Isolated bladder training or in combination with other therapies to improve overactive bladder symptoms: a systematic review and meta-analysis of randomized controlled trials.

BACKGROUND: Bladder training (BT), the maintenance of a scheduled voiding regime at gradually adjusted intervals, is a common treatment for overactive bladder (OAB). OBJECTIVES: To assess the effects of isolated BT and/or in combination with other therapies on OAB symptoms. METHODS: A systematic review of eight databases was conducted. After screening titles and abstracts, full texts were retrieved. Cochrane RoB 2 and the GRADE approach were used. RESULTS: Fourteen RCTs were included: they studied isolated BT (n = 11), BT plus drug treatment (DT; n = 5), BT plus intravaginal electrical stimulation (IVES; n = 2), BT plus biofeedback and IVES (n = 1), BT plus pelvic floor muscle training and behavioral therapy (n = 2), BT plus percutaneous tibial nerve stimulation, and BT plus transcutaneous tibial nerve stimulation (n = 1). In a meta-analysis of short-term follow-up data, BT plus IVES resulted in greater improvement in nocturia (mean difference [MD]: 0.89, 95% CI: 0.5, 1.20), urinary incontinence (UI; MD: 1.93, 95% CI: 1.32, 2.55), and quality of life (QoL; MD: 4.87, 95% CI: 2.24, 7.50) than isolated BT, while DT and BT improved UI (MD: 0.58, 95% CI: 0.23, 0.92) more than isolated BT. CONCLUSION: In the short term, BT plus IVES improves the OAB symptoms of nocturia and UI while improving QoL. The limited number of RCTs and heterogeneity among them provide a low level of evidence, making the effect of BT on OAB inconclusive, which suggests that new RCTs should be performed.

Development and characterization of 3D printed ethylene vinyl acetate (EVA) as drug delivery device for the treatment of overactive bladder.

The overactive bladder is a condition characterized by a sudden urge to urinate, even with small volumes of urine present in the bladder. The current treatments available for this pathology consist on conservative approaches and the continuous administration of drugs, which when made by conventional methods has limitations related to the first pass metabolism, bioavailability, severe side effects, and low patient adherence to treatments, ultimately leading to low effectiveness. Within this context, the present work proposes the design, manufacture, and characterization of an intravesical implant for the treatment of overactive bladder pathology, using EVA copolymer as a matrix and oxybutynin as a drug. The fabrication of devices through two manufacturing techniques (extrusion and additive manufacturing by fused filament fabrication, FFF) and the evaluation of the implants through characterization tests was proposed. The usability and functionality were evaluated through simulated insertion of the device/prototype in a bladder model through catheter insertion tests. The safety and effectiveness of the devices was investigated from mechanical testing as well as drug release assays. Drug release assays presented a burst release in the first 24 h, followed by a release of 1.8 and 2.8 mg/d, totalizing 32 d. Mechanical tests demonstrated an increase in the stiffness of the specimens due to the addition of the drug, showing a change in maximum stress and strain at break. The released dose was higher than that usually presented when considering the oral administration route, showing the optimization of the development of this implant has the potential to improve the quality of life of patients with overactive bladder.

Sacral neuromodulation therapy for urinary and defecatory disorders: experience in a Latin American public hospital

Abstract Objective: To show the experience of a Latin American public hospital, with SNM in the management of either OAB, NOUR or FI, reporting feasibility, short to medium-term success rates, and complications. Methods: A retrospective cohort was conducted using data collected prospectively from patients with urogynecological conditions and referred from colorectal surgery and urology services between 2015 and 2022. Results: Advanced or basic trial phases were performed on 35 patients, 33 (94%) of which were successful and opted to move on Implantable Pulse Generator (GG) implantation. The average follow-up time after definitive implantation was 82 months (SD 59). Of the 33 patients undergoing, 27 (81%)reported an improvement of 50% or more in their symptoms at last follow-up. Moreover, 30 patients (90%) with a definitive implant reported subjective improvement, with an average PGI-I "much better" and 9 of them reporting to be "excellent" on PGI-I. Conclusion: SNM is a feasible and effective treatment for pelvic floor dysfunction. Its implementation requires highly trained groups and innovative leadership. At a nation-wide level, greater diffusion of this therapy among professionals is needed to achieve timely referral of patients who require it.

Impact of deep resection of endometriosis in the pelvis on urodynamic parameters.

PURPOSE: To evaluate the effects of deep resection of endometriosis in the posterior pelvic region on urodynamic parameters. METHODS: A prospective observational study conducted with female patients diagnosed with deep pelvic endometriosis before and after endometriosis resection surgery. Clinical history, image exams, the Female Lower Urinary Tract Symptoms questionnaire, urodynamic examination, cystometry, and voiding study were evaluated. RESULTS: Patients aged 30-39 years old, operative duration of 132.5 minutes, and 2.7 days of hospital stay. Uroflowmetry and cystometry showed tendency for an increase after the surgery in the flow duration, time to maximum flow, and first voiding desire and decreased residual volume and maximum cystometric capacity. Opening, maximum urinary flow, and maximum flow pressure decreased at T1, and the closing parameters increased, although statistically non significant. The variables decreased at T1 in the urodynamic, except for detrusor overactivity. Although we observed a reasonable number of low bladder compliance and abnormal bladder sensation, the results were maintained at T1. General scores for filling and incontinence showed a significant decrease after surgery. CONCLUSIONS: A significant response in the patient's perception of urinary function was demonstrated after surgery. It is observed that the surgical procedure did not affect the uroflowmetric and cystometric characteristics of the evaluated patients.

Bladder training compared to bladder training associated with pelvic floor muscle training for overactive bladder symptoms in women: A randomized clinical trial.

AIMS: To compare the effects of bladder training (BT) versus BT with pelvic floor muscle training (PFMT) in women with overactive bladder (OAB) symptoms. METHODS: Randomized controlled clinical trial including women with OAB symptoms, randomized into two groups: BT versus BT + PFMT. For 12 consecutive weeks, the women received home BT. The BT + PFMT performed supervised PFMT, once/week, associated at home PFMT protocol. Primary outcomes were urinary urgency, daytime voiding frequency, nocturia and urgency urinary incontinence assisted by both 3-day bladder diary and International Consultation on Incontinence OAB (ICIQ-OAB) questionnaire. Secondary outcomes were 24-h pad test and Patient Global Impression of Improvement. T-test, analysis of variance, Mann-Whitney (SPSS 20.0) and power/effect size (G-power) were applied in data analyses. RESULTS: Sixty-three women were included (B = 31; BT + PFMT = 32). There was no significant statistical difference between groups in terms of urinary symptoms: daytime frequency (BT: pre: 11.59 [±5.80], post: 9.10 [±4.05]; BT + PFMT: pre: 10.67 [±3.73], post: 8.08 [±3.38]) p = 0.75; nocturia: (BT: pre: 1.46 [±0.91], post: 0.82 [±0.82]; BT + PFMT: pre: 1.80 [±2.26], post: 0.82 [±1.15]) p = 0.70; urinary urgency (BT: pre: 3.22 [±4.70], post: 4.49 [±4.32]; BT + PFMT: pre: 6.87 [±5.60], post: 6.15 [±4.52]) p = 0.10; ICIQ-OAB total score: (BT: pre: 9.16 [±2.55], post: 6.32 [±3.77]; (BT + PFMT: pre: 9.75 [±2.06], post: 5.06 [±3.44] p = 0.30. CONCLUSIONS: Supervised PFMT added to BT did not provide further improvements than isolated BT in women with OAB symptoms.

Mirabegron and Anticholinergics in the Treatment of Overactive Bladder Syndrome: A Meta-analysis.

OBJECTIVE: To compare the use of mirabegron with anticholinergics drugs for the treatment of overactive bladder (OB). DATA SOURCE: Systematic searches were conducted in EMBASE, PUBMED, Cochrane, and LILACS databases from inception to September 2021. We included RCTs, women with clinically proven OB symptoms, studies that compared mirabegron to antimuscarinic drugs, and that evaluated the efficacy, safety or adherence. DATA COLLECTION: RevMan 5.4 was used to combine results across studies. We derived risk ratios (RRs) and mean differences with 95% CIs using a random-effects meta-analytic model. Cochrane Collaboration Tool and GRADE was applied for risk of bias and quality of the evidence. DATA SYNTHESIS: We included 14 studies with a total of 10,774 patients. Fewer total adverse events was reported in mirabegron group than in antimuscarinics group [RR 0.93 (0.89-0.98)]. The risk of gastrointestinal tract disorders and dry mouth were lower with mirabegron [RR 0,58 (0.48-0.68); 9375 patients; RR 0.44 (0.35-0.56), 9375 patients, respectively]. No difference was reported between mirabegron and antimuscarinics drugs for efficacy. The adherence to treatment was 87.7% in both groups [RR 0.99 (0.98-1.00)]. CONCLUSION: Mirabegron and antimuscarinics have comparable efficacy and adherence rates; however, mirabegron showed fewer total and isolated adverse events.

OBJETIVO: Comparar o uso de mirabegrom com anticolinérgicos para o tratamento da bexiga hiperativa (BH). FONTE DE DADOS: Buscas sistemáticas foram realizadas nas bases de dados EMBASE, PUBMED, Cochrane e LILACS desde o início até setembro de 2021. Incluímos ECR, mulheres com sintomas de BH clinicamente comprovados, estudos que compararam mirabegrom a medicamentos antimuscarínicos e avaliaram a eficácia, segurança ou adesão. COLETA DE DADOS: RevMan 5.4 foi usado para combinar os resultados entre os estudos. Derivamos razões de risco (RRs) e diferenças médias com intervalo de confiança (IC) de 95% usando um modelo meta-analítico de efeitos aleatórios. Cochrane Collaboration Tool e GRADE foi aplicado para risco de viés e qualidade da evidência. SíNTESE DOS DADOS: Foram incluídos 14 estudos com um total de 10.774 pacientes. Menos eventos adversos totais foram relatados no grupo mirabegrom do que no grupo antimuscarínicos [RR: 0,93 (0,89­0,98)]. O risco de distúrbios do trato gastrointestinal e boca seca foram menores com mirabegrom [RR: 0,58 (0,48­0,68); 9.375 pacientes; RR: 0,44 (0,35­0,56), 9.375 pacientes, respectivamente]. Nenhuma diferença foi relatada entre mirabegrom e drogas antimuscarínicos para eficácia. A adesão ao tratamento foi de 87,7% em ambos os grupos [RR: 0,99 (0,98­1,00)]. CONCLUSãO: Mirabegrom e antimuscarínicos têm eficácia e taxas de adesão comparáveis, porém o mirabegrom apresentou menos eventos adversos totais e isolados.

Comparative assessment of efficacy and safety of approved oral therapies for overactive bladder: a systematic review and network meta-analysis.

bladder based on a systematic review and network meta-analysis approach. METHODS: Pubmed, Embase, Web of Science, and the Cochrane Register of Clinical Trials databases were systematically searched. The search time frame was from database creation to June 2, 2022. Randomized controlled double-blind trials of oral medication for overactive bladder were screened against the protocol's entry criteria. Trials were evaluated for quality using the Cochrane Risk of Bias Assessment Tool, and data were statistically analyzed using Stata 16.0 software. RESULT: A total of 60 randomized controlled double-blind clinical trials were included involving 50,333 subjects. Solifenacin 10mg was the most effective in mean daily micturitions and incontinence episodes, solifenacin 5/10mg in mean daily urinary urgency episodes and nocturia episodes, fesoterodine 8mg in urgency incontinence episodes/d and oxybutynin 5mg in voided volume/micturition. In terms of safety, solifenacin 5mg, ER-tolterodine 4mg, mirabegron, vibegron and ER-oxybutynin 10mg all showed a better incidence of dry mouth, fesoterodine 4mg, ER-oxybutynin 10mg, tolterodine 2mg, and vibegron in the incidence of constipation. Compared to placebo, imidafenacin 0.1mg showed a significantly increased incidence in hypertension, solifenacin 10mg in urinary tract infection, fesoterodine 4/8mg and darifenacin 15mg in headache. CONCLUSION: Solifenacin showed better efficacy. For safety, most anticholinergic drugs were more likely to cause dry mouth and constipation, lower doses were better tolerated. The choice of drugs should be tailored to the patient's specific situation to find the best balance between efficacy and safety.

Manejo exitoso de síndrome de vejiga hiperactiva refractaria con toxina botulínica A / Successful management of refractory overactive bladder syndrome with botulinum toxin A

Introducción: El síndrome de vejiga hiperactiva (VHA) afecta hasta al 43% de las mujeres. La terapia escalonada incluye cambios de hábitos, fármacos y neuromodulación. Hasta el 40% de las pacientes llegan a requerir terapia avanzada alternativa, como toxina botulínica (TB). Objetivo: Reportar los resultados del tratamiento con toxina botulínica en mujeres con VHA refractaria a tratamiento de primera y segunda línea, en un hospital público en Chile. Método: Estudio de cohorte retrospectivo desde una base de datos recolectada prospectivamente del Hospital Sótero del Río entre 2018 y 2022. Se incluyeron 33 pacientes con tratamiento farmacológico y neuromodulación previa, con una edad promedio de 57 años, sometidas a inyección cistoscópica de TB a detrusor, analizando datos demográficos, antecedentes y complicaciones. Se realizó seguimiento con frecuencia miccional, paños/día, escala de gravedad de Sandvik (ISI) y encuesta Patient Global Impression Improvement (PGI-I). Resultados: Los datos comparativos pre/post TB, respectivamente, fueron: frecuencia miccional diurna 11/6 y nocturna 5/1; paños/día 5/3; ISI 8/3. Veinte de 33 mujeres refirieron estar excelente o mucho mejor (PGI-I). Conclusiones: Es posible realizar manejo con TB en mujeres con VHA refractaria a primera y segunda línea, con buenos resultados e impacto significativo en la calidad de vida.

Introduction: Overactive bladder syndrome (OABS) affects up to 43% of women. Staggered therapy includes habit changes, drugs, and peripheral neuromodulation. Up to 40% of patients may require advanced alternative therapy such as botulinum toxin A (BT). Objective: To report the results of treatment with TB in women with OABS refractory to first- and second-line treatment in a public hospital in Chile. Method: Retrospective cohort study from prospectively collected database from Hospital Sótero del Río between 2018 and 2022. Thirty-three patients with previous pharmacological treatment and neuromodulation were included, with an average age of 57 years, undergoing cystoscopic injection of TB to detrusor. Demographic data, history, and complications were analyzed. Follow-up was performed with voiding frequency, cloths/day, Sandvik Severity Scale (ISI) and Patient Global Impression Improvement (PGI-I) survey. Results: Comparative data pre/post TB, respectively showed: daytime voiding frequency 11/6 and nighttime 5/1; cloths/day 5/3; ISI 8/3. 20 of 33 women reported being excellent or much better (PGI-I). Conclusions: TB management in women with OABS refractory to first- and second-line treatment has good results and significant impact on quality of life.

Mirabegron and Anticholinergics in the Treatment of Overactive Bladder Syndrome: A Meta-analysis / Mirabegron e anticolinérgicos no tratamento da síndrome da bexiga hiperativa: metanálise

Abstract Objective To compare the use of mirabegron with anticholinergics drugs for the treatment of overactive bladder (OB). Data Source Systematic searches were conducted in EMBASE, PUBMED, Cochrane, and LILACS databases from inception to September 2021. We included RCTs, women with clinically proven OB symptoms, studies that compared mirabegron to antimuscarinic drugs, and that evaluated the efficacy, safety or adherence. Data Collection RevMan 5.4 was used to combine results across studies. We derived risk ratios (RRs) and mean differences with 95% CIs using a random-effects meta-analytic model. Cochrane Collaboration Tool and GRADE was applied for risk of bias and quality of the evidence. Data Synthesis We included 14 studies with a total of 10,774 patients. Fewer total adverse events was reported in mirabegron group than in antimuscarinics group [RR 0.93 (0.89-0.98)]. The risk of gastrointestinal tract disorders and dry mouth were lower with mirabegron [RR 0,58 (0.48-0.68); 9375 patients; RR 0.44 (0.35-0.56), 9375 patients, respectively]. No difference was reported between mirabegron and antimuscarinics drugs for efficacy. The adherence to treatment was 87.7% in both groups [RR 0.99 (0.98-1.00)]. Conclusion Mirabegron and antimuscarinics have comparable efficacy and adherence rates; however, mirabegron showed fewer total and isolated adverse events.

Resumo Objetivo Comparar o uso de mirabegrom com anticolinérgicos para o tratamento da bexiga hiperativa (BH). Fonte de Dados Buscas sistemáticas foram realizadas nas bases de dados EMBASE, PUBMED, Cochrane e LILACS desde o início até setembro de 2021. Incluímos ECR, mulheres com sintomas de BH clinicamente comprovados, estudos que compararam mirabegrom a medicamentos antimuscarínicos e avaliaram a eficácia, segurança ou adesão. Coleta de Dados RevMan 5.4 foi usado para combinar os resultados entre os estudos. Derivamos razões de risco (RRs) e diferenças médias com intervalo de confiança (IC) de 95% usando um modelo meta-analítico de efeitos aleatórios. Cochrane Collaboration Tool e GRADE foi aplicado para risco de viés e qualidade da evidência. Síntese dos Dados Foram incluídos 14 estudos com um total de 10.774 pacientes. Menos eventos adversos totais foram relatados no grupo mirabegrom do que no grupo antimuscarínicos [RR: 0,93 (0,89-0,98)]. O risco de distúrbios do trato gastrointestinal e boca seca foram menores com mirabegrom [RR: 0,58 (0,48-0,68); 9.375 pacientes; RR: 0,44 (0,35-0,56), 9.375 pacientes, respectivamente]. Nenhuma diferença foi relatada entre mirabegrom e drogas antimuscarínicos para eficácia. A adesão ao tratamento foi de 87,7% em ambos os grupos [RR: 0,99 (0,98-1,00)]. Conclusão Mirabegrom e antimuscarínicos têm eficácia e taxas de adesão comparáveis, porém o mirabegrom apresentou menos eventos adversos totais e isolados.

Transcutaneous tibial nerve electrical stimulation versus vaginal electrical stimulation in women with overactive bladder syndrome: Is there a role for short-term interventions?

OBJECTIVE: To assess the efficacy of vaginal electrical stimulation (VS) versus transcutaneous tibial nerve electrical stimulation (TTNS) in women with overactive bladder syndrome (OAB). MATERIAL AND METHODS: Sixty-nine patients were randomized to receive 12 sessions of VS versus TTNS, or no treatment (control group-CG), over 6 weeks. OAB impact according to international consultation on incontinence questionnaire overactive bladder module (ICIQ-OAB), symptoms discomfort scores and voiding diaries were evaluated at baseline, 6 weeks and 1-month post-treatment. RESULTS: Both TTNS (mean difference = -4.2; 95% confidence interval [CI] = -6.5 to -1.9) and VS (-3.8; -6.0 to -1.6) were associated with significant reduction of ICIQ-OAB scores, as well as discomfort sensation (-3.9; -6.2 to -1,7; p < 0.001 for the TTNS and -2.8; -5.0 to -0.6; p = 0.01 for the VS) at 6 weeks when compared to CG (p < 0.001). ICIQ-OAB score remained low only in the TTNS group when compared to the CG (-3.6; -6.0 to -1.2/p = 0.00) 1 month after treatment. Discomfort symptoms improved in both active groups when compared to CG (TTNS [-3.2; -5.2 to -1.2; p < 0.001] and VS groups [-2.6; -4.7 to -0.6; p = 0.01]). No statistically differences were found in primary outcomes comparing TTNS and VS Secondary analysis showed significant improvement in urinary urgency incontinence episodes (UUI) in both TTNS and VS, but CG. UUI episodes were still reduced in the VS group and urgency in the TTNS group 1-month post-treatment. CONCLUSION: Short-term interventions (6 weeks) of TTNS and VS were both effective in treating women with OAB. TTNS provided residual effects at one-month postintervention on ICIQ-OAB score.

Defining bladder outlet obstruction and detrusor underactivity in females with overactive bladder: Are we forgetting about the free uroflowmetry?

INTRODUCTION: Both detrusor underactivity (DU) and bladder outlet obstruction (BOO) can coexist in patients with overactive bladder. Definitions of both DU and BOO are based on pressure-flow study (PFS) data. However, invasive urodynamics study can differ from a natural micturition, in fact, discrepancies between free uroflowmetry (UFM) and PFS have been largely described. Our goal is to assess the correlation of free-flowmetry and PFS among patients with OAB and to evaluate how different definitions of DU/BOO are able to discriminate patients with different free UFMs. METHODS: A retrospective review of urodynamics performed at a single institution was conducted. Females with OAB who voided more than 150 mL in both UFM and PFS were included. Parameters from both voiding episodes were compared with nonparametric test. Two definitions of DU were applied; PIP1: Pdet@Qmax+Qmax < 30 and Gammie: Pdet@Qmax < 20 cmH2 O, Qmax < 15 mL/s, and BVE < 90% (Bladder voiding efficiency). Also, two definitions of obstruction were chosen; Defretias: Pdet@Qmax ≥25 cmH2 O and Qmax ≤ 12 mL/s and Solomon-Greenwell female BOO index ≥ 18. Patients who matched with each definition were compared to those who did not, to assess if any definitions were able to discriminate different noninvasive uroflowmetries. RESULTS: A total of 195 patients were included. Overall, mean age was 55 ± 12 years, 90.8% had mixed urinary incontinence, and 39% complained of at least one voiding symptom. Globally, Qmax and BVE correlated poorly between UFM and PFS, showing that most of the variation corresponded to a systematic error. Twenty-two individuals were found to have DU, they had a difference of 13 mL/s on both maximum flows. Fifty-four patients showed BOO, with a difference between their Qmax of 19 mL/s. Among the four definitions analyzed, only PIP1 and Defreitas were able to discriminate patients with actually a lower Qmax on the free UFM. CONCLUSIONS: Patients with overactive bladder seem to have a systematic discordance between the urine flow of the free and invasive studies. Current definitions of DU and BOO, which are based on the PFS parameters, are not consistently able to discriminate patients who actually void deficiently on the free UFM.

Anxiety and depression in association with lower urinary tract symptoms: results from the COBaLT study.

PURPOSE: Depression and anxiety have been associated with lower urinary tract symptoms (LUTS) in several studies. In our population, the prevalence of LUTS is high, consequently, it is essential and an objective of this study, to determine the association between anxiety, depression, and LUTS in a large Hispanic population. METHODS: A sub-analysis of a cross-sectional population-based study to estimate LUTS prevalence in the Colombian population was performed (COBaLT study) (Plata et al. in Neurourol Urodyn 38:200-207, 2018). The Hospital Anxiety and Depression Scale (HADS) was used to evaluate mental health. Logistic regression was carried out to estimate the association of depression and anxiety with different LUTS. Variables that proved statistically significant (p < 0.05) were included in a multivariate model. RESULTS: A total of 1060 individuals were assessed. The prevalence of anxiety in women and men was 17.1% and 6.7%, respectively. Depression in women and men was 20.1% and 9.4%, respectively. An association was found between anxiety and overactive bladder (OAB) without urinary incontinence (OR = 3.7) and moderate or severe LUTS in men (OR = 3.8). In women, anxiety was associated with nocturia (OR = 4.2) and stress urinary incontinence (OR = 2.4). For depression, an association was found between sexual dysfunction (OR = 4.3) and moderate or severe LUTS (OR = 4.0) in men; while in women it was associated with stress urinary incontinence (OR = 2.3), the sensation of incomplete emptying (OR = 1.7) and decreased frequency of sexual activity (OR = 1.8). CONCLUSIONS: The associations found are consistent with other reports. It is essential to inquire about possible symptoms related to the mental sphere in the urology consultation to make appropriate referrals and subsequent management.

Efficacy and Safety of Vibegron for the Treatment of Overactive Bladder in Women: A Subgroup Analysis From the Double-Blind, Randomized, Controlled EMPOWUR Trial.

IMPORTANCE: The international phase 3 EMPOWUR trial demonstrated efficacy and safety of vibegron, a newer ß 3 -adrenergic receptor agonist, in adults with overactive bladder (OAB). Women are disproportionately affected by OAB, especially those with bothersome symptoms, such as urge urinary incontinence (UUI). OBJECTIVE: This subgroup analysis from EMPOWUR assessed efficacy and safety of vibegron in women. STUDY DESIGN: In EMPOWUR, patients with OAB were randomized 5:5:4 to 12 weeks of treatment with once-daily vibegron 75 mg, placebo, or tolterodine 4-mg extended release. Efficacy end points included change from baseline at week 12 in mean daily number of micturitions, UUI episodes, and urgency episodes. Safety was assessed through adverse events (AEs). RESULTS: Of the patients included in the analysis, 1286 (84.9%) were women (vibegron, n = 463; placebo, n = 459; tolterodine, n = 364). At week 12, women receiving vibegron showed significant reductions (95% confidence intervals of least squares mean differences does not include 0) from baseline versus placebo in mean daily micturitions, UUI episodes, and urgency episodes, with least squares mean differences (95% confidence intervals) of -0.5 (-0.8 to -0.2), -0.7 (-1.0 to -0.4), and -0.8 (-1.3 to -0.4), respectively. Treatment-emergent AE incidence was similar with vibegron (39%) and placebo (35%); the most common AE with incidence higher with vibegron (4.3%) than placebo (2.6%) was headache. CONCLUSIONS: In this subgroup analysis, women receiving vibegron showed significant reductions in key efficacy end points versus placebo and favorable safety profile, consistent with the overall results from EMPOWUR, suggesting that vibegron is efficacious and safe for the treatment of OAB in this patient population.

One-day voiding diary in the evaluation of Lower Urinary Tract Symptoms in children.

INTRODUCTION: Voiding diary (VD) is an important tool in the evaluation of children with voiding symptoms. Voiding frequency, maximal voided volume (MVV), average voided volume (AVV) and nocturnal volume (NV) can be extracted and are valuable in diagnosing and monitoring these disorders. Recently, ICCS has reduced the period of data recording on VD from 3 to 2 days.We hypothesized that one day voiding diary would be enough for guiding treatment. MATERIALS AND METHODS: Children with overactive bladder (OAB) and primary monosymptomatic enuresis (PMNE) were oriented to fulfill a 3-day VD. Data obtained from VD were evaluated for the first day (1dVD), the first two days (2dVD), and all 3 days (3dVD) and compared according to the MVV, AVV, frequency, NV and expected bladder capacity (EBC). The Friedman, Student's t test and the Fisher's exact was used. ANOVA was used for multiple comparisons. We also used Pearson correlation test. RESULTS: Ninety-eight children were included, 59 had PMNE and 30 OAB. Frequency, AVV and VN were similar regardless how many days the voiding episodes were recorded. Only MVV was higher by a mean of only 32 mL on 3dVD compared to 1dVD. A 1dVD has a sensitivity of 93,9% and a positive likelihood ratio of 2.2. As for the correlation of MVV and EBC it was observed that in 83% of children, MVV was lower than EBC. MVV corresponds to 67% and 69% of EBC in children with PMNE and OAB, respectively. CONCLUSION: We believe that 1dVD is sufficient to assess these children. It has a high sensitivity and good correlation to 3dVD in evaluating these children. Bladder capacity in this population, evaluated by maximum voided volume, was close to 68% of that obtained by the EBC.

Quality of life and psychological aspects in children with overactive bladder treated with parasacral transcutaneous electrical nerve stimulation - A prospective multicenter study.

OBJECTIVE: To assess the impact of parasacral transcutaneous electrical nerve stimulation (parasacral TENS) on quality of life (QoL) and psychological aspects in children treated for overactive bladder (OAB). METHODS: This international, multicenter, prospective cohort study involved individuals of 6-16 years of age under TENS treatment for OAB. The study was conducted between June 2016 and December 2019 in four participating centers: two in Australia, one in Germany and one in Brazil. Patients with anatomical and/or neurological abnormalities of the urinary tract were excluded. Questionnaires were applied before and after parasacral TENS treatment: the Dysfunctional Voiding Symptom Score (DVSS), used in Brazil, or the International Consultation on Incontinence Questionnaire - Pediatric Lower Urinary Tract Symptoms (ICIQ-CLUTS), used in Germany and Australia, to analyze urinary symptoms; the Strengths and Difficulties Questionnaire (SDQ) to assess emotional and behavioral aspects; and the Pediatric Incontinence Questionnaire (PinQ) for bladder-specific Qol. RESULTS: Fifty-three patients (28 girls and 25 boys) with a mean age of 8.64 ± 2.63 years were included. Median DVSS was 11 (range 6-13.5) and 3 (range 0-7), (p < 0.001), and median ICIQ-CLUTS was 12 (range 9-14) and 9 (range 5.7-12), (p < 0.001), before and after treatment, respectively. Median PinQ score decreased from 47.8 (range 38.9-59.7) to 39 (range 29-53.15) following treatment (p = 0.04). Median total SDQ score before and after treatment was 17 (range 13.5-21) and 15 (range 12-21), respectively (p = 0.939). CONCLUSION: Parasacral TENS was associated with a significant improvement in urinary symptoms and QoL; however, there was no change in psychological symptoms, as measured using the SDQ.

Use of Urodynamics by Gynecologists and Urologists in Brazil.

OBJECTIVE: Urodynamic studies (UDSs) are a set of tests that assess the storage and emptying of urine, and they are widely used by gynecologists and urologists in the management of urinary incontinence (UI), despite the discussion about its indications. The objectives of the present study were to verify whether UDSs are routinely used in the conservative and surgical approaches to female UI, their other clinical indications, and to compare the responses of Brazilian gynecologists and urologists. METHODS: The present is an opinion survey applied from August 2020 to January 2021 through a semistructured questionnaire about the clinical practice sent by e-mail to all participants. The responses were compared through statistical analyses. RESULTS: Of the 329 participants, 238 were gynecologists (72.3%) and 91, urologists (27.7%). Most gynecologists (73.5%) and urologists (86.6%) do not request UDSs before the conservative treatment of UI; but UDSs are indicated in the preoperative period of anti-incontinence surgeries. Most participants request UDSs in the initial approach to overactive bladder (gynecologists: 88.2%; urologists: 96.7%), and the urologist has greater chance to request this study (odds ratio [OR] = 3.9). For most participants, it is necessary to request uroculture before the UDSs. CONCLUSION: Most Brazilian gynecologists and urologists who participated in the present study do not request UDSs before the conservative treatment of UI, according to national and internacional guidelines, and often request it before the surgical treatment for female UI. The indication of this exam in the initial approach of idiopathic overactive bladder should be reviewed by the participants.

OBJETIVO: O estudo urodinâmico (EU) é um conjunto de exames que avalia o armazenamento e esvaziamento da urina, e é amplamente utilizado por ginecologistas e urologistas no manejo da incontinência urinária (IU), apesar das discussões sobre suas indicações. O objetivo deste estudo foi verificar se a urodinâmica é rotineiramente utilizada nas abordagens conservadora e cirúrgica da IU feminina, além de outras de suas indicações clínicas, e comparar as respostas de ginecologistas e urologistas brasileiros. MéTODOS: Trata-se de uma pesquisa de opinião, realizada entre agosto de 2020 e janeiro de 2021, por meio de questionário semiestruturado composto por perguntas sobre a prática clínica enviado por e-mail a todos os participantes. As respostas foram comparadas mediante análises estatísticas. RESULTADOS: Dos 329 participantes, 238 eram ginecologistas (72,3%) e 91, urologistas (27,7%). A maioria dos ginecologistas (73,5%) e urologistas (86,6%) não solicita EU antes do tratamento conservador da IU; mas o EU é indicado no pré-operatório de cirurgias para IU. A maioria dos participantes solicita EU na abordagem inicial da bexiga hiperativa (ginecologistas: 88,2%; urologistas: 96,7%), e os urologistas têm maior chance de solicitar esse exame (razão de chances [RC] = 3,9). Para a maioria dos entrevistados, é necessário solicitar urocultura junto com o EU. CONCLUSãO: A maioria dos ginecologistas e urologistas brasileiros que participaram deste estudo não solicita EU antes do tratamento conservador da IU, de acordo com as principais diretrizes nacionais e internacionais, e muitas vezes o solicita antes do tratamento cirúrgico da IU feminina. A indicação desse exame na abordagem inicial da bexiga hiperativa idiopática deve ser revista pelos participantes.

Use of Urodynamics by Gynecologists and Urologists in Brazil / Uso da urodinâmica por ginecologistas e urologistas no Brasil

Abstract Objective Urodynamic studies (UDSs) are a set of tests that assess the storage and emptying of urine, and they are widely used by gynecologists and urologists in the management of urinary incontinence (UI), despite the discussion about its indications. The objectives of the present study were to verify whether UDSs are routinely used in the conservative and surgical approaches to female UI, their other clinical indications, and to compare the responses of Brazilian gynecologists and urologists. Methods The present is an opinion survey applied from August 2020 to January 2021 through a semistructured questionnaire about the clinical practice sent by e-mail to all participants. The responses were compared through statistical analyses. Results Of the 329 participants, 238 were gynecologists (72.3%) and 91, urologists (27.7%). Most gynecologists (73.5%) and urologists (86.6%) do not request UDSs before the conservative treatment of UI; but UDSs are indicated in the preoperative period of anti-incontinence surgeries. Most participants request UDSs in the initial approach to overactive bladder (gynecologists: 88.2%; urologists: 96.7%), and the urologist has greater chance to request this study (odds ratio [OR] = 3.9). For most participants, it is necessary to request uroculture before the UDSs. Conclusion Most Brazilian gynecologists and urologists who participated in the present study do not request UDSs before the conservative treatment of UI, according to national and internacional guidelines, and often request it before the surgical treatment for female UI. The indication of this exam in the initial approach of idiopathic overactive bladder should be reviewed by the participants.

Resumo Objetivo O estudo urodinâmico (EU) é um conjunto de exames que avalia o armazenamento e esvaziamento da urina, e é amplamente utilizado por ginecologistas e urologistas no manejo da incontinência urinária (IU), apesar das discussões sobre suas indicações. O objetivo deste estudo foi verificar se a urodinâmica é rotineiramente utilizada nas abordagens conservadora e cirúrgica da IU feminina, além de outras de suas indicações clínicas, e comparar as respostas de ginecologistas e urologistas brasileiros. Métodos Trata-se de uma pesquisa de opinião, realizada entre agosto de 2020 e janeiro de 2021, por meio de questionário semiestruturado composto por perguntas sobre a prática clínica enviado por e-mail a todos os participantes. As respostas foram comparadas mediante análises estatísticas. Resultados Dos 329 participantes, 238 eram ginecologistas (72,3%) e 91, urologistas (27,7%). A maioria dos ginecologistas (73,5%) e urologistas (86,6%) não solicita EU antes do tratamento conservador da IU; mas o EU é indicado no pré-operatório de cirurgias para IU. A maioria dos participantes solicita EU na abordagem inicial da bexiga hiperativa (ginecologistas: 88,2%; urologistas: 96,7%), e os urologistas têm maior chance de solicitar esse exame (razão de chances [RC] = 3,9). Para a maioria dos entrevistados, é necessário solicitar urocultura junto com o EU. Conclusão A maioria dos ginecologistas e urologistas brasileiros que participaram deste estudo não solicita EU antes do tratamento conservador da IU, de acordo com as principais diretrizes nacionais e internacionais, e muitas vezes o solicita antes do tratamento cirúrgico da IU feminina. A indicação desse exame na abordagem inicial da bexiga hiperativa idiopática deve ser revista pelos participantes.