Modeling study of the effect of placebo and medical therapy on storage and voiding symptoms, nocturia, and quality of life in men with prostate enlargement at risk for progression.

BACKGROUND: Modeling studies using large datasets from men with lower urinary tract symptoms/benign prostate enlargement (LUTS/BPE) can predict changes in International Prostate Symptom Score (IPSS) and risk of acute urinary retention/surgery under different treatment regimens and according to predictors (baseline characteristics) that commonly define risk of progression. We assessed the impact of treatments on different symptom types (storage, voiding, and nocturia), quality of life (QoL; IPSS Q8), and BPH Impact Index [BII]). METHODS: Generalized least squares models were used to predict each outcome. Data from the CombAT study were used to predict outcomes for active treatments (dutasteride, tamsulosin, combination therapy). Predictors included: age; IPSS total, storage, voiding, nocturia and QoL (IPSS Q8) scores; BII; prostate volume; maximum urine flow rate (Qmax), prostate-specific antigen, postvoid residual urine (PVR); alpha-blocker usage within 12 months. Data from phase III dutasteride monotherapy studies were used to predict placebo outcomes. Results were visualized using an interactive web-based tool ( www.bphtool.com ). RESULTS: Combination therapy provided greater predicted benefit than either monotherapy for all five outcomes for most patient profiles within the CombAT inclusion criteria. PVR and corresponding subscores were significant predictors of change in both storage and voiding subscores. Alpha-blocker use within 12 months, age (storage subscore), and Qmax (voiding subscore) were also significant predictors. PVR, age, Qmax, and nocturia score were significant predictors of change in nocturia. PVR, Qmax, previous alpha-blocker use, total IPSS, and QoL (IPSS Q8) score were significant predictors of change in QoL (IPSS Q8) score. For BII, significant predictors were PVR, age, total IPSS, and BII score. The multivariable effect of covariates and treatments is best visualized through the interactive web-based tool. CONCLUSIONS: This predictive modeling study informs our understanding of how risk factors for disease progression interact and affect treatment impact on different symptom types and QoL scores.

Neuro-Urology: Call for Universal, Resource-Independent Guidance.

Neurogenic lower urinary tract dysfunction (NLUTD), the abnormal function of the lower urinary tract in the context of neurological pathology, has been the subject of multiple efforts worldwide for the development of clinical practice guidelines. These guidelines are based on the same body of evidence, and are therefore subject to the same gaps. For example, sexual and bowel dysfunction in the context of NLUTD, optimal renal function assessment in those who are non-ambulatory or with low muscle mass, optimal upper tract surveillance timing, and modification of diagnostic and treatment modalities for low-resource nations and communities are inadequately addressed. In addition, many aspects of the conclusions and final recommendations of the guidelines are similar. This duplicative work represents a large expenditure of time and effort, which we believe could be focused instead on evidence gaps. Here, we call for a global unified approach to create a single, resource-independent, comprehensive guidance on NLUTD, neurogenic sexual, and neurogenic bowel dysfunction. Targeted research addressing the evidence gaps should be called for and pursued. This will allow for focus to shift to filling the gaps in the evidence for future guidelines.

Understanding Treatment Response in Individual Profiles of Men with Prostatic Enlargement at Risk of Progression.

BACKGROUND: It is unclear how cumulative multivariable effects of clinically relevant covariates impact response to pharmacological treatments for lower urinary tract symptoms (LUTS)/benign prostatic enlargement (BPE). OBJECTIVE: To develop models to predict treatment response in terms of International Prostate Symptom Score (IPSS) and the risk of acute urinary retention (AUR) or BPE-related surgery, based on large data sets and using as predictors baseline characteristics that commonly define the risk of disease progression. DESIGN, SETTING, AND PARTICIPANTS: A total of 9167 patients with LUTS/BPE at risk of progression in three placebo-controlled dutasteride trials and one comparing dutasteride, tamsulosin, and dutasteride + tamsulosin combination therapy (CT) were included in the analysis to predict response to placebo up to 24 mo and active treatment up to 48 mo. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Predictors included age, IPSS, total prostate volume (PV), maximum urinary flow rate (Qmax), prostate-specific antigen, postvoid residual urine (PVR), α-blocker usage within 12 mo, and randomised treatment. A generalised least-squares model was developed for longitudinal IPSS and a Cox proportional-hazards model for time to first AUR/surgery. RESULTS AND LIMITATIONS: The vast majority of patients benefit from dutasteride or CT when compared with tamsulosin alone. The predicted IPSS improvement with dutasteride or CT increased with greater PV and severity of symptoms at baseline. The tamsulosin effect was lower with greater baseline PV and tended to decrease over time. Predicted AUR/surgery risk was greater with tamsulosin versus CT or dutasteride; this risk increased with larger PV, higher PVR, and lower Qmax (all at baseline). An educational interactive web-based tool facilitates visualisation of the results (www.bphtool.com). Limitations include: the placebo and active-treatment predictions are from different studies, the lack of similar studies for external validation, and the focus on a population at risk of progression from the 4-yr CombAT study. CONCLUSIONS: Predictive modelling based on large data sets and visualisation of the risk for individual profiles can improve our understanding of how risk factors for disease progression interact and affect response to different treatments, reinforcing the importance of an individualised approach for LUTS/BPE management. PATIENT SUMMARY: We used data from previous studies to develop statistical models for predicting how men with lower urinary tract symptoms or benign prostate enlargement and at risk of disease complications respond to certain treatments according to their individual characteristics.

Incontinence outcomes in women undergoing retropubic mid-urethral sling: a retrospective cohort study comparing Safyre™ and handmade sling

ABSTRACT Purpose This study examined and compared efficacy, safety, satisfaction, and complications of the retropubic Safyre™ sling and a retropubic hand-made synthetic sling (HMS) in a short-, mid- and long-term follow-up. Methods We retrospectively reviewed a prospectively maintained database of women who underwent Safyre™ or HMS between March 7ths 2005 and December 27ths, 2017. Patients had first assessment (7-10 days), second (40-45 days), and third (sixth month) postoperatively. Between September and December 2018, patients who completed at least one year of surgery, received a telephone call. Follow-up compared quartiles of follow-up time to determine complications (Clavien-Dindo), success rates (International Consultation on Incontinence Modular Questionnaire for Urinary Incontinence Short Form - ICIQ-UI SF), and patient satisfaction. Results Three hundred fifty-one patients underwent surgery and 221 (63%) were evaluated after a median of 78.47 (± 38.69) months, 125 (55%) in the HMS, and 96 (45%) in the Safyre™ group. Higher intraoperative bladder injury was observed with Safyre™ (0% vs. 4.2%, p=0.034), and a tendency for urinary retention, requiring indwelling urinary catheter over 24 hours (2.4% vs. 8.3%, p=0.061). Both HMS (p<0.001) and Safyre™ (p<0.001) presented improvements on ICIQ-UI SF. There were no differences in satisfaction, subjective cure rates, ICIQ-UI SF, or complications between groups. Conclusions Both HMS and Safyre™ have similar satisfaction and subjective cure rates, with marked ICIQ-UI SF score improvement. Higher rates of intraoperative bladder injury were seen in patients who received Safyre™ retropubic sling.

Incontinence outcomes in women undergoing retropubic mid-urethral sling: a retrospective cohort study comparing Safyre™ and handmade sling.

PURPOSE: This study examined and compared efficacy, safety, satisfaction, and complications of the retropubic Safyre™ sling and a retropubic hand-made synthetic sling (HMS) in a short-, mid- and long-term follow-up. METHODS: We retrospectively reviewed a prospectively maintained database of women who underwent Safyre™ or HMS between March 7ths 2005 and December 27ths, 2017. Patients had first assessment (7-10 days), second (40-45 days), and third (sixth month) postoperatively. Between September and December 2018, patients who completed at least one year of surgery, received a telephone call. Follow-up compared quartiles of follow-up time to determine complications (Clavien-Dindo), success rates (International Consultation on Incontinence Modular Questionnaire for Urinary Incontinence Short Form - ICIQ-UI SF), and patient satisfaction. RESULTS: Three hundred fifty-one patients underwent surgery and 221 (63%) were evaluated after a median of 78.47 (± 38.69) months, 125 (55%) in the HMS, and 96 (45%) in the Safyre™ group. Higher intraoperative bladder injury was observed with Safyre™ (0% vs. 4.2%, p=0.034), and a tendency for urinary retention, requiring indwelling urinary catheter over 24 hours (2.4% vs. 8.3%, p=0.061). Both HMS (p<0.001) and Safyre™ (p<0.001) presented improvements on ICIQ-UI SF. There were no differences in satisfaction, subjective cure rates, ICIQ-UI SF, or complications between groups. CONCLUSIONS: Both HMS and Safyre™ have similar satisfaction and subjective cure rates, with marked ICIQ-UI SF score improvement. Higher rates of intraoperative bladder injury were seen in patients who received Safyre™ retropubic sling.

Botulinum toxin for treating overactive bladder in men: A systematic review.

PURPOSE: We sought to systematically review the literature on the use of botulinum toxin (BTX-A) injections in the bladder to treat overactive bladder (OAB) in men. MATERIALS AND METHODS: A systematic review was performed to identify clinical trials on efficacy and safety of BTX-A injections in the detrusor for treatment of OAB in men published from inception to October 2020. Quality assessment was performed using the Cochrane Collaboration's tool for assessing risk of bias and study characteristics were extracted by two reviewers independently. RESULTS: After screening 75 abstracts, 12 trials were included in the qualitative synthesis, of which 6 were conducted exclusively in men (mean age: 66.7 years). Only two were randomized controlled studies and the remaining were observational studies, mostly case series. Total number of participants in each study ranged from 28 to 146. Therapeutic response to intravesical BTX-A injection was assessed differently across the studies, which used quality-of-life symptom questionnaires and voiding diary parameters. Urodynamics findings were reported separately for men before and after intravesical injection of BTX-A in two studies only. Pooling of outcome data was possible with adverse events reported after BTX-A by seven studies, which showed urinary tract infection, urinary retention, increased postvoid residual, de novo interstitial cystitis, and hematuria rates of 29.8%, 20.0%, 37.3%, 28.3%, and 12.4%, respectively. CONCLUSIONS: Limited information regarding the efficacy and safety of BTX-A bladder injections for male OAB from relatively low evidence is available. Further research is needed to better understand the risk-benefit profile of BTX-A in the male population.

Tradução para o português An International Continence Society (ICS) report on the terminology for adult neurogenic lower urinary tract dysfunction (ANLUTD)

RESUMO Introdução A terminologia para disfunção neurogênica do trato urinário inferior em adultos (DNTUIA) deve ser definida e organizada com base clínica em um relatório de consenso. Métodos Este relatório foi criado por um Grupo de Trabalho sob o endosso e diretrizes do Standardization Steering Committee (SSC) da International Continence Society (ICS), auxiliado em intervalos por julgadores externos. Todas as definições relevantes para DNTUIA foram atualizadas com base em pesquisas nos últimos 14 anos. Um extenso processo de 18 rodadas de revisão interna e externa foi realizado para examinar exaustivamente cada definição, com tomada de decisão pela opinião coletiva (consenso). Resultados O Relatório de Terminologia para a DNTUIA, englobando 97 definições (42 novas e oito modificadas), foi desenvolvido. Este relatório é clinicamente baseado nos diagnósticos definidos mais comuns. Clareza e facilidade de uso têm sido os principais objetivos para torná-lo interpretável por profissionais e pessoas em treinamento em todos os diferentes grupos envolvidos não só na disfunção do trato urinário inferior, mas também em muitas outras especialidades médicas. Conclusão Baseado no consenso, o Relatório de Terminologia para a DNTUIA foi produzido para auxiliar na pesquisa e na prática clínica.

Is coronavirus disease 2019 associated with indicators of long-term bladder dysfunction?

OBJECTIVE: Early reports have suggested that coronavirus disease 2019 (COVID-19) can present with significant urinary frequency and nocturia, and that these symptoms correlate with markers of inflammation in the urine. We evaluated surrogate markers of chronic urinary symptoms to determine if they were more frequent after COVID-19 infection. METHODS: Routinely collected data from the province of Ontario was used to conduct a matched, retrospective cohort study. We identified patients 66 years of age or older who had a positive COVID-19 test between February and May 2020 and survived at least 2 months after their diagnosis. We matched them to two similar patients who did not have a positive COVID-19 test during the same time period. We measured the frequency of urology consultation, cystoscopy, and new prescriptions for overactive bladder medications during a subsequent 3-month period. Proportional hazard models were adjusted for any baseline differences between the groups. RESULTS: We matched 5617 patients with COVID-19 to 11,225 people who did not have COVID-19. The groups were similar, aside from a higher proportion of patients having hypertension and diabetes in the CoVID-19 cohort. There was no significantly increased hazard of new receipt of overactive bladder medication (hazards ratio [HR]: 1.04, p = 0.88), urology consultation (HR: 1.40, p = 0.10), or cystoscopy (HR: 1.14, p = 0.50) among patients who had COVID-19, compared to the matched cohort. CONCLUSION: Surrogate markers of potential bladder dysfunction were not significantly increased in the 2-5 months after COVID-19 infection.

Is there a role for sacral neuromodulation in patients with neurogenic lower urinary tract dysfunction?

ABSTRACT Purpose To review current literature regarding sacral neuromodulation (SNM) for neurogenic lower urinary tract dysfunction (NLUTD) focused on indications, barriers and latest technological developments. Material and Methods A PubMed database search was performed in April 2020, focusing on SNM and various neuro-urological conditions. Results SNM has been increasingly indicated for lower urinary tract dysfunction (LUTD) in neuro-urological patients. Most studies are cases series with several methodological limitations and limited follow-up, lacking standardized definition for SNM clinical success. Most series focused on neurogenic overactive bladder in spinal cord injured (incomplete lesions) and multiple sclerosis patients. Barriers for applying this therapy in neurogenic LUTD were mainly related to magnetic resonance imaging incompatibility, size of the implantable pulse generator (IPG), and battery depletion. Newer technological advances have been made to address these limitations and will be widely available in the near future. Conclusions SNM seems a promising therapy for neurogenic LUTD in carefully selected patients with incomplete lesions. Further studies are still needed to define which subgroups of neurological patients benefit the most from this minimally invasive technique.