Treatment of Primary Axillary Hyperhidrosis with Two Doses of Botulinum Toxin A-Observational Study.

Hyperhidrosis (HH) is defined as the production of more sweat than is necessary for its thermoregulatory function, negatively affecting patients' quality of life and interfering with their social, work and family life. In this context, the aim of thisstudy was to evaluate the efficacy of two different doses of botulinum toxin type A (50 or 100 units) in each axilla in severe primary axillary hyperhidrosis. A descriptive, observational, cross-sectional and post-authorisation study was conducted onpatients referred to our department.Thirty-one patients with severe primary axillary hyperhidrosis were included, some of whom received more than one infiltration during the follow-up period, performing a total of 82 procedures. They were assigned by simple random sampling to two types of treatment: infiltration of 50 or 100 units (U) of botulinum toxin A per axilla.Hyperhidrosis severity was assessed using the Hyperhidrosis Disease Severity Scale (HDSS), and quality of life was assessed using the Dermatology Life Quality Index (DLQI) questionnaire. Onabotulinum toxin A infiltration reduced the severity of hyperhidrosis and improved the quality of life of the treated patients, with no significant differences between the two groups.

Intradetrusor Versus Suburothelial Onabotulinum Toxin A in Adults with Neurogenic and Non-neurogenic Overactive Bladder Syndrome: A Meta-Analysis.

PURPOSE: This systematic review and meta-analysis aimed to compare the effectiveness and safety of submucosal injection of onabotulinum toxin A (OnabotA) with intradetrusor injection for overactive bladder syndrome (OAB). METHODS: This systematic review is registered with PROSPERO (CRD42021237964). A licensed librarian surveyed Medline, EMBASE, Scopus, and Google Scholar databases to conduct a comprehensive search. Studies comparing suburothelial and intradetrusor techniques of OnabotA injection for OAB were included, along with clinical and urodynamic variables and complications. The studies were assessed for quality on the basis of Cochrane Collaboration guidelines and evaluated using statistical analysis via a random-effect model and I2 statistic. Data extraction and analysis were conducted using Covidence systematic review platform and Review Manager software. RESULTS: Six studies with 299 patients were included in the systematic review, with four reporting that suburothelial injection of OnabotA was as effective as intradetrusor injection and two reporting intradetrusor injection to be more effective. The meta-analysis found no significant difference between the suburothelial and intradetrusor groups for mean daily catheter or voiding frequency (mean difference: 2.12 [95% confidence interval (CI): -1.61, 5.84]) and the mean number of urgency/urge incontinence episodes (mean difference: 0.08 [95% CI: -1.42, 1.57]). However, a significant heterogeneity was found among the studies. Only the mean volume at first detrusor contraction showed a significant difference, being higher for suburothelial injection (mean difference: 33.39 [95% CI: 0.16, 66.63]). No significant difference was noted for mean compliance, mean bladder capacity, and mean maximum detrusor pressure. Urinary tract infections (UTIs) (p = 0.24) and acute urinary retention (p = 0.92) showed no significant difference between the two groups. The risk of bias varied among the studies. CONCLUSIONS: Suburothelial injection of OnabotA is as effective as intradetrusor injection in improving OAB symptoms, and it has similar complication rates. A higher mean volume of the first detrusor contraction was found in a urodynamic study with suburothelial injection.

Reducing the Impact of Headache and Allodynia Score in Chronic Migraine: An Exploratory Analysis from the Real-World Effectiveness of Anti-CGRP Monoclonal Antibodies Compared to Onabotulinum Toxin A (RAMO) Study.

BACKGROUND: Chronic migraine (CM) is a disabling and hard-to-treat condition, associated with high disability and high cost. Among the preventive treatments, botulinum toxin A (BoNT-a) and monoclonal antibodies against the calcitonin gene-related protein (anti-CGRP mAbs) are the only disease-specific ones. The assessment of the disease burden is complex, and among others, tools such as the allodynia symptoms checklist (ASC-12) and headache impact test (HIT-6) are very useful. This exploratory study analysed the impact of these two therapies on migraine burden. METHODS: The RAMO study was a multicentre, observational, retrospective investigation conducted in two headache centres: the Fondazione IRCCS Istituto Neurologico Carlo Besta (Milan) and the Fondazione Policlinico Campus Bio-Medico (Rome). This study involved patients with chronic migraine treated with mAbs or BoNT-A. We conducted a subgroup exploratory analysis on HIT-6 and ASC-12 scores in the two groups. The Wilcoxon rank-sum test, Fisher's exact test, and ANOVA were performed. RESULTS: Of 126 patients, 36 on mAbs and 90 on BoNT-A had at least one available follow-up. mAbs resulted in a mean reduction of -11.1 and -11.4 points, respectively, in the HIT-6 at 6 and 12 months, while BoNT-A was reduced -3.2 and -3.6 points, respectively; the mAbs arm resulted in mean reductions in ASC-12 at 6 and 12 months of follow-up of -5.2 and -6.0 points, respectively, while BoNT-A showed lesser mean changes of -0.5 and -0.9 points, respectively. The adjusted analysis confirmed our results. CONCLUSIONS: In this exploratory analysis, anti-CGRP mAbs showed superior effectiveness for HIT-6 and ASC12 compared to BoNT-A. Reductions in terms of month headache days (MHD), migraine disability assessment test (MIDAS), and migraine acute medications (MAM) were clinically relevant for both treatments.

A Discrete Mathematics Approach for Understanding Risk Factors in Overactive Bladder Treatment.

Introduction Discrete mathematics, a branch of mathematics that includes graph theory, combinatorics, and logic, focuses on discrete mathematical structures. Its application in the medical field, particularly in analyzing patterns in patient data and optimizing treatment methods, is invaluable. This study, focusing on post-void residual (PVR) urine following overactive bladder (OAB) treatment, utilized discrete mathematics techniques to analyze PVR and its associated risk factors. Methods A retrospective study was conducted on 128 OAB patients who received intradetrusor onabotulinum toxin A injections between 2020 and 2022. Network graphs based on graph theory were used to analyze correlations between clinical variables, and clustering analysis was performed with PVR as the primary variable. Results The network graph analysis revealed that frailty, daytime frequency, and nocturia episodes were closely related to PVR. Clustering analysis with PVR as the primary variable divided the patients into three groups, suggesting that the group with particularly high frailty (Cluster 1) is at high risk for PVR. Moreover, significant differences in clinical indicators such as age, voiding efficiency, Overactive Bladder Symptom Score, and International Consultation on Incontinence Questionnaire-Short Form were observed in the remaining two clusters (Cluster 0 and 2). Conclusion This study demonstrates the effectiveness of discrete mathematics methods in identifying risk factors for PVR after OAB treatment and in distinguishing clinical subgroups based on patient characteristics. This approach could contribute to the formulation of individualized treatment strategies and the improvement of patient care quality. Further development and clinical application of this methodology are expected in future research.

A Retrospective Comparison of Onabotulinum Toxin A and Incobotulinum Toxin A in Terms of Efficacy, Tolerability, Duration of Effect, and Pain on Injection Administration Site for the Treatment of Chronic Migraine.

Background Onabotulinum toxin A (OnA) is a well-tolerated and effective treatment for chronic migraine (CM). However, based on research indications that incobotulinum toxin A (InA) would be equally effective, a Veterans Health Administration medical center mandated a two-year trial of InA as a more cost-effective alternative to OnA. Although InA is used for many similar indications as OnA, it is not Food and Drug Administration-approved for treating CM, and complications occurred in several patients with CM following this treatment change. We conducted this retrospective analysis to evaluate differences in the efficacy of OnA and InA and identify the reasons for the adverse effects of InA in some of these patients. Methods We performed a retrospective review of 42 patients who had been effectively treated with OnA and were then switched to InA. The differences between treatment responses to OnA and InA were assessed through the evaluation of pain on injection, number of headache days, and duration of action. Patients received injections at 10- to 13-week intervals. Those who reported severe pain on injection of InA were switched back to OnA. Results Severe burning pain on InA injection was reported by 38% of patients (nine males and seven females, i.e., a total of 16 patients out of 42 patients). One male patient reported the same degree of pain from both InA and OnA injections. A total of 66.7% of women with obesity and 83.3% of men with obesity or diabetes experienced severe pain on injection. Neither migraine suppression nor the duration of effect was significantly different between OnA and InA. Conclusions OnA is better tolerated than InA in the treatment of CM. InA appears to effectively suppress migraines, but some patients complain of a severe localized burning sensation during the injections. Some of these patients, all of whom were previously treated with OnA, requested to switch back to OnA. This suggested that InA is not equivalent to OnA in terms of tolerability and effectiveness. The present study found 2.38% of patients experienced an insufficient duration of effect with InA, and none with OnA. However, these lower rates may, in part, be due to variability in injection intervals in this sample, which could be because of scheduling considerations at the Harry S. Truman Veterans Health Administration Medical Center. In cases where OnA fails because of the development of antibodies, it might be reasonable to switch to InA treatment. Reformulation of InA with a pH-buffered solution may eliminate the difference in pain on injection. InA would then be a good alternative to OnA for treating CM.

Investigation of intradetrusor onabotulinum toxin A efficacy and safety in older adults with urge urinary incontinence.

PURPOSE: Intradetrusor onabotulinum toxin A (BTX-A) has been demonstrated to be an effective treatment option for overactive bladder (OAB). However, concerns about frailty and frequent injections may deter its use in the elderly. This study aims to assess the safety, efficacy, and treatment duration of BTX-A in managing OAB in elderly women. METHODS: We retrospectively reviewed female patients aged 70 and above who were diagnosed with OAB with predominant urge urinary incontinence and underwent intravesical BTX-A treatment. We collected demographic and clinical data, with repeat BTX-A injections re-administered upon patient-reported symptom recurrence. RESULTS: Twenty-one female patients, median age 77 (range 71-92), were included. The median time between the first and second injection was 185 (84-448) days, 186 (105-959) days between the second and third injection, and increased to 206.5 (84-256) days between the third and fourth injection. However, the median interval trended downward after the fourth injection (Fig. 1). Patients with four or more injections had a shorter median interval between injections, 154 days, compared to those with fewer injections, 210 days. Two patients (6.9%) experienced urinary retention after the initial treatment, with 1 (2.2%) among a total of 46 subsequent treatments (Table 3). There were ten (13.3%) episodes of UTIs within 2 weeks of treatment. Patients reported improvement in symptoms following 93.3% of the injections. CONCLUSION: This real-world study demonstrates that BTX-A effectively controls OAB symptoms in elderly women, with just two injections annually. BTX-A appears safe and efficacious for treating OAB in elderly females.

Laryngeal dystonia: Phenomenology, genetics, and management.

Laryngeal dystonia is a task-specific movement disorder causing abnormal movement of the adductor or abductor muscles of the vocal folds. In 1984, Blitzer pioneered the first use of onabotulinum toxin A to treat this disorder. Over 1400 patients were diagnosed with laryngeal dystonia in the last thirty years. In this paper, we summarize their clinical and endoscopic findings as well as treatment results. We also summarize the underlying genetics of the disorder. 82% of patients were diagnosed with adductor type laryngeal dystonia and 17% of patients manifested an abductor laryngeal dystonia. Patients with adductor dystonia were treated with toxin to the thyroarytenoid muscles and those with abductor dystonia were treated with toxin to the posterior cricoarytenoid muscle. All patient achieved greater than 70% improvement in percent normal function. Laryngeal dystonia is a rare movement disorder of the larynx with an incidence of approximately 35.1 per 100,000 individuals (Simonyan et al., 2021). Presently, there is no cure for laryngeal dystonia, but botulinum toxin has shown significant success in treating the symptoms of the disorder.

Hypersensitivity Reactions Following Onabotulinum Toxin A Touch-up Injection Possibly Associated with Covid-19 Infection.

As one of the most common cosmetic procedures, botulinum toxin A (BTX-A) injections are basically safe. The typical allergic reactions include erythema, edema, pruritus, and wheal, which generally occur at the initial injection. Herein, we reported two cases of hypersensitivity reactions following cosmetic BTX-A touch-up injection. Type I allergic reactions provoked by re-exposure to the excipients such as gelatin may play a role in the event. In addition, this condition may be associated with the preceding Covid-19 infection, even with complete symptoms remission and negative tests results. Noteworthily, one case developed anaphylactic symptoms resembling purpuric drug eruption (PDE). These cases may serve as a significant complement to the botulinum toxin treatment safety profiles. LEVEL OF EVIDENCE V: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

Retrograde Cricopharyngeus Dysfunction effectively treated with low dose botulinum toxin. A case report from Italy.

A large constellation of hitherto unexplained symptoms including inability to burp, gurgling noises from the chest and lower neck, abdominal bloating, flatulence, painful hiccups and emetophobia was defined as Retrograde Cricopharyngeus Dysfunction (R-CPD) in 2019. First choice treatment of R-CPD involves injection of botulinum toxin into the cricopharyngeus muscle under local or general anesthesia. This treatment has been found to be effective in the vast majority of subjects, with limited adverse events and prolonged therapeutic effects. Notwithstanding, R-CPD is still a poorly understood and underestimated disease, and a specific therapeutic dosage range of botulinum toxin (BT) has not been yet established. In this report, we describe the first case of R-CPD diagnosed in Italy, successfully treated with unilateral, anesthesia-free injection of 10 units of onabotulinum toxin into the cricopharyngeus muscle, representing the lowest dose reported to date.

Botulinum Toxin for Pediatric Migraine: A Retrospective Multisite Cohort Study.

BACKGROUND: Onabotulinum toxin A is effective in adult chronic migraine, but the efficacy is not well established in adolescent patients. The objective of this study is to describe the safety and efficacy of onabotulinum toxin A and incobotulinum toxin A for adolescent chronic migraine headache. METHODS: We performed a chart review of adolescents who received onabotulinum toxin A or incobotulinum toxin A for headache prevention. Demographic information and baseline headache characteristics were collected. The primary end point was a 50% reduction in headache frequency. Secondary outcome measures included reduction in headache frequency, repeat appointments for injections, reduction in other migraine medications, and adverse events. RESULTS: We included 51 adolescents who received at least one injection of either incobotulinum toxin A or onabotulinum toxin A for chronic migraine. Mean age at first dose was 16.0 (1.1; 13 to 17), (S.D. and range). Patients averaged 24.0 headache days per month (7.6; 4 to 28), (S.D. and range) before injection. In addition, 36 of the 51 adolescents (71%) were experiencing continuous headaches. Thirty-five (69%) adolescents had experienced 50% reduction in headache days by the time of first follow-up, which occurred on average at 16.6 weeks from initial injection (11.5; 2 to 55.7) (S.D. and range). Adolescents reported an average decrease of 13.1 headaches days per month. Only two adolescents reported side effects (4%), which were neck soreness and headache following injection. CONCLUSIONS: Botulinum toxin had better efficacy in our adolescent migraine population than has been demonstrated in other studies.

Experience of treatment of chronic migraine with botulinum toxin type A among aesthetic medicine professionals in Poland.

INTRODUCTION: This study aimed to evaluate the knowledge and standard of treatment of chronic migraine with botulinum toxin by Polish aesthetic medicine professionals. RATIONALE FOR THE STUDY: Onabotulinum toxin A injections are used as a preventive treatment for chronic migraine. Besides neurologists, healthcare professionals of multiple specialisms can offer this treatment. Aesthetic medicine professionals commonly use the treatment to extend the scope of their practice. This may bring about a situation wherein physicians with different levels of experience and training are providing botulinum toxin injections for chronic migraine. MATERIAL AND METHODS: An online survey asking about patient qualification procedures, the level of adherence to the PREEMPT paradigm, product-, technique-, dosing-, and treatment intervals-related aspects of the treatment, efficacy evaluation practices and concerns about the use of botulinum toxin in chronic migraine was sent to 110 Polish physicians practicing aesthetic medicine. RESULTS: The response rate was 73.6%. The results of the survey revealed multiple deviations from the current paradigm of treatment of chronic migraine with botulinum toxin, from improper patient qualification through treatment procedure to the evaluation of the efficacy. Only around one-third of professionals evaluated the observed effectiveness of therapy as very good. Most respondents wanted to expand their knowledge and skills in chronic migraine treatment. CONCLUSIONS: There is a considerable willingness among aesthetic medicine specialists to treat patients with chronic migraine with botulinum toxin. The current levels of knowledge and skills in this treatment are limited, and multiple physicians declared deviations from the diagnostic criteria and the therapeutic protocol. Transferring aesthetic medicine practices to neurology treatment is common and may result in a lack of effectiveness of treatment or even intensification of symptoms. An appropriate educational programme should be implemented for all physicians authorised to administer BoNT-A in Poland.

Sex and Gender Differences in the Pharmacology of the Overactive Urinary Bladder.

Dysfunction of the lower urinary tract in general and the overactive bladder syndrome (OAB) in particular are prevalent and have major impact on the quality of life of the afflicted patients and their partners. We concisely review sex and gender differences in patients and animal models in physiological bladder function, its alterations in disease (mostly OAB), and its responses to treatment. Women appear to have a smaller functional bladder capacity and, therefore, must void more often than men. On the other hand, men have a greater bladder outlet resistance, which is partly attributed to a longer urethra and partly to the presence of the prostate. Sex and gender differences in bladder contractility appear small and were not found consistently. The ability of bladder smooth muscle to relax may be somewhat smaller in females. However, females are heavily underrepresented in experimental studies on bladder function. Stress urinary incontinence is found predominantly in women (particularly those after childbirth). OAB is similarly prevalent in men and women. Females seek treatment much more often and are overrepresented in clinical trials. Treatment responses in OAB patients are similar in both genders for oral medications, but improvements upon injections of onabotulinum toxin type A appear smaller in men. We conclude that there is no evidence for major sex and gender differences in bladder dysfunction as related to OAB and its treatment responses, but female animals are heavily underrepresented in experimental studies.

What Are the Short-term Benefits and Potential Harms of Therapeutic Modalities for the Management of Overactive Bladder Syndrome in Women? A Review of Evidence Under the Auspices of the European Association of Urology, Female Non-neurogenic Lower Urinary Tract Symptoms Guidelines Panel.

CONTEXT: Overactive bladder syndrome (OAB) is highly prevalent among women and has a negative impact on their quality of life. The current available treatments for OAB symptoms include conservative, pharmacological, or surgical modalities. OBJECTIVE: To provide an updated contemporary evidence document regarding OAB treatment options and determine the short-term effectiveness, safety, and potential harms of the available treatment modalities for women with OAB syndrome. EVIDENCE ACQUISITION: The Medline, Embase, and Cochrane controlled trial databases and clinicaltrial.gov were searched for all relevant publications up to May 2022. The risk of bias assessment followed the recommended tool in the Cochrane Handbook for Systematic Reviews of Interventions, and quality of evidence was assessed using the modified Grading of Recommendations Assessment, Development, and Evaluation (GRADE) criteria. A meta-analysis was performed where appropriate. EVIDENCE SYNTHESIS: Antimuscarinics and beta-3 agonists were significantly more effective than placebo across most outcomes, with beta-3 agonists being more effective at reducing nocturia episodes and antimuscarinics causing significantly higher adverse events. Onabotulinumtoxin-A (Onabot-A) was more effective than placebo across most outcomes, but with significantly higher rates of acute urinary retention/clean intermittent self-catheterisation (six to eight times) and urinary tract infections (UTIs; two to three times). Onabot-A was also significantly better than antimuscarinics in the cure of urgency urinary incontinence (UUI) but not in the reduction of mean UUI episodes. Success rates of sacral nerve stimulation (SNS) were significantly higher than those of antimuscarinics (61% vs 42%, p = 0.02), with similar rates of adverse events. SNS and Onabot-A were not significantly different in efficacy outcomes. Satisfaction rates were higher with Onabot-A, but with a higher rate of recurrent UTIs (24% vs 10%). SNS was associated with 9% removal rate and 3% revision rate. CONCLUSIONS: Overactive bladder is a manageable condition, with first-line treatment options including antimuscarinics, beta-3 agonists, and posterior tibial nerve stimulation. Second-line options include Onabot-A bladder injections or SNS. The choice of therapies should be guided by individual patient factors. PATIENT SUMMARY: Overactive bladder is a manageable condition. All patients should be informed and advised on conservative treatment measures in the first instance. The first-line treatment options for its management include antimuscarinics or beta-3 agonists medication, and posterior tibial nerve stimulation procedures. The second-line options include onabotulinumtoxin-A bladder injections or sacral nerve stimulation procedure. The therapy should be chosen based on individual patient factors.

Onabotulinum Toxin A Intradetrusor Injections in Children with Neurogenic Lower Urinary Tract Dysfunction: Long-Term Histological Effects on the Bladder Wall.

BACKGROUND: In the last twenty-five years, Onabotulinum Toxin A (BTX-A) has gained increasing popularity for neurogenic lower urinary tract dysfunction (NLUTD) treatment. To maintain its efficacy, repeated BTX-A intradetrusor injections are required over time, with unknown effects on the bladder wall in children. The aim of this paper is to report long-term effects on the bladder wall in children treated with BTX-A. METHODS: Children with NLUTD not responsive to anticholinergics were treated with BTX-A, according to our protocol, with bladder wall control using endoscopic cold-cup biopsy. Specimens were evaluated considering edema, chronic inflammation, and fibrosis. RESULTS: Of the 230 patients treated from 1997 to 2022, we considered only specimens obtained in patients who had received ≥5 treatments (36 children), considered as the threshold to evaluate clinical effectiveness on long-term treatment with BTX-A. Most of them had congenital NLUTD (25 patients) and detrusor overactivity (27 patients). In all, increased edema and chronic inflammation with reduced fibrosis over time was reported; these data were not statistically significant. No difference was observed between patients with congenital and acquired diseases. CONCLUSIONS: Repeated intradetrusor BTX-A injections are not related to significant histological alterations in children, similarly with adults, and repeated injections could be considered safe.

Onabotulinum toxin A vs. incobotulinum toxin A for the treatment of chronic migraine: a retrospective review.

Background: Onabotulinum toxin A (OnA) is a well-tolerated and effective treatment for chronic migraine (CM). However, based on research indications that incobotulinum toxin A (InA) would be equally effective, a Veterans' Health Administration Medical Center mandated a 2-year trial of InA as more cost-effective alternative to OnA. Although InA is used for many similar indications as OnA, it is not Food and Drug Administration approved for treating CM, and complications occurred in several patients with CM following this treatment change. We conducted this retrospective analysis to evaluate differences in the efficacy of OnA and InA and identify the reasons for the adverse effects of InA in some of these patients. Methods: We performed a retrospective review of 42 patients who had been effectively treated with OnA and were then switched to InA. The differences between treatment responses to OnA and InA were assessed through the evaluation of pain on injection, number of headache days, and duration of action. Patients received injections at 10- to 13-week intervals. Those who reported excessive pain on injection of InA were switched back to OnA. Findings: Severe burning pain on injection was reported by 16 (38%) patients for InA only and by 1 (2%) patient for both InA and OnA. Neither migraine suppression nor the duration of effect was significantly different between OnA and InA. Conclusions: Reformulation of InA with a pH-buffered solution may eliminate the difference in pain on injection. InA would then be a good alternative to OnA for treating CM.

Urethral Sphincter Botulinum Toxin A Injection for Non-Spinal Cord Injured Patients with Voiding Dysfunction without Anatomical Obstructions: Which Patients Benefit Most?

OBJECTIVE: Treating voiding dysfunction without anatomical obstructions is challenging. Urethral onabotulinum toxin A (BoNT-A) is used in treating voiding dysfunction; however, the success rate varies widely, and patients may not be satisfied with the treatment outcome. This study compared the efficacy of the urethral BoNT-A injection between patients with different non-spinal cord injury (SCI) voiding dysfunctions. MATERIALS AND METHODS: This study retrospectively analyzed patients with refractory voiding dysfunction, including detrusor underactivity (DU), dysfunctional voiding (DV), and poor relaxation of the external sphincter (PRES) who received the urethral sphincter 100 U BoNT-A injection. The treatment outcomes were assessed via a global response assessment (GRA) one month after treatment. Baseline and follow-up videourodynamic study (VUDS) parameters were also compared. RESULTS: Totally, 161 patients (60 with DU, 77 with DV, and 24 with PRES) with a mean age of 58.8 ± 20.2 were enrolled, of which 62.1% had a good response (GRA ≥ 2) after urethral BoNT-A injection. DV patients had a higher success rate (76.6%) than DU (50%) and PRES (45.8%) patients (p = 0.002). A diagnosis of DV, higher voided volume and recurrent urinary tract infection were predictors of a good treatment response, while the cervical cancer status post-radical surgery predicted a poor response. Receiver operating characteristic (ROC) curve analyses identified PVR > 250 mL as a negative predictor (p = 0.008) in DU patients. CONCLUSIONS: The urethral BoNT-A injection provides a satisfactory success rate for non-SCI voiding dysfunction. Patients with DV benefit most from both subjective and objective parameters. Approximately 50% of patients with DU and PRES also had a fair response. PVR > 250 mL was a negative predictor in DU patients.

Long-term Safety and Tolerability of Repeated Treatments With OnabotulinumtoxinA in Children With Neurogenic Detrusor Overactivity.

PURPOSE: OnabotulinumtoxinA is an approved treatment for neurogenic detrusor overactivity in adults inadequately managed with anticholinergics, and more recently was approved in children on the basis of a phase 3, 48-week, single-treatment study (NCT01852045). Given the paucity of long-term pediatric data, we report on the continued safety in these patients after repeated onabotulinumtoxinA treatment. MATERIALS AND METHODS: This was a multicenter, double-blind, repeat-treatment extension study (NCT01852058) in patients who entered from the preceding single-treatment study. Data were integrated across both studies. All patients (5-17 years) used clean intermittent catheterization and could receive dose escalations based on response to preceding treatment (50 U, 100 U, or 200 U onabotulinumtoxinA [not to exceed 6 U/kg]). RESULTS: Overall, 95, 90, 55, and 11 patients received 1, 2, 3, and 4 treatments with onabotulinumtoxinA, respectively, and median (quartiles) duration of follow-up was 82 (65, 94) weeks. The safety profile was similar across doses and after repeat treatments. The most common treatment-emergent adverse event during cycles 1, 2, and 3 was urinary tract infection (31%, 34%, 22%). Three serious treatment-emergent adverse events related to study treatment (3/95; 3.2%) were reported during the study, which were all cases of urinary tract infection. Annualized urinary tract infection rates post-treatment were similar to pre-screening rates. There were no cases of autonomic dysreflexia, neutralizing antibodies, and treatment-emergent adverse events related to distant spread of toxin. CONCLUSIONS: OnabotulinumtoxinA continued to be well tolerated after repeated treatments in pediatric neurogenic detrusor overactivity patients with similar safety profiles across dose groups. Treatment-emergent adverse events were primarily urological with no new safety concerns.

Quality of Life in Female Patients with Overactive Bladder after Botulinum Toxin Treatment.

BACKGROUND: Manifestations of OAB can considerably diminish the quality of life. Botulinum toxin has emerged as a valuable treatment option in diseases whose symptoms cannot be controlled adequately with other available therapies. The aim of the present study was to compare the subjective quality of life of patients with OAB before the injection of botulinum toxin and three and six months after the intervention. METHODS: This study was based on a diagnostic survey with three validated questionnaires, ICIQ-OAB, ICIQ-OABqol, and ICIQ-LUTSqol, and an additional questionnaire developed by the authors to collect sociodemographic characteristics and selected medical data. RESULTS: This study demonstrated significant differences between pre-treatment scores and those at three and six months post injection. At three and six months after the intervention, mean scores for all three instruments (ICIQ-OAB, ICIQ-OABqol, ICIQ-LUTSqol) were significantly lower than the respective pre-treatment values, implying a significant attenuation of OAB symptoms and their lower impact on the quality of life. However, the severity of OAB symptoms and their impact on the quality of life at six months post intervention were significantly higher than at three months, except for the social interaction domain. CONCLUSIONS: Botulinum toxin is an effective treatment for OAB.

Efficacy of Onabotulinum Toxin A on Obsessive-Compulsive Traits in a Population of Chronic Migraine Patients.

BACKGROUND: Drug addiction may play an important role in chronic migraine (CM) with medication-overuse headache (MOH). Psychiatric diseases are associated with CM, but data regarding obsessive-compulsive disorder (OCD) are lacking. We aimed to establish the prevalence of OCD traits in CM patients with MOH and the impact on onabotulinum toxin A (OBT-A) treatment. METHODS: A total of 75 patients with CM and MOH undergoing treatment with OBT-A in our Headache Centre were evaluated. At baseline and after four injection sessions, we assessed the migraine burden and the presence of OCD traits with the Obsessive-Compulsive Inventory-Revised (OCI-R) test. RESULTS: At baseline, 28% of patients had OCI-R scores compatible with borderline OCD aspects, while 22.7% were pathological. An improvement in headache was significantly associated with an increase in the number of subjects with a normal OCI-R score at T0 and T1, whereas patients with a pathological OCI-R score at T0 showed a significantly higher prevalence of CM at T1. CONCLUSIONS: Our data showed a significant rate of OCD traits at baseline, which could strengthen the hypothesis of an addictive disorder underlying CM with MOH. OCD traits seem to influence the OBT-A response. An OCD assessment could be useful in improving patients' selections before starting treatments.

Effect of Intratrigonal Botulinum Toxin in Patients with Bladder Pain Syndrome/Interstitial Cystitis: A Long-Term, Single-Center Study in Real-Life Conditions.

The high percentage of treatment failures seen in patients with bladder pain syndrome/interstitial cystitis (BPS/IC) managed conservatively frequently demands invasive treatment options. We aimed to evaluate the long-term efficacy and adverse events of intratrigonal botulinum toxin injection in such circumstances, as well as to determine possible predictors of response to toxin treatment. A retrospective cohort study included 47 female BPS/IC patients treated with onabotulinum toxin A (OnabotA) in a tertiary hospital between the years 2009 and 2022. All patients received 100 U of OnabotA in ten injections limited to the trigonal area. Patients were divided into three groups based on their treatment response as responders, non-responders and lost to follow-up due to non-medical reasons. The clinical and surgical records of the individuals were retrieved, including the 10-point visual analogue scale (VAS), the number of treatments, the time between injections, and the age at the first injection. A total of 25 patients (>50% of the cohort) were long-term responders, but none of the evaluated parameters was a predictor for this circumstance: age, pain intensity, or duration of improvement following the injection. The time between injections was stable (around 1 year). No severe adverse events were registered. The intratrigonal injection of botulinum toxin in patients with BPS/IC was an effective and safe long-term treatment for patients' refractory to conservative forms of treatment. Age, basal pain intensity, and time to injection request did not predict long-term response to OnaBotA.