the upper limb in combination with occupational therapy ( OT ) in children with cerebral palsy ( CP ) . DESIGN R and omized controlled trial with follow-up at 2 weeks , 3 months , and 6 months . SETTING Specialist outpatient physical disabilities clinic within a public pediatric teaching hospital . PARTICIPANTS Eighty children with spastic quadriplegic , triplegic , or hemiplegic CP from these clinics were r and omly assigned to BTX-A plus OT , BTX-A alone , OT alone , or a no-treatment control group . INTERVENTIONS Single set of BTX-A ( Botox ) injections and 12 weeks of OT . MAIN OUTCOME MEASURES Canadian Occupational Performance Measure ( COPM ) and Goal Attainment Scale ( GAS ) . RESULTS The combination of BTX-A and OT result ed in accelerated attainment of functional goals measured by the COPM and GAS . There were no differences between groups on the Melbourne Assessment of Unilateral Upper Limb Function , Quality of Upper Extremity Skills Test , Pediatric Evaluation of Disability Inventory , Child Health Question naire , or active and passive range of motion . As expected , there was a significant reduction in muscle tone at follow-up 2 weeks after injection , which returned to baseline level by 6 months . CONCLUSIONS OT enhanced individualized functional outcomes following BTX-A injections in the upper limbs of children with CP 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 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 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 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 Current antispastic medications are unsatisfactory for spasticity treatment , but botulinum toxin type A ( BTX-A ) shows promise as a new therapeutic option . This open-label , prospect i ve study aim ed to assess the effectiveness of BTX-A in improving functional mobility in the early post-stroke population using an individualised , flexible range of doses and targeted muscle groups . Twenty-one stroke patients ( 13 male , 8 female ) were enrolled and injected with BTX-A ( Botox , Allergan , mean dose : 255 U ; range : 185–300 ) according to individual spasticity patterns . Assessment s were made at baseline and weeks 2 , 4 , 6 , 10 and 16 post-treatment . Outcome measures comprised : Modified Ashworth Scale ( MAS ) , finger flexion scale ( Bhakta ) , MRC scale , Physician ’s Rating Scale ( PRS ) , Nine Hole Peg Test ( 9HPT ) , Motor Assessment Scale , Clinical Global Impression ( CGI ) , Global Assessment of Spasticity ( GASS ) and Visual Analogue Scale ( VAS ) for pain assessment . Statistically significant improvements in muscle tone as determined by the MAS were found in all areas ( except arm ) till week 16 ( p<0.05 ) . Finger positioning improved for the study duration , whilst muscle power increased only slightly in specific muscles . PRS revealed significant improvements to week 10 and slight improvement in 9HPT performance in selected patients was observed . Motor Assessment Scale results were statistically significant for arm , h and and advanced h and functions , although the overall functional benefit was mild . GASS and CGI results also showed improvement . Pain was present only in 11 patients and did not significantly improve following treatment . Individualised BTX-A injection regimens may be an effective , reversible and safe new treatment option for patients with spasticity . Nevertheless , functional improvement may be reached only in selected patients 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
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 ) .