Long-term outcome of adjustable transobturator male system for stress urinary incontinence in the Iberian multicentre study.

AIM: The aim of this study is to evaluate long-term durability and effectiveness of the adjustable transobturator male system (ATOMS). MATERIALS AND METHODS: The retrospective multicenter Iberian ATOMS study (n = 215) was updated to evaluate long-term continence status, complications, explants, and secondary treatments. Mean follow-up from surgery to March 2020 was 60.6 ± 18.4 months (range, 39-91). Eleven patients deceased of an unrelated causes. Kaplan-Meier curves were performed to evaluate device durability and incontinence free of recurrence interval. The multivariate analysis defined the population at risk of device explant. RESULTS: A total of 155 patients were dry at the last follow-up visit (72.1%); 99 (46%) used no pads and 56 (26%) used a security pad/day with urine loss less than 10 mL; 96% of dry patients after adjustment remained free of incontinence 1 year later, 93.6% 2 years later, 91.1% 3 years later, 89.2% 5 years later, and 86.7% 8 years later. Complications during follow-up occurred in 43 of 215 (20%). In total, 25 (11.6%) devices were explanted and causes were inefficacy 11 (44%), inefficacy and pain 3 (12%), port erosion 10 (40%), and wound infection 1 (4%). The secondary implant was performed in 11 (5.1%) cases, 6 artificial urinary sphincter and 5 repeated ATOMS. Time to explant was associated to complications (P < .0001), baseline stress urinary incontinence (SUI) severity (P = .01), and former irradiation (P = .03). Multivariate analysis revealed complications (hazard ratio [HR] = 8.71; 3.83-19.82), baseline SUI severity (>5 compared to 1-2 pads/day; HR = 14.9; 1.87-125), and irradiation before ATOMS (HR = 2.26; 1.02-5.18) predicted earlier ATOMS explant. Three cases received radiation after implant without complication. CONCLUSIONS: ATOMS device is efficacious and safe in the long term. Determinants for device explant include complications, baseline severity of incontinence, and previous irradiation. Currently, the durability of the device after 5 years is reassuring.

[Functional urology during COVID-19: Recommendations during de-escalation.] / La urología funcional en la era COVID-19. Consejos para la desescalada.

OBJECTIVES: Due to the COVID-19 Pandemic, all surgical activity that was not life threatening was cancelled , as well as most face-to-face consultations. Currently the beginning of the de-escalation phases that will led us to a new normal, forces us to establish some degree of priority in the interventions as well as in the medical consultations. Our objective is to establish some recommendation on Functional Urology office visits and surgical interventions that serve as a tool to facilitate decision-making. MATERIAL AND METHODS: Experts in Functional Urology from different autonomous communities of Spain were contacted to design a strategy to reorganize the activity of both, diagnosis and treatment. A modified nominal group technique has been used due to the extraordinary restrictions of assembly and mobility during the COVID pandemic. The first signer (EMC) made the first draft with the measures adopted and the strategy to be followed during the evolution of the COVID-19 pandemic. The proposal was sent to the rest of the authors, in order to unify criteria and experiences to reach a quick consensus on the relative priority of the different activities, problems and solutions. A final version was approved by all authors May 27, 2020. RESULTS: Tables of recommendation have been prepared for outpatient consultation, surgical and technical interventions, according to de-escalation phases proposed by the Spanish Associations of Surgeons. CONCLUSIONS: The change that COVID-19 Pandemich as involved in our clinical practice force us to seek alternative methods to treat our patients, some of which may already be established. Mean while, a consensusin decision making is necessary. Documents such as the current one, are intended to guide the management of patients with urological functional pathology in exceptional situations. Logically, it should be adapted to material and human availability, and to the idiosyncrasy of each Urology service.

OBJETIVOS: Debido a la Pandemia COVID-19 se suspendió toda actividad quirúrgica que no fuera una urgencia vital, así como la mayoría de consultas presenciales. Actualmente el inicio de las fases dedesescalada que nos llevarán a una nueva normalidad nos obliga a establecer unos grados de prioridad en las intervenciones así como en las consultas médicas. Nuestro objetivo es establecer una serie de recomendaciones sobre las consultas de Urología Funcional y las intervenciones quirúrgicas que sirva como herramientade ayuda en la toma de decisiones.MATERIAL Y MÉTODOS: Expertos en Urología Funcionalde distintas comunidades autónomas de España fueron contactados para diseñar una estrategia parareorganizar la actividad tanto de diagnóstico como de tratamiento. Se ha utilizado una técnica de grupo nominal modificada debido a las restricciones extraordinarias de reunión y movilidad durante la pandemia COVID. El primer firmante (EMC) realizó el primer borrado rcon las medidas adoptadas y la estrategia a seguir durante la evolución de la pandemia COVID19. Se remitió la propuesta al resto de autores, con el fin de unificar criterios y experiencias para llegar a un rápido consenso sobre la importancia relativa de las distintas actividades, problemas y soluciones. Se realizó una versión definitiva, aprobada por todos los autores, el día 27 de mayo de 2020. RESULTADOS: Se han elaborado tablas de recomendaciones tanto para consultas externas, como para intervenciones quirúrgicas y técnicas, de acuerdo con las fases de desescalada propuestas por la Asociación Española de Cirujanos (AEC). CONCLUSIONES: El cambio que ha supuesto la Pandemia COVID-19 en nuestra práctica clínica nos obliga a buscar métodos alternativos para seguir y tratar a nuestros pacientes, algunos de los cuales pueden ya quedar instaurados. Mientras, es necesario un consenso en la toma de decisiones. Documentos como el actual, pretenden orientar en el manejo de los pacientes con patología funcional urológica en situaciones excepcionales. Lógicamente, deberá adaptarse alas disponibilidades materiales y humanas, y a la idiosincrasia de cada servicio de Urología.

Consensus document on the multidisciplinary management of neurogenic lower urinary tract dysfunction in patients with multiple sclerosis.

AIM: Neurogenic lower urinary tract dysfunction (NLUTD) is very common in multiple sclerosis (MS) patients. Early diagnosis and treatment are crucial to avoid irreversible damage and improve quality of life. Our aim was to develop recommendations to improve NLUTD identification in MS patients, along with their referral and management. METHODS: A multidisciplinary group of 14 experts in the management of patients with MS and NLUTD (nine urologists, three neurologists, and two rehabilitators) was selected. A comprehensive review of the literature was undertaken and a set of recommendations was generated and submitted to a Delphi panel of 114 experts. Recommendations were presented according to the grade of agreement (GA). RESULTS: Early diagnosis in asymptomatic patients with risk factors for complications is recommended (GA 94%). Postvoid residual volume should be measured if changes in urinary symptoms (GA 87%), preferably ultrasound-guided (GA 86%). Early referral to urologist is recommended if urinary incontinence (GA 91%), significant post-void residual volume (94%), quality of life impairment (GA 98%) and recurrent urinary infections (GA 97%). The initial evaluation should include physical examination (GA 99%) and urodynamics including cystometry (GA 89%), pressure-flow study (90%) and electromyography (GA 70%). The panel recommends multidisciplinary collaboration (GA 100%) with a rehabilitation specialist and trained nurses in the management of NLUTD (GA 99%). CONCLUSIONS: Multidisciplinary management for patients with NLUTD due to MS is advised, including urologists, neurologists, rehabilitation, and nurses. Panel recommends early diagnosis with post-void residual volume in symptomatic patients before referring to urologist and urodynamics when referred.

Patient satisfaction with adjustable transobturator male system in the Iberian multicenter study.

BACKGROUNDS: Patient-reported outcome measurements are important for urinary incontinence. We analyze self-assessed patient satisfaction and define the clinical profile of patient with highest satisfaction with the adjustable transobturator male system (ATOMS). METHODS: Patient perception of results was evaluated in a series of 181 patients after ATOMS adjustment. Baseline incontinence severity was defined in pads-per-day (PPD) as mild (2), moderate (3-5) or severe (≥ 6), and dryness as use of none or one security PPD. Post-operative pain at discharge was evaluated by 0-10 visual analogue scale and complications by Clavien-Dindo classification. Multivariate analysis was performed to anticipate "very much better" than baseline perception on patient global impression of improvement and a predictive nomogram was developed. RESULTS: Dryness was achieved in 80.7% (94.9% mild, 80.8% moderate and 65.8% severe groups). Mean pad-test and pad-count decrease with respect to baseline was 458 ± 330 ml and 3.2 ± 1.9 PPD, respectively (both p < .0001). Complications presented in 25 (13.8%). The proportion of patients that self-declared satisfied with the procedure was 87.1%; 90.6% perceived their situation "better" and 48.1% "very much better" than before. Multivariate analysis revealed best perception is defined by dryness after adjustment (p < .0001), baseline severity of incontinence (p = .007), low post-operative pain at discharge (p = .0018) and lack of complications (p = .007). CONCLUSIONS: Self-assessed satisfaction with ATOMS is very high. Factors that predict best perception of improvement include dryness, baseline SUI severity, presence of complications and pain level during admission. Radiotherapy and device generation were not independent predictors. A nomogram to predict patients that are completely satisfied with ATOMS after adjustment is proposed.

Efficacy of Transdermal Oxybutynin in the Treatment of Overactive Bladder Syndrome: Does It Make Sense Using It in 2017?

OBJECTIVES: Evaluation of changes in symptoms among patients with overactive bladder syndrome treated with transdermal oxybutynin and tolerability after 12 months of follow-up. METHODS: This was a multicenter, retrospective, single-cohort, observational study. Changes in symptoms were evaluated primarily with a 3-day voiding diary. Results were compared to baseline. Subgroup analyses were performed in patients previously treated for OAB or not and aged < 65 years versus ≥65 years. RESULTS: Clinical records of 105 patients were examined; 92.4% were women. At 12 months, 58 patients continued to receive transdermal oxybutynin. Changes in symptoms according to the voiding diary were evaluated in 47 patients. Significant improvements from baseline were observed in urinary frequency (-2.6 voids/24 hours (95% CI: -3.5; -1.8), p < 0.001); daily number of urgent episodes (-4.7 episodes/day (95% CI: -6.1; -3.6), p < 0.001); and urge incontinence (-1.9 episodes/day (95% CI: -2.9; -1.3), p < 0.001). No statistically significant differences were found in subgroup analyses. In total, 38.1% of patients had adverse events, primarily in the application site (27.6%). No severe systemic adverse events occurred. Only 6 patients (5.7%) reported dry mouth. CONCLUSIONS: Improved symptoms and good tolerability observed after 1 year of treatment with transdermal oxybutynin shows that it currently has a place in the treatment of OAB patients.

Treatment of male stress urinary incontinence with the adjustable transobturator male system: Outcomes of a multi-center Iberian study.

AIM: To evaluate effectiveness and safety of the adjustable transobturator male system (ATOMS) for male stress urinary incontinence (SUI). MATERIAL AND METHODS: A retrospective multicenter study was conducted in nine Iberian institutions using a board-approved database for 215 patients intervened between 2012 and 2017, with no case excluded. Continence status, patient satisfaction, number, and grade of complications (Clavien-Dindo) and factors affecting dry rate at adjustment were evaluated. Multivariate analysis defined the population at best success rate. Incontinence recurrence due to device failure and/or explant was evaluated and Kaplan-Meier curve for durability performed. RESULTS: Adjustment was achieved at a mean 1.4 ± 1.9 fillings. Dry-rate after adjustment was 80.5% (96.2% mild and 75.3% moderate-severe), 121 (56.3%) used no pads, and 52 (24.2%) a security pad with urine loss under 10 mL. Mean basal daily pad-test and pad-count decreased from 484 ± 372.3 mL and 3.9 ± 2 pads to 63.5 ± 201.2 mL and 0.9 ± 1.5pads (both P < 0.0001). Satisfaction rate was 85.1% (94.3% mild and 82.1% moderate-severe). Factors associated to dryness were: lesser severity of SUI (P < .0001), absence of radiotherapy (P = 0.0002) and device generation (P = 0.05). Multivariate analysis revealed absence of radiation (OR = 3.12; 1.36-7.19), mild (OR = 19.61; 3.95-100), and moderate (OR = 2.48; 1.1-5.59) SUI were independent predictors. Complications presented in 33(15.35%); 66.7% grade 1, 9.1% grade 2, and 24.2% grade 3. At 24.3 ± 15 mo mean follow-up device was explanted in seven (3.25%) and SUI worsened after adjustment in nine (4.2%). Dry-rate at follow-up was 73% and durability of device in dry patients at adjustment was 89.8% (82.9-94) at 2-years. CONCLUSIONS: This study confirms ATOMS device is safe and achieves high treatment efficacy and patient satisfaction in a multicenter setting. Significantly better results are achieved in less severe and non-irradiated cases. Durability of the device is reassuring in the short-term.