How can we measure bladder volumes in women with advanced pelvic organ prolapse?

OBJECTIVES: To compare bladder volumes determined by three different formulae using measurements obtained from two-dimensional translabial ultrasound (2D-US), with true bladder volumes, in women with advanced pelvic organ prolapse (POP). METHODS: This was a prospective observational multicenter study of consecutive women on the waiting list for prolapse surgery in 24 gynecology departments. All women had a symptomatic genital prolapse Stage 2 or higher according to the Pelvic Organ Prolapse Quantification System (POP-Q). Bladder volumes were calculated before and after spontaneous voiding by 2D-US, and true bladder volumes were determined by micturition and catheterization. Volumes determined by US were calculated using three formulae (Haylen, Dietz and Dicuio). Correlation was calculated between the volume determined by US measurement before micturition and the true volume, and also between the volume determined by US measurements after micturition and the true volume. Correlations (Spearman's rho) and concordance (intraclass correlation coefficient (ICC)) were estimated for each of the three formulae considered. RESULTS: One-hundred and eighty-six women with POP were included in the study. A total of 349 bladder volumes (186 before micturition and 163 after micturition) were obtained. Good correlation (rho, 0.818-0.849) and concordance (ICC, 0.827-0.898) were found between total measured volume (volume of spontaneous bladder voiding + volume obtained from catheterization) and the volume determined by US using the three different formulae, as well as between the post-void residual volume measured by catheterization and the post-void volume calculated by US using the three formulae (rho, 0.739-0.777; ICC, 0.840-0.877). CONCLUSIONS: Bladder volumes in women with advanced POP can be measured easily by 2D-US. Volumes determined using the three different formulae show good correlations and concordance with true bladder volume.

[Is Cinacalcet a cost-effective treatment in severe secondary hyperparathyroidism in patients on hemodialysis?]. / Es el cinacalcet un tratamiento coste-efectivo en el hiperparatiroidismo secundario severo en pacientes en hemodiálisis?

BACKGROUND: A previous study using cinacalcet, as compared to vitamin D alone, showed a better reduction response of PTH levels and a significant diminution of secondary effects. The objective of present study was to evaluate the additional cost of adding cinacalcet to the standard treatment of patients with severe secondary hyperparathyroidism (SHPT) taking into account the treatment goals achieved. METHODS: 12 month prospective study of 23 patients with severe SHPT. Two treatment regimens were considered: standard treatment (m 0) and standard treatment plus cinacalcet (m 12). Four consequences of inadequate control of SHPT were registered: parathiroid hormone (PTH), Calcium (Ca), Phosphorus (P) and the Ca x P product serum levels. Treatment effectiveness was measured as percentage of patients who achieved treatment goal according to each indicator: PTH < 800 pg/mL, PTH between 150 and 300 pg/mL, Calcium < 9.5 mg/dL, Phosphorus < 5.5 mg/dL, and Ca x P product < 55. Annual and monthly costs were calculated for both treatment regimens using Spanish 2007 tariffs, and taking into account the dose reduction in some other treatments. Results are presented as incremental costs and cost per patient who achieved treatment goal. RESULTS: At 12 month it was observed a higher percentage of patients who achieved simultaneously the 4 therapeutic goals with respect to basal moment, from 0% to 52.1%. Cinacalcet allowed to save costs in concomitant drugs, achieving a total saving of 149 euros per patient and month. At 12 month, Cinacalcet achieved a reduction of percentage of patients with PTH > 800 pgr/mL with half of costs than standard treatment (651.35 euros vs 1363.68 euros). It was not possible to calculate the cost for PTH indicator since at the study onset, there was no patient who achieved a level between 150 and 300 pg/mL. Cinacalcet allowed reaching treatment goals in Calcium, Phosphorus and Ca x P product in a more cost-effective way (2164.2 euros vs 2684.8 euros). CONCLUSIONS: Although Cinacalcet is expensive,p atients treated with Cinacalcet showed a minor cost per patient who achieved treatment goal than patients without Cinacalcet. The ability of cinacalcet to reduce PTH secretion, along with the reductions in the serum Ca, P, and Ca x P product, provides an alternative to the traditional treatment paradigm, and should be a welcomed addition in the management of SHPT.

[Questionnaire for evaluation of sexual function in women with genital prolapse and/or incontinence. Validation of the Spanish version of "Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12)"]. / Cuestionario para evaluación de la función sexual en mujeres con prolapso genital y/o incontinencia. Validación de la versión española del "Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12)".

This article summarizes the work done to adapt and to validate the short form of Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12) for its use in Spain. It will become the first validated questionnaire in this country for the evaluation of the sexual function in women with Pelvic Organ Prolapse and/or Urinary Incontinence. PATIENTS AND METHOD: 49 women who visited a specialized unit with symptoms of pelvic floor were included. Patients filled in the Spanish version of the questionnaire to validate (PISQ-12), the Urinary Incontinence Questionnaire (ICIQ-UI-SF); the Female Sexual Function Questionnaire (FSM) and the Bladder Control Autoevaluation Questionnaire (CACV). Factibility, reliability and validity of the new questionnaire were evaluated. RESULTS: Factibility: 99.83% of the sample answered all the items (only one patient did not answer one of the items); average administration time 3.5 (1.5) minutes. RELIABILITY: Cronbach's alpha was 0,829. VALIDITY: PISQ-12 correlation with FSM was 0,71; with ICIQ-UI-SF it was -0,038; with the CACV "symptoms" dimension the correlation was -0,30 and with the "discomfort" dimension it was -0,40. The existence of the same three dimensions of the PISQ-12 original version in the adapted Spanish questionnaire is checked through a factorial analysis. The score in PISQ-12 was worse (lower) in the case of women with Hyperactive Bladder symptoms and discomfort measured with the CACV questionnaire and in women with sexual dysfunction measured with FSM. PISQ-12 is an instrument with the appropriate psychometric characteristics to evaluate sexual function in women with pelvic floor problems.

Validation of the Spanish version of the Bladder Pain/Interstitial Cystitis-Symptom Score (BPIC-SS) questionnaire. A useful tool for the diagnosis of bladder pain syndrome. / Validación de la versión española del cuestionario Bladder Pain/Interstitial Cystitis-Symptom Score (BPIC-SS). Un instrumento útil para el diagnóstico del síndrome de dolor vesical.

OBJECTIVES: Validation of the Spanish version of the Bladder Pain/Interstitial Cystitis-Symptom Score (BPIC-SS) questionnaire to evaluate its utility for the diagnosis of Bladder Pain Syndrome (BPS) patients in the Female and Urodynamics Urology Functional Units in Spain. MATERIAL AND METHODS: The Spanish adaptation of the BPIC-SS questionnaire was evaluated in 243 BPS patients. EQ-5D-5L, Patient Perception of Bladder Condition (PPBC) and global impression questionnaire (CGI-S) were collected. Consistency, test-retest reliability in patients without clinical changes at 15 days, criterion validity and sensitivity to change were assessed in BPS patients with clinical changes at 6 months. The cut-off point for discriminating BPS patients from other similar pathologies (Hyperactive Bladder or other urinary pathologies) was analysed using ROC curve. RESULTS: Mean (SD) BPIC-SS score (0-38) was 16.2 (12.0) points. Cronbach's alpha was 0.92 and intraclass coefficient correlation (ICC) was 0.82, ranging from 0.5-0.9 per item. Convergent validity determined a Spearman correlation of 0.63 with PPBC and -0.40 with EQ-5D-5L Visual Analogue Scale (VAS) and the effect size obtained in patients who improved their clinical status was 1.9. A score greater than or equal to 12 points in the BPIC-SS has been established as the best cut-off point for the diagnosis of BPS (87.5% sensitivity and 91.9% specificity). CONCLUSIONS: The Spanish version of the BPIC-SS is a valid and reliable instrument for the diagnosis and follow-up of patients with BPS in Spain.

Erythropoietin safety and efficacy in chronic allograft nephropathy.

BACKGROUND: Patients with chronic allograft nephropathy (CAN) very frequently suffer anemia. Correction of anemia by means of recombinant erythropoietin (rEpo) is possible and useful, but safety and efficacy must be assessed. METHODS: This multicenter, prospective, open study included patients with a cadaver renal transplant, CAN, and non-ferropenic anemia. The aim of the study was to determine the safety and efficacy of treatment with rEpo to target hematocrit (HCT) values around 35% and/or hemoglobin (Hb) levels of 11 g/dL. RESULTS: Twenty-four patients were included: 71% males and 29% females aged 49.5 +/- 14 years. At last follow-up, 48% did not show anemia-related symptoms, and 19% experienced adverse events possibly or probably related to rEpo. In 86% of cases, anemia was corrected and in 71%, graft survival was conserved. Patients whose anemia was not corrected had poor initial renal function (sCr 5 +/- 1 mg/dL vs sCr 3.2 +/- 1 mg/dL, P = .028). Patients with graft survival showed correction of anemia (P = .001) on a relatively low dose of rEpo and without a significant increase in blood pressure. CONCLUSIONS: All patients who had graft survival and only half of those who lost their graft showed a correction of anemia. The rEpo treatment neither accelerated nor decelerated renal failure. The difference between patients in whom anemia was corrected, or not, did not depend upon the previous level of HCT/Hb, but upon worse renal function. Thus, rEpo in patients with CAN is safe and effective, so administration should be initiated early to avoid adverse events deriving from anemia.

Epidemiología del ictus cardioembólico y su asociación con la penetración de los ACOD en España: primer estudio poblacional 2005-2018 / Epidemiology of atrial fibrillation-related ischemic stroke and its association with DOAC uptake in Spain: first national population-based study 2005 to 2018

Introducción y objetivos: La prevalencia y la incidencia de la fibrilación auricular (FA), un importante factor de riesgo de ictus cardioembólico, han aumentado sustancialmente en los últimos años. Sin embargo, varios estudios europeos han observado una disminución en la tasa de ictus cardioembólico asociada con un aumento de la penetración de los anticoagulantes orales de acción directa (ACOD). Este estudio ecológico evalúa la asociación entre la penetración de los ACOD y la tasa de incidencia de ictus cardioembólicos en España. Métodos: Los datos se obtuvieron del Registro de Actividad Sanitaria Especializada del Ministerio de Sanidad de España (RAE-CMBD). Los ictus cardioembólicos se identificaron mediante códigos ICD. Las tasas de incidencia se estandarizaron por edad y se ajustaron a la población estándar europea de 2013. Se utilizaron modelos de regresión de Poisson para estimar la asociación entre la penetración de los ACOD y la tasa de ictus cardioembólico en pacientes de 65 o más años. Resultados: La tasa de incidencia ajustada (TI) del ictus cardioembólico aumentó desde 2005 (2,20/100.000 personas/año) hasta 2012 (2,67). A partir de 2012, tras la introducción de los ACOD para la prevención del ictus cardioembólico en España, la TI se ha mantenido constante o ha disminuido ligeramente (en 2018, 2,66). Los resultados del modelo de regresión de Poisson indican que la penetración de los ACOD tiene una influencia estadísticamente significativa en la tasa de ictus cardioembólicos de los mayores de 65 años (RDI=0,995; IC95%, 0,995-0,996). Conclusiones: Los resultados de este estudio muestran una asociación entre la penetración de los ACOD y una menor incidencia de ictus cardioembólicos. A pesar de que esta asociación no implica causalidad, indica que una mayor penetración de los ACOD podría llevar a un mayor beneficio clínico para los pacientes con FA en España (AU)

Introduction and objectives: The incidence and prevalence of atrial fibrillation (AF), a major risk factor for stroke, has increased substantially in the past few years. However, several studies have reported a decline in AF-related stroke rates associated with higher uptake of direct oral anticoagulants (DOACs). This ecological study evaluated the association between DOAC uptake in Spain and the incidence rate (IR) of AF-related ischemic stroke. Methods: Data were obtained from the Registry of Activity of Specialized Healthcare of the Spanish Ministry of Health (RAE-MDS). AF-related ischemic strokes were identified using International Classification of Diseases codes. IR were age-standardized and adjusted to the 2013 European standard population. Poisson regression models were used to identify the association between DOAC uptake and AF-related ischemic stroke in patients aged ≥ 65 years. Results: Before the use of DOACs, the adjusted IR of AF-related ischemic stroke increased steadily from 2005 (IR=2.20 per 100 000 person/y) to 2012 (IR=2.67). Upon DOAC uptake in Spain from 2012 onwards for AF-related ischemic stroke prevention, the IR remained constant or decreased slightly (IR in 2018=2.66). Poisson regression showed that DOAC uptake was a significant predictor for the rate of AF-related ischemic stroke in patients older than 65 years (IRR=0.995; 95%CI, 0.995-0.996). Conclusions: This study shows an association between DOAC use and a reduced incidence of AF-related ischemic stroke. While this association is based on aggregate data and cannot demonstrate causality, these findings suggest that higher DOAC uptake could improve health outcomes in AF patients in Spain (AU)

Study on health-related quality of life in patients with advanced heart failure before and after transplantation.

UNLABELLED: Our objective was to evaluate health-related quality of life in patients with advanced heart failure on the waiting list for a heart transplant. MATERIALS AND METHODS: The study was performed using the EUROQOL-5D questionnaire (EQ-5D) on 38 patients (age: 53 +/- 2 years, 82% men) who were analyzed consecutively during the pretransplant period, as well as at 3, 6, and 12 months after transplantation. We excluded pediatric transplants, retransplantations, heart and lung transplantation, and patients scoring below 17 points on the Folstein's Cognitive Mini-Examination. The studied variables included the five dimensions of the EQ-5D test: mobility, self-care, daily activities, pain-discomfort, anxiety and depression; a visual analog scale from 0 to 100; and perception of health status. Statistics included analysis of variance and chi-square tests. Significance was set at P < .05. RESULTS: There were significant differences in all tested parameters. The worst values were observed prior to transplantation, with a significant improvement at 3 months. CONCLUSIONS: Patients with heart failure showed a significant impairment in health-related quality of life before transplantation. The improvement in health-related quality of life was significant and rapidly evident in the posttransplantation period. The most affected dimensions were activities of daily living and pain-discomfort. All dimensions became stable at 3 months, except for anxiety and depression. At 6 to 12 months, a plateau was reached in the feelings of well-being.

Posttransplantation diabetes mellitus: prevalence and risk factors.

BACKGROUND: Prevalence of diabetes mellitus (DM) type 2 in Asturias is 10%. The associations between age, family history of diabetes, hypertension, obesity, hypertriglyceridemia, and development of type 2 diabetes are well established. The aim of this study was to evaluate the prevalence of and risk factors for posttransplantation diabetes mellitus (PTDM). METHODS: We retrospectively studied 500 patients who had received a cadaveric renal transplant. Subjects with pretransplantation diabetes (5.6% type 1 and 7% type 2) and nondiabetics (78.2%) were excluded. We only evaluated 46 (9.2%) patients with PTDM. The follow-up period was 6 months to 15 years. We reviewed gender, age, family history of diabetes, body weight, hypertension, cardiovascular events, serum creatinine, hepatitis C virus infection, triglycerides, hyperuricemia, high-density lipoprotein and low-density lipoprotein cholesterol, and immunosuppressive therapies. RESULTS: The median time to diagnosis of PTDM was 3 months (range 1-56 months) after transplantation, a period in which 47% patients developed this complication. Compared with nondiabetics, PTDM patients were significantly older (P = .000), more obese (P = .002), received tacrolimus (P = .027), and had hypertension (P = .014) or cardiovascular events (P = .000). Serum creatinine and hepatitis C virus infection rated were similar in both groups. On multivariate analyses, the risk factors significantly associated with the development of PTDM were greater age (P = .0024), obesity (P = .0032), and hypertension (P = .0516). CONCLUSIONS: Half of the patients with PTDM developed new-onset diabetes within the first 3 months. Age, obesity, and hypertension were among the risk factors for diabetes posttransplantation. After the transplantation, the modifiable risk factors are control of body weight and control of hypertension.

Influence of erectile dysfunction on health related quality of life of male kidney transplant patients.

The objective of the present study was to investigate if a psychological adaptation capacity exists in kidney transplant bearers, even with ageing, in relation to erectile dysfunction (ED). We studied ED using IIEF-5 and health-related quality of life (HRQoL) using the SF-36 Health Survey, in a large sample of male renal transplant patients (n=242), searching for the influence of ED on HRQoL. Patients included 199 patients (82%); the median age was 52 y (43-62); 106 patients (54.9%) presented ED. These patients were divided into four groups according to median age. SF-36 scores were worse for ED vs non-ED patients in the first three age groups, but not in age group 4. SF-36 Mental Component Summary was similar for patients with ED and without ED in all age groups. We confirm the hypothesis that a psychological adaptation occurs in renal transplant patients in all age groups, when suffering ED.

Factors associated with erectile dysfunction in male kidney transplant recipients.

A transversal study was carried out in order to evaluate the prevalence of erectile dysfunction (ED) in adult kidney transplant patients of our region (N=243), and to investigate the sociodemographic, analytic, and clinical factors associated with it. To evaluate ED, the Spanish five items version of the International Index of Erectile Function (IIEF-5) was employed. Sociodemographic, analytic, and clinical data, including 12 cardiovascular risk factors, were also collected. A total of 199 patients (82%) were included. The median age was 52 y (43-62 y); 106 patients (54.9%) presented with ED. Variables associated with ED were: higher age; longer time on dialysis prior to transplantation; higher comorbidity; presence of diabetes mellitus; had undergone prostatic surgery or peripheric artheriopathy; lower diastolic pressure; and some anti hypertensive drugs. Logistic Regression Model performed step by step showed (R(2)=0.52) that factors independently associated with ED were: age, time on dialysis previous to transplant, and peripheric artheriopathy.

[Interpretation of health-related quality of life of patients on replacement therapy in end-stage renal disease]. / Interpretación de los resultados de la calidad de vida relacionada con la salud de pacientes en terapia sustitutiva de la insuficiencia renal terminal.

UNLABELLED: STATEMENT: Older age is associated with a worse Health-Related Quality of Life (HRQOL) in patients with End-Stage Renal Disease (ESRD). The aim of this study is to demonstrate that differences on HRQOL between two groups of patients, defined according to age (< 65 years and > or = 65 years or elderly), change according to the form in which the results are analysed. METHODS: We evaluated the HRQOL of 170 patients undergoing hemodialysis and 210 transplant patients from Asturias (Spain), using the SF-36 Health Survey. Sociodemographic and clinical data, Karnofsky Scale and a Comorbidity Index were also collected. The raw scores of the SF-36 and the standardised scores according to age and gender were employed. RESULTS: The majority of elderly patients on hemodialysis lived alone, constituted a smaller percentage on the transplant waiting list, had a lower serum albumin and lower score of the Karnofsky Scale, than patients under 65 years. No differences were found in transplant patients. The raw scores on the SF-36 were less for the elderly patients on hemodialysis and transplant. The raw scores for elderly undergoing hemodialysis were less than those obtained by the general population, and raw scores for elderly transplant patients were similar or slightly greater. The standardized scores of the SF-36 were greater for the elderly in both treatment groups. CONCLUSIONS: Important differences exist in the evaluation of HRQOL differences between the two groups of age according to the method of analysing the results. The HRQOL of elderly patients is better than that of patients under 65 years of age.

[Factors associated with health related quality of life in patients undergoing renal replacement therapy]. / Factores asociados a la calidad de vida relacionada con la salud (CVRS) de los pacientes en terapia renal sustitutiva (TRS).

The aim of this study was to investigate the sociodemographic and clinical variables which influence health-relate quality of life (HRQOL) of patients on renal replacement therapy (RRT). A cross-sectional study was carried out with a sample including all patients on hemodialysis (n = 170) and transplant patients (n = 210) of our region. The HRQOL assessment instruments used in this study were: the Spanish versions of the sickness impact profile (SIP) and the SF-36 health survey (SF-36). Sociodemographic and clinical data (including age at start of RRT, age at the interview, gender, hospital, socioeconomic level, educational level, living conditions, inclusion in transplant waiting list, renal disease diagnosis, time in any RRT, hemoglobin, hematocrit, serum urea, creatinine, proteins and albumin, hospital admissions and length of hospital stay during last year), a comorbidity index and the Karnofsky performance scale score step. To investigate which studied variables had independent influence over the HRQOL measures, logistic regression method was employed in the case of the SF-36, and multiple regression, in the case of the SIP. A model was adjusted step by step in each RRT method (hemodialysis and transplantation) for each dimension of the PCE (physical dimension, psychosocial dimension and total score), and for each component summary score of the SF-36 (physical and mental component summary). In patients on hemodialysis, variables associated with better HRQOL were: higher age, female gender, higher educational level, and better functional status; and variables associated with worse HRQOL were: higher number of hospital admissions, and higher comorbidity index. In transplant patients, variables associated with better HRQOL were: higher age and higher functional status; and variables associated with worse HRQOL were: longer time on dialysis before transplant, longer time with functioning transplant, and higher comorbidity index. Despite the independent influence on the HRQOL demonstrated for some of the studied variables, it seems that HRQOL assessment instruments scores may mainly depend on other non-studied variables, and it may be that these instruments evaluate other aspects of the patients which have not been taken into account until now.

[Changes in health-related quality of life in the first year of kidney transplantation]. / Cambios en la calidad de vida relacionada con la salud durante el primer año del trasplante renal.

OBJECTIVE: To study the changes in the health related quality of life (HRQOL) during the first year following renal transplant (RT), comparing azathioprine vs mycophenolate mofetil (MMF) in triple immunosuppressant therapy with prednisone and cyclosporine. METHODS: Prospective, open and random study with 26 patients who received a primary cadaveric renal transplant consecutively. Analysis of clinical variables: delayed graft function (DGF), acute rejection (AR), infections and comorbidity; analytical: haemogram, albumin and serum creatinine, hepatic function, cyclosporin levels; instruments for assessing the HRQOL: Psychological General Well-being Index (PGWBI) and Euroqol-5d (EQ-5d) health questionnaire, which includes a self-assessment scale of the state of health, Visual Analogical Scale (VAS). Controlled collection of data upon discharge following renal transplant, and subsequently 1, 3, 6, and 12 months following the first questionnaire. RESULTS: There were no differences between patients on azathioprine or MMF, except that AR occurred less frequently with MMF (7% vs 42%, p = 0.065). Global AR: 23%, cytomegalovirus infection/illness: 81%/8%, readmissions: 42%. There was an improvement in HRQOL measured by the progressive increase in the scores on the PGWBI, EQ-5d and VAS during the first three months following RT. By the sixth month, in comparison to the third, a decrease in the score was observed (PGWBI, p = 0.011). Later the HRQOL improved, but without reaching the maximum scores achieved. CONCLUSIONS: Patients on MMF showed less frequent incidence of AR. The HRQOL decreases during the third and the sixth month, but with less intensity in patients on MMF, probably related to the lower rate of AR, and excluding the over 60s.

[Physical symptoms and emotional disorders in patient on a periodic hemodialysis program]. / Síntomas físicos y trastornos emocionalés en pacientes en programa de hemodiálisis periódicas.

OBJECTIVES: To establish the frequency and severity of somatic symptoms and emotional distress (anxiety and/or depression) among our chronic hemodialysis (CHD) patients and to study the relationship between them as well as their influence on the perceived health status. PATIENTS AND METHODS: All patients who had been on CHD for a minimum of three months were eligible for the study. Eight of them were excluded: six because they were unable to answer the questionnaires and two because they refused to participate. The 58 remaining patients were the subject of our study (median age 68.5 years; median duration of HD 29.5 months). Diverse sociodemographic and clinical data were recorded. The patients answered the following questionnaires: 1) The "physical symptoms" dimension of the Kidney Disease Questionnaire; 2) A measure of anxiety (STAI); 3) A measure of depression (Beck Depression Inventory and Cognitive Depression Index); and 4) The Nottingham Health Profile (NHP). RESULTS: The most frequent and severe symptoms were tiredness, itching, thirst, bone and joint pain and sleep disturbance. The severity of the symptoms was positively associated with female sex, and the presence of clinically relevant degrees of anxiety and/or depression. A quarter of the patients were anxious and almost half of them suffered from depression. Emotional disturbances were associated with the severity of somatic symptoms and comorbidity. Only anxiety and depression were significantly associated with the global NHP score; they explained 47% of its variance. A score of 50 or more in the "Emotional Reactions" dimensions with the NHP detected 69% of the patients with anxiety and 81% of those with depression. CONCLUSIONS: Somatic symptoms are common among patients on CHD and they appear to be associated with emotional distress (anxiety and depression) that influences significantly the perceived health status. Measuring the perceived health status by means of generic and specific questionnaires, may help to establish the diagnosis of these problems.