Evaluación de las propiedades psicométricas de la versión en español del cuestionario ICIQ-Male Lower Urinary Tract Symptoms (ICIQ-MLUTS) en España / Assessment of the Psychometric Properties of the Spanish Language Version of Questionnaire ICIQ-Male Lower Urinary Tract Symptoms (ICIQ-MLUTS)

Objetivos: Evaluar las propiedades psicométricas de la versión en castellano del cuestionario ICIQ-Male Lower Urinary Tract Symptoms (ICIQ-MLUTS): factibilidad (porcentaje de cumplimentación y efecto suelo y techo), fiabilidad (test-retest), validez convergente (vs. Cuestionario de Autoevaluación del Control de la Vejiga [CACV] y vs. International Prostate Symptom Score [I-PSS]) y validez de criterio (según presencia o no de síntoma). Material y métodos: Estudio observacional, no intervencionista y multicéntrico. Participaron 223 pacientes varones de 18-65 años con síntomas del tracto urinario inferior (STUI), predominantemente de llenado. Los pacientes cumplimentaron el ICIQ-MLUTS (test-retest), el I-PSS y el CACV y refirieron sus síntomas urinarios en visita única, a excepción de un subgrupo de 49 pacientes que lo cumplimentaron 15 días después para evaluar la fiabilidad test-retest. El cuestionario contiene 13 ítems en 2 subescalas: Vaciado (V), de 0-20, e Incontinencia (I), de 0-24. Resultados: Porcentaje de pacientes que responden a todos los ítems: 98,84%. Efecto suelo, 0%, y techo menor de 6% en las 2 subescalas del cuestionario. Fiabilidad test-retest: el coeficiente de correlación intraclase (CCI) osciló entre 0,66 y 0,88, salvo en Retardo. El kappa muestra buen acuerdo, entre 0,60 y 0,81, a excepción de Nicturia. Validez convergente: la correlación (Spearman) entre las puntuaciones de las subescalas del cuestionario y el resto de medidas es estadísticamente significativa (p < 0,01 y p < 0,05). Validez de criterio: diferencias estadísticamente significativas (p < 0,05) entre las puntuaciones en el ICIQ-MLUTS de los pacientes que refieren los síntomas respecto a los que no. Conclusión: El ICIQ-MLUTS versión en español muestra adecuada factibilidad, fiabilidad y validez

Objectives: To evaluate the psychometric properties of the Spanish version of the ICIQ-Male Lower Urinary Tract Symptoms Questionnaire (ICIQ-MLUTS): feasibility (% of completion and ceiling/ground effects), reliability (test-retest), convergent validity (vs. Bladder Control Self-Assessment Questionnaire [BSAQ] and vs. International Prostate Symptom Score [I-PSS]) and criterion validity (according to presence or absence of symptoms). Materials and methods: This was an observational, non-interventionist and multicenter study. 223 male patients with lower urinary tract symptoms (LUTS), predominantly storage symptoms and aged 18-65, took part in the study. Patients completed the ICIQ-MLUTS (test), I-PSS and BSAQ questionnaires and referred their urinary symptoms in a single visit, with the exception of a subgroup composed by 49 patients who completed the questionnaire again 15 days after initial visit to evaluate test-retest reliability. The questionnaire includes 13 items divided in 2 sub-scales: Voiding symptoms (V) from 0 to 20 and Incontinence symptoms (I) from 0 to 24. Results: Percentage of patients who completed all items: 98.84%. Ground effect is 0 and ceiling effect was under 6% in both sub-scales. Test-retest reliability: Intraclass correlation coefficient (ICC) ranged from 0.68 to 0.88, except on Delay. Kappa shows a good agreement, between 0.60 and 0.81, except for Nocturia. Convergent validity: Correlation (Spearman) between the questionnaire sub-scales scores and the rest of measures is statistically significant (p < 0.01 and p < 0.05). Criterion validity: Statistically significant differences (p < 0.05) between scores on ICIQ-MLUTS, from patients who refer experiencing symptoms and those who do not. Conclusion: The Spanish version of the ICIQ-MLUTS questionnaire shows adequate feasibility, reliability and validity

Assessment of the psychometric properties of the Spanish language version of questionnaire ICIQ-Male Lower Urinary Tract Symptoms (ICIQ-MLUTS).

OBJECTIVES: To evaluate the psychometric properties of the Spanish version of the ICIQ-Male Lower Urinary Tract Symptoms Questionnaire (ICIQ-MLUTS): Feasibility (% of completion and ceiling/ground effects), reliability (Test-retest), convergent validity (vs Bladder Control Self-Assessment Questionnaire [BSAQ] and vs International Prostate Symptom Score [I-PSS]) and criterion validity (according to presence or absence of symptoms). MATERIAL AND METHODS: This was an observational, non-interventionist and multicenter study. 223 male patients with lower urinary tract symptoms (LUTS), predominantly storage symptoms and aged 18-65, took part in the study. Patients completed the ICIQ-MLUTS (test), I-PSS and BSAQ questionnaires and referred their urinary symptoms in a single visit, with the exception of a subgroup composed by 49 patients that completed the questionnaire again 15 days after initial visit to evaluate test-retest reliability. The questionnaire includes 13 items divided in 2 sub-scales: Voiding symptoms (V) from 0-20 and Incontinence symptoms (I) from 0-24. RESULTS: Percentage of patients that completed all items: 98.84%. Ground effect is 0 and ceiling effect was under 6% in both sub-scales. Test-retest reliability: Intraclass correlation coefficient (ICC) ranged from 0.68 to 0.88, except on Delay. Kappa shows a good agreement, between 0.60 and 0.81, except for Nocturia. Convergent validity: Correlation (Spearman) between the questionnaire sub-scales scores and the rest of measures is statistically significant (P < .01 and P < .05). Criterion validity: Statistically significant differences (P < .05) between scores on ICIQ-MLUTS, from patients that refer experiencing symptoms and those who do not. CONCLUSION: The Spanish version of the ICIQ-MLUTS questionnaire shows adequate feasibility, reliability and validity.

[Lymphatic invasion of the bladder wall in T1 superficial bladder carcinoma. Prognostic value]. / Permeación linfática de la pared vesical en el carcinoma superficial de vejiga t1. Valor pronóstico.

INTRODUCTION: It is not usual to use as prognostic factor the bladder lymphatic vessels invasion. METHOD & MATERIAL: 519 T1 bladder tumors with complete resection and follow up of one year at least. Prophylaxis with 81 mg of BCG weekly during six weeks in 54%. RESULTS: Follow up without recurrence of 38 months. 49%. Tumour recurrence of 49% and progression of 7%. 5.8% of the tumours are L1 and 70.7% L0. There are significative statistic relation between lympatic invasion and progression (p. 005), tumoral grade (p. 000) and actual situation (p. 02). 23% of the L1 tumours progressed vs 5% of L0. Prophylaxis with BCG reduces progression risk (33% without treatment vs 16 with BCG (p n.s.)). In multivariate analysis, resected volume (p. 024) and prophylactic treatment are independent variables for recurrence and lymphatic vessels invasion (p. 0478) and tumoral grade (p. 092) for progression. CONCLUSIONS: 1) L1 tumours has more probabilities of progression. 2) BCG disminishes progression rate but this is not statistical significative. 3) We need new markers to select which L1 tumours will progress.

Permeación linfática de la pared vesical en el carcinoma superficial de vejiga T1. Valor pronóstico / Bladder wall´s lymphatic vessels invasion in superficial bladder cancer prognostic value

INTRODUCCIÓN: La permeación de los vasos linfáticos de la pared vesical (L+) es poco utilizada. MATERIAL Y MÉTODO: 519 tumores T1, RTU completa y seguimiento mínimo de un año. Tratamiento profiláctico con 81 mg de BCG semanal durante seis semanas en el 54 por ciento. RESULTADOS: Tiempo libre de enfermedad de 38 meses. Han recidivado el 49 por ciento de los tumores, progresando en estadio el 7 por ciento. Son L1 el 5,8 por ciento y L0 el 70,7 por ciento de los tumores. Existe relación significativa entre permeación linfática y progresión (p,005), grado tumoral (p,000) y situación vital (p,002). Progresan el 23 por ciento de los L1 frente al 5 por ciento de los L0. La profilaxis con BCG reduce el riesgo de progresión (33 por ciento en los no tratados frente a 16 por ciento con BCG (p n.s.)). En el análisis multivariado son variables independientes para recidiva el volumen tumoral resecado (p,024) y el tratamiento profiláctico (p,0000), mientras que para progresión lo son la permeación linfática (p,0478) y el grado tumoral (p,0092). CONCLUSIONES: 1) Los tumores L1 tienen mayor probabilidad de progresión. 2) El uso de BCG disminuye la tasa de progresión de manera no significativa. 3) Hacen falta nuevos marcadores que nos permitan seleccionar que tumores L1 tienen mayor riesgo de progresión (AU)

INTRODUCTION: It is not usual to use as prognostic factor the bladder lymphatic vessels invasion. METHOD & MATERIAL: 519 T1 bladder tumors with complete resection and follow up of one year at least. Prophylaxis with 81 mg of BCG weekly during six weeks in 54%. RESULTS: Follow up without recurrence of 38 months. 49%. Tumour recurrence of 49% and progression of 7%. 5,8% of the tumours are L1 and 70,7% L0. There are significative statistic relation between lympatic invasion and progression (p.005), tumoral grade (p.000) and actual situation (p.02). 23% of the L1 tumours progressed vs 5% of L0. Prophylaxis with BCG reduces progression risk (33% without treatment vs 16 with BCG (p n.s.)). In multivariate analysis, resected volume (p.024) and prophylactic treatment are independent variables for recurrence and lymphatic vessels invasion (p.0478) and tumoral grade (p.092) for progression. CONCLUSIONS: 1) L1 tumours has more probabilities of progression. 2) BCG disminishs progression rate but this is not statistical significative. 3) We ned new markers to select which L1 tumours will progress (AU)

[DNA ploidy determination with flow cytometry, Ki-67 index and overexpression of p53 protein in 121 T1 superficial bladder carcinomas. Retrospective studies. Part II: Prognostic value and usefulness in the indication for prophylactic treatment with BCG]. / Determinación de ploidía de ADN mediante citometría de flujo, indice Ki-67 y sobre-expresión de proteína p53 en 121 carcinomas superficiales de vejiga T1. Estudio retrospectivo. 2a Parte: Valor pronóstico y utilidad en la indicación de tratamiento profiláctico con BCG.

OBJECTIVE: Evaluate the utility of Ki-67 label index, p53 expression and flow cytometry-DNA ploidy in the selection of groups to be treated with prophylactic BCG and the prognostic value compared with the classic variables (grade, lymphatic permeation, multiplicity, volume, primary). MATERIAL & METHOD: 121 superficial bladder tumors T1. 10% Cut-off level for Ki-67 and p53. Aneuplody is defined as a tumor with DNA index different of 1 or more than 20% in G2-M phase. 71 (58.7%) received BCG. RESULTS: In uni and multivariate analysis positivity to Ki-67 is correlated with recurrence. Progression is correlated with lymphatic permeation (p .0003), volume (p .016), ploidy (p .022) and positivity to p53 (p .007). In multivariate analysis, volume and positivity to p53 are independent variables. None were of utility to prevent recurrence, but Ki-67 positive or aneuploid treated tumors had less progression (p .025 and p .009 respectively). The p53 negative treated tumors had less progression too. CONCLUSIONS: Only Ki-67 is correlated with tumoral recurrence. P53 and tumor volume are correlated with stage progression. If the results are confirmed with bigger series, the Ki-67 positive and/or aneuploid tumors would obtain benefits of prophylactic treatment with BCG.

Determinación de ploidía de adn mediante citometría de flujo, índice Ki-67 y sobre-expresión de proteína p53 en 121 carcinomas superficiales de vejiga T1. estudio retrospectivo. 2ª parte: valor pronóstico y utilidad en la indicación de tratamiento profiláctico con BCG / Flow cytometry. DNA ploidy, Ki-67 label and overexpression of P53 protein in 121 T1 superficial bladder cancer. Retrospective study. 2nd Part: Prognostic value and utility in the selection of the treatment with prophylactic BCG

OBJETIVO: Valorar la utilidad del índice Ki-67, la expresión de proteína p53 y la ploidía de ADN para seleccionar grupos que se beneficien de terapia profiláctica con BCG y la capacidad pronóstica comparándola con las variables clásicas (grado, permeación linfática, volumen tumoral, multiplicidad, primario). MATERIAL Y MÉTODO: 121 carcinomas vesicales T1. Nivel de corte para Ki-67 y p53 del 10 por ciento. Se considera aneuploide cuando el tumor tiene un índice de ADN distinto de 1 ó más del 20 por ciento de la población en fase G2-M. 71 (58,7 por ciento) recibieron BCG. RESULTADOS: Ninguna de las variables clásicas tiene valor pronóstico para recidiva, y de las tres técnicas utilizadas sólo el ser Ki-67 positivo (p 0.001), confirmándose en el estudio multivariante. Para progresión tumoral alcanzan significación, la permeación linfática (p 0.0003), el volumen tumoral (p .016), la ploidía (p 0.022) y la positividad para p53 (p 0.007), confirmándose en el estudio multivariante el volumen tumoral y la positividad para p53. Ninguna de las variables fue útil para seleccionar grupos que disminuyeran su recidiva tumoral. Sin embargo los tumores aneuploides y/o Ki-67 positivos que recibieron tra-tamiento profiláctico progresaron menos (p 0.009 y p 0.025 respectivamente). Los p53 negativos tratados también progresaron menos (p 0.040).Combinando las variables, sólo los Ki-67 positivo y aneuploides se benefician de tratamiento (p 0.031). CONCLUSIONES: Ki-67 es la única variable que se correlaciona con recidiva tumoral. La progresión a estadio infiltrante se correlaciona con la positividad para p53 y el volumen tumoral. Si los resultados se confirman en series más amplias, los tumores Ki-67 positivos y/o aneuploides se beneficiarían de tratamiento profiláctico con BCG (AU)

Determinación de ploidía de ADN mediante citometría de flujo, índice Ki-67 y sobreexpresión de proteína p53 en 121 carcinomas superficiales de vejiga T1. Estudio retrospectivo correlación con las variables clásicas / Flow cytometry-DNA ploidy, Ki67 label and overexpression of P53 protein in 121 T1 superficial bladder cancer. Retrospective study. 1st Part: Corelation with classic variables

OBJETIVO: Observar la correlación entre el índice Ki-67, la expresión de proteína p53 y la ploidía de ADN mediante citometría de flujo con las variables clásicas (grado, permeación linfática, volumen tumoral, multiplicidad, primario).MATERIAL Y MÉTODO: 121 carcinomas vesicales T1. Nivel de corte para Ki-67 y p53 del 10 por ciento. Se considera aneuploide cuando el tumor tiene un índice de ADN distinto de 1 ó más del 20 por ciento de la población en fase G2-M.RESULTADOS: Se aprecia una correlación estadísticamente significativa entre las tres técnicas y las variables grado y permeación linfática, así como de las tres técnicas entre sí. El índice Ki-67 y la expresión de proteína p53 distingue entre G1, G2 frente a G3 y Lx, L0 frente a L1. Se aprecia también relación entre volumen tumoral y positividad para p53.CONCLUSIONES: La aneuploidía y la positividad para Ki-67 y p53 aumenta conforme aumenta el grado y la permeación linfática. (AU)

[DNA ploidy determination with flow cytometry, Ki-67 index, and overexpression of p53 protein in 121 T1 superficial bladder carcinoma. Retrospective study. Correlation with classic variables]. / Determinación de ploidía de ADN mediante citometría de flujo, índice Ki-67 y sobreexpresión de proteína P53 en 121 carcinomas superficiales de vejiga T1. Estudio retrospectivo. Correlación con las variables clásicas.

OBJECTIVE: Observe the correlation between Ki-67 label index, p53 expression and flow cytometry-DNA ploidy with the classic variables (grade, lymphatic permeation, multiplicity, volume, primary). MATERIAL AND METHOD: 121 superficial bladder tumors T1. 10% Cut-off level for Ki-67 and p53. Aneuploidy is defined as a tumor with DNA index different of 1 or more than 20% in G2-M phase. RESULTS: Statistical correlation with grade and lymphatic permeation. Ki-67 label index and p53 expression can distinguish between G1, G2 vs G3 and Lx, L0 vs. L1. The volume correlates with positivity to p53. CONCLUSIONS: Aneuploidy and positivity to Ki-67 and p53 increase with grade and lymphatic permeation.

[The prevention of stage-T1 superficial bladder tumors with 27 mg. of BCG weekly over 6 weeks]. / Profilaxis de los tumores superficiales de vejiga estadio T1 con 27 mg. de BCG semanal durante seis semanas.

OBJECTIVE: To evaluate the utility of prophylactic treatment of stage T1 superficial tumors of the bladder with 27 mg BCG weekly for 6 weeks and to compare the results reported in the literature. METHODS: BCG instillations were offered to 235 patients and was accepted by 111 (group A) and refused by 124 (group B). Three weeks thereafter, intravesical instillation of 27 mg BCG was administered for 6 weeks. The patients were controlled regularly according to the standard control procedures utilized in our setting. RESULTS: 39% of the patients in group A showed recurrence versus 71.7% of those in group B (p < 0.001). No differences in progression of tumor stage was observed; 6.3% for group A and 10.9% for group B. By grade, significant differences were found in the number of recurrence in those with G1 (28.5% vs 69%; p < 0.001) and G2 (47% vs 72%; p < 0.01) tumors, but not for G3 (53% vs 77%; p = n.s.). No differences were found in the number of progressions. For those with G2 and G3, the results were not as good as those reported in the literature. The incidence of toxicity was 33%. CONCLUSIONS: The results achieved in patients with G2 and especially G3 tumors were not as good as those reported in the literature, therefore we do not recommend this approach. For those with G1 tumors and assuming a toxicity rate of 33%, the results are similar to those reported elsewhere using higher doses, and therefore this approach could be utilized.

[The prognostic factors in T1 superficial bladder carcinoma. Our experience]. / Factores pronósticos en el carcinoma superficial de vejiga T1. Nuestra experiencia.

OBJECTIVE: To identify the prognostic factors for recurrence and disease progression in T1 superficial carcinoma of the bladder for prophylactic therapeutic planning. METHODS: Of 309 patients with superficial carcinoma of the bladder that had only undergone TUR, we selected 196 patients that met the following requirements: T1 tumor, one year minimum follow-up (except for recurrence), TUR complete on gross examination. The changes observed with recurrence (presence of a tumor regardless of grade or stage) and disease progression (higher tumor stage and therefore infiltrating) in the following parameters were analyzed: tumor grade, node involvement, volume resected, number of tumors, primary or recurrent and age. RESULTS: 141 (72%) showed recurrence and 23 disease progression (11.7%) at two-years' mean follow-up. The resected tumor volume was found to be a prognostic factor for recurrence by univariate (0.010) and multivariate analysis (0.039). Tumor grade (0.0005) and node involvement (0.040) were prognostic factors for disease progression by univariate analysis and tumor grade (0.006) by multivariate analysis. CONCLUSIONS: Resected tumor volume, node involvement and tumor grade were found to be prognostic factors. The incidence of disease progression in this series falls within the lower ranges reported in the literature.

[C.F.C.-type ureterosigmoidostomy. Results]. / Ureterosigmoidostomía tipo C.F.C. Aportación de resultados.

This paper presents the results obtained with a C.F.C. type ureterosygmoidostomy technique described by us. A total of 25 patients aged between 52 and 74 years (mean age, 65 years), 23 (23/25) male and 2 (2/25) female were evaluated. 24 of the total 25 patients had infiltrant neoplasia of the bladder (pT2: 8; pT3a: 12; pT3b: 4) which was graded as moderately differentiated (G2: 10) or undifferentiated (G3: 14). The remaining patient, a female, had tuberculous microbladder. Male patients underwent radical cystoprostatectomy (23/25); while in two females traditional cystectomy was performed (2/25). Patients with neoplasia of the bladder (24/25) were performed bilateral lymphadenectomy prior to radical surgery. All 25 patients were performed C.F.C. type ureterosygmoidostomy (Actas Urol Esp 20: 324, 1996). Follow-up of patients was carried out over a mean period of 27 months (July 1994-October 1997). The complications reported were 4 cases of ureterointestinal stricture and one stercoral fistula. The strictures were resolved with endoscopic techniques and the fistula through discharge colostomy. Death (6/25) occurred as a result of the tumour progression, and in no case was related to the surgical technique. All patients showed daytime continence (100%), and 22/25 were also continent during the nighttime (88%): there were occasional leaks in 5/25 (20%). No metabolic disorders were seen in any of the patients. (All patients were given drug therapy to prevent metabolic acidosis).

[Histologic-ultrasonographic correlation of gland asymmetry and "pseudoruptures" of the prostatic capsule]. / Correlación histoecográfica de la asimetría glandular y de las "pseudorupturas" de la cápsula prostática.

An histo-ultrasound correlation was carried out between the information obtained with pre-operative transrectal ultrasound and that obtained with the histopathological study of 29 prostate specimens from patients with mean age 63 years (range, 52 to 71 years), who underwent radical cystoprostatectomy for infiltrant neoplasia of the bladder (22/29) and radical prostatectomy for prostate cancer (7/29). The (extrinsic and intrinsic) ultrasound parameters were analyzed focusing in the study of the prostatic capsule or "pseudocapsule". With this comparative, echographic and histological study the concept of capsular "pseudorupture" that results from the presence of (arterial and/or venous) vessels, nerves and fibromuscular folds at the periprostatic fat tissue is introduced. The interruption of the capsular echogram was seen as an indication of tumoral involvement of the capsule, and extracapsular spread. Our results allow us to suggest that this assertion should be reconsidered since these capsular "interruptions", "irregularities" or "pseudoruptures" are present in the normal prostate. Similarly, glandular asymmetry in relation with an heterogenous growth in one lobe in defined to differentiate it from that seen in neoplastic processes.

[Randomized prospective study comparing BCG and BCG plus oral tegafur in the prevention of stage T1 superficial tumors of the bladder. Results after 2.5 years]. / Estudio aleatorio prospectivo comparando BCG y BCG más Tegafur oral en la profilaxis de los tumores superficiales de vejiga estadio T1. Resultados a dos años y medio.

We present our experience in eighty patients with superficial bladder cancer stage T1. They have been randomized to receive BCG 27 mg weekly x 6 and monthly until complete one year (Group A) or the same schedule plus Tegafur 800 mg daily until complete one year. Results are similar in both groups. With a median follow up of two years and a half, 33% in Group A and 20% in Group B have had recurrence; 7.6% in group A and 3% in group B have had progression in stage. Differences are not significant in both cases. Tolerance of Tegafur is good with only 11% of secondary effects. We concluded that there are no differences in both treatments but there is a trend to better results with combinant therapy. It is necessary more patients to achieve definitive results.

[The BTA test in the diagnosis of bladder tumors. Usefulness in the hospital setting]. / Test de bta en el diagnóstico de los tumores vesicales. Utilidad en un medio hospitalario.

We show our results in the diagnostic and follow-up of the bladder tumors comparing de BTA test with Void Cytology, in order to substitute this with the former. We performed BTA test, Void Cytology (of the same sample) and abdominal ultrasound to 133 patients. They are divided in three groups: 45 with bladder tumor, 16 healthy controls, 72 in follow-up with and without prophylaxis. The sensibility and specificity in tumor's group were similar. In controls' and follow-up's groups the void cytology specificity was superior. There is a high number of false positives in the follow-up group with a large number of "white" cystoscopes. A high number of false positives was seen if the BTA test was done in he first three months of follow-up. In the subgroup in prophylaxis with cystostatic there weren't false positives. We conclude that BTA test is useful in the diagnostic of bladder tumor but not in the follow-up, especially in the first three months.