Search

Background: Neurogenic detrusor overactivity incontinence (NDOI) is often inadequately managed with oral therapy., Objective: To assess efficacy and safety of abobotulinumtoxinA (aboBoNT-A; Dysport®; Ipsen Ltd.) according to etiology of NDOI., Design, Setting, and Participants: Two phase III, randomized, double-blind studies (CONTENT1 [NCT02660138] conducted in Asia, Europe and North America; CONTENT2 [NCT02660359] conducted in the Americas, Asia, Europe and Oceania) both included patients with spinal cord injury (SCI) or multiple sclerosis (MS), with inadequately managed NDOI, regularly performing clean intermittent catheterization (CIC)., Intervention: Patients in CONTENT1 and CONTENT2 received aboBoNT-A injections 600 U (n = 162)/800 U (n = 161), or placebo (n = 162) into the detrusor muscle., Outcome Measurements and Statistical Analysis: Primary endpoint: mean change from baseline in number of NDOI episodes/week at Week 6. Secondary endpoints: proportion of patients with no NDOI episodes; incontinence-related quality of life (I-QoL); urodynamic parameters; and time-to-retreatment. Safety was also assessed. Statistical analyses were conducted for pooled populations by etiology (aboBoNT-A doses vs. placebo)., Results and Limitations: Of 485 randomized patients, 341 (70%) and 144 (30%) had SCI and MS etiologies, respectively. A significant reduction was observed in mean NDOI episodes/week at Week 6 with both aboBoNT-A doses versus placebo in the SCI (all p < 0.001) and MS (all p < 0.01) groups, as well as significant improvements in I-QoL and urodynamic parameters. Median time-to-retreatment was longer in patients with MS (48-62 weeks across doses) than those with SCI (39-44 weeks). Safety data were similar between etiologies. Urinary tract infection was the most frequent adverse event; similar numbers were reported across treatment groups., Conclusions: AboBoNT-A was well tolerated and significantly improved continence and bladder function, and QoL, in patients with SCI or MS with NDOI performing regular CIC., Patient Summary: AboBoNT-A injections improved QoL, symptoms, and bladder function in patients with SCI or MS with bladder muscle overactivity that causes incontinence., (© 2022 The Authors. Neurourology and Urodynamics published by Wiley Periodicals LLC.)

Aims: OnabotulinumtoxinA (onaBNTa) for treating neurogenic detrusor overactivity (NDO) is widely used after its regulatory approval in adults. Although the administration of onaBNTa is still considered off-label in children, data have already been reported on its efficacy and safety. Nowadays, there is a lack of standardized protocols for treatment of NDO with onaBNTa in adolescent patients in their transition from the childhood to the adult age. With the aim to address this issue a consensus panel was obtained., Methods: A panel of leading urologists and urogynaecologists skilled in functional urology, neuro-urology, urogynaecology, and pediatric urology participated in a consensus-forming project using a Delphi method to reach national consensus on NDO-onaBNTa treatment in adolescence transitional care., Results: In total, 11 experts participated. All panelists participated in the four phases of the consensus process. Consensus was reached if ≥70% of the experts agreed on recommendations. To facilitate a common understanding among all experts, a face-to-face consensus meeting was held in Rome in march 2015 and then with a follow-up teleconference in march 2017. By the end of the Delphi process, formal consensus was achieved for 100% of the items and an algorithm was then developed., Conclusions: This manuscript represents the first report on the onaBNTa in adolescents. Young adults should be treated as a distinct sub-population in policy, planning, programming, and research, as strongly sustained by national public health care. This consensus and the algorithm could support multidisciplinary communication, reduce the extent of variations in clinical practice and optimize clinical decision making., (© 2017 Wiley Periodicals, Inc.)

Purpose: To assess the response in spinal cord injured patients alternatively treated with different types and dosages of Botulinum neurotoxin type A (BoNT/A) over 15 years., Material and Methods: Patients who underwent first BoNT/A from 1999-2001 and practiced intermittent catheterization were included. Baseline 3-day bladder diary (BD) and urodynamics were collected. BoNT/A failure was defined when patients asked for re-injection ≤ 3 months post-treatment. Criteria for re-injection was at least one daily episode of urinary incontinence at BD. Before re-injection, patients were asked if they had reached 6 months of dryness without antimuscarinics (YES response)., Results: Overall, 32/60 (53.4%) "No failure" (NF) group; 16 (26.6%) "occasional failure" (OF) and 12 (20%) "consecutive failure" (CF) were included. A total of 822 BoNT/A infiltrations were performed. The mean interval from previous injection to treatment re-scheduling was 8 months. No significant differences between treatments were found within the three groups (p>0.05). The percentage of YES responses increased from 19% (AboBoNT/A 500IU) to 29 % (OnaBoNT/A 300IU) in NF, and from 18% (AboBoNT/A 500IU) to 25% (OnaBoNT/A 300IU) for OF. Five NF cases (15.6%) maintained 6 months of dryness after each injection. Among the baseline variables, only low compliance (< 20mL/cmH2O) was found as predictor for failure (p=0.006)., Conclusions: Long term BoNT/A for NDO did not increase failures, independent of the types of treatments and switching. Definition of failure and other criteria for continuing repetitive BoNT/A treatment is mandatory. CF was predictable for no response in earlier follow-up., Competing Interests: Conflict of interest: None declared., (Copyright® by the International Brazilian Journal of Urology.)

Aims: Assess the efficacy and safety of abobotulinumtoxinA (Dysport®) in adult patients with neurogenic detrusor overactivity (NDO)., Methods: This Phase IIa, international, multicentre, double-blind, randomised, placebo controlled, pilot study enrolled 47 patients with NDO and urinary incontinence resulting from spinal cord injury (SCI) or multiple sclerosis (MS). Patients were treated with 15 intra-detrusor injections of Dysport 750 U or the equivalent placebo (n = 16 and 7) or 30 injections of Dysport 750 U or the equivalent placebo (n = 17 and 7). Primary endpoint was change from baseline in mean number of daily incontinence episode frequency (IEF) at day 84. Secondary endpoints included change from baseline in urodynamic parameters and quality of life (QOL). A safety assessment was also conducted., Results: Adjusted mean changes from baseline in IEF were -3.2 (-76%) and -1.7 (-15%) for 15 injections Dysport and placebo groups, respectively, (P = 0.1103) and -3.2 (-88%) and -2.6 (-73%) for 30 injections Dysport and placebo groups, respectively, (P = 0.0686). Statistically significant improvements in maximum cystometric capacity, maximum detrusor pressure and volume at first contraction were reported in the Dysport groups compared with placebo (P < 0.05). Improvements in QOL were reported. Three muscle weakness episodes were reported as serious adverse events in two tetraplegic and one paraplegic patient, all in the 15 injections Dysport group., Conclusions: Both 15 and 30 injections administration modes of Dysport decreased daily IEF and resulted in significant improvements in urodynamic parameters in NDO patients with MS or SCI. Reduction to 15 injection sites did not appear to be associated with any impact on efficacy. Neurourol. Urodynam. 36:457-462, 2017. © 2016 Wiley Periodicals, Inc., (© 2016 Wiley Periodicals, Inc.)

Purpose: We developed a consensus on best practice in the real-life management of patients with overactive bladder (OAB) with onabotulinumtoxin A (Onabot/A)., Methods: In March 2015, an interdisciplinary conference was convened. Eleven panelists were invited to review the literature, to present their personal experience and to respond to a number of questions from: "when do we propose Onabot/A treatment" to "when do you decide to re-inject a patient?" A summary of findings of the meeting was provided to all panelists for review and approval., Results: The following statements were agreed. Refractory OAB can be defined based on lack of adherence to first- and second-line treatments for OAB regardless of the underlying cause. Onabot/A treatment can be proposed to refractory OAB patients provided they are willing to perform intermittent catheterization if needed. Before treatment, uroflowmetry with post-void residual evaluation is needed to rule out voiding dysfunction, while urodynamics should be done in cases of complicated OAB wet. Urinary tract infection should be ruled out or treated before the injection. The injection can be performed in the endoscopy room, in an out-patient basis, with local anesthesia. Antibiotic prophylaxis should be initiated with oral drugs. A first follow-up visit should be planned 10-15 days after treatment and residual urine checked. Retreatment can be decided on patients' request, when symptoms worsen., Conclusions: This consensus document provides a guide for the management of refractory OAB patients with Onabot/A in real life. A number of questions about the effectiveness of Onabot/A in real life remain open.

Aims: To present final efficacy/safety results from a prospective, long-term extension trial of onabotulinumtoxinA for urinary incontinence (UI) due to neurogenic detrusor overactivity (NDO); patients received treatment for up to 4 years., Methods: Patients who completed a 52-week, phase III trial of onabotulinumtoxinA for NDO were eligible to enter a 3-year, multicenter, open-label extension study of intradetrusor onabotulinumtoxinA (200U or 300U). Patients were treated "as needed" based on their request and fulfillment of prespecified qualification criteria (≥12 weeks since previous treatment and a UI episode threshold). Assessments included change from study baseline in UI episodes/day (primary efficacy measure), volume/void, and Incontinence Quality of Life (I-QOL) total score (week 6); duration of effect; adverse events (AEs); and initiation of de novo clean intermittent catheterization (CIC). Data are presented for up to six treatments., Results: OnabotulinumtoxinA 200U consistently reduced UI episodes/day; reductions from baseline ranged from -3.2 to -4.1 across six treatments. Volume/void consistently increased, nearly doubling after treatment. I-QOL improvements were consistently greater than twice the minimally important difference (+11 points). Overall median duration of effect was 9.0 months (200U). Results were similar for onabotulinumtoxinA 300U. Most common AEs were urinary tract infections and urinary retention. De novo CIC rates were 29.5, 3.4, and 6.0% (200U), and 43.0, 15.0, and 4.8% (300U) for treatments 1-3, respectively; de novo CIC rates were 0% for treatments 4-6., Conclusions: OnabotulinumtoxinA treatments consistently improve UI, volume/void, and QOL in patients with UI due to NDO in this 4-year study, with no new safety signals. Neurourol. Urodynam. 36:368-375, 2017. © 2015 The Authors. Neurourology and Urodynamics Published by Wiley Periodicals, Inc., (© 2015 The Authors. Neurourology and Urodynamics Published by Wiley Periodicals, Inc.)

Purpose: We assessed the year-to-year consistency of outcomes in patients with urinary incontinence due to neurogenic detrusor overactivity who completed 4 years of onabotulinumtoxinA treatment., Materials and Methods: Eligible patients who completed a 52-week phase 3 trial of onabotulinumtoxinA for urinary incontinence could enter a 3-year open label extension study of onabotulinumtoxinA 200 or 300 U administered as needed for symptom control. This analysis focused on 227 patients who completed the 4-year study. Outcomes assessed by year of treatment included mean treatments per year, mean change from baseline at week 6 in urinary incontinence episodes per day and the I-QOL (Incontinence Quality of Life) total summary score, the proportion of patients with 50% or greater and 100% reductions in urinary incontinence episodes per day, duration of effect and adverse events., Results: Patients reported 4.3 urinary incontinence episodes per day at baseline and received 1.4 to 1.5 onabotulinumtoxinA treatments per year. The decrease in urinary incontinence following onabotulinumtoxinA consistently ranged from -3.4 to -3.9 episodes per day across 4 years. A high proportion of patients achieved 50% or greater and 100% urinary incontinence reductions in each year (range 86.6% to 94.1% and 43.6% to 57.4%, respectively). Consistent and clinically relevant improvements in I-QOL scores were observed in each treatment year. The overall median duration of effect of onabotulinumtoxinA was 9.0 months or greater (range 3.0 to 49.2) and 26.0% or more of patients experienced a duration of effect of 12 months or greater. The most common adverse event was urinary tract infection with no increased incidence with time., Conclusions: Patients with neurogenic detrusor overactivity who completed 4 years of onabotulinumtoxinA treatment experienced a consistent duration of treatment effect and year-to-year improvements in urinary incontinence and quality of life with no new safety signals., (Copyright © 2016 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.)

Study Design: This is an observational prospective noncontrolled study. We enrolled 105 patients affected by neurogenic detrusor overactivity (NDO) who underwent botulinum neurotoxin A (BONT-A) intradetrusor injection and were followed-up for 270 days., Objectives: To investigate the use of oxybutynin after BONT-A administration in NDO patients., Setting: Careggi University Hospital in Florence and Tor Vergata University Hospital in Rome., Methods: Prospective data from two Italian centers were collected in 1 year. Patients showing limited efficacy but good tolerability and adherence to oxybutynin 5 mg three times a day (t.i.d.). were enrolled in the study. Patients received BONT-A intradetrusor injection (onabotulinumtoxinA, 300 U) with a trigone-sparing technique, and the use of oxybutynin was registered at every visit., Results: 105 patients were included. At visit 1, only 30 patients (28.6%) used oxybutynin t.i.d., whereas 47 (45,2%) used a lower dosage and 28 (26.7%) stopped the therapy. At visit 2, 77.3% of patients who had reduced oxybutynin intake, maintained the dosage decided at visit 1. At visit 3, 51.9% returned to oxybutynin t.i.d.; 44.8% were on a reduced dosage and only 3 (2.9%) were not taking the drug. At visit 4, only 37.5% of patients were taking less than oxybutynin t.i.d., Conclusion: This study provides some important insights on the use of oral antimuscarinics in patients treated by means of BONT-A intradetrusor administration for NDO; in particular, it suggests that, after an initial reduction in the use of oxybutynin, patients tend to increase the dosage of this drug during the follow-up after the BONT-A treatment.

Aims: OnabotulinumtoxinA significantly reduces urinary incontinence (UI) and improves bladder management in patients with neurogenic detrusor overactivity (NDO). We evaluated the impact of onabotulinumtoxinA on patient-reported outcomes (PROs) in patients with UI due to NDO in a double-blind, placebo-controlled study., Methods: Patients with UI due to NDO (from multiple sclerosis or spinal cord injury) were randomized to intradetrusor placebo (n = 92) or onabotulinumtoxinA 200 U (n = 92) or 300 U (n = 91). PROs included Incontinence Quality of Life (I-QOL) Questionnaire to assess health-related quality of life (HRQoL), the 16-item modified Overactive Bladder-Patient Satisfaction with Treatment Questionnaire (OAB-PSTQ) to assess treatment satisfaction, and Patient Global Assessment to assess treatment goal achievement., Results: Mean improvement in I-QOL total score at weeks 6 and 12 was significantly greater with both onabotulinumtoxinA 200 U and 300 U versus placebo (Δ12.3 for 200 U and Δ14.9 for 300 U vs. placebo; P < 0.001), and was clinically meaningful. For those patients who completed the OAB-PSTQ, improvement in satisfaction at weeks 6 and 12 was significantly greater for onabotulinumtoxinA versus placebo (P < 0.001, all comparisons). At 6 weeks, greater proportions of onabotulinumtoxinA-treated patients than placebo reported being somewhat or very satisfied (200 U, 77.5% and 300 U, 67.8% vs. placebo, 39.5%), and significant progress toward or complete achievement of primary treatment goal (200 U, 62.9% and 300 U, 61.6% vs. placebo, 16.5%)., Conclusions: NDO patients treated with onabotulinumtoxinA 200 or 300 U had significantly greater improvement in HRQoL and greater treatment satisfaction compared with placebo-treated patients, with no clinically relevant differences between onabotulinumtoxinA doses., (Copyright © 2012 Wiley Periodicals, Inc.)

Objective: Determine long-term effect of English botulinum neurotoxin type A (BoNTA; Dysport) for refractory neurogenic detrusor overactivity (NDO) for possible reduction of BoNTA efficacy after repeated injections., Methods: Between 1999 and 2005, 199 patients with spinal cord lesions with refractory NDO were treated with Dysport. All patients underwent a clinical examination, urinalysis, and videourodynamic study at baseline and at 3, 6, and 12 mo after each treatment, as well as a visual analogue scale (VAS) assessment and a bladder diary checked for 1 wk before each visit. We used 1000, 750, 500 IU BoNTA at the beginning of our experience, and thereafter we mainly used 750 IU. Outcome measures included frequency of urge urinary incontinence (Incontinence Episode Frequency [IEF] test); urodynamic parameters including maximum cystometric bladder capacity (MCBC), reflex volume (RV), bladder compliance (BC); number of pads/condoms; antimuscarinic drug consumption; short- and long-term side-effects; and quality of life measured with VAS., Results: No statistically significant differences were found in efficacy duration with the three Dysport doses (p=0.5274). The difference between the intervals of injections was not statistically significant (p=0.2659). MCBC, RV, and BC improved significantly after treatment compared with baseline values (p<0.001) and there were no statistically significant differences after each retreatment or regarding Dysport dose (p>0.05). There was a significant improvement in patient satisfaction after each retreatment as expressed on the VAS (p<0.001). There was a significant reduction in IEF score and pads/condoms use in the first 4 wk after each treatment (p<0.0001)., Conclusion: After repeated injections the effect of BoNTA remained constant.

Objectives: To present a comprehensive experience with botulinum-A toxin (BTA) injected into the detrusor muscle in patients with spinal cord injuries/diseases causing neurogenic incontinence., Methods: Ten European medical centers provided the results of 231 patients with neurogenic detrusor overactivity who were treated with BTA. 300 units of Botox (Allergan Inc.) were injected cystoscopically into the detrusor muscle at 30 different locations, while sparing the trigonum. Urinary continence status, concomitant anticholinergic medication use and patient satisfaction were recorded. Key urodynamic parameters (reflex volume, maximum detrusor pressure during voiding, detrusor compliance and maximum cystometric bladder capacity) at baseline and at the first and second urodynamic follow-up examinations were analyzed., Results: By the time of the initial (mean 12 weeks after injection) as well as at the second urodynamic follow-up examinations (mean 36 weeks after injection), the mean cystometric bladder capacity (p < 0.0001) and the mean reflex volume (p < 0.01) increased significantly, while the mean voiding pressure (p < 0.0001) decreased significantly. The mean bladder compliance had increased significantly (p < 0.0001) by the first follow-up examination and non-significantly by the time of the second follow-up. No injection related complications or toxin related side effects were reported. The patients considerably reduced or even stopped taking anticholinergic drugs without recurrence of reflex incontinence and were satisfied with the treatment., Conclusions: This retrospective European multicenter study presents the most extensive experience to date with BTA injections into the detrusor muscle to treat neurogenic incontinence due to detrusor overactivity and confirms that this new treatment is safe and valuable. Significant improvement of bladder function corresponds with continence and the subjective satisfaction indicated by the treated patients.