Efficacy and tolerability of lodenafil carbonate for oral therapy of erectile dysfunction: a phase III clinical trial.

INTRODUCTION: This is a phase III, prospective, randomized, double-blind, placebo-controlled clinical trial on lodenafil carbonate (LC), a novel phosphodiesterase 5 inhibitor developed in Brazil. AIM: Expanding information on LC efficacy and safety. MAIN OUTCOME MEASURES: International Index of Erectile Function (IIEF) erectile domain, positive answers to the sexual encounter profile (SEP)-2 and SEP-3 questions and incidence of adverse events (AEs). METHODS: A total of 350 men with erectile dysfunction (ED) of all degrees were randomized to placebo, LC 40 mg or LC 80 mg and followed for 4 weeks. They completed the IIEF and answered the SEP questions 2 and 3 after each intercourse without and with the use of LC. RESULTS: IIEF Erectile Domain scores without and with the use of medication were the following (mean [M] +/- standard deviation [SD]): placebo = 13.9 +/- 5.2 and 14.8 +/- 7.8; LC 40 mg = 13.6 +/- 5.3 and 18.6 +/- 8.0; LC 80 mg = 13.4 +/- 4.9 and 20.6 +/- 7.7 (analysis of variance [ANOVA] P < 0.01). Positive answers to SEP-2 without and with the use of medication were the following (M +/- SD): placebo = 55.3 +/- 43.2% and 52.1 +/- 41.4%; LC 40 mg = 46.4 +/- 44.3% and 63.5 +/- 42.0%; LC 80 mg = 50.2 +/- 40.9% and 80.8 +/- 32.3% (ANOVA P < 0.01). Positive answers to SEP-3 were the following: placebo = 20.2 +/- 32.3% and 29.7 +/- 38.1%; LC 40 mg = 19.6 +/- 34.3% and 50.8 +/- 44.4%; LC 80 mg = 20.8 +/- 33.2% and 66.0 +/- 39.3% (ANOVA P < 0.01). The patients with at least one AE were placebo = 28.7%, LC 40 mg = 40.9%, and LC 80 mg = 49.5%. AEs whose incidence was significantly higher with LC than with placebo included rhinitis, headache, flushing, visual disorder, and dizziness. CONCLUSIONS: LC showed a satisfactory efficacy-safety profile for oral therapy of ED.

Laparoscopic radical prostatectomy: 10 years experience.

PURPOSE: The authors assess the morbidity, functional results and oncologic follow-up of a series of laparoscopic radical prostatectomies performed in over a 10-year period. MATERIALS AND METHODS: The data on 780 laparoscopic radical prostatectomies performed between September 1997 and December 2007 were stored in a personal database. The following parameters are described and critically analyzed: operative time, blood transfusions, conversions, length of hospital stay, complications, functional results of sexual potency and urinary continence, surgical margins and oncologic follow-up. RESULTS: Operative time averaged 125 minutes, with a mean bleeding volume of 335 mL and mean hospital stay of 4.3 days. The rate of conversion to open surgery was 1.36% and the overall complication rate was 14.24%. The pathology analysis showed pT2 tumors in 82.60% and pT3 tumors in 17.39% of cases. The overall positive margin rate was 19.58%, with a biochemical recurrence of 10.27% at a mean follow-up of 62.5 months. Urinary continence and sexual potency yielded rates of 88% and 61%, respectively, 12 months after surgery. CONCLUSIONS: Laparoscopic radical prostatectomy is a technically well-defined procedure that provides good oncologic and functional results after proper training.

Laparoscopic radical prostatectomy: 10 years experience

Purpose: The authors assess the morbidity, functional results and oncologic follow-up of a series of laparoscopic radical prostatectomies performed in over a 10-year period. Material and Methods: The data on 780 laparoscopic radical prostatectomies performed between September 1997 and December 2007 were stored in a personal database. The following parameters are described and critically analyzed: operative time, blood transfusions, conversions, length of hospital stay, complications, functional results of sexual potency and urinary continence, surgical margins and oncologic follow-up. Results: Operative time averaged 125 minutes, with a mean bleeding volume of 335 mL and mean hospital stay of 4.3 days. The rate of conversion to open surgery was 1.36 percent and the overall complication rate was 14.24 percent. The pathology analysis showed pT2 tumors in 82.60 percent and pT3 tumors in 17.39 percent of cases. The overall positive margin rate was 19.58 percent, with a biochemical recurrence of 10.27 percent at a mean follow-up of 62.5 months. Urinary continence and sexual potency yielded rates of 88 percent and 61 percent, respectively, 12 months after surgery. Conclusions: Laparoscopic radical prostatectomy is a technically well-defined procedure that provides good oncologic and functional results after proper training.

Mechanical circular stapler device loaded with nonabsorbable titanium staples for ileo-prostate capsuloplasty following prostate capsule sparing cystectomy: initial experience in cadavers.

PURPOSE: Mechanical linear staplers have been safely used in urology with an acceptable 0% to 7.9% rate of stone formation in long-term follow-up. We sought to evaluate the feasibility of using mechanical circular stapler devices to perform ileocapsuloplasty following cystoadenomectomy in cadavers. MATERIAL AND METHOD: Three unfrozen cadavers were used in this study. The prostate was enucleated and removed along with the bladder, leaving an ample cavity wherein the 21-mm anvil could be easily accommodated. A 2-0 purse string suture was then placed at the prostate capsule rim and tightly tied around the anvil. Following this, the circular stapler device was introduced into the neobladder through its opened limb and the center rod of the stapler device was passed through an opening made at the most dependent portion of the pouch where another purse string suture was placed and tied around it. Finally, the center rod of the stapler was connected to the anvil and fired, thus completing the anastomosis. RESULTS: The procedure was feasible in all cases and 2 intact rings of prostatic capsule and bowel tissue were obtained, thus attesting the integrity of the anastomoses. Retrograde injection of methylene blue reassured that a watertight anastomosis was achieved whereas cystoscopic and macroscopic examination of the anastomotic site demonstrated a wide patent anastomosis in all cases. CONCLUSIONS: Use of mechanical circular stapler to perform ileocapsuloplasty in cadavers is feasible and has potential advantages such as decreased anastomotic time, diminished chances of urinary extravasations, and reduced degree of difficulty.

Complications in laparoscopic radical cystectomy. The South American experience with 59 cases.

OBJECTIVE: In this study, we have gathered the second largest series yet published on laparoscopic radical cystectomy in order to evaluate the incidence and cause of intra and postoperative complication, conversion to open surgery, and patient mortality. MATERIALS AND METHODS: From 1997 to 2005, 59 laparoscopic radical cystectomies were performed for the management of bladder cancer at 3 institutions in South America. Twenty nine patients received continent urinary diversion, including 25 orthotopic ileal neobladders and 4 Indiana pouches. Only one case of continent urinary diversion was performed completely intracorporeally. RESULTS: Mean operative time was 337 minutes (150-600). Estimated intraoperative blood loss was 488 mL (50-1500) and 12 patients (20%) required blood transfusion. All 7 (12%) intraoperative complications were vascular in nature, that is, 1 epigastric vessel injury, 2 injuries to the iliac vessels (1 artery and 1 vein), and 4 bleedings that occurred during the bladder pedicles control. Eighteen (30%) postoperative complications (not counting mortalities) occurred, including 3 urinary tract infections, 1 pneumonia, 1 wound infection, 5 ileus, 2 persistent chylous drainage, 3 urinary fistulas, and 3 (5%) postoperative complications that required surgical intervention (2 hernias - one in the port site and one in the extraction incision, and 1 bowel obstruction). One case (1.7%) was electively converted to open surgery due to a larger tumor that precluded proper posterior dissection. Two mortalities (3.3%) occurred in this series, one early mortality due to uncontrolled upper gastrointestinal bleeding and one late mortality following massive pulmonary embolism. CONCLUSIONS: Laparoscopic radical cystectomy is a safe operation with morbidity and mortality rates comparable to the open surgery.

Laparoscopic-assisted radical cystectomy with U-shaped orthotopic ileal neobladder constructed using nonabsorbable titanium staples.

INTRODUCTION: Recently, nonabsorbable staples have been safely used in a variety of urologic open and laparoscopic extirpative and reconstructive procedures. We report the surgical steps of our technique of U-shaped orthotopic ileal neobladder created with titanium staples. TECHNICAL CONSIDERATIONS: Using stay stitches, a 45 to 50-cm ileal segment is arranged in a U shape with two segments of approximately 20 cm and an afferent limb of 5 or 10 cm. An opening is made at the lowest point of the U-ileal segment on its antimesenteric border. The jaws of the 80 x 3.5-mm nonabsorbable mechanical stapler are accommodated within the bowel loop and fired twice, bringing together and detubularizing approximately 15 cm of each arm of the U. To complete the pouch detubularization, another small opening is made at the bottom of the chimney on its medial border. After this, a third nonabsorbable mechanical stapler had its jaws introduced through this opening and through the open end of the bowel segment on the right side and the stapler is fired, completing the U pouch. Subsequently, the open ends of the U segment and the opening made at the base of the afferent limb are closed with absorbable running sutures. CONCLUSIONS: Our technique is feasible and may represent an alternative to expand the spectrum of continent urinary reservoirs that could be expeditiously created with nonabsorbable staples. Continued surveillance is mandatory to determine the lithiasis-inducing potential of these titanium staples within the urinary tract.

Complications in laparoscopic radical cystectomy: The South American experience with 59 cases

OBJECTIVE: In this study, we have gathered the second largest series yet published on laparoscopic radical cystectomy in order to evaluate the incidence and cause of intra and postoperative complication, conversion to open surgery, and patient mortality. MATERIALS AND METHODS: From 1997 to 2005, 59 laparoscopic radical cystectomies were performed for the management of bladder cancer at 3 institutions in South America. Twenty nine patients received continent urinary diversion, including 25 orthotopic ileal neobladders and 4 Indiana pouches. Only one case of continent urinary diversion was performed completely intracorporeally. RESULTS: Mean operative time was 337 minutes (150-600). Estimated intraoperative blood loss was 488 mL (50-1500) and 12 patients (20 percent) required blood transfusion. All 7 (12 percent) intraoperative complications were vascular in nature, that is, 1 epigastric vessel injury, 2 injuries to the iliac vessels (1 artery and 1 vein), and 4 bleedings that occurred during the bladder pedicles control. Eighteen (30 percent) postoperative complications (not counting mortalities) occurred, including 3 urinary tract infections, 1 pneumonia, 1 wound infection, 5 ileus, 2 persistent chylous drainage, 3 urinary fistulas, and 3 (5 percent) postoperative complications that required surgical intervention (2 hernias - one in the port site and one in the extraction incision, and 1 bowel obstruction). One case (1.7 percent) was electively converted to open surgery due to a larger tumor that precluded proper posterior dissection. Two mortalities (3.3 percent) occurred in this series, one early mortality due to uncontrolled upper gastrointestinal bleeding and one late mortality following massive pulmonary embolism. CONCLUSIONS: Laparoscopic radical cystectomy is a safe operation with morbidity and mortality rates comparable to the open surgery.

Use of titanium knot placement device (TK-5) to secure dorsal vein complex during laparoscopic radical prostatectomy and cystoprostatectomy.

INTRODUCTION: We evaluated the feasibility and describe the surgical technique of using the Ti-Knot device TK-5 to secure the dorsal vein complex (DVC) during 20 consecutive cases of laparoscopic radical prostatectomy and cystoprostatectomy. TECHNICAL CONSIDERATIONS: Bloodless DVC ligation and transection was successfully achieved in 19 (95.03%) of 20 cases. In only 1 case, venous bleeding occurred after DVC transection. However, in this case, the two stitches used to ligate the DVC were tightly tied, and the bleeding probably occurred because the stitches were passed too superficially on the DVC. In another case, a third stitch had to be placed and tied with the aid of the Ti-Knot device because the second 2-0 Vicryl stitch placed at the DVC broke. In only 1 case did we experience some degree of trouble with the knotting process because one of the ends of the Vicryl suture slipped back into the abdominal cavity. The time to tie each suture with the Ti-Knot device, defined after the moment the needle was passed underneath the DVC to the moment the titanium knot was crimped and the Vicryl suture trimmed, was less than 1 minute (median 50 seconds, range 45 to 56) in all cases, except the case described above. No cases of the Ti-Knot device misfiring or malfunction occurred in this series. CONCLUSIONS: In our experience, the Ti-Knot titanium knot placement device proved to be safe and efficient during laparoscopic ligation and control of the DVC.

Laparoscopic radical cystectomy with intracorporeally constructed Y-shaped orthotopic ileal neobladder using nonabsorbable titanium staples exclusively.

Increasing evidence in published reports has suggested that titanium staples may be well tolerated inside the urinary tract. Recently, the Italian Group from Piedmont described an "easy, fast, and reliable" technique of a Y-shaped ileal neobladder that was created during open surgery with nonabsorbable mechanical staples. They observed an acceptable 6% rate of stone formation at a median follow-up of 20 months (range 8 to 47). We describe our initial experience with laparoscopic Y-shaped orthotopic ileal neobladder constructed entirely intracorporeally using titanium staples exclusively in an attempt to mitigate the time-consuming and skill-intensive task of freehand suturing required during laparoscopic creation of continent reservoirs.

Laparoscopic assisted radical cystoprostatectomy with Y-shaped orthotopic ileal neobladder constructed with non-absorbable titanium staples through a 5 cm Pfannensteil incision.

INTRODUCTION: We performed a laparoscopic radical cystoprostatectomy followed by constructing a Y-shaped reservoir extra-corporeally with titanium staples through a 5-cm muscle-splitting Pfannenstiel incision. SURGICAL TECHNIQUE: Upon completion of the extirpative part of the operation, the surgical specimen was entrapped and removed intact through a 5-cm Pfannenstiel incision. Through the extraction incision, the distal ileum was identified and a 40 cm segment isolated. With the aid of the laparoscope, the ureters were brought outside the abdominal cavity and freshened and spatulated for approximately 1.5-cm. Bilateral double J ureteral stents were then inserted up to the renal pelvis and the ureters were directly anastomosed to the open ends of the limbs of the neobladder. Following this, the isolated intestinal segment was arranged in a Y shape with two central segments of 14 cm and two limbs of 6 cm. The two central segments were brought together and detubularized, with two sequential firings of 80 x 3.5 mm and 60 x 3.5 mm non-absorbable mechanical stapler (Multifire GIA--US Surgical) inserted through an opening made at the lowest point of the neobladder on its anti-mesenteric border. The neobladder was reinserted inside the abdominal cavity and anastomosed to the urethra with intracorporeal laparoscopic free-hand suturing. CONCLUSION: Although this procedure is feasible and the preliminary results encouraging, continued surveillance is necessary to determine the lithiasis-inducing potential of these titanium staples within the urinary tract.

Laparoscopic assisted radical cystoprostatectomy with Y-shaped orthotopic ileal neobladder constructed with non-absorbable titanium staples through a 5 cm Pfannensteil incision

INTRODUCTION: We performed a laparoscopic radical cystoprostatectomy followed by constructing a Y-shaped reservoir extra-corporeally with titanium staples through a 5-cm muscle-splitting Pfannenstiel incision. SURGICAL TECHNIQUE: Upon completion of the extirpative part of the operation, the surgical specimen was entrapped and removed intact through a 5-cm Pfannenstiel incision. Through the extraction incision, the distal ileum was identified and a 40 cm segment isolated. With the aid of the laparoscope, the ureters were brought outside the abdominal cavity and freshened and spatulated for approximately 1.5-cm. Bilateral double J ureteral stents were then inserted up to the renal pelvis and the ureters were directly anastomosed to the open ends of the limbs of the neobladder. Following this, the isolated intestinal segment was arranged in a Y shape with two central segments of 14 cm and two limbs of 6 cm. The two central segments were brought together and detubularized, with two sequential firings of 80 x 3.5 mm and 60 x 3.5 mm non-absorbable mechanical stapler (Multifire GIA - US Surgical) inserted through an opening made at the lowest point of the neobladder on its anti-mesenteric border. The neobladder was reinserted inside the abdominal cavity and anastomosed to the urethra with intracorporeal laparoscopic free-hand suturing. CONCLUSION: Although this procedure is feasible and the preliminary results encouraging, continued surveillance is necessary to determine the lithiasis-inducing potential of these titanium staples within the urinary tract.

Stapleless laparoscopic assisted radical cystectomy with ileal neobladder in a male and with ileal loop in a female: initial report from Brazil.

INTRODUCTION: Here, we report our initial experience with laparoscopic assisted radical cystectomy without the use of surgical staples. CASES REPORT: A 70 year old male and a 55 year old female were diagnosed to have T2G3 transitional cell carcinoma of the bladder with negative metastatic work-out. Both patients were scheduled and agreed to a laparoscopic assisted radical cystectomy. In both cases, urinary diversion (orthotopic ileal Studer neobladder in the male and ileal conduit in the female) was performed extracorporeally following radical cystectomy. In both cases control of the bladder vascular pedicle was accomplished with a combination of metallic and hem-o-lock clips. The total surgical time was 6.5 hours in both cases. Estimated intra-operative blood loss was 500 cc and 350 cc respectively, however both patients required postoperative blood transfusions. No intraoperative complications occurred. In both cases, pathology revealed negative surgical margins. CONCLUSIONS: Extracorporeal creation of urinary diversion decrease the overall operative time. Laparoscopic pelvic lymphadenectomy can be performed following the extended template. The use of surgical clips instead of vascular Endo-GIA titanium staples to control the bladder vascular pedicles is feasible and safe in selected patients, thus reducing intraoperative surgical costs. Considerable experience with laparoscopic radical prostatectomy is necessary before one attempts laparoscopic radical cystectomy.

Stapleless laparoscopic assisted radical cystectomy with ileal neobladder in a male and with ileal loop in a female: initial report from Brazil

INTRODUCTION: Here, we report our initial experience with laparoscopic assisted radical cystectomy without the use of surgical staples. CASES REPORT: A 70 year old male and a 55 year old female were diagnosed to have T2G3 transitional cell carcinoma of the bladder with negative metastatic work-out. both patients were scheduled and agreed to a laparoscopic assisted radical cystectomy. In both cases, urinary diversion (orthotopic ileal Studer neobladder in the male and ileal conduit in the female) was performed extracorporeally following radical cystectomy. In both cases control of the bladder vascular pediclewas accomplished with a combination of metallic and hem-o-lock clips. The total surgical time was 6.5 hours in both cases. Estimated intra-operative blood loss was 500 cc and 350 cc respectively, however both patients required postoperative blood transfusions. No intraoperative complications occurred. In both cases, pathology revealed negative surgical margins. CONCLUSIONS: Extracorporeal creation of urinary diversion decrease the overall operative time. Laparoscopic pelvic lymphadenectomy can be performed following the extended template. The use of surgical clips instead of vascular Endo-GIA titanium staples to control the bladder vascular pedicles is feasible and safe in selected patients, thus reducing intraoperative surgical costs. Considerable experience with laparoscopic radical prostatectomy is necessary before one attempts laparoscopic radical cystectomy.

Avaliaçäo multicêntrica da eficácia e tolerabilidade do extrato lipidoesterólico de Serenoa repens em pacientes com hiperplasia prostática benigna sintomática / Efficacy and tolerability of the extract of Serenoa repens in a multicentric study in patients with symptomatic Benign Prostatic Hyperplasia

Objetivo: investigar a eficácia e a tolerabilidade do extrato lipoesterólico de Serenoa repens (LSESr) no tratamento da Hiperplasia Prostática Benigna (HPB). Métodos: estudo multicêntrico prospectivo, aberto, näo-controlado, realizado em 17 clínicas urológicas. Estudados 142 pacientes ambulatoriais com idade acima dos 50 anos e HPB sintomática, Pontuaçäo Internacional de Sintomas Prostáticos (I-PSS) maior ou igual a 8 na escala da OMS e taxa máxima de fluxo urinário menor ou igual a 12 ml/s para um volume urinário maior ou igual a 150 ml. Os pacientes receberam uma capsula de 160 mg do extrato lipidoesterólico de Serenoa repens duas vezes ao dia durante três meses. Avaliados I_PSS, índice de qualidade de vida (QV), urofluxometria e dosagem do antígeno prostático específico (PSA) sérico no início e ao término do estudo. Os efeitos colaterais foram registrados sistematicamente. A análise estatística foi realizada, utilizando-se um teste "t" pareado para avaliar a evoluçäo do I-PSS e da urofluxometria em D90 comparado ao D0. Obsevadas alteraçöes significativas nos parâmetros, nenhuma reaçäo adversa séria foi observada, outras reaçöes adversas leves e passageiras foram registradas em 10,56 porcento dos casos, principalmente gastrointestinais. Somente um paciente abandonou o tratamento devido à reaçäo adversa gastrointestinal. Näo houve diferença estatísticamente significante entre a média basal e final dos valores do PSA. Neste estudo o extrato lipidoesterólico da Serenoa repens demonstrou ser uma terapia medicamentosa da HPB com boa eficácia na sintomatologia e nas aferiçöes objetivas, além de ter sido muito bem tolerado pela grande maioria dos pacientes.(au)