Resumo O cumprimento dos prazos legais para incorporação e disponibilização de tecnologias no Sistema Único de Saúde (SUS) é fundamental para o acesso da população aos medicamentos considerados essenciais. Objetivou-se analisar o cumprimento destes prazos comparando a Oncologia e o Componente Especializado de Assistência Farmacêutica (CEAF). Comparou-se os processos de incorporação de medicamentos no SUS da Oncologia e do CEAF que foram submetidos à Conitec no período de 01 de janeiro de 2017 a 30 de abril de 2020. No período, 83 processos de incorporação de medicamentos foram recomendados para incorporação pela Conitec, dos quais 13 (15,66%) eram da Oncologia e 70 (84,34%) eram do CEAF. Verifica-se que o tempo de análise e recomendação pela Conitec até a publicação da decisão pelo Ministério da Saúde foi, em média, 15 dias maior para processos que continham medicamentos oncológicos e o tempo para disponibilização das tecnologias incorporadas da área da oncologia foi, em média, 389 dias maior que do CEAF. Reconhece-se o importante avanço obtido com a criação da Conitec no Brasil, porém os resultados deste estudo apontam para a necessidade de aprimoramento do processo de disponibilização de tecnologias incorporadas no SUS, em especial da Oncologia.

Abstract Compliance with legal deadlines for the assessment and incorporation of technologies in Brazil’s Unified Health System (SUS) is essential to ensure public access to essential medicines. The scope of this paper was to analyze the compliance with legal deadlines for incorporation and availability of medicines in the SUS, comparing Oncology and the Specialized Component of Pharmaceutical Assistance (SCPA). A comparison was made of the drugs incorporated that were submitted to Conitec in the period from January 1, 2017, to April 30, 2020. A total of 85 drugs were recommended for incorporation by Conitec, of which 15 (17.64%) were for Oncology and 70 (82.36%) were for SCPA. The time between analysis and recommendation by Conitec until the publication of the decision by the Ministry of Health was, on average, 86 days longer for oncological drugs and the availability timeframe of technologies incorporated in the oncology area was, on average, 389 days longer than for SCPA. The major progress achieved with the creation of Conitec in Brazil is acknowledged, but the results of this study point to a pressing need to improve the process of making available technologies incorporated into the SUS, especially in oncology.

Resumo O cumprimento dos prazos legais para incorporação e disponibilização de tecnologias no Sistema Único de Saúde (SUS) é fundamental para o acesso da população aos medicamentos considerados essenciais. Objetivou-se analisar o cumprimento destes prazos comparando a Oncologia e o Componente Especializado de Assistência Farmacêutica (CEAF). Comparou-se os processos de incorporação de medicamentos no SUS da Oncologia e do CEAF que foram submetidos à Conitec no período de 01 de janeiro de 2017 a 30 de abril de 2020. No período, 83 processos de incorporação de medicamentos foram recomendados para incorporação pela Conitec, dos quais 13 (15,66%) eram da Oncologia e 70 (84,34%) eram do CEAF. Verifica-se que o tempo de análise e recomendação pela Conitec até a publicação da decisão pelo Ministério da Saúde foi, em média, 15 dias maior para processos que continham medicamentos oncológicos e o tempo para disponibilização das tecnologias incorporadas da área da oncologia foi, em média, 389 dias maior que do CEAF. Reconhece-se o importante avanço obtido com a criação da Conitec no Brasil, porém os resultados deste estudo apontam para a necessidade de aprimoramento do processo de disponibilização de tecnologias incorporadas no SUS, em especial da Oncologia.

Abstract Compliance with legal deadlines for the assessment and incorporation of technologies in Brazil’s Unified Health System (SUS) is essential to ensure public access to essential medicines. The scope of this paper was to analyze the compliance with legal deadlines for incorporation and availability of medicines in the SUS, comparing Oncology and the Specialized Component of Pharmaceutical Assistance (SCPA). A comparison was made of the drugs incorporated that were submitted to Conitec in the period from January 1, 2017, to April 30, 2020. A total of 85 drugs were recommended for incorporation by Conitec, of which 15 (17.64%) were for Oncology and 70 (82.36%) were for SCPA. The time between analysis and recommendation by Conitec until the publication of the decision by the Ministry of Health was, on average, 86 days longer for oncological drugs and the availability timeframe of technologies incorporated in the oncology area was, on average, 389 days longer than for SCPA. The major progress achieved with the creation of Conitec in Brazil is acknowledged, but the results of this study point to a pressing need to improve the process of making available technologies incorporated into the SUS, especially in oncology.

PURPOSE: Duplex system is one of the most common anomalies of upper urinary tract. Anatomical and clinical presentation determine its treatment. Usually, the upper moiety has a poor function and requires resection, but when it is not significantly impaired, preservation is recommended. Laparoscopic reconstruction with upper pole preservation is presented as an alternative treatment. MATERIALS AND METHODS: Four female patients with duplex system, one presenting with recurrent urinary tract infection and the others with urinary incontinence associated to infrasphincteric ectopic ureter, were treated. Surgical procedure envolved a laparoscopic ureteropyeloanastomosis of the upper pole ureter to the pelvis of the lower moiety, with prior insertion of a double J stent. RESULTS: Surgical time varied from 120 to 150 minutes, with minimal blood loss in all cases. Follow-up varied from 15 to 30 months, with resolution of the clinical symptoms and preservation of the upper moiety function. CONCLUSION: Laparoscopic ureteropyeloanatomosis is a feasible and safe minimally invasive option in the treatment of duplex system.

OBJECTIVE: To assess the presence of metabolic disorders in elderly men with urolithiasis. METHODS: We performed a case-control study. The inclusion criteria were as follows: (1) men older than 60 years of age and either (2) antecedent renal colic or an incidental diagnosis of urinary lithiasis after age 60 (case arm) or (3) no antecedent renal colic or incidental diagnosis of urolithiasis (control arm). Each individual underwent an interview, and those who were selected underwent all clinical protocol examinations: serum levels of total and ionized calcium, uric acid, phosphorus, glucose, urea, creatinine and parathyroid hormone, urine culture, and analysis of 24-hour urine samples (levels of calcium, citrate, creatinine, uric acid and sodium, pH and urine volume). Each case arm patient underwent two complete metabolic urinary investigations, whereas each control arm individual underwent one examination. ClinicalTrials.gov: NCT01246531. RESULTS: A total of 51 subjects completed the clinical investigation: 25 in the case arm and 26 in the control arm. In total, 56% of the case arm patients had hypocitraturia (vs. 15.4% in the control arm; p = 0.002). Hypernatriuria was detected in 64% of the case arm patients and in 30.8% of the controls (p = 0.017). CONCLUSION: Hypocitraturia and hypernatriuria are the main metabolic disorders in elderly men with urolithiasis.

PURPOSE: Two different regimens of SWL delivery for treating urinary stones were compared. METHODS: Patients with urinary stones were randomly divided into two groups, one of which received 3000 shocks at a rate of 60 impulses per minute and the other of which received 4000 shocks at 90 impulses per minute. Success was defined as stone-free status or the detection of residual fragments of less than or equal to 3 mm three months after treatment. Partial fragmentation was considered to have occurred if a significant reduction in the stone burden was observed but residual fragments of 3mm or greater remained. RESULTS: A total of 143 procedures were performed with 3000 impulses at a rate of 60 impulses per minute, and 156 procedures were performed with 4000 impulses at 90 impulses per minute. The stone-free rate was 53.1% for patients treated with the first regimen and 54.8% for those treated with the second one (p = 0.603). The stone-free rate for stones smaller than 10 mm was 60% for patients treated with 60 impulses per minute and 58.6% for those treated with 90 impulses per minute. For stones bigger than 10 mm, stone-free rates were 34.2% and 45.7%, respectively (p = 0.483). Complications occurred in 2.3% of patients treated with 60 impulses per minute and 3.3% of patients treated with 90 impulses per minute. CONCLUSION: No significant differences in the stone-free and complication rates were observed by reducing the total number of impulses from 4000 to 3000 and the frequency from 90 to 60 impulses per minute.

Objectives: Vesico-ureteric reflux (VUR) is a common cause of urinary tract infections in children, being less commonly diagnosed in adults. Several anti-reflux plasties have been used successfully for the treatment of such condition, such as Politano-Leadbetter, Cohen and Gregoir-Lich techniques, the latter being our preferred approach in open procedures. Here we describe our experience with laparoscopic Gregoir-Lich anti-reflux plasty (LGLP) in children and adults. Methods: The LGLP was used for the treatment of VUR in 15 patients (7 adults and 8 children). Four adults and 5 children had bilateral disease and both sides were treated at the same procedure. Data was collected prospectively and we analysed age at treatment, laterality, degree of VUR, previous anti-reflux procedures, operative time, number of detrusor stitches used in each side, intra-operative and post-operative complications, success rate and follow-up. Results: A total of 23 ureteral units were treated. VUR was graded as I in one unit, II in 4 units, III in 10 units, IV in 7 units and 1 unit was not classified, as it was diagnosed by radioisotopic cystography. Two children had failed previous endoscopic procedures. There were no open conversions. Two muccosal perforations occurred during the procedure and were successfully treated laparoscopically. Nineteen out of 21 ureteral units (90%) presented no VUR at the cystographic control, and no bladder dysfunction was identified on follow-up. Conclusions: The LGLP is a feasible, minimally invasive alternative for VUR that reproduces the open procedure. It has an excelent success rate and is not associated to bladder disfunction, even in bilateral procedures.

Objetivo: El reflujo vesicoureteral (RVU) es una causa común de infecciones del tracto urinario en niños, siendo diagnosticado con menos frecuencia en adultos. Se han utilizado varias técnicas antirreflujo para el tratamiento de dicha condición, como las técnicas de Politano-Leadbet-ter, Cohen y Gregoir-Lich, siendo ésta última nuestro abordaje preferido en cirugía abierta. Describimos nuestra experiencia con la plastia antirreflujo laparoscópica de Gregoir-Lich en niños y adultos. Métodos: La plastia de Gregoir-Lich laparoscópica fue utilizada en el tratamiento del RVU en 15 pacientes (7 adultos y 8 niños). Cuatro adultos y cinco niños respectivamente tenían reflujo bilateral, tratándose ambos lados en el mismo acto quirúrgico. Los datos fueron recogidos prospectivamente y se analizó edad en el momento el tratamiento, lado, grado de RVU, operaciones antirreflujo previas, tiempo operatorio, número de puntos del detrusor utilizados en cada lado, complicaciones intra y postoperatorias, tasa de éxitos y seguimiento. Resultados: Se trataron un total de 23 unidades ureterales. El RVU fue grado I en 1 uréter, II en 4, III en 10 y IV en 7, en un uréter no se asignó grado porque se diagnosticó mediante cistografía radioisotópica. Dos niños habían tenido operaciones endoscópicas previas que fracasaron. No hubo ninguna conversión a cirugía abierta. Hubo dos casos de perforación mucosa durante el procedimiento que fueron tratadas con éxito por vía laparoscópica. Diecinueve de las 21 unidades ureterales (90%) no presentaban RVU en el control mediante cistografía, y no se identificó disfunción vesical en el seguimiento. Conclusiones: La plastia laparoscópica de Gregoir-Lich es una alternativa factible, mínimamente invasiva para el RVU que reproduce el procedimiento abierto. Tiene un excelente porcentaje de éxitos y no se asocia con disfunción vesical, cruzó en procedimientos bilaterales.

PURPOSE: To evaluate the results of a sequence of 47 laparoscopic Anderson-Hynes pyeloplasties for the treatment of patients with ureteropelvic junction obstruction, independently of the etiology. MATERIALS AND METHODS: Twenty male and 27 female patients diagnosed with ureteropelvic junction obstruction were treated by Anderson-Hynes transperitoneal laparoscopic dismembered pyeloplasty from April 2002 to January 2006. The age of the patients ranged from four to 75 years, with a mean age of 32.3 years. The follow-up ranged between six and 30 months, with a mean follow-up time of 24 months. The outcomes were evaluated through the assessment of symptoms and imaging studies. RESULTS: In 44 (93.6%) of the 47 patients, resolution of the pain and a reduction in ureteropelvic dilation were observed. The mean operative time was 157 minutes (ranging from 90 to 270 minutes). Neither blood transfusion nor conversion to open surgery was required. The mean hospital stay was 2.2 days. The presence of crossing vessels over the ureteropelvic junction was verified in 26 patients (55%), and vessel transposition in relation to the urinary tract was performed in 25 of these cases. In one patient, the crossing vessel was mobilized out of the ureteropelvic junction with a perivascular suture to the renal capsule associated with the pyeloplasty. CONCLUSIONS: The outcome of transperitoneal Anderson-Hynes laparoscopic pyeloplasty used for different causes of pyeloureteral obstruction presented a success rate similar to a previously-published open procedure, with the advantage of being less invasive. This procedure may be considered the first option for the treatment of ureteropelvic junction obstruction.

INTRODUCTION: This work evaluates the results of ureteroscopic treatment of impacted ureteral stones with a pneumatic lithotripter. MATERIALS AND METHODS: From March 1997 to May 2002, 42 patients with impacted ureteral stones were treated by retrograde ureteroscopic pneumatic lithotripsy. Twenty-eight patients were female and 14 were male. The stone size ranged from 5 to 20 mm. The ureteral sites of the stones were distal in 21, middle in 12 and proximal in 9. RESULTS: Considering stones with distal location in the ureter, 1 patient had ureteral perforation and developed a stricture in the follow-up (4.7%). As for stones in the middle ureter, 2 perforations and 1 stricture were observed (8.3%) and regarding stones located in the proximal ureter, 5 perforations and 4 strictures occurred (44%). In the mid ureter, 1 ureteral avulsion was verified. In 34 patients without ureteral perforation, only 1 developed a stricture (2.9%). Of 8 patients who had perforation, 6 developed strictures. The overall incidence of stricture following treatment of impacted ureteral calculi was 14.2%. CONCLUSIONS: Ureteroscopy for impacted ureteral calculi is associated with a higher incidence of ureteral perforation and stricture. Ureteroscopy of proximal ureteral calculi is associated with a high risk of perforation, when compared to mid or distal ureteral calculi. Ureteral perforation at the site of the stone seems to be the primary risk factor for stricture formation in these cases.