Is bladder outlet obstruction responsible for a successful surgical outcome in women with complicated stress urinary incontinence? Urodynamic results before and after a Remeex® readjustable sling.

AIMS: To describe the changes in urodynamic parameters after Remeex® placement in women with recurrent stress urinary incontinence (rSUI) or intrinsic sphincteric deficiency (ISD) and to analyze a potential relationship between postoperative bladder outlet obstruction and a successful surgical outcome. METHODS: Retrospective analysis of those women who had undergone Remeex® placement due to rSUI or ISD in our department between 2000 and 2017. All patients underwent urodynamic evaluation before and after the surgery. If tension readjustment was required, postoperative urodynamics was performed after the last regulation, once the final continence status had been achieved. The female Bladder Outlet Obstruction Index (BOOIf) was calculated for all patients postoperatively. Obstruction was considered present if BOOIf was >18. Pre- and postoperative urodynamic variables were compared. Postoperative urodynamic changes were also compared between cured and noncured patients. RESULTS: A total of 205 women were included. After a follow-up of 89 ± 36 months, 165 women (80.5%) were continent. A significant impairment in the majority of the urodynamic parameters was observed. Mean postoperative BOOIf was -11.8 ± 21.5 in cured patients and -15.3 ± 23.1 in noncured patients (p = 0.365); 15 (9.1%) patients in the cured group had a postoperative BOOIf >18, whereas all (100%) patients in the noncured group had a postoperative BOOIf <18. CONCLUSIONS: Most urodynamic parameters may worsen after the Remeex® system placement. Postoperative urodynamic parameters may not differ substantially between cured and noncured patients, although a certain grade of bladder outlet obstruction could be related to postoperative continence status in some patients.

Development and validation of a short version of the Female Sexual Function Index in the Spanish population.

BACKGROUND: The Female Sexual Function Index (FSFI) is a commonly used scale for the assessment of female sexual function. Our aim was to develop and validate a Spanish short version of the FSFI. METHODS: A parallel exploratory, sequential mixed-methods approach was used, involving 2 sites. The process consisted of 2 steps: (1) cognitive and content validation of the previously translated FSFI in the Spanish population, both through a focus group; and item selection based on the difficulty and discrimination parameters using item response theory (IRT), thereby obtaining a short version of the scale (sFSFI-sv); (2) assessment of test-retest reliability (intraclass correlation coefficient, ICC) of the sFSFI-sv. The presence or absence of a sexual disorder variable based on clinical interview was used on the Receiver Operating Characteristic (ROC) to establish the cut off point whose Area Under the Curve (AUC) based on sensibility and specificity was maximum. RESULTS: Specific modifications of the FSFI were made according to the focus group results. 114 women were included for IRT analysis. The initial IRT model pointed to the exclusion of items 1, 2, 5, 11, 18, and 19 (S-χ2 p < 0.001). Items 3, 9, 11, and 14 showed the best discrimination and difficulty parameters. On the basis of the IRT and focus group results, items 1, 3, 9, 12, 16, and 17 were included in the final sFSFI-sv. sFSFI-sv showed good reliability (ICC 0.91) in a group of 93 women. A total score ≤ 18 could indicate a higher risk of sexual disorder (sensitivity: 81.0%, specificity: 73.3%). CONCLUSION: A focus group and the IRT analysis allowed the development of a 6-item Spanish version of the FSFI, which showed good reliability in a group of Spanish women.

Pelvic Organ Prolapse Repair with Mesh: Description of Surgical Technique Using the Surelift® Anterior Repair System.

INTRODUCTION: Although the use of transvaginal mesh (TVM) in the repair of pelvic organ prolapse (POP) has been restricted, there are still some cases in which TVM may be the most appropriate approach. The TVM Surelift® anterior repair surgical technique has not been described previously. OBJECTIVE: The aim of this study was to describe the surgical technique and to report our preliminary results regarding efficacy and complications. METHODS: A step-by-step description of surgical technique is presented. A descriptive retrospective analysis was performed to evaluate our preliminary results in 17 women who underwent POP repair using the Surelift® anterior repair system in our department between 2014 and 2017. TVM was offered to patients with symptomatic apical (primary or recurrent) or recurrent anterior POP stage ≥2. POP recurrence was classified as asymptomatic anatomic or symptomatic. Patients rated satisfaction with surgery on a scale from 0 to 10. Complications during follow-up were classified according to the International Urogynecological Association/International Continence Society recommendations. RESULTS: Median (IQR) follow-up was 19.9 months (24.8). Two (11.8%) anatomic recurrences were identified, both symptomatic, but neither required further surgery. No cases of pelvic pain, dyspareunia, voiding, or defecatory dysfunction were detected. Two (11.8%) patients presented a <1-cm vaginal mesh exposure (2AaT3S2) requiring partial mesh removal through a vaginal approach. At the end of follow-up, median satisfaction (IQR) with the surgery was 9 (3.1). CONCLUSION: The Surelift® anterior repair system is effective in correcting apical or recurrent anterior POP, with a high patient satisfaction rate. Complications after this surgery are infrequent and are mostly related to vaginal mesh exposure.

Onabotulinumtoxin a injection with or without hydrodistension for treatment of bladder pain syndrome.

INTRODUCTION: Onabotulinumtoxin A (BoNT-A) injection has been used for bladder pain syndrome (BPS) treatment with good results. Our aim was to assess the efficacy and safety of BoNT-A injection with or without hydrodistension (HD). METHODS: Retrospective analysis of patients treated with BoNT-A injection with or without HD because of BPS between 2008 and 2014 in our department. One hundred U of Botox® was injected in the trigone and 100 U in the bladder wall. Follow-up included a VAS of pain (0-10), a patient satisfaction scale (0-10) and a treatment benefit scale (1-2: response to treatment; 3-4: non-response to treatment). Complications were classified according to the Clavien-Dindo (CD) classification. BoNT-A retreatment was offered at the patient's request. Reasons for non-retreatment request were collected. Postoperative outcomes were compared between BoNT-A and BoNT-A + HD. RESULTS: Forty-one patients were included (39 females, 2 males), median age: 73 years (69-78.5). Reduction in VAS, postoperative VAS = 0, satisfaction with surgery and responders to treatment were significantly higher after BoNT-A + HD (n = 26) than after BoNT-A (n = 15). Eleven (26.8%) complications (CD ≤ 2) were detected, with no differences between treatment groups. Mean follow-up was 153 (± 83) months. Twelve (46.2%) patients in the BoNT-A + HD group and seven (46.7%) patients in the BoNT-A group requested retreatment. Lack of severe pain was a common reason for treatment discontinuation. CONCLUSION: BoNT-A injection could represent a safe and effective BPS treatment. BoNT-A + HD seems to be better than BoNT-A alone for pain relief, with no significant additional morbidity.

[Management of neurourological patients during the COVID-19 pandemic.] / Manejo del paciente neurourológico durante la pandemia COVID-19.

OBJECTIVES:  To report the recommendations of an expert panel to reorganize Neurourology units and to prioritize examinations and both conservative and surgical treatments during the COVID-19 pandemic. MATERIALS AND METHODS: Non-systematic review of the literature and national experts' opinion summarizing the recommendations in the diagnosis, management, and follow-up of neurourological patients during the COVID-19 pandemic. A modified nominal group technique was used due to extraordinary meeting and mobility restrictions during COVID-19 pandemic. RESULTS: Neurourological patients have special physiological and pathological characteristics that make them more vulnerable to SARS-CoV-2 infection. For prioritization purposes, they encompass in Functional Urology patients and their management is considered non-urgentor delayable with no specific deadline of recovery from normality. However, it is important to identify individual situations jeopardising the upper urinary tract, urinary retention or predisposing to urinary infections/sepsis. A classification is provided prioritizing conservative/outpatient management and the surgical treatment of the events occurring in neurourological patients during the COVID-19 pandemic. CONCLUSIONS: In neurourological patients we can find exceptional clinical situations in which a delayed treatment could develop irreversible changes in the upper urinary tract, advocating a more urgent treatment inspecific scenarios.

OBJETIVOS: Exponer las recomendaciones de un comité de expertos para la reorganización de las unidades de neurourología y la priorización de estudios y tratamientos durante la pandemia COVID-19.MATERIAL Y MÉTODOS: Revisión no sistemática de la literatura científica y opinión de expertos nacionales  para resumir las recomendaciones en el diagnóstico, tratamiento y seguimiento de los pacientes neurourológicos durante la pandemia COVID-19. Se utiliza una técnica de grupo nominal modificada debido a las restricciones extraordinarias de reunión y movilidad durante la pandemia COVID-19. RESULTADOS: Los pacientes neurourológicos poseen características fisiopatológicas especiales que les hace más vulnerables frente a la infección por SARS-CoV-2. Han sido englobados en general en el grupo de la Urología Funcional, relegando su manejo al de las situaciones no urgentes y demorables sin plazo concreto de recuperación de la normalidad. Sin embargo, es importante identificar situaciones específicas en las que exista compromiso funcional del aparato urinario superior, retención urinaria, o desarrollo de infecciones/sepsis urinaria. Se realiza una clasificación según el nivel de prioridad tanto del manejo ambulatorio y conservador como del tratamiento quirúrgico de eventos relacionados con pacientes neurourológicos durante la pandemia COVID-19. CONCLUSIONES: En los pacientes neurourológicos encontramos situaciones clínicas excepcionales en las que un retraso de su tratamiento puede conllevar alteraciones irreversibles en el tracto urinario superior, dada su condición de vejiga de riesgo funcional, por lo que debe individualizarse un manejo más precoz en ciertos escenarios.

Manejo de la hiperplasia benigna de próstata durante la pandemia COVID-19 / Benign prostatic hyperplasia management during COVID-19 pandemia

OBJETIVOS: Exponer las recomendaciones de un comité de expertos para la reorganización de las unidades de neurourología y la priorización de estudios y tratamientos durante la pandemia COVID-19. MATERIAL Y MÉTODOS: Revisión no sistemática de la literatura científica y opinión de expertos nacionales para resumir las recomendaciones en el diagnóstico, tratamiento y seguimiento de los pacientes neurourológicos durante la pandemia COVID-19. Se utiliza una técnica de grupo nominal modificada debido a las restricciones extraordinarias de reunión y movilidad durante la pandemia COVID-19. RESULTADOS: Los pacientes neurourológicos poseen características fisiopatológicas especiales que les hace más vulnerables frente a la infección por SARS-CoV-2. Han sido englobados en general en el grupo de la Urología Funcional, relegando su manejo al de las situaciones no urgentes y demorables sin plazo concreto de recuperación de la normalidad. Sin embargo, es importante identificar situaciones específicas en las que exista compromiso funcional del aparato urinario superior, retención urinaria, o desarrollo de infecciones/sepsis urinaria. Se realiza una clasificación según el nivel de prioridad tanto del manejo ambulatorio y conservador como del tratamiento quirúrgico de eventos relacionados con pacientes neurourológicos durante la pandemia COVID-19. CONCLUSIONES: En los pacientes neurourológicos encontramos situaciones clínicas excepcionales en las que un retraso de su tratamiento puede conllevar alteraciones irreversibles en el tracto urinario superior, dada su condición de vejiga de riesgo funcional, por lo que debe individualizarse un manejo más precoz en ciertos escenarios

OBJECTIVES: To report the recommendations of an expert panel to reorganize Neurourology units and to prioritize examinations and both conservative and surgical treatments during the COVID-19 pandemic. MATERIALS AND METHODS: Non-systematic review of the literature and national experts' opinion summarizing the recommendations in the diagnosis, management, and follow-up of neurourological patients during the COVID-19 pandemic. A modified nominal group technique was used due to extraordinary meeting and mobility restrictions during COVID-19 pandemic. RESULTS: Neurourological patients have special physiological and pathological characteristics that make them more vulnerable to SARS-CoV-2 infection. For prioritization purposes, they encompass in Functional Urology patients and their management is considered non-urgent or delayable with no specific deadline of recovery from normality. However, it is important to identify individual situations jeopardising the upper urinary tract, urinary retention or predisposing to urinary infections/sepsis. A classification is provided prioritizing conservative/outpatient management and the surgical treatment of the events occurring in neurourological patients during the COVID-19 pandemic. CONCLUSIONS: In neurourological patients we can find exceptional clinical situations in which a delayed treatment could develop irreversible changes in the upper urinary tract, advocating a more urgent treatment in specific scenarios

Manejo del paciente neurourológico durante la pandemia COVID-19 / Management of neurourological patients during the COVID-19 pandemic

OBJETIVOS: Exponer las recomendaciones de un comité de expertos para la reorganización de las unidades de neurourología y la priorización de estudios y tratamientos durante la pandemia COVID-19. MATERIAL Y MÉTODOS: Revisión no sistemática de la literatura científica y opinión de expertos nacionales para resumir las recomendaciones en el diagnóstico, tratamiento y seguimiento de los pacientes neurourológicos durante la pandemia COVID-19. Se utiliza una técnica de grupo nominal modificada debido a las restricciones extraordinarias de reunión y movilidad durante la pandemia COVID-19. RESULTADOS: Los pacientes neurourológicos poseen características fisiopatológicas especiales que les hace más vulnerables frente a la infección por SARS-CoV-2. Han sido englobados en general en el grupo de la Urología Funcional, relegando su manejo al de las situaciones no urgentes y demorables sin plazo concreto de recuperación de la normalidad. Sin embargo, es importante identificar situaciones específicas en las que exista compromiso funcional del aparato urinario superior, retención urinaria, o desarrollo de infecciones/sepsis urinaria. Se realiza una clasificación según el nivel de prioridad tanto del manejo ambulatorio y conservador como del tratamiento quirúrgico de eventos relacionados con pacientes neurourológicos durante la pandemia COVID-19. CONCLUSIONES: En los pacientes neurourológicos encontramos situaciones clínicas excepcionales en las que un retraso de su tratamiento puede conllevar alteraciones irreversibles en el tracto urinario superior, dada su condición de vejiga de riesgo funcional, por lo que debe individualizarse un manejo más precoz en ciertos escenarios

OBJECTIVES: To report the recommendations of an expert panel to reorganize Neurourology units and to prioritize examinations and both conservative and surgical treatments during the COVID-19 pandemic. MATERIALS AND METHODS: Non-systematic review of the literature and national experts' opinion summarizing ther ecommendations in the diagnosis, management, and follow-up of neurourological patients during the COVID-19 pandemic. A modified nominal group technique was used due to extraordinary meeting and mobility restrictions during COVID-19 pandemic. RESULTS: Neurourological patients have special physiological and pathological characteristics that make them more vulnerable to SARS-CoV-2 infection. For prioritization purposes, they encompass in Functional Urology patients and their management is considered non-urgent or delayable with no specific deadline of recovery from normality. However, it is important to identify individual situations jeopardising the upper urinary tract, urinary retention or predisposing to urinary infections/sepsis. A classification is provided prioritizing conservative/outpatient management and the surgical treatment of the events occurring in neurourological patients during the COVID-19 pandemic. CONCLUSIONS: In neurourological patients we can find exceptional clinical situations in which a delayed treatment could develop irreversible changes in the upper urinary tract, advocating a more urgent treatment in specific scenarios

Position of Ibero-American Society of Neurourology and UroGynecology (SINUG) on the use of vaginal meshes in pelvic organ prolapse.

AIMS: Pelvic organ prolapse (POP) is a very prevalent condition with a great impact on women's quality of life. At present, there is great controversy regarding the use of mesh in POP surgery. To understand the current moment, it is advisable to make a brief summary of the historical evolution of mesh use for pelvic floor pathology. The aim of this paper is to establish the position of the Ibero-American Society of Neurourology and UroGynecology (SINUG for its acronym in Spanish) regarding vaginal mesh reconstructive surgery. METHODS: A working committee from the SINUG's scientific board performed a literature search about the use of vaginal meshes for pelvic organ prolapse reconstructive surgery and about the position of different societies. We analyzed the evolution into three periods: before the Food and Drug Administration (FDA) statement, FDA statement, and after the statement. SINUG drew up a position statement regarding vaginal mesh reconstructive surgery, based on the available scientific evidence and the evolution of its use in different contexts. RESULTS: Before mesh appearance in the 1990s, native tissue repair was the surgical treatment of choice for POP. Vaginal mesh reconstructive surgery has been frequently accompanied by procedure underestimation by inexperienced surgeons, besides inadequate diagnoses and indications. This situation led to the presentation of serious complications including mesh extrusion, exposure, and contraction. CONCLUSIONS: Once reviewed the available evidence and the position of different societies, SINUG presents its vision in this communication, which is a summary of the document prepared by the society's scientific board.

Position of the Ibero-American Society of Neurourology and Urogynecology in relation to the use of synthetic suburethral meshes for the surgical treatment of female stress incontinence.

AIMS: The aim of this paper is to stablish de position of the Ibero-American Society of Neurourology and Urogynecology (SINUG) in relation to the use of suburethral meshes for the surgical treatment of female stress incontinence. METHODS: Tension-free mid-urethral slings (MUS) have become the most popular procedure for the treatment of stress urinary incontinence (SUI). In July 2018, the British government announced a pause in the use of meshes for both pelvic organ prolapse (POP) and urinary incontinence (UI) treatment without differentiating whether the meshes were used for treating UI or POP. The decision was taken to stop their use until the publication of the updated UI and POP guidelines of the British National Health Service, which is available from April 2019. SINUG has reviewed the evidence and official position of different societies in relation to the safety and efficacy of MUS in the surgical treatment of incontinence differentiating them from meshes used to repair POP. RESULTS: Data from synthetic mesh manufacturers indicate that in 2010, 300 000 women underwent surgical procedures to repair POP and approximately 260 000 were operated on for SUI. According to these estimates, approximately more than 80% of the surgical techniques for UI treatment were performed transvaginally with meshes. CONCLUSIONS: Once reviewed evidence and position of different societies, the SINUG presents its vision in this communication, which is a summary of the document analysing the state of topic prepared by the society.

Treatment Response and Complications after Intradetrusor OnabotulinumtoxinA Injection in Male Patients with Idiopathic Overactive Bladder Syndrome.

PURPOSE: We sought to assess the treatment response, complications and treatment continuation after onabotulinumtoxinA injection in male patients. MATERIALS AND METHODS: We performed a retrospective study of men with refractory idiopathic overactive bladder treated with intradetrusor injection of 100 IU onabotulinumtoxinA since 2007 in our department. Patients with previous radical prostatectomy were excluded from analysis. The treatment response was assessed using a treatment benefit scale of 1-greatly improved, 2-improved, 3-not changed and 4-worse after treatment. A treatment benefit scale score of 1 or 2 was considered a treatment response. Complications were classified according to the CD (Clavien-Dindo) classification. Treatment was considered to have continued if at the last visit patients had received an onabotulinumtoxinA injection within the preceding 12 months. We performed univariate and multivariate analyses to assess factors predictive of the treatment response, complications and continuation on treatment. RESULTS: Of the 146 men with a mean ± SD age of 70.1 ± 13.3 years who were included in study 91 (62.3%) reported a response to treatment. A total of 24 complications (16.4%) were detected, including 19 cases (13%) of urinary retention (CD 2), 2 (1.3%) of hematuria (CD 1) and 3 (2%) of urinary infection (CD 2). Followup was more than 12 months in 128 patients, of whom 88 (68.8%) had discontinued treatment by the end of followup. A higher bladder outlet obstruction index was the only factor predicting a lower treatment response rate and a higher complication rate. CONCLUSIONS: Most male patients with idiopathic overactive bladder showed a treatment response after intradetrusor onabotulinumtoxinA injection. However, the majority discontinued treatment. A higher bladder outlet obstruction index was related to a lower treatment response and a higher complication rate.

Long-term follow-up after cystectomy for bladder pain syndrome: pain status, sexual function and quality of life.

PURPOSE: To assess the long-term complications, pain status, sexual function and quality of life after cystectomy for bladder pain syndrome (BPS). METHODS: We retrospectively reviewed functional variables for 35 patients (34 women/1 man, 67 ± 9 years old) who underwent cystectomy due to BPS since 1993 in our department. Cystectomy was offered to patients with BPS refractory to conservative treatments. Six cystectomies with ileal conduit (17.1%) and 29 supratrigonal cystectomies with enterocystoplasty (82.9%) were performed. Prospectively, patients completed questionnaires on pain [BPIC-SS, visual analogue scale (VAS) for pain], health-related quality of life (EQ-5D) and sexual function (FSFI; 2-36), rated satisfaction with surgery (0-10) and reported whether they would undergo the same surgery again. RESULTS: Mean follow-up was 107 ± 83 months. In two (5.7%) patients, pain persisted and in one patient (2.8%) pain recurred after 20 months. Significant improvements in daytime and nighttime frequency and bladder capacity were observed postoperatively. 21 patients completed questionnaires. Mean BPIC-SS was 7.5 ± 8.4, mean VAS score 2.5 ± 2.8. 14 (66.7%) patients reported no problems related to pain on the EQ-5D, similar to our regional reference population. 13 (61.9%) patients had sexual intercourse after surgery, ten of them without pain. Mean FSFI score was 9.5 ± 9. Satisfaction with surgery was 8.8 ± 1.7 and 20 (95.2%) patients would undergo the same surgery again. CONCLUSION: Pain persistence or recurrence after cystectomy for BPS is infrequent. Quality of life related to pain is similar to that in the general population and patients can resume sexual activity without pain.

Pelvic Organ Prolapse Repair with Mesh: Mid-Term Efficacy and Complications.

INTRODUCTION: Our aim was to assess the efficacy and complications of pelvic organ prolapse (POP) correction with transvaginal mesh (TVM). MATERIALS AND METHODS: We retrospectively assessed patients who had undergone a repair of an apical (primary or recurrent) or recurrent POP using TVM in our department since 2007. Meshes used were Prolift®, Elevate®, and Surelift®. Satisfaction with surgery was assessed on a 0-10 scale. RESULTS: A total of 83 patients were included (33 Prolift®, 36 Elevate®, 14 Surelift®), with a mean age of 67.8 ± 9.7 years. Eighteen (21.6%) patients underwent a recurrent POP correction. Follow-up was 49 ± 34 months. Twelve (14.4%) symptomatic recurrences were identified, 3 of which required further surgery. Satisfaction was 8.7. Four (4.8%) vaginal exposures were detected, 2 of which required partial mesh removal. Three (3.6%) cases of dyspareunia and 1 (1.2%) case of mild pelvic pain were reported, which did not require further treatment. CONCLUSION: The use of TVM for apical or recurrent POP repair is effective and is associated with a high satisfaction rate while complications are infrequent.

A re-adjustable sling for female recurrent stress incontinence and intrinsic sphincteric deficiency: Long-term results in 205 patients using the Remeex sling system.

AIMS: To evaluate the outcomes and complications at long-term follow-up after a Remeex re-adjustable sling for recurrent stress urinary incontinence (rSUI) and intrinsic sphincteric deficiency (ISD) in women. METHODS: Two hundred thirty women with SUI were evaluated after undergoing a re-adjustable sling operation. Twenty-five patients were lost to follow-up, 205 were classified by Q-tip, urodynamic, and clinical criteria into ISD (109) and rSUI (96). Outcome measures included number of pads, 1 h pad-test, urodynamics and subjective satisfaction index with the procedure. RESULTS: After a mean follow-up of 89 months (26-159), 165 patients were cured of SUI (71.7% in the intention to treat analysis (itt), 80.5% in per protocol analysis (pp)). Forty patients remained incontinent (17.4% in itt, 19.5 in pp). Thirty-one patients (15.1%) had detrusor overactivity (DH) incontinence, 21 (10.2%) with de-novo DH and 10 with previous urodynamic mixed incontinence. Eighty-eight patients required re-adjustment of the sling during the follow-up. The tension was increased in 82 cases due to recurrence of SUI and reduced in six due to outlet obstruction. The overall complications rate was 28.8%, (3.4% clavien III). CONCLUSIONS: The Remeex re-adjustable sling provides a good cure rate for rSUI and ISD at long-term follow-up. The complications rate is acceptable since most complications are clavien II. The ability to re-adjust the sling tension during the follow-up allowed us to achieve cure for recurrence after the initial procedure, and to relieve obstruction in every case attempted.

Healthcare resource utilization and cost among males with lower urinary tract symptoms with a predominant storage component in Spain: The epidemiological, cross-sectional MERCURY study.

AIMS: To assess the relationship between storage-predominant LUTS and healthcare resource consumption and cost among males in Spain. METHODS: In this non-interventional, cross-sectional study, urologists enrolled males with storage-predominant LUTS and recorded the consumption of healthcare resources (medical visits, diagnostic tests/monitoring, treatment, and hospitalizations) within the previous 6 months. The cost of healthcare resources was calculated from unit costs extracted from a Spanish eHealth database. Severity of LUTS was assessed by the Bladder Self-Assessment Questionnaire (BSAQ) and patients were stratified by symptom score (<6 or ≥6) to assess the relationship between LUTS severity and healthcare resource consumption and cost. RESULTS: Among 610 enrolled patients (BSAQ symptom score <6, n = 191; BSAQ symptom score ≥6, n = 419), the majority (87.7%) consumed healthcare resources during the previous 6 months in the form of medical visits (86.2%), diagnostic tests/monitoring (83.4%), and treatment (85.9%). Patients with BSAQ symptom scores ≥6 used more healthcare resources compared with patients with BSAQ symptom scores <6. The most common treatments for LUTS were α-blockers used as monotherapy (n = 229 [37.5%]) or in combination with antimuscarinics (n = 227 [37.2%]). The estimated median annual cost was €1070 per patient, consisting of diagnostic tests/monitoring (54.6%), medical visits (20.5%), and treatment (29.6%), and was higher in patients with BSAQ symptom score ≥6 (€1127) than in patients with BSAQ symptom score <6 (€920; P < 0.001). CONCLUSIONS: More severe LUTS are associated with higher healthcare consumption and cost. These findings highlight the importance of symptom management in LUTS patients to help minimize healthcare consumption and cost.

[Expert opinion about the use of transdermic oxybutynin in Spain for the treatment of adult overactive bladder.] / Opinión de expertos sobre el uso de la oxibutinina transdérmica en España para el tratamiento de la vejiga hiperactiva en adultos.

OBJECTIVES: To define the different characteristics of transdermal oxybutynin (TO) for the treatment of overactive bladder in adults, to know the barriers for the use of this drug and to establish proposals to minimize these barriers. METHODS: Local sessions were held with 111 urologists from all over the country divided into 12 sessions. They were moderated by a brainstorming technique led by an external consultant. RESULTS: 75% of experts believe that tolerability and clinical efficacy (50%) are the most important attributes to choose this formulation, being the lack of scientific publications the least valued (12%). These opinions were based on their own clinical experience with TO or on scientific publications, without establishing comparison with other treatment options. The main barriers would be administrative obstacles (84%), difficulty in its use (54%) and the lack/rejection of the transdermal administration by the patient (33%). Actions were proposed to correct the 8 most significant barriers, such as better training for specialists (both Urology and other specialties) and for patients, creating informative materials to reinforce health education in managing patches, generating greater volume of scientific evidence to support their use in overactive bladder and clearly identifying the profile of patients who will benefit most from this therapeutic strategy. CONCLUSIONS: Although oxybutynin has been standard treatment of overactive bladder in recent years the conclusion of this working group is that its new transdermal formulation offers a better-tolerated alternative for patients, and, therefore the necessary tools to generate more evidence should be implemented to increase the proper use among specialists and patients.

Opinión de expertos sobre el uso de la oxibutinina transdérmica en España para el tratamiento de la vejiga hiperactiva en adultos / Expert opinión about the use of transdermic oxybutynin in Spain for the treatment of adult overactive bladder

OBJETIVO: Definir las características diferenciales de la oxibutinina transdérmica (OT) en el tratamiento de la vejiga hiperactiva en pacientes adultos, conocer las barreras de uso y establecer propuestas para minimizar estas barreras. MÉTODOS: Se realizaron 12 sesiones de ámbito local a las que acudieron 111 urólogos en total de todo el territorio nacional, que fueron moderadas mediante una técnica de brainstorming dirigida por un consultor externo. RESULTADOS: El 75% de los expertos opina que la tolerabilidad y la eficacia clínica (50%) son los 'atributos' más importantes para escoger esta formulación, siendo el menos valorado la escasez de publicaciones científicas (12%), basándose en su propia experiencia clínica con OT o la referida en publicaciones científicas, sin establecer comparación con otras alternativas de tratamiento. Las principales 'barreras' para su uso serían las trabas administrativas (84%), la dificultad en su manejo (54%) y el desconocimiento-rechazo de la vía transdérmica por parte del paciente (33%). Se acordaron acciones para subsanar las 8 barreras más significativas, como mayor formación para especialistas (tanto Urología como otras especialidades) y para pacientes, creación de materiales informativos para reforzar la educación en el manejo de parches, generar mayor volumen de evidencia científica que avale su uso en la vejiga hiperactiva e identificar claramente los perfiles de pacientes más beneficiarios de esta estrategia terapéutica. CONCLUSIONES: Este grupo de expertos identificó la tolerabilidad y eficacia como los dos atributos clave que debe tener un fármaco para el tratamiento de la vejiga hiperactiva, de los cuales la OT destaca en el primero de ellos. Además, deben emprenderse acciones formativas, educativas y de investigación a todos los actores implicados con el fin de superar las barreras que dificultan el correcto manejo de este fármaco

OBJECTIVES: To define the different characteristics of transdermal oxybutynin (TO) for the treatment of overactive bladder in adults, to know the barriers for the use of this drug and to establish proposals to minimize these barriers. METHODS: Local sessions were held with 111 urologists from all over the country divided into 12 sessions. They were moderated by a brainstorming technique led by an external consultant. RESULTS: 75% of experts believe that tolerability and clinical efficacy (50%) are the most important attributes to choose this formulation, being the lack of scientific publications the least valued (12%). These opinions were based on their own clinical experience with TO or on scientific publications, without establishing comparison with other treatment options. The main barriers would be administrative obstacles (84%), difficulty in its use (54%) and the lack/rejection of the transdermal administration by the patient (33%). Actions were proposed to correct the 8 most significant barriers, such as better training for specialists (both Urology and other specialties) and for patients, creating informative materials to reinforce health education in managing patches, generating greater volume of scientific evidence to support their use in overactive bladder and clearly identifying the profile of patients who will benefit most from this therapeutic strategy. CONCLUSIONS: Although oxybutynin has been standard treatment of overactive bladder in recent years the conclusion of this working group is that its new transdermal formulation offers a better-tolerated alternative for patients, and, therefore the necessary tools to generate more evidence should be implemented to increase the proper use among specialists and patients

Utilidad de los cuestionarios en pacientes con vejiga hiperactiva y síntomas del tramo urinario inferior / The usefulness of questionnaires in the management of overactive bladder and lower urinary tract symptoms

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Adaptación cultural al Español y validación psicométrica de la Escala de Beneficio del Tratamiento ( Treatment Benefit Scale –TBS) en el tratamiento sintomático de la vejiga hiperactiva / Spanish cultural adaptation and psychometrical validation of the Treatment Benefit Scale (TBS) in the symptomatic treatment of overactive bladder

Fundamento y objetivo: Validación psicométrica de la versión española de la Escala de Beneficio del Tratamiento (TBS) para valorar el beneficio para el paciente del tratamiento de los síntomas asociados a vejiga hiperactiva. Pacientes y método: La versión española de la escala TBS fue administrada en la visita final de un estudio clínico, prospectivo y observacional, después de 3 meses de intervención médica. Se incluyeron pacientes con vejiga hiperactiva, de ambos géneros, mayores de 18 años, con una puntuación ≥8 en la escala OAB-V8 y capaces de entender cuestionarios de salud en español. Se midió la variabilidad, la validez de criterio y la validez de grupos conocidos de la escala. Resultados: Se incluyeron 246 pacientes (media de edad de 57,7 años, 76% mujeres). El 1,7% no cumplimentó la escala. El 30% de los pacientes observó una mejoría extrema, el 58% mejoró, el 11% no cambió y el 2% empeoró tras la intervención médica. La TBS correlacionó significativamente con los cambios según criterio clínico; (r=0,743; p<0,001). Se observó una asociación lineal con los cambios en ambos dominios de la escala OABq-SF; severidad: Flineal=33,89, p<0,001 y calidad de vida relacionada con la salud: Flineal=41,69, p<0,001. La TBS diferenció grupos de pacientes según el nivel de severidad y de calidad de vida; F=11,17; p<0,001 y F=13,95; p<0,001. Conclusión: La versión española de la escala TBS ha mostrado poseer adecuadas propiedades psicométricas de validez en pacientes españoles con vejiga hiperactiva, lo que apoya su uso en la práctica médica diaria en la evaluación de resultados subjetivos relacionados con el tratamiento de la vejiga hiperactiva (AU)

Background and objective: Psychometric validation of the Spanish version of the Treatment Benefit Scale(TBS) scale for assessing the patient’s treatment benefit on symptoms associated to overactive bladder. Patients and methods: The Spanish version of the TBS was administered in the final visit of a prospective observational clinic study, after 3 months of a clinical intervention. Overactive bladder patients, above18 years old, of both genders, with an OAB-V8 score 8, and able to understand health questionnaires in Spanish were recruited. Results: A total of 246 patients (57.7 years, 76% women) were included. The scale was not completed by1.7% of patients. Extreme improvement was experienced by 30% of patients, 58% improved, 11% did not change, and 2% worsened after medical intervention. The TBS significantly correlated with the clinical criterion of change; (r=0.743; P<.001). A linear association was observed with changes in both OABq-SF scale domains; severity: Flinear=33.89, P<.001 and health related quality of life: Flinear=41.69, P<.001. The TBS was able to distinguish between groups of patients by severity and quality of life, F=11.17, P<.001and F=13.95, P<.001.Conclusion: The Spanish version of the TBS scale has shown good validity psychometric properties in Spanish overactive bladder patients, supporting its use in routinely clinical practice for assessing subjective outputs related to overactive bladder treatment (AU)