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INTRODUCTION: Overactive bladder (OAB) affects approximately 500 million people worldwide, with a higher prevalence in women than in men, significantly impacting the quality of life of female patients. Treatment options for OAB are currently limited. Previous research has proposed that electroacupuncture could be a viable treatment for OAB in women, but there is a lack of high-quality clinical evidence. This study aims to evaluate the effectiveness of electroacupuncture as a safe and efficient non-pharmacological treatment for female OAB by comparing it with solifenacin succinate. METHODS AND ANALYSIS: This study is a multicentre, single-blind, double-dummy randomised controlled non-inferiority clinical trial involving 204 eligible female participants with OAB. Participants will be randomly assigned in a 1:1 ratio to either the electroacupuncture group (receiving electroacupuncture and placebo) or the solifenacin succinate group (receiving sham electroacupuncture and solifenacin succinate). Each participant will undergo 12 sessions of electroacupuncture (or sham electroacupuncture) treatment and solifenacin succinate (or placebo) treatment over a 4-week period. The primary outcome measure will be the percentage change in the number of micturition episodes every 24 hours at week 4 compared with baseline. Secondary outcomes will include a percentage reduction in the number of micturition episodes every 24 hours at 2th, 8th and 16th weeks of the trial, Overactive Bladder Symptom Score, number of urinary incontinence and urgency episodes every 24 hours based on a 3-day voiding diary, OAB Questionnaire, Generalised Anxiety Disorder Scale-7, King's Health Questionnaire and Participant Self-evaluation of Therapeutic Effects. Adverse events will be monitored throughout the study. Efficacy analyses will be conducted on both the intention-to-treat population and the per-protocol set population. ETHICS AND DISSEMINATION: Ethical approval has been obtained from the Medical Ethics Committee of Longhua Hospital Shanghai University of Traditional Chinese Medicine (approval number: 2022LCSY097). Each participant will sign a written informed consent before randomisation. The results of this study will be published in a peer-reviewed journal. TRIAL REGISTRATION NUMBER : NCT05798403.
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Electroacupuntura , Antagonistas Muscarínicos , Succinato de Solifenacina , Vejiga Urinaria Hiperactiva , Humanos , Succinato de Solifenacina/uso terapéutico , Vejiga Urinaria Hiperactiva/terapia , Vejiga Urinaria Hiperactiva/tratamiento farmacológico , Femenino , Electroacupuntura/métodos , Antagonistas Muscarínicos/uso terapéutico , Adulto , Persona de Mediana Edad , Calidad de Vida , Método Simple Ciego , Estudios Multicéntricos como Asunto , Resultado del Tratamiento , Estudios de Equivalencia como Asunto , Agentes Urológicos/uso terapéutico , AncianoRESUMEN
PURPOSE: This study aims to prospectively analyze the effects of anticholinergic therapy using imidafenacin on detrusor overactivity occurring after robot-assisted radical prostatectomy (RARP). MATERIALS AND METHODS: Patients were followed-up at outpatient visits 2-4 weeks post-surgery (visit 2) to confirm the presence of urinary incontinence. Those confirmed with urinary incontinence were randomly assigned in a 1:1 ratio to the anticholinergic medication group (imidafenacin 0.1 mg twice daily) or the control group. Patients were followed-up at 1, 3, and 6 months post-surgery for observational assessments, including the International Prostate Symptom Score (IPSS) and Overactive Bladder Symptom Score (OABSS). RESULTS: A total of 49 patients (25 in the treatment group and 24 in the control group) were randomized for the study. There were no differences observed between the groups in terms of age, comorbidities, prostate size, or pathological staging. According to the IPSS questionnaire results, there was no statistically significant difference between the medication and control groups (p=0.161). However, when comparing storage and voiding symptoms separately, there was a statistically significant improvement in storage symptom scores (p=0.012). OABSS also revealed statistically significant improvement in symptoms from 3 months post-surgery (p=0.005), which persisted until 6 months post-surgery (IPSS storage: p=0.023, OABSS: p=0.013). CONCLUSIONS: In the case of urinary incontinence that occurs after RARP, even if the function of the intrinsic sphincter is sufficiently preserved, if urinary incontinence persists due to changes in the bladder, pharmacological therapy using imidafenacin can be beneficial in managing urinary incontinence.
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Imidazoles , Prostatectomía , Neoplasias de la Próstata , Incontinencia Urinaria , Humanos , Masculino , Prostatectomía/efectos adversos , Prostatectomía/métodos , Imidazoles/uso terapéutico , Imidazoles/administración & dosificación , Imidazoles/efectos adversos , Incontinencia Urinaria/etiología , Estudios Prospectivos , Anciano , Neoplasias de la Próstata/cirugía , Persona de Mediana Edad , Vejiga Urinaria Hiperactiva/tratamiento farmacológico , Vejiga Urinaria Hiperactiva/etiología , Recuperación de la Función , Complicaciones Posoperatorias/tratamiento farmacológico , Resultado del Tratamiento , Esquema de Medicación , Antagonistas Colinérgicos/uso terapéutico , Antagonistas Colinérgicos/administración & dosificación , Antagonistas Colinérgicos/efectos adversos , Agentes Urológicos/uso terapéutico , Agentes Urológicos/administración & dosificación , Procedimientos Quirúrgicos Robotizados/efectos adversosRESUMEN
OBJECTIVE: We hypothesized that combination therapy would provide a synergistic effect to improve treatment outcomes for overactive bladder (OAB), thus enhancing the motivation for continuous exercise, and that it would be associated with fewer adverse events than monotherapy. Therefore, we investigated whether biofeedback-assisted pelvic floor muscle training (PFMT), drug therapy, or a combination of both would be more effective in improving the symptoms of OAB. STUDY DESIGN: This randomized controlled trial included women diagnosed with OAB. Group 1 received biofeedback-assisted pelvic muscle floor training (PFMT) for 12 weeks; group 2 took 5 mg of solifenacin/day for 12 weeks; and group 3 received 5 mg of solifenacin/day in combination with biofeedback-assisted PFMT during the first 4 weeks and biofeedback-assisted PFMT for another 8 weeks. All participants had 5 follow-up visits. The primary outcomes were objective improvement of OAB symptoms and quality of life. The secondary outcomes were treatment-related adverse events, subjective improvement of OAB symptoms, and electromyographic activity of pelvic floor muscle (PFM) contraction. RESULTS: All participants reported significant improvement of OAB symptoms and quality of life. Participants in group 2 experienced more pronounced adverse events than those in group 3. Intervention duration was positively associated with subjective improvement in OAB symptoms in groups 2 and 3. Drug-related adverse events, including dry mouth, myalgia, and restlessness, had a negative impact on the subjective improvement of OAB symptoms in group 2. In group 1, exercise adherence was positively correlated with subjective improvement of OAB symptoms, whereas in group 3, PFM contraction and biofeedback effect were positively correlated with symptom improvement. CONCLUSION: Combination therapy is efficacious in treating women with OAB.
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Biorretroalimentación Psicológica , Terapia por Ejercicio , Diafragma Pélvico , Succinato de Solifenacina , Vejiga Urinaria Hiperactiva , Humanos , Vejiga Urinaria Hiperactiva/terapia , Vejiga Urinaria Hiperactiva/tratamiento farmacológico , Femenino , Diafragma Pélvico/fisiopatología , Biorretroalimentación Psicológica/métodos , Persona de Mediana Edad , Terapia por Ejercicio/métodos , Terapia Combinada , Adulto , Succinato de Solifenacina/administración & dosificación , Succinato de Solifenacina/uso terapéutico , Resultado del Tratamiento , Calidad de Vida , AncianoRESUMEN
Interstitial cystitis/bladder pain syndrome (IC/BPS) is a chronic bladder inflammation characterized by the main symptoms of urinary frequency, urgency, and pelvic pain. The hypersensitivity of bladder afferent neurons is considered a significant pathophysiologic mechanism in IC/PBS. Serotonin (5-HT, 5-hydroxytryptamine) receptors are known to be involved in the regulation of the micturition reflex and hyperalgesia, but the effect of 5-HT receptors on cystitis remains unknown. In this study, a rat model of interstitial cystitis induced by intraperitoneal injection of cyclophosphamide (CYP) was used to investigate the role of 5-HT receptors on cystitis. The histology and urodynamics exhibited chronic cystitis and overactive bladder in CYP-treated rats. Notably, among 5-HT1A, 5-HT2A and 5-HT7 receptors, the expression of 5-HT2A receptor was significantly increased in bladder afferent neurons in CYP-treated rats. Intrathecal administration of the 5-HT2A receptor antagonist M100907 could alleviate bladder overactivity and hyperalgesia in CYP-induced cystitis rats. Neuronal calcium imaging of bladder afferent neurons revealed increased calcium influx induced by the 5-HT2A receptor agonist or capsaicin in cystitis rats, which could be inhibited by M100907. Moreover, RNA sequencing indicated that differentially expressed genes were enriched in inflammation-related pathways and cellular calcium homeostasis. These findings suggest that the 5-HT2A receptor is involved in the hypersensitivity of bladder afferent neurons in CYP-induced cystitis, and M100907 could alleviate bladder overactivity and hyperalgesia in CYP-induced cystitis by inhibiting neuronal hypersensitivity in the afferent pathways. The 5-HT2A receptor may be a potential therapeutic target for the treatment of IC/BPS.
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Ciclofosfamida , Cistitis , Neuronas Aferentes , Ratas Sprague-Dawley , Receptor de Serotonina 5-HT2A , Vejiga Urinaria , Animales , Vejiga Urinaria/efectos de los fármacos , Vejiga Urinaria/inervación , Vejiga Urinaria/patología , Vejiga Urinaria/metabolismo , Neuronas Aferentes/metabolismo , Neuronas Aferentes/efectos de los fármacos , Receptor de Serotonina 5-HT2A/metabolismo , Ratas , Cistitis/inducido químicamente , Cistitis/metabolismo , Cistitis/patología , Femenino , Hiperalgesia/inducido químicamente , Hiperalgesia/metabolismo , Cistitis Intersticial/inducido químicamente , Cistitis Intersticial/metabolismo , Cistitis Intersticial/tratamiento farmacológico , Cistitis Intersticial/patología , Antagonistas del Receptor de Serotonina 5-HT2/farmacología , Vejiga Urinaria Hiperactiva/inducido químicamente , Vejiga Urinaria Hiperactiva/metabolismo , Vejiga Urinaria Hiperactiva/fisiopatología , Vejiga Urinaria Hiperactiva/tratamiento farmacológico , Modelos Animales de EnfermedadRESUMEN
Despite the efficacy of onabotulinumtoxinA, its safety profile remains a concern. This meta-analysis reviewed the major adverse events (AEs) associated with intravesical onabotulinumtoxinA treatment in patients with neurogenic detrusor overactivity (NDO) and idiopathic overactive bladder (iOAB). Randomized controlled trials (RCTs) conducted between January 2000 and December 2022 were searched for adult patients administered different onabotulinumtoxinA dosages or onabotulinumtoxinA vs. placebo. Quality assessment was performed using the Cochrane Collaboration tool, and statistical analysis was performed using Review Manager version 5.3. A total of 26 RCTs were included in the analysis, including 8 on NDO and 18 on iOAB. OnabotulinumtoxinA vs. placebo significantly increased the urinary tract infection (UTI) incidence in patients with NDO (relative risk, or RR, 1.54) and iOAB (RR, 2.53). No difference in the RR with different onabotulinumtoxinA dosages was noted. Urinary retention was frequent with onabotulinumtoxinA use in the NDO (RR, 6.56) and iOAB (RR, 7.32) groups. Similar observations were made regarding the risks of de novo clean intermittent catheterization (CIC). The risk of voiding difficulty increased with onabotulinumtoxinA use in patients with iOAB. Systemic AEs of onabotulinumtoxinA, including muscle weakness (RR, 2.79) and nausea (RR, 3.15), were noted in patients with NDO; most systemic AEs had a low incidence and were sporadic.
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Toxinas Botulínicas Tipo A , Vejiga Urinaria Neurogénica , Vejiga Urinaria Hiperactiva , Humanos , Administración Intravesical , Toxinas Botulínicas Tipo A/efectos adversos , Toxinas Botulínicas Tipo A/administración & dosificación , Ensayos Clínicos Controlados Aleatorios como Asunto , Vejiga Urinaria Neurogénica/tratamiento farmacológico , Vejiga Urinaria Hiperactiva/tratamiento farmacológico , Infecciones Urinarias/epidemiología , Infecciones Urinarias/etiologíaRESUMEN
Overactive bladder (OAB) is a common urological disease with a high prevalence in older adult populations. Antimuscarinic drugs have been the most common treatment for OAB for more than a decade, but their anticholinergic side-effects and potential impact on cognitive function among older patients are usually underestimated. This consensus aimed to provide practical recommendations concerning OAB management, with a particular emphasis on older patients. A joint consensus panel was formed by representatives of the Hong Kong Urological Association and the Hong Kong Geriatrics Society. Literature searches regarding OAB and its management were performed in PubMed and Ovid. Several working meetings were held to present and discuss available evidence, develop consensus statements, and vote for the statements. A modified Delphi method was used in this consensus process. To address questions regarding various aspects of OAB, 29 consensus statements were proposed covering the following areas: diagnosis, initial assessment, non-pharmacological treatments, considerations before administration of pharmacological treatments, various pharmacological treatments, combination therapy, and surgical treatment. Twenty-five consensus statements were accepted.
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Geriatría , Antagonistas Muscarínicos , Vejiga Urinaria Hiperactiva , Humanos , Vejiga Urinaria Hiperactiva/terapia , Vejiga Urinaria Hiperactiva/tratamiento farmacológico , Vejiga Urinaria Hiperactiva/diagnóstico , Hong Kong , Antagonistas Muscarínicos/uso terapéutico , Anciano , Geriatría/normas , Consenso , Sociedades Médicas , Técnica Delphi , Urología/normasRESUMEN
Introduction: Overactive bladder (OAB) is a highly prevalent condition with limited treatment options due to poor efficacy, side effects, and patient compliance. Novel drug delivery systems that can target the bladder wall may improve OAB therapy. Methods: We explored a polydopamine (PDA)-coated lactobacillus platform as a potential carrier for localized OAB treatment. Urinary microbiome profiling was performed to identify the presence of lactobacillus in healthy and OAB groups. Lactobacillus-PDA nanoparticles were synthesized and characterized by electron microscopy and spectrophotometry. A rat bladder perfusion model and human bladder smooth muscle cell spheroids were used to assess the distribution and penetration of the nanoparticles. The efficacy of the Lactobacillus-PDA system (LPS) for delivering the antimuscarinic drug solifenacin was evaluated in an OAB rat model. Results: Urinary microbiome profiling revealed lactobacillus as a dominant genus in both healthy and OAB groups. The synthesized Lactobacillus-PDA nanoparticles exhibited uniform size and optical properties. In the rat bladder perfusion model, the nanoparticles distributed throughout the bladder wall and smooth muscle without toxicity. The nanoparticles also penetrated human bladder smooth muscle cell spheroids. In the OAB rat model, LPS facilitated the delivery of solifenacin and improved treatment efficacy. Discussion: The results highlight LPS as a promising drug carrier for targeted OAB therapy via penetration into bladder tissues. This bacteriotherapy approach may overcome limitations of current systemic OAB medications. Lactobacillus, a probiotic bacterium present in the urinary tract microbiome, was hypothesized to adhere to and penetrate the bladder wall when coated with PDA nanoparticles, making it a suitable candidate for localized drug delivery.
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Indoles , Lactobacillus , Microbiota , Polímeros , Vejiga Urinaria Hiperactiva , Vejiga Urinaria , Animales , Indoles/química , Indoles/farmacocinética , Vejiga Urinaria Hiperactiva/terapia , Vejiga Urinaria Hiperactiva/tratamiento farmacológico , Humanos , Polímeros/química , Microbiota/efectos de los fármacos , Ratas , Esferoides Celulares , Succinato de Solifenacina/farmacocinética , Succinato de Solifenacina/química , Succinato de Solifenacina/administración & dosificación , Modelos Animales de Enfermedad , Ratas Sprague-Dawley , Nanopartículas/química , Sistemas de Liberación de Medicamentos/métodos , Femenino , Miocitos del Músculo Liso/efectos de los fármacos , Antagonistas Muscarínicos/farmacocinética , Antagonistas Muscarínicos/farmacología , Antagonistas Muscarínicos/química , Antagonistas Muscarínicos/administración & dosificación , Portadores de Fármacos/químicaRESUMEN
OBJECTIVE: Tolterodine tartrate (TOTA) is a first-line therapy to treat overactive urinary bladder (OAB). Oral delivery causes high hepatic clearance, xerostomia, headache, constipation, and blurred vision. We addressed Hansen solubility parameter (HSP) and Design Expert oriented optimized cationic elastic liposomes for transdermal application. METHODS: The experimental solubility was conducted in HSPiP predicted excipients to tailor formulations using surfactants, stearylamine, ethanol, and phosphatidylcholine (PC). These were evaluated for formulation characteristics. The optimized OTEL1 and OTEL1-G (gel) were compared against the drug solution (DS) and liposomes. In vitro and ex vivo studies were accomplished to investigate the insights into the mechanistic understanding of TOTA release and permeation ability. Finally, confocal laser scanning microscopy (CLSM) supported ex vivo results. RESULTS: HSP values of TOTA were closely related to tween-80, stearylamine, and human's skin. The size (153 nm), %EE (87.6%), and PDI (0.25) values of OTEL1 were in good agreement to the predicted values (161 nm, 80.4%, and 0.31) with high desirability (0.963). Spherical and smooth OTEL1 (including OTEL1-G and liposomes) vesicles followed non-Fickian drug release as compared to DS (Fickian) as evidence with n > 0.5 (Korsmeyer and Peppas coefficient). OTEL1 (containing lipid and surfactant as 90 mg and 13.8 mg, respectively) exhibited 2.6 and 1.8-folds higher permeation flux than DS and liposomes, respectively. Biocompatible cationic OTEL1 was safe and non-hemolytic. CONCLUSIONS: OTEL1 was promised as a lead vesicular approach and an alternative to conventional oral therapy to treat OAB in children and advanced age patients.
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Administración Cutánea , Cationes , Liposomas , Absorción Cutánea , Solubilidad , Tartrato de Tolterodina , Humanos , Animales , Tartrato de Tolterodina/administración & dosificación , Tartrato de Tolterodina/farmacocinética , Cationes/química , Piel/metabolismo , Liberación de Fármacos , Excipientes/química , Masculino , Vejiga Urinaria Hiperactiva/tratamiento farmacológico , Composición de Medicamentos/métodos , AminasRESUMEN
OBJECTIVE: To describe the prevalence of frailty among Medicare beneficiaries with overactive bladder (OAB), analyze oral therapy patterns, and examine potential disparities in treatment. METHODS: This retrospective cohort study utilized the 20% Research Identifiable File Medicare Part D prescription claims dataset (2013-2018). Using the Claims-Based Frailty Index (CFI), Medicare beneficiaries ≥65 years old with OAB were categorized as not frail (CFI <0.15), prefrail (0.15 ≤CFI<0.25), and frail (CFI >0.25). Logistic regression models assessed associations between frailty and pharmacotherapy utilization. RESULTS: Among 111,761 patients (15.8% of the OAB cohort) receiving oral pharmacotherapy (anticholinergic oral medications or mirabegron), 71% were women, 83% were White, and 11.9% were frail. After controlling for age, copayments and dual eligibility status, frail status (OR 1.16; 95% CI [1.09-1.24]), urology (OR 2.05; 95% CI [1.94-2.16]) or gynecology (OR 1.74; 95% CI [1.6-1.9]) prescribers and residing in the Southern United States (OR 1.53; CI [1.49-1.61]) were associated with higher likelihood of mirabegron utilization. Black (OR 0.79; 95% CI [0.74-0.85]) and American Indian/Alaska Native (OR 0.54; 95% CI [0.39-0.74]) patients were less likely to utilize Mirabegron than White beneficiaries. CONCLUSION: Frail beneficiaries and those with urology and gynecology prescribers showed higher likelihoods of beta-3 agonist utilization. Despite adjustments, Black and American Indian/Alaskan Native patients were less likely to fill mirabegron prescriptions, suggesting disparities in treatment. Our findings highlight the need for policies, interventions, and initiatives to promote equitable OAB oral therapy utilization in vulnerable populations.
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Acetanilidas , Disparidades en Atención de Salud , Medicare Part D , Vejiga Urinaria Hiperactiva , Humanos , Vejiga Urinaria Hiperactiva/tratamiento farmacológico , Estados Unidos , Femenino , Anciano , Masculino , Estudios Retrospectivos , Medicare Part D/estadística & datos numéricos , Disparidades en Atención de Salud/estadística & datos numéricos , Administración Oral , Anciano de 80 o más Años , Acetanilidas/uso terapéutico , Tiazoles/uso terapéutico , Antagonistas Colinérgicos/uso terapéutico , Fragilidad , Factores Sociodemográficos , Estudios de CohortesRESUMEN
BACKGROUND: Potentially inappropriate medication remains a significant concern in general practices, particularly in the context of overactive bladder (OAB) treatment for individuals aged 65 years and older. This study focuses on the exploration of alternative options for treating OAB and the deprescribing of anticholinergic drugs commonly used in OAB. The research aims to comprehensively evaluate the efficiency of deprescribing through a mixed methods approach, combining quantitative assessment and qualitative exploration of perceptions, experiences, and potential barriers among patients and health care personnel. OBJECTIVE: This study aims to evaluate the efficiency and safety of the intervention in which health care staff in primary care encourage patients to participate in deprescribing their drugs for OAB. In addition, we aim to identify factors contributing to or obstructing the deprescribing process that will drive more informed decisions in the field of deprescribing and support effective and safe treatment of patients. METHODS: The drugs for overactive bladder in primary care (DROP) study uses a rigorous research design, using a randomized controlled trial (RCT) with an embedded sequential explanatory mixed methods approach. All general practices within the North Denmark Region will be paired based on the number of general practitioners (GPs) and urban or rural locations. The matched pairs will be randomized into intervention and control groups. The intervention group will receive an algorithm designed to guide the deprescribing of drugs for OAB, promoting appropriate medication use. Quantitative data will be collected from the RCT including data from Danish registries for prescription analysis. Qualitative data will be obtained through interviews and focus groups with GPs, staff members, and patients. Finally, the quantitative and qualitative findings are merged to understand deprescribing for OAB comprehensively. This integrated approach enhances insights and supports future intervention improvement. RESULTS: The DROP study is currently in progress, with randomization of general practices underway. While they have not been invited to participate yet, they will be. The inclusion of GP practices is scheduled from December 2023 to April 2024. The follow-up period for each patient is 6 months. Results will be analyzed through an intention-to-treat analysis for the RCT and a thematic analysis for the qualitative component. Quantitative outcomes will focus on changes in prescriptions and symptoms, while the qualitative analysis will explore experiences and perceptions. CONCLUSIONS: The DROP study aims to provide an evidence-based intervention in primary care that ensures the deprescription of drugs for OAB when there is an unfavorable risk-benefit profile. The DROP study's contribution lies in generating evidence for deprescribing practices and influencing best practices in health care. TRIAL REGISTRATION: ClinicalTrials.gov NCT06110975; https://clinicaltrials.gov/study/NCT06110975. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/56277.
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Deprescripciones , Atención Primaria de Salud , Vejiga Urinaria Hiperactiva , Humanos , Vejiga Urinaria Hiperactiva/tratamiento farmacológico , Anciano , Femenino , Masculino , Prescripción Inadecuada/prevención & control , Prescripción Inadecuada/estadística & datos numéricos , Ensayos Clínicos Controlados Aleatorios como Asunto , DinamarcaRESUMEN
The objective of this study was to assess the clinical effectiveness and safety of type A botulinum toxin in the treatment of refractory overactive bladder in adolescents. We conducted a retrospective analysis of 37 adolescent patients with refractory overactive bladder who were treated at the Urology Department of Hangzhou Third People's Hospital between January 2018 and August 2023. These patients received intravesical injections of type A botulinum toxin at a concentration of 10 U/mL, with an average of 20 injection points. We recorded changes in urination diaries and urodynamic parameters both before and 1 month after treatment. After 1 month of treatment, significant improvements were observed in several parameters, when compared to the pretreatment values. These included daytime frequency of urination (11.13â ±â 6.45), average single void volume (173.24â ±â 36.48) mL, nighttime frequency of urination (2.43â ±â 0.31), urgency episodes (3.12â ±â 0.27), initial bladder capacity (149.82â ±â 41.34) mL, and maximum bladder capacity (340.25â ±â 57.12) mL (all Pâ <â .001). After the first treatment, 5 patients had mild hematuria, 4 patients had urinary tract infection, and 1 patient had urinary retention, which was relieved after catheterization. No serious complications or adverse reactions were observed in other patients. The follow-up period ranged from 6 to 18 months, and the duration of efficacy varied from 2 to 8 months. Eight patients who initially had treatment failure achieved symptom relief after reinjection. In adolescents with refractory overactive bladder who do not respond well to conventional drug therapy, type A botulinum toxin can be administered safely and effectively. It significantly improves lower urinary tract symptoms and enhances the quality of life for these patients.
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Toxinas Botulínicas Tipo A , Vejiga Urinaria Hiperactiva , Humanos , Vejiga Urinaria Hiperactiva/tratamiento farmacológico , Toxinas Botulínicas Tipo A/uso terapéutico , Toxinas Botulínicas Tipo A/administración & dosificación , Toxinas Botulínicas Tipo A/efectos adversos , Adolescente , Femenino , Estudios Retrospectivos , Masculino , Resultado del Tratamiento , Administración Intravesical , Fármacos Neuromusculares/administración & dosificación , Fármacos Neuromusculares/uso terapéutico , Fármacos Neuromusculares/efectos adversos , Urodinámica/efectos de los fármacosRESUMEN
OBJECTIVES: This study aimed to evaluate the efficacy and safety of Vibegron for the treatment of residual overactive bladder (OAB) symptoms after laser vaporization of the prostate (photo-selective vaporization of the prostate, contact laser vaporization of the prostate, and thulium laser vaporization). METHODS: This randomized, open-label, parallel-group, single-center superiority trial with a 12-week observation (jRCTs071190040) enrolled male patients with OAB aged 40 years or older who had undergone laser vaporization of the prostate for not less than 12 weeks and not more than 1 year earlier. Patients were allocated to receive Vibegron 50 mg once daily or follow-up without treatment for 12 weeks. RESULTS: Forty-seven patients were enrolled between January 2020 and March 2023. The median age (interquartile range) was 75.5 (72.5-78.5) years for the Vibegron group and 76.5 (71.0-81.0) years for the control group. The intergroup difference in the mean change (95% confidence interval) in the 24-hour urinary frequency at 12 weeks after randomization was -3.66 (-4.99, -2.33), with a significant decrease for the Vibegron group. The Overactive Bladder Symptom Score, International Prostate Symptom Score, IPSS storage score, and Overactive Bladder Questionnaire score significantly improved for the Vibegron group. Voided volume per micturition also increased for the Vibegron group. CONCLUSIONS: The administration of 50 mg of Vibegron once daily for 12 weeks showed significant improvement compared with follow-up without treatment in bladder storage (OAB) symptoms after laser vaporization of the prostate for symptomatic benign prostatic hyperplasia.
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Terapia por Láser , Vejiga Urinaria Hiperactiva , Humanos , Masculino , Anciano , Vejiga Urinaria Hiperactiva/etiología , Vejiga Urinaria Hiperactiva/tratamiento farmacológico , Estudios Prospectivos , Terapia por Láser/métodos , Terapia por Láser/efectos adversos , Hiperplasia Prostática/cirugía , Hiperplasia Prostática/complicaciones , Resultado del Tratamiento , Anciano de 80 o más Años , Pirimidinonas , PirrolidinasRESUMEN
PURPOSE: To investigate the protective effect of intravesical glucosamine in treating overactive bladder (OAB). METHODS: Ninety-two female Sprague-Dawley (SD) rats were divided into 4 groups i.e. protamine sulfate (PS), N-acetylcysteine (NAC), and glucosamine-treated PS (GPS), and normal saline control (NC) were used. We induced hyperactivity in rats via intravesical infusion of PS and potassium chloride (KCl), whereas the NC group underwent a sustained intravesical saline infusion for 1 h. N-acetylcysteine (NAC), a potential antioxidant as well as anti-inflammatory agent was employed as positive control. Cystometrography (CMG) was then conducted to determine urodynamic parameters, i.e., leak point pressure (LPP, n = 48) and inter-contractile interval, the duration between two voids (ICI, n = 32). RESULTS: LPP was significantly elevated in the GPS group (mean ± SD: 110.9 ± 6.2 mmHg) compared to the NC (81.0 ± 32.5 mmHg), PS (40.3 ± 10.9 mmHg), and NAC group (70.3 ± 19.4 mmHg). The cystometrogram data also reveals a prolonged ICI in the GPS group (241.3 ± 40.2 s) compared to the NC group (216.0 ± 41.7 s), PS group (128.8 ± 23.6 s), and NAC group (193.8 ± 28.3 s). CONCLUSION: This preliminary study implies the ameliorative impact of GPS treatment on OAB in terms of improved urodynamic parameters, including LPP and ICI.
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Modelos Animales de Enfermedad , Glucosamina , Cloruro de Potasio , Protaminas , Ratas Sprague-Dawley , Vejiga Urinaria Hiperactiva , Animales , Vejiga Urinaria Hiperactiva/tratamiento farmacológico , Femenino , Ratas , Administración Intravesical , Glucosamina/farmacología , Glucosamina/uso terapéutico , Glucosamina/administración & dosificaciónRESUMEN
OBJECTIVES: Multiple sclerosis (MS) is a chronic neuroinflammatory and neurodegenerative progressive disease of central nervous system that mostly affects young adults. (1) Because of involvement of spinal cord and brain, lower urinary dysfunction symptoms are commonly encountered. MS patients mostly show overactive bladder symptoms like urgency, frequent daytime urination, and urgency incontinence. Among MS patients, antimuscarinic therapy is the first-line treatment with overactive bladder symptoms as well as in general population yet 30% of the patients show insufficient improvement or intolerance to the treatment (2). In our study, our aim is to evaluate the efficacy and safety of mirabegron add-on treatment in MS patients after inadequate response to antimuscarinic monotherapy. METHODS: University of Kyrenia and Dr Burhan Nalbantoglu State hospital's databases were screened for the study. Seventy patients who were residents diagnosed with MS according to McDonald criteria were questioned. Among these patients, a total of 22 of them were included in the study. Inclusion criteria was at least 3 years of MS diagnosis, score of <6 at Expanded Disability Status Scale, and a score of ≥3 at Overactive Bladder Symptom Score Scale. RESULTS: Among selected patients, 10 mg solifenacin treatment was daily started and followed for 4 weeks. Mirabegron add-on treatment was initiated to the 11 patient who had inadequate improvement in overactive bladder symptom score. After mirabegron add-on treatment among 11 patient, there was a sufficient improvement in overactive bladder symptom score ( P < 0.008). CONCLUSIONS: In our study, we have found that antimuscarinic and mirabegron combination causes improved efficacy for overactive bladder in MS population.
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Acetanilidas , Quimioterapia Combinada , Esclerosis Múltiple , Antagonistas Muscarínicos , Succinato de Solifenacina , Tiazoles , Vejiga Urinaria Hiperactiva , Humanos , Acetanilidas/uso terapéutico , Acetanilidas/efectos adversos , Vejiga Urinaria Hiperactiva/tratamiento farmacológico , Vejiga Urinaria Hiperactiva/etiología , Tiazoles/uso terapéutico , Tiazoles/efectos adversos , Succinato de Solifenacina/uso terapéutico , Proyectos Piloto , Masculino , Femenino , Adulto , Persona de Mediana Edad , Antagonistas Muscarínicos/uso terapéutico , Antagonistas Muscarínicos/efectos adversos , Esclerosis Múltiple/tratamiento farmacológico , Esclerosis Múltiple/complicaciones , Resultado del Tratamiento , Agentes Urológicos/uso terapéutico , Agentes Urológicos/efectos adversosRESUMEN
Introduction: Transurethral injections into the bladder wall with botulinum toxin are an established treatment for refractory overactive bladder or detrusor overactivity. With the current injection technique, an average of approx. 18% and up to 40% of botulinum toxin is injected next to the bladder wall, potentially causing reduced efficacy or non-response. The article aims to evaluate the reasons for incorrect injections and propose strategies for complete delivery of the entire botulinum toxin fluid into the bladder wall. Material and Methods: Unstructured literature search and narrative review of the literature. Results: Incorrect injection of botulinum toxin fluid next to the bladder wall is caused by pushing the injection needle too deep and through the bladder wall. Bladder wall thickness decreases with increasing bladder filling and has a thickness of less than 2 mm beyond 100 mL in healthy individuals. Ultrasound imaging of the bladder wall before botulinum toxin injection can verify bladder wall thickness in individual patients. Patient movements during the injection therapy increase the chance of incorrect placement of the needle tip. Conclusions: Based on the literature search, it is helpful and recommended to (1) perform pretreatment ultrasound imaging of the bladder to estimate bladder wall thickness and to adjust the injection depth accordingly, (2) fill the bladder as low as possible, ideally below 100 mL, (3) use short needles, ideally 2 mm, and (4) provide sufficient anesthesia and pain management to avoid patient movements during the injection therapy.
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Vejiga Urinaria Hiperactiva , Vejiga Urinaria , Humanos , Vejiga Urinaria/efectos de los fármacos , Vejiga Urinaria/diagnóstico por imagen , Vejiga Urinaria Hiperactiva/tratamiento farmacológico , Toxinas Botulínicas/administración & dosificación , Administración Intravesical , Inyecciones , UltrasonografíaRESUMEN
PURPOSE: The objective was to evaluate the efficacy of transcutaneous electrical nerve stimulation (TENS) combined with mirabegron therapy compared with mirabegron monotherapy in the treatment of female patients with overactive bladder (OAB). METHODS: In this randomized controlled study, 100 female outpatients with OAB were screened. Among these patients, 86 who met the inclusion criteria were randomly divided into the TENS combined with mirabegron treatment group and mirabegron monotherapy treatment group, with 43 patients in each group. The voiding diary, Overactive Bladder Symptom Score (OABSS), Overactive Bladder Questionnaire Symptom Bother Score (OAB-q SBS), total health-related quality of life (OAB-q HRQoL), and treatment satisfaction-visual analog scale (TS-VAS) score before and after treatment were recorded to evaluate the efficacy of OAB treatment. Seventy-nine of the 86 patients (40 in the TENS plus mirabegron group and 39 in the mirabegron monotherapy group) completed 12 weeks of treatment. RESULTS: TENS combined with mirabegron therapy was superior to mirabegron monotherapy in improving the primary endpoints, including the daily number of micturition episodes and the daily MVV/micturition and secondary endpoints, including the daily number of urgency episodes, the OABSS, the OAB-q SBS, the HRQoL score and TS-VAS score. There were no statistically significant differences in urgency urinary incontinence and nocturia between the groups. Some minor adverse effects were observed, including muscle pain, local paresthesia and constipation. CONCLUSIONS: The combination of TENS and mirabegron was more effective than mirabegron alone in the treatment of female patients with OAB. TRIAL REGISTRATION NUMBER: ChiCTR2400080528 (31.01.2024, retrospectively registered).
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Acetanilidas , Tiazoles , Estimulación Eléctrica Transcutánea del Nervio , Vejiga Urinaria Hiperactiva , Humanos , Vejiga Urinaria Hiperactiva/terapia , Vejiga Urinaria Hiperactiva/tratamiento farmacológico , Femenino , Acetanilidas/uso terapéutico , Tiazoles/uso terapéutico , Estimulación Eléctrica Transcutánea del Nervio/métodos , Persona de Mediana Edad , Estudios Prospectivos , Resultado del Tratamiento , Terapia Combinada , Anciano , Adulto , Agonistas de Receptores Adrenérgicos beta 3/uso terapéutico , Agentes Urológicos/uso terapéuticoRESUMEN
BACKGROUND: There is a lack of approved treatments for pediatric patients with overactive bladder (OAB) with inadequate response to anticholinergic therapy. OnabotulinumtoxinA 100U is approved to treat OAB in adults based on data from randomized, pivotal trials. OBJECTIVE: To investigate the efficacy and safety of onabotulinumtoxinA treatment of OAB in children aged 12-17 years who were not adequately managed with anticholinergics. STUDY DESIGN: In this multinational, multicenter, randomized, double-blind, parallel-group, multiple-dose study (NCT02097121), pediatric patients with OAB were randomized 1:1:1 to receive onabotulinumtoxinA 25U, 50U, or 100U (≤6 U/kg). Patients could request retreatment starting at week 12. The primary endpoint was change from baseline to week 12 after treatment 1 in daily frequency of daytime urinary incontinence (UI) episodes. Safety assessments evaluated treatment-emergent adverse events (TEAEs). RESULTS: Of 68 screened patients, 55 received ≥1 treatment. Mean age was 14 years; 85.5% of patients were female. At week 12 after treatment 1, least squares mean change from baseline in daily frequency of daytime UI episodes showed a numerically greater reduction in the 100U arm (-2.4) versus the 25U arm (-1.4; P = 0.38), with a significant within-group change from baseline in the 100U arm (P = 0.0027). Achievement of treatment response was significantly greater with onabotulinumtoxinA 100U vs 25U (Figure). Median time to request retreatment was ≥16 weeks in all groups. The most frequently reported TEAEs were nasopharyngitis (10.9%) and urinary tract infection (UTI; 10.9%). Urinary retention was observed in 1 patient during treatment cycle 2; there were no serious TEAEs of UTI or urinary retention. Throughout 2 additional treatment cycles continued efficacy for the 100U dose arm was observed along with a consistent safety profile. DISCUSSION: Change in daily frequency of UI episodes at week 12 in treatment cycle 1 was not significantly different between arms. However, ≥50% response rate was significantly higher with onabotulinumtoxinA 100U versus 25U. Enrollment challenges that lowered the sample size could have reduced statistical power. Also, the lack of a placebo arm and the observed benefit with the 25U comparator limited interpretation. CONCLUSIONS: OnabotulinumtoxinA injections were well tolerated in children with OAB at all doses studied. Although the primary endpoint was not met, the significantly greater treatment response rate observed with onabotulinumtoxinA 100U versus 25U suggests additional benefit of the higher dose, without additional safety concerns.
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Toxinas Botulínicas Tipo A , Vejiga Urinaria Hiperactiva , Humanos , Toxinas Botulínicas Tipo A/administración & dosificación , Toxinas Botulínicas Tipo A/efectos adversos , Vejiga Urinaria Hiperactiva/tratamiento farmacológico , Femenino , Adolescente , Niño , Masculino , Método Doble Ciego , Resultado del Tratamiento , Relación Dosis-Respuesta a Droga , Fármacos Neuromusculares/administración & dosificación , Fármacos Neuromusculares/efectos adversosRESUMEN
INTRODUCTION: Office administration of intradetrusor onabotulinumtoxinA is commonly used to treat overactive bladder. For preprocedure analgesia, either 50 mL 2% intravesical lidocaine instillation for 20 to 30 minutes or 200 mg oral phenazopyridine can be used. Phenazopyridine is associated with shorter appointment times and is noninferior to lidocaine for pain control in this setting. We performed a cost analysis of phenazopyridine vs lidocaine for analgesia before office intradetrusor onabotulinumtoxinA injection for the treatment of idiopathic overactive bladder. METHODS: A health care sector-perspective cost analysis was performed. The following assumptions were made: (1) similar efficacy of each medication in providing adequate analgesia, (2) similar physician ease of performing the procedure with either analgesic, and (3) similar patient satisfaction with either analgesic. Average cost of medications, adverse reactions, nursing tasks, and office visit time were found in publicly available data. Sensitivity analyses were performed using TreeAge Pro 2021, R1 software. RESULTS: Phenazopyridine is less costly compared to lidocaine per visit for office intradetrusor onabotulinumtoxinA injection ($827 vs $925). A difference of $98 per procedure provides a total annual cost savings of over $24 million if all procedures are performed with phenazopyridine instead of lidocaine. Sensitivity analysis showed that phenazopyridine remained less costly under most circumstances, and threshold analysis provided exact circumstances under which phenazopyridine is no longer cost saving. CONCLUSIONS: Phenazopyridine provides cost savings compared to lidocaine for analgesia before office intradetrusor onabotulinumtoxinA injection for the treatment of idiopathic overactive bladder. If adopted by providers nationwide, phenazopyridine may reduce health care spending and minimize office visit time while maintaining patient pain control and satisfaction.
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Anestésicos Locales , Toxinas Botulínicas Tipo A , Lidocaína , Fenazopiridina , Humanos , Toxinas Botulínicas Tipo A/administración & dosificación , Toxinas Botulínicas Tipo A/economía , Toxinas Botulínicas Tipo A/uso terapéutico , Lidocaína/administración & dosificación , Lidocaína/economía , Lidocaína/uso terapéutico , Fenazopiridina/administración & dosificación , Fenazopiridina/economía , Fenazopiridina/uso terapéutico , Administración Intravesical , Anestésicos Locales/administración & dosificación , Anestésicos Locales/economía , Anestésicos Locales/uso terapéutico , Vejiga Urinaria Hiperactiva/tratamiento farmacológico , Vejiga Urinaria Hiperactiva/economía , Administración Oral , Costos y Análisis de Costo , Manejo del Dolor/economía , Manejo del Dolor/métodos , Cuidados Preoperatorios/métodos , Cuidados Preoperatorios/economíaRESUMEN
Following a description of the historic evolution of botulinum toxin A detrusor injections for neurogenic and nonneurogenic bladder overactivity, which was mainly driven by German-speaking countries, the terminological revolution of 2002 and the influence on design and outcomes of upcoming approval studies for the indication overactive bladder (OAB) are examined. OnabotulinumtoxinA (100â¯IU) for second-line treatment of OAB received European approval in 2013. Phase IV observational studies concerning therapeutic persistence and adherence with onabotulinumtoxinA are analyzed and compared with therapeutic alternatives. Predictors of treatment success and complications are identified and compared to the required preinterventional diagnostic effort. Since onabotulinumtoxinA and sacral neuromodulation (SNM) are competing for second-line OAB treatment, both options are compared with regard to differential indications, effectivity, durability and patient adherence. Gender-specific causes of urgency and urge incontinence in women are differentiated from the diagnosis of OAB and require priority treatment. On the basis of diagnostic examination results, an algorithm for invasive second-line treatment of OAB is presented, since overly liberal utilization of onabotulinumtoxinA in therapy-naive OAB patients has not proven superiority over oral antimuscarinergic standard therapy, which can only be explained by improper patient selection.