Resultados de la subpoblación española del estudio BELIEVE. Evaluación de la calidad de vida y persistencia al tratamiento de pacientes tratados con mirabegrón

Introduction and objectiveThe BELIEVE study is a European, non-interventional study which includes patients with overactive bladder who were prescribed mirabegron as part of routine clinical practice. Data from the Spanish subpopulation has been obtained for the present study, aiming to analyze health-related quality-of-life (HRQoL) and treatment persistence of these patients.Materials and methodsData from 11 Spanish hospitals of the BELIEVE study were analyzed. The primary endpoint was to evaluate change of HRQoL from baseline with overactive bladder questionnaire (OAB-q). Secondary endpoints included treatment persistence, HRQoL based on the EQ-5D-5L questionnaire and adverse events. Study follow-up was 12 months, with two visit windows at 2-4 months and 10-12 months.Results153 Spanish patients were enrolled in the study. In the Full Analysis Set (FAS), 63.1% were women, and the mean age was 66 years. Symptom bother and HRQoL improved from baseline to 2-4 months and 10-12 months. EQ-5D-5L questionnaire also showed an improved patients’ HRQoL. Treatment persistence was high, as 49% of patients remained with mirabegron at 10-12 months. Adverse events were consistent with previous safety profile results of mirabegron, and no unexpected safety issues were observed.ConclusionsSpanish patients treated with mirabegron in real clinical practice reported improvements in HRQoL, with a good tolerability and persistence to treatment.     

Validación de la versión española del cuestionario «Beneficio,satisfacción y disposición para continuar el tratamiento» en pacientes con vejiga hiperactiva

ObjectivesTo perform the linguistic and psychometric validation of the Spanish version of the BSW (Benefit, Satisfaction and Willingness to continue) questionnaire.Material and methodsEpidemiologic, observational, multicenter, prospective (October 2008-February 2009) study in patients ≥ 40 years old with de novo overactive bladder syndrome who start treatment with antimuscarinics by physicians assessment. Data was recorded at baseline (face-to-face) and the follow-up of the study after 1 and 3 months (closed surveys by phone). Morisky-Green questionnaire was used to assess compliance. Bladder Control Self-assessment Questionnaire (B-SAQ) and BSW questionnaire were completed, performing the validation of BSW.Results312 evaluable patients were recruited, 93 remained until the 3 months visit. 65% and 71% of patients were not compliant with treatment at 1 and 3 months, respectively. The correlation between the BSW and the B-SAQ questionnaires after 1 and 3 months was moderate and statistically significant. The internal consistency between the BSW questionnaire items was high (Cronbach alpha: 0,89 at 1 month and 0,84 at 3 months). 92% of patients understood the questions and 84% were able to fill the BSW questionnaire without need of previous instructions (N = 25).ConclusionsThe BSW questionnaire has been shown to be a feasible, valid and reliable tool to know the patient self-assessment of the treatment, according to its psychometric properties.     

Análisis del síndrome de vejiga hiperactiva y de la incontinencia urinaria en varones en la franja de edad de los 50 a los 65 años. Estudio EPICC

IntroductionThe Overactive Bladder syndrome (OAB) and Urinary Incontinence (UI) result in an important personal and economic impact. This work concentrates on the detailed analysis of OAB and UI (derived symptoms and tendencies in medical consultation and resource consumption), in a sample of working men aged 50-65.Material and methodsThis study is within the framework of the EPICC study of the Spanish Association of Urology (epidemiologic, observational, multicentric, national study) and concentrates on the detailed analysis of the characteristics of the sample of working men aged 50–65 (N=1071) and of the subgroup of individuals with VH and/or IU (N=55).Results0.56% of the subjects presented UI, 3.55% OAB, 1.03% presented both pathologies. Taking into account those individuals with UI and/or OAB, 45.45% had problems to retain urine, and 16.36% suffered leakage daily; 45.45% suffered uncontrollable urge to urinate daily; 23.64% had never sought medical advice, 65.45% had visited an urologist, 14.55% would like to visit an specialist in incontinence; 40% had received treatment, from which 81.82 had received pharmacologic treatment.ConclusionIn this study, specific data about VH and IU in the reported sample are presented, including those referring to the magnitude of these conditions and use of sanitary resources in subjects with UI and/or OAB, aiming at contributing to a better diagnose and handling of patients and resources.     

Electroestimulación del suelo pélvico en mujeres con incontinencia urinaria y/o síndrome de vejiga hiperactiva: una revisión sistemática

ContextElectrostimulation (ES) is one of the techniques employed in conservative treatment of urinary incontinence (UI) and/or overactive bladder syndrome (OAB). Nevertheless, there is controversy in the scientific literature regarding its effectiveness as monotherapy.ObjectiveTo evaluate the scientific evidence on ES of the pelvic floor in women with UI and with/without OAB.Evidence acquisitionA systematic review of clinical trials was carried out in the following databases: PubMed, Cochrane, PEDro, Elsevier (Doyma) and EnFisPo (1980-2011). Quality of study registries was evaluated and information was obtained from those that presented the inclusion criteria established in the review.Evidence synthesisThe 27 clinical trials were included in the review: 13 randomized controlled trials, 11 randomized non-controlled trials and 3 non-randomized trials.ConclusionMost of the clinical trials conclude that ES is effective in the treatment of UI and OAB in women. However, better methodological quality studies are needed to obtain a higher level of scientific evidence and to know the optimal current modality, type and parameters for each type of UI and OAB.     

Distribución demográfica y prevalencia de la vejiga hiperactiva en Venezuela

ObjectiveThere is a lack of information regarding overactive bladder (OAB) in South America. Our aim in this study was to estimate the prevalence of overactive bladder (OAB) in Venezuela based on the 2002 International Continence Society (ICS) consensus criteria and also to verify its demographic distribution in this country.Subjects and methodsWe performed a multicentric prospective evaluation of patients from 2003 to 2007 in different cities in Venezuela. A number 3.407 adults (M:38%, F:62%) between 18 and 75 years of age (mean age 54 years) completed a physician guided questionnaire (V8) of urinary symptoms, bladder function, diet, general habits and general medical condition. Statistical procedures were carried out using software based on R programming for computational statistics.ResultsThe overall prevalence of OAB in Venezuela was determined as 21%. Female were more affected as compared to male (25.6% vs. 13.7% in men, p < 0.005) OAB was detected at early age (18 yrs) maintaining higher prevalence in women (M: 9%, F: 14%). In the studied cohort OAB shows its highest prevalence between the subgroup of 65 to 69 years of age. In all statistical tests the level of significance was defined as p < 0.005, with a confidence interval of 95%.ConclusionThe OAB-V8 questionnaire aids to clearly identify patients with OAB symptoms. The overall prevalence of OAB in Venezuela is 21%. It is present in both genders, predominantly women and can be detected at early age.     

Repercusión clínica y urodinámica de la presencia de hiperactividad del detrusor en mujeres con vejiga hiperactiva

ObjectiveTo evaluate the clinical and urodynamic differences (associated with the presence or absence of detrusor overactivity [DO]) in women with overactive bladder (OAB) referred to Functional Urology and Urodynamic Units in Spain.Material and methodsObservational, cross-sectional, multicenter and prospective study conducted in Spain in women with clinical diagnosis of OAB, who had been referred to urodynamic study (UDS) of which centralized reading was performed. Patients completed the 3-day voiding diary (DM3d) with the PPIUS scale (Patient Perception of Intensity of Urgency Scale), the B-SAQ (Bladder Self-Assessment Questionnaire) and the OABq-SF (Overactive Bladder Questionnaire Short Form). The questionnaires and UDS variables of women with OAV, with or without DO, were compared using the Mann-Whitney test (continuous variables) and the chi-square test (χ²) (categorical variables).ResultsA total of 247 women with OAB were evaluated, and 103 of them had DO. According to the presence or absence of DO, significant differences were observed in the number of episodes of urge urinary incontinence (UUI), urinary frequency, nocturia, mean micturition volume and number of pads (P < .05 for all comparisons). A higher percentage of patients with OAB and DO presented reduced bladder capacity, urgency, urge urinary incontinence (UUI) and lower volume for first voiding desire, strong desire to void and maximum cystomanometric capacity in UDS compared with patients without DO (P < .05 for all comparisons). The only significant differences between both groups were regarding the B-SAQ symptoms scale (P = .011).ConclusionsThe presence of DO in women with OAB is related to a more severe alteration of the bladder filling phase.     

Efectos de la electroestimulación superficial en las mujeres mayores con incontinencia urinaria de esfuerzo: estudio piloto aleatorio controlado

ObjectiveThe objective of this study was to evaluate the effects of surface electrical stimulation in elderly women with stress urinary incontinence (SUI) as compared to no treatment.Materials and methodsThis randomized controlled pilot study included women over the age of 60 years, with at least one episode of stress urinary leakage during the previous month. Fourteen women were allocated according to a computer generated randomization list in two groups: surface electrical stimulation (SES), and control group (CG). The women in the SES group were treated with surface electrical stimulation using four electrodes, during six weeks with two weekly sessions of 20 minutes each. They were evaluated before and after treatment primary outcome, urinary leakage, and secondary outcomes, King's Health Questionnaire, pressure perineometry, and subjective satisfaction.ResultsFor the urinary leakage, there was a significant decrease in SES group after treatment (P = .017). Significant differences were observed between the SES group and CG in the evaluation after treatment (P < .01; effect size: -1,38; 95% confidence interval from 1,18 to 14,14). No significant differences were observed in both groups for the outcome pelvic floor muscle pressure. In the evaluation of quality of life, a significant reduction of score in the gravity domain was observed for the SES group after treatment (P = .017).ConclusionThe results of this study showed that surface electrical stimulation in elderly women with SUI can be an effective method for the improvement of urinary leakage.     

Correlación entre la edad y los síntomas de vejiga hiperactiva en mujeres jóvenes en Brasil

Overactive Bladder Syndrome (OAB) is defined by the ICS (International Continence Society) as urinary urgency, with or without urgency incontinence and frequently associated with increase of frequency and nocturia.PurposeThe aim of the study was to establish a correlation between OAB symptoms and Age in women aged 20-45.Materials and methodsWe interviewed 1050 women aged 20-45 in the area of Campinas, Brazil, to investigate the prevalence of Overactive Bladder Symptoms. In this study we used the ICIQ-OAB questionnaire (ICS standard), in its validated Portuguese version and a specific questionnaire for the demographics.ResultsOverall, women aged 35-45 years showed significantly higher scores in the ICIQ-OAB questionnaire than all other groups (P < .001). Older women (35-45) presented a significantly higher score than younger women (all other groups) (P < .0001) regarding urinary frequency. Regarding frequency, there was a significant difference between the age group 35-45 (higher score) and the age groups 20-22 and 23-27 (P < .0001). Women aged 35-45 presented significantly more nocturia than women in the age groups of 28-34, 23-27 and 20-22. Women in the group of 28-34 also presented more nocturia than women aged 20-22 (P < .0001). Women aged 35-45 experienced more urgency than those in the age groups of 28-34 and 23-27 (P < .0001). Women aged 35-45 had significantly more urgency incontinence than all the other groups, and women in group of 20-22 also presented more incontinence than those aged 23-27 (P < .0001). Significant differences were also found regarding symptom bother, women in group 35-45 years old presented higher scores than the other groups regarding frequency (P < .0001), nocturia (P = .0011), urgency (P = .0015) and urgency incontinence (P < .0001).ConclusionsIn conclusion, older women present more OAB symptoms and therefore a higher score than younger women.     

Factores pronósticos del resultado del tratamiento rehabilitador en la incontinencia urinaria femenina

BackgroundUrinary incontinence is the involuntary loss of urine. It is highly prevalent in women and has a great biopsychosocial impact. Numerous risk factors are associated with this entity. Rehabilitative treatment is established as the first line, although its use has not been protocolized.AimTo identify which personal risk factors and type of treatment applied are statistically related to patient improvement.MethodsRetrospective cohort study of female patients diagnosed with urinary incontinence who attended the Pelvic Floor Rehabilitation Clinic of the Río Hortega University Hospital of Valladolid, receiving rehabilitation treatment during the year 2021. The minimum follow-up period was 12 weeks, evaluating improvement or not according to 7 objective and subjective variables, establishing improvement as positive evolution in at least 5 of the 7.ResultsA total of 114 women with urinary incontinence were analyzed. The most frequent types of incontinence were stress (53%) and mixed (36%). The most important risk factors and associated pathology were episiotomy (68%), repeated urinary tract infections (61%), and constipation (40.9%). None of these factors showed a statistically significant relationship with patient improvement with a p > 0.05. The most used rehabilitative treatment was kinesitherapy + biofeedback (51%), which showed a statistically significant relationship with the improvement of these patients (p = 0.037), together with biofeedback + posterior tibial nerve electrostimulation (p = 0.044).ConclusionThe results are in line with other published studies. Biofeedback together with kinesitherapy or posterior tibial nerve electrostimulation are established as the most effective rehabilitative procedures.     

Resultados de la rama española del Estudio Randomizado Europeo de Screening del Cáncer de Próstata (ERSPC). Actualización tras 21 años de seguimiento

Introduction and objectiveThe objective of the European Randomized Study of Screening for Prostate Cancer (ERSPC) is to assess whether prostate cancer (PCa) screening leads to an improvement of cancer-specific survival. This multicenter study (eight European countries) has recruited more than 180,000 asymptomatic men. After a follow-up period of 16 years, it has been shown that PSA screening reduces PCa mortality by 20%, and that it does not affect all-cause mortality. This article provides updated the results of the Spanish arm of the ERSPC after 21 years of follow-up.Materials and methodsThe study invited 18,612 men (aged 45 – 70) of the Spanish section (Getafe and Parla, Madrid) to participate. They were randomly assigned to the intervention arm (serum PSA-based screening) and to the control arm (follow-up without intervention). The diagnoses of PCa were recorded, as well as the PCa-specific and all-cause mortality rates. A comparison between the survival curves of both arms of the study and detailed analysis of the causes of death were performed.ResultsThe study finally included 4,276 men (2,415 intervention arm, 1,861 control arm). The median age, serum PSA and follow-up time were 57 years, 0.9 ng/ml and 21.1 years, respectively. There were 285 cases with PCa diagnosis, 188 (7.8%) from the intervention arm and 97 (5.2%) from the control arm (p< ,001). A total of 216 (75.8%) presented organ-confined disease. There were 994 deaths were recorded; 544 (22.5%) in the intervention arm and 450 (24.2%) in the control arm. No significant differences were detected between the arms of the study in terms of cancer-specific (p = .768) or all-cause (p = .192) mortality rates. The main cause of death was malignant tumors (492 patients, 49.5% of overall mortality), and the most frequent sites were lung and bronchus (29.5%), colon and rectum (14.8%), and hematologic (9.8%). Only 20 patients (0.4% of the patients recruited) died from PCa, with no significant difference between study arms.ConclusionsIn this update of the results of the Spanish section of the ERSPC study after 21 years of follow-up, we have not detected a benefit of PCa screening in terms of overall and cancer-specific survival.     

Aportaciones de la Armada española en la introducción de la anestesia en España. La ciencia médica en el último tercio del siglo xix

The last decades of the xix century were years of resurgence and progress in the field of Naval Health, which was in the vanguard of European health structures at that time. In this era, the navy physicians produced some documents known as “Memorias Clínicas” (Clinical Reports), previously established as obligatory in their rules and regulations. Valuable documents on medical science and the art of healing are deposited in the Archivo General de la Marina (Viso del Marqués, Ciudad Real). Although the information recorded in these Reports varies considerably, we have centred our interest on those that focus on the discovery and development of anaesthesia. The introduction of these discoveries was surrounded by immense controversy, with its defenders and critics. The exclusiveness of the documents presented here is an original testimony to the medical-surgical knowledge of the era and places Naval Health in the vanguard of European health structures at that time.