Cell Therapy in the Treatment of Female Stress Urinary Incontinence: Current Status and Future Proposals.

BACKGROUND: Stress urinary incontinence (SUI) is a common condition with a significant impact on the quality of life of female patients. The limitations of current treatment strategies have prompted the exploration of new effective and minimally invasive alternative approaches, including cell therapy. METHODS: A literature search was conducted to update the current clinical status of stem cell therapy in the management of female stress urinary incontinence. RESULTS: Over thirty clinical studies have been designed to assess the feasibility, safety and efficacy of cell therapy for female SUI. Despite differences in cell types and protocols, the overall treatment procedures were similar. Standard subjective and objective assessment tools, and follow-up periods ranged from 6 weeks to 6 years have been used. Cell injection has shown to be a safe therapy in the treatment of female SUI. However, the results from more recent randomized trials have shown less promising results than expected in restoring continence. Heterogeneous research methodologies using different cell types and doses make it difficult to draw conclusions about effectiveness. Several key points remain that need to be further explored in future clinical trials. CONCLUSION: To advance in the development of cell therapy, it is essential to know the mechanisms involved to be able to direct it properly, its efficacy and the durability of the injected cells. Rigorous and homogenized preclinical and clinical studies that demonstrate its scope and improve its application are necessary for validation in the treatment of female SUI.

Safety and efficacy of autologous non-hematopoietic enriched stem cell nebulization in COVID-19 patients: a randomized clinical trial, Abu Dhabi 2020.

BACKGROUND: The novel SARS-CoV-2 has caused the coronavirus disease 2019 (COVID-19) pandemic. Currently, with insufficient worldwide vaccination rates, identifying treatment solutions to reduce the impact of the virus is urgently needed. METHOD: An adaptive, multicentric, open-label, and randomized controlled phase I/II clinical trial entitled the "SENTAD-COVID Study" was conducted by the Abu Dhabi Stem Cells Center under exceptional conditional approval by the Emirates Institutional Review Board (IRB) for COVID-19 Research Committee from April 4th to July 31st, 2020, using an autologous peripheral blood non-hematopoietic enriched stem cell cocktail (PB-NHESC-C) administered by compressor (jet) nebulization as a complement to standard care therapy. The primary endpoints include safety and efficacy assessments, adverse events, the mortality rate within 28 days, and the time to clinical improvement as measured by a 2-point reduction on a seven-category ordinal scale or discharge from the hospital whichever occurred first. RESULTS: The study included a total of 139 randomized COVID-19 patients, with 69 in the experimental group and 70 in the control group (standard care). Overall survival was 94.20% for the cocktail-treated group vs. 90.27% for the control group. Adverse events were reported in 50 (72.46%) patients receiving PB-NHESC-C and 51 (72.85%) in the control group (p = 0.9590), with signs and symptoms commonly found in COVID-19. After the first 9 days of the intervention, 67.3% of cocktail-treated patients recovered and were released from hospitals compared to 53.1% (RR = 0.84; 95% CI, 0.56-1.28) in the control group. Improvement, i.e., at least a 2-point reduction in the severity scale, was more frequently observed in cocktail-treated patients (42.0%) than in controls (17.0%) (RR = 0.69; 95% CI, 0.56-0.88). CONCLUSIONS: Cocktail treatment improved clinical outcomes without increasing adverse events. Thus, the nebulization of PB-NHESC-C was safe and effective for treatment in most of these patients. TRIAL REGISTRATION: ClinicalTrials.gov. NCT04473170. It was retrospectively registered on July 16th, 2020.

Nuevo sistema de comparación de resultados tras nefrolitotomía percutánea de un modo más homogéneo / Standarization of PCNL reporting: Comparative methodology

OBJETIVO: Evaluar el impacto de una nueva clasificación de la litiasis renal sobre la tasa libre de litiasis, para su utilización como sistema que permita comparar distintas series de nefrolitotomía percutánea de un modo más homogéneo. MATERIAL Y MÉTODOS: Se analizaron de forma retrospectiva pacientes sometidos a nefrolitotomía percutánea (NLPC) entre noviembre 2011 y noviembre 2016. Las litiasis se clasificaron en simples (litiasis pélvica y/o calicial que requirieron de un único acceso y/o utilización de un nefroscopio rígido), compleja (requirieron la utilización de más de un acceso percutáneo y/o instrumental flexible y/o acceso combinado) y extremadamente compleja (litiasis coraliforme completa o alteraciones anatómicas), de acuerdo con la clasificación de Ibarluzea-Llanes. También se analizaron las variables edad, sexo, antecedentes de diabetes, hipertensión o toma de anticoagulantes, composición de la litiasis, colocación de nefrostomía posquirúrgica y tiempo quirúrgico. Realizamos un análisis univariado y multivariado mediante el test de chi-cuadrado o de Fisher y regresión logística. RESULTADOS: Se incluyeron 69 procedimientos en 57 pacientes con una edad media de 51,3 años (13-84) y un tiempo medio de seguimiento de 32,57 meses (rango 71). La tasa libre de litiasis fue del 86%, 75% y 55% para una litiasis simple, compleja o extremadamente compleja, tanto a los tres meses como al año. Únicamente el tipo de litiasis se relacionó con una peor tasa libre de litiasis (p 0,03) con RR de 2,5. CONCLUSIONES: La clasificación del tipo de litiasis de Ibarluzea-Llanes resultó ser un buen modelo predictivo de tasa libre de litiasis tras nefrolitotomía percutánea

OBJECTIVE: To evaluate the impact of a new renal lithiasis classification on the stone free rate. The new system would allow standarization of comparison between different series of percutaneous nephrolithotomy. MATERIAL AND METHODS: Patients undergoing NPCL between November 2011 and November 2016 were retrospectively analyzed. The stones were classified as simple (pelvic and/or calyceal stones that required a single access and/or use of a rigid nephroscope), complex (required the use of more than one percutaneous Access and/or flexible instruments and/or combined access) and extremely complex (complete staghorn stones or anatomical alterations), according to the Ibarluzea-Llanes classification. Other variables analyzed were age, sex, diabetes, hypertension or taking anticoagulants, stones composition, placement of postoperative nephrostomy and surgical time. We performed a univariate and multivariate analysis using the chi-square or Fisher test and logistic regression. RESULTS: Sixty-nine procedures were included in 57 patients with a mean age of 51 years (13-84) and a mean follow-up time of 30 months. The stone free rate was 86%, 75% and 55% for a simple, complex or extremely complex stone, both at three months and a year. Only the stone type was associated with a worse stone free rate (p 0.03) with RR of 2.5 for a 95% CI. CONCLUSIONS: The Ibarluzea-Llanes clasification could be used as a new system for standarization of PCNL outcomes reporting

[Standarization of PCNL reporting: Comparative methodology.] / Nuevo sistema de comparación de resultados tras nefrolitotomía percutánea de un modo más homogéneo.

OBJECTIVE: To evaluate the impact of a new renal lithiasis classification on the stone free rate. The new system would allow standarization of comparison between different series of percutaneous nephrolithotomy. MATERIAL AND METHODS: Patients undergoing NPCL between November 2011 and November 2016 were retrospectively analyzed. The stones were classified as simple (pelvic and/or calyceal stones that required a single access and/or use of a rigid nephroscope), complex (required the use of more than one percutaneous access and/or flexible instruments and/or combined access) and extremely complex (complete staghorn stones or anatomical alterations), according to the Ibarluzea-Llanes classification. Other variables analyzed were age, sex, diabetes, hypertension or taking anticoagulants, stones composition, placement of postoperative nephrostomy and surgical time. We performed a univariate and multivariate analysis using the chi-square or Fisher test and logistic regression. RESULTS: Sixty-nine procedures were included in 57 patients with a mean age of 51 years (13-84) and a mean follow-up time of 30 months. The stone free rate was 86%, 75% and 55% for a simple, complex or extremely complex stone, both at three months and a year. Only the stone type was associated with a worse stone free rate (p 0.03) with RR of 2.5 for a 95% CI. CONCLUSIONS: The Ibarluzea-Llanes clasification could be used as a new system for standarization of PCNL outcomes reporting.

OBJETIVO: Evaluar el impacto de una nueva clasificación de la litiasis renal sobre la tasa libre de litiasis, para su utilización como sistema que permita comparar distintas series de nefrolitotomía percutánea de un modo más homogéneo.MATERIAL Y MÉTODOS: Se analizaron de forma retrospectiva pacientes sometidos a nefrolitotomía percutánea (NLPC) entre noviembre 2011 y noviembre 2016. Las litiasis se clasificaron en simples (litiasis pélvica y/o calicial que requirieron de un único acceso y/o utilización de un nefroscopio rígido), compleja (requirieron la utilización de más de un acceso percutáneo y/o instrumental flexible y/o acceso combinado) y extremadamente compleja (litiasis coraliforme completa o alteraciones anatómicas), de acuerdo con la clasificación de Ibarluzea-Llanes. También se analizaron las variables edad, sexo, antecedentes de diabetes, hipertensión o toma de anticoagulantes, composición de la litiasis, colocación de nefrostomía posquirúrgica y tiempo quirúrgico. Realizamos un análisis univariado y multivariado mediante el test de chi-cuadrado o de Fisher y regresión logística. RESULTADOS: Se incluyeron 69 procedimientos en 57 pacientes con una edad media de 51,3 años (13-84) y un tiempo medio de seguimiento de 32,57 meses (rango 71). La tasa libre de litiasis fue del 86%, 75% y 55% para una litiasis simple, compleja o extremadamente compleja, tanto a los tres meses como al año. Únicamente el tipo de litiasis se relacionó con una peor tasa libre de litiasis (p 0,03) con RR de 2,5. CONCLUSIONES: La clasificación del tipo de litiasis de Ibarluzea-Llanes resultó ser un buen modelo predictivo de tasa libre de litiasis tras nefrolitotomía percutánea.

[Preliminary data of the Spanish contribution to the European Randomized Study on Screening of Prostate Cancer (ERSPC)]. / Datos preliminares de la contribución española al estudio randomizado europeo de screening del cancer de próstata (ERSPC).

OBJECTIVES: Data from the participation of our department in the ERSPC study in terms of detection and PSA diagnostic yield, staging, therapeutic management and mortality in the context of a multicentric randomized screening study for prostate cancer. METHODS: Patients were recruited between February 1996 and June 1999, randomized in screening and control arms, with several rounds for screening patients with four-year intervals, with PSA analysis and sextant prostate biopsy (t PSA > 4 ng/ml before May 1998, tPSA > 2.99 ng/ml after May 1998). These tests were not done in the control group. All deaths were studied (date and cause) RESULTS: A total of 4278 patients were included, 24 16 in the screening arm (56.4%) and 1862 in the control arm (43.5%), with an age between 45 and 70 years (mean age 57.8 years, 95 CI 57.6-58.0). Median follow-up was 8.77 years. 142 prostate cancers were found, 113 in the screening arm (accumulated detection rate 4.7%) and 29 in the control arm (1.6%). Detection rates were 1.7%, 2.2% and 0% in the first, second and third round respectively. Organ confined cancers (T1 and T2) were 102 in the screening arm (90.3%) and 24 in the control arm (82.8%), p = 0.254 . Metastatic disease was found in six patients (4.2% out of 142), 3 in the screening arm ( 2.7%) and three in the control arm (10.3%), p = 0.187. Radical prostatectomy was the most frequently performed treatment: 47 cases in the screening arm (41.6%), 10 in the control arm (34.5%). 151 patients have died, 82 in the screening arm and 69 in the control arm. Only 3 of this deaths were secondary to prostate cancer, all of them in the screening arm (p = 0.308). CONCLUSIONS: We observed a non significant tendency to lower clinical stages in patients undergoing screening. Radical surgery was the treatment of choice in patients with prostate cancer. Even with the current follow-up in the series (close to 9 years), no differences have been observed in terms of prostate cancer mortality between both study arms.

Datos preliminares de la contribución española al estudio randomizado europeo de screening del cáncer de próstata (ERSPC) / Preliminary data of the Spanish contribution to the European RAndomized Study on Screening of Prostate Cancer (ERSPC)

OBJETIVO: Datos de la participación de nuestro Centro en el ERSPC en términos de detección y rendimiento diagnóstico del PSA, estadiaje, manejo terapéutico y mortalidad, en el contexto de un estudio multicéntrico randomizado de screening del cáncer de próstata (CaP). MÉTODOS: Se reclutaron pacientes entre febrero de 1996 y junio de 1999, randomizando en brazos screening y control, realizado varias rondas a los pacientes del brazo screening con intervalo de 4 años, con determinación de PSA y biopsia prostática sextante (PSAt >4ng/mL hasta mayo de 1998, posteriormente PSAt >2.99ng/mL), sin realizar dichos tests en los varones del grupo control. Se investigaron los fallecimientos (fecha de defunción y causa de la misma). RESULTADOS: Se incluyeron un total de 4.278 pacientes, 2.416 del brazo screening (56,4%) y 1.862 del brazo control (43,5%), con edad entre 45 a 70 años y media de 57,8 años (IC95 57,6-58,0). La mediana del tiempo de seguimiento fue de 8,77 años. Se encontraron 142 cánceres, 113 del brazo screening (tasa de detección acumulada 4,7%) y 29 del brazo control (1,6%). Las tasas de detección fueron de 1,7%, 2,2% y 0% en la primera, segunda y tercera ronda respectivamente. Los cánceres órgano confinados (T1 y T2) fueron 102 en el brazo screening (90,3%) y 24 en el control (82,8%), p=0,254. Se detectaron 6 pacientes con enfermedad metastásica (4,2% de 142), 3 del brazo screening (2,7%) y 3 del control (10,3%), p=0,187. El tratamiento más realizado fue la prostatectomía radical: 47 del brazo screening (41,6%) y 10 del control (34,5%). Se han producido 151 fallecimientos, 82 en el brazo screening y 69 en el control, de estos sólo 3 fallecimientos por CaP, todos del brazo screening (p=0,308). CONCLUSIONES: Se observa tendencia no significativa hacia estadíos clínicos más precoces en los pacientes sometidos a screening. El tratamiento de elección en los pacientes con CaP fue la cirugía radical. Aún con el seguimiento actual de esta serie (cercano a los 9 años), no se han observado en nuestro Centro diferencias en cuanto a la mortalidad por CaP entre los dos brazos del estudio

OBJECTIVES: Data from the participation of our department in the ERSPC study in terms of detection and PSA diagnostic yield, staging, therapeutic management and mortality in the context of a multicentric randomized screening study for prostate cancer. METHODS: Patients were recruited between February 1996 and June 1999, randomized in screening and control arms, with several rounds for screening patients with four-year intervals, with PSA analysis and sextant prostate biopsy (t PSA > 4 ng/ml before May 1998, tPSA > 2.99 ng/ml after May 1998). These tests were not done in the control group. All deaths were studied (date and cause) RESULTS: A total of 4278 patients were included, 2416 in the screening arm (56.4%) and 1862 in the control arm (43.5%), with an age between 45 and 70 years (mean age 57.8 years, 95 CI 57.6-58.0). Median follow-up was 8.77 years. 142 prostate cancers were found, 113 in the screening arm (accumulated detection rate 4.7%) and 29 in the control arm (1.6%). Detection rates were 1.7%, 2.2% and 0% in the first, second and third round respectively. Organ confined cancers (T1 and T2) were 102 in the screening arm (90.3% ) and 24 in the control arm ( 82.8% ) , p = 0.254 . Metastatic disease was found in six patients ( 4.2% out of 142 ) , 3 in the screening arm ( 2.7% ) and three in the control arm ( 10.3% ) , p = 0 . 187 . Radical prostatectomy was the most frequently performed treatment: 47 cases in the screening arm (41. 6 %), 10 in the control arm (34. 5 %). 151 patients have died, 82 in the screening arm and 69 in the control arm. Only 3 of this deaths were secondary to prostate cancer, all of them in the screening arm (p = 0.308). CONCLUSIONS: We observed a non significant tendency to lower clinical stages in patients undergoing screening. Radical surgery was the treatment of choice in patients with prostate cancer. Even with the current follow-up in the series (close to 9 years), no differences have been observed in terms of prostate cancer mortality between both study arms