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ROBOTIC REPAIR OF RECTOVESICAL FISTULA SECONDARY TO OPEN RADICAL PROSTATECTOMY
THE JOURNAL OF UROLOGY®
Vol. 181, No. 4, Supplement, Tuesday, April 28, 2009
favorability. Briefly, the ureters are dissected, separated from the bladder plate and reimplanted in a cephalad orientation. Subsequently, the bladder neck is tailored to achieve a funneled configuration, similar to normal anatomy. Thus far we have performed this procedure in 13 consecutive patients. RESULTS: CPRE-BUR has been performed in 9 boys and 4 girls with classic bladder exstrophy and a favorable bladder plate. With a mean follow-up of 21 months (6-42) no complications associated with the ureteral reimplantation have been detected and no VUR has been observed on postoperative voiding cystogram. Mild hydronephrosis presented in 1 patient but resolved spontaneously. CONCLUSIONS: CPRE-BUR can be easily and safely performed during primary bladder closure of newborns with bladder extrophy. This maneuver may prevent renal damage by early correction of VUR and decrease febrile UTI. Source of Funding: None
V1553 ROBOTIC REPAIR OF RECTOVESICAL FISTULA SECONDARY TO OPEN RADICAL PROSTATECTOMY Rene J Sotelo*, Robert J De Andrade, Oswaldo J Carmona, Juan C Astigueta, Rinci Dubois, Andres Hansen, Otto Moreira, Calkins Herrera, Rafael Clavijo, Caracas, Venezuela; David Canes, Burlington, MA INTRODUCTION AND OBJECTIVES: Rectovesical fistula is a rare entity that can develop after trauma, radiation, congenital diseases, inflammatory bowel disease, and open radical prostatectomy. Herein we present our experience with robotic assisted fistula repair. METHODS: Three patients were treated. The etiology of rectovesical fistula developed was open radical prostatectomy in all patients. The robotic procedure was preoperative following failed open repair in two patients, and primary in the third. All patients had previously undergone fecal diversion. The operative steps were as follows: (1) cystoscopy, (2) RVF catheterization (3) five-port transperitoneal laparoscopic mobilization of omental pedicle flap, (4) cystotomy extending towards to the fistula tract, (5) robot docking (6) dissection of the rectovesical plane, (7) interrupted rectal closure, (8) omental interposition, (9) bladder closure, (10) suprapubic tube placement (11) drain placement. RESULTS: Mean operative time was 153 minutes (range 120180). No intraoperative or postoperative complications occurred. All patients remain free of fistula recurrence by cystographic studies at mean followup of ranging from 2 weeks to 10 months. Bowel continuity has been restored in 2 patients and is planned in 1. CONCLUSIONS: While we await longer followup and experience in larger series, robotic repair of rectovesical fistula appears feasible and represents an attractive alternative to open or laparoscopic approaches. Source of Funding: None
555
Late Breaking Science Forum Tuesday, April 28, 2009
1:00 pm - 2:30 pm
LBA1 FURTHER ANALYSES FROM THE REDUCE PROSTATE CANCER RISK REDUCTION TRIAL Gerald Andriole*, St. Louis, MO; David Bostwick, Richmond, VA; Otis Brawley, Atlanta, GA; Leonard Gomella, Philadelphia, PA; Michael Marberger, Vienna, Austria; Francesco Montorsi, Milan, Italy; Curtis Pettaway, Houston, TX; Teuvo Tammela, Tampere, Finland; Claudio Teloken, Porto Alegre, Brazil; Donald Tindall, Rochester, MN; Matthew Somerville, Ivy Fowler, Roger Rittmaster, Research Triangle Park, NC INTRODUCTION AND OBJECTIVES: The REDUCE study was initiated to examine the hypothesis that, in men at elevated risk of developing prostate cancer, dual 5A-reductase inhibition with dutasteride will alter the natural history of the disease, delaying the formation of new tumors or slowing the rate of progression of clinically undetectable cancers, resulting in a reduced rate of detection on biopsy. METHODS: REDUCE was a 4-year, international, multicenter, randomized, double-blind, placebo-controlled, parallel-group study evaluating the efficacy and safety of oral, once-daily dutasteride 0.5 mg in men at increased risk of developing prostate cancer. Eligible subjects were men aged 50-75 years, with a PSA 2.5-10 ng/ml (men aged 50-60 years) or 3.0-10 ng/ml (>60 years) at the initial screening visit, and who had a single, negative prostate biopsy (6-12 cores) within 6 months prior to enrollment. Principal exclusion criteria were more than one prior negative prostate biopsy, a previous diagnosis of prostate cancer, or evidence of high-grade prostatic intraepithelial neoplasia (HG-PIN) or atypical small acinar proliferation (ASAP) on the pre-entry prostate biopsy. After screening, eligible subjects completed a 4-week placebo run-in period and were then randomized to either dutasteride or matched placebo. There were scheduled assessments (including PSA measurements) every 6 months post-randomization. Subjects underwent a 10-core transrectal ultrasound (TRUS)-guided biopsy at 2 and 4 years; biopsies could however be performed at any time if clinically indicated. Those biopsies conducted between months 19-24 and 43-48 were considered “protocol-mandated”; those conducted between months 1-18 and 25-42 were considered “protocol-independent”. RESULTS: Data will be presented for the primary study endpoint: biopsy-detectable prostate cancer after 4 years of treatment in the efficacy population (all randomized subjects with a negative entry prostate biopsy as determined by the central pathology laboratory and who received q1 dose of study treatment). The distribution of Gleason scores for subjects diagnosed with prostate cancer, as well as the occurrence of adverse events in the safety population (all subjects randomized to study drug), will also be reported. CONCLUSIONS: The results of the REDUCE study will help to determine the value of dual 5A-reductase inhibition with dutasteride in reducing the risk of biopsy-detectable prostate cancer in men at elevated risk of developing the disease. Source of Funding: GlaxoSmithKline
LBA2 A PHASE 2 STUDY - TENGION AUTOLOGOUS NEO-BLADDER AUGMENT™ (NBA) FOR AUGMENTATION CYSTOPLASTY IN SUBJECTS WITH NEUROGENIC BLADDER SECONDARY TO SPINA BIFIDA David Joseph*, Birmingham, AL; Joseph Borer, Boston, MA; Roger De Filippo, Los Angeles, CA; Gordon McLorie, Salem, NC; Lisa Goldberg, Michael Tillinger, Elyse Seltzer, East Norriton, PA INTRODUCTION AND OBJECTIVES: The ability to use an autologous cell-seeded biodegradable scaffold for bladder augmentation was demonstrated in patients with neurogenic bladder (NB) due to spina bifida (SB) at Children’s Hospital Boston (CHB) [1]. We conducted a confirmatory prospective multicenter Phase 2 study of the Tengion NBA
Vol. 181, No. 4, Supplement, Tuesday, April 28, 2009
favorability. Briefly, the ureters are dissected, separated from the bladder plate and reimplanted in a cephalad orientation. Subsequently, the bladder neck is tailored to achieve a funneled configuration, similar to normal anatomy. Thus far we have performed this procedure in 13 consecutive patients. RESULTS: CPRE-BUR has been performed in 9 boys and 4 girls with classic bladder exstrophy and a favorable bladder plate. With a mean follow-up of 21 months (6-42) no complications associated with the ureteral reimplantation have been detected and no VUR has been observed on postoperative voiding cystogram. Mild hydronephrosis presented in 1 patient but resolved spontaneously. CONCLUSIONS: CPRE-BUR can be easily and safely performed during primary bladder closure of newborns with bladder extrophy. This maneuver may prevent renal damage by early correction of VUR and decrease febrile UTI. Source of Funding: None
V1553 ROBOTIC REPAIR OF RECTOVESICAL FISTULA SECONDARY TO OPEN RADICAL PROSTATECTOMY Rene J Sotelo*, Robert J De Andrade, Oswaldo J Carmona, Juan C Astigueta, Rinci Dubois, Andres Hansen, Otto Moreira, Calkins Herrera, Rafael Clavijo, Caracas, Venezuela; David Canes, Burlington, MA INTRODUCTION AND OBJECTIVES: Rectovesical fistula is a rare entity that can develop after trauma, radiation, congenital diseases, inflammatory bowel disease, and open radical prostatectomy. Herein we present our experience with robotic assisted fistula repair. METHODS: Three patients were treated. The etiology of rectovesical fistula developed was open radical prostatectomy in all patients. The robotic procedure was preoperative following failed open repair in two patients, and primary in the third. All patients had previously undergone fecal diversion. The operative steps were as follows: (1) cystoscopy, (2) RVF catheterization (3) five-port transperitoneal laparoscopic mobilization of omental pedicle flap, (4) cystotomy extending towards to the fistula tract, (5) robot docking (6) dissection of the rectovesical plane, (7) interrupted rectal closure, (8) omental interposition, (9) bladder closure, (10) suprapubic tube placement (11) drain placement. RESULTS: Mean operative time was 153 minutes (range 120180). No intraoperative or postoperative complications occurred. All patients remain free of fistula recurrence by cystographic studies at mean followup of ranging from 2 weeks to 10 months. Bowel continuity has been restored in 2 patients and is planned in 1. CONCLUSIONS: While we await longer followup and experience in larger series, robotic repair of rectovesical fistula appears feasible and represents an attractive alternative to open or laparoscopic approaches. Source of Funding: None
555
Late Breaking Science Forum Tuesday, April 28, 2009
1:00 pm - 2:30 pm
LBA1 FURTHER ANALYSES FROM THE REDUCE PROSTATE CANCER RISK REDUCTION TRIAL Gerald Andriole*, St. Louis, MO; David Bostwick, Richmond, VA; Otis Brawley, Atlanta, GA; Leonard Gomella, Philadelphia, PA; Michael Marberger, Vienna, Austria; Francesco Montorsi, Milan, Italy; Curtis Pettaway, Houston, TX; Teuvo Tammela, Tampere, Finland; Claudio Teloken, Porto Alegre, Brazil; Donald Tindall, Rochester, MN; Matthew Somerville, Ivy Fowler, Roger Rittmaster, Research Triangle Park, NC INTRODUCTION AND OBJECTIVES: The REDUCE study was initiated to examine the hypothesis that, in men at elevated risk of developing prostate cancer, dual 5A-reductase inhibition with dutasteride will alter the natural history of the disease, delaying the formation of new tumors or slowing the rate of progression of clinically undetectable cancers, resulting in a reduced rate of detection on biopsy. METHODS: REDUCE was a 4-year, international, multicenter, randomized, double-blind, placebo-controlled, parallel-group study evaluating the efficacy and safety of oral, once-daily dutasteride 0.5 mg in men at increased risk of developing prostate cancer. Eligible subjects were men aged 50-75 years, with a PSA 2.5-10 ng/ml (men aged 50-60 years) or 3.0-10 ng/ml (>60 years) at the initial screening visit, and who had a single, negative prostate biopsy (6-12 cores) within 6 months prior to enrollment. Principal exclusion criteria were more than one prior negative prostate biopsy, a previous diagnosis of prostate cancer, or evidence of high-grade prostatic intraepithelial neoplasia (HG-PIN) or atypical small acinar proliferation (ASAP) on the pre-entry prostate biopsy. After screening, eligible subjects completed a 4-week placebo run-in period and were then randomized to either dutasteride or matched placebo. There were scheduled assessments (including PSA measurements) every 6 months post-randomization. Subjects underwent a 10-core transrectal ultrasound (TRUS)-guided biopsy at 2 and 4 years; biopsies could however be performed at any time if clinically indicated. Those biopsies conducted between months 19-24 and 43-48 were considered “protocol-mandated”; those conducted between months 1-18 and 25-42 were considered “protocol-independent”. RESULTS: Data will be presented for the primary study endpoint: biopsy-detectable prostate cancer after 4 years of treatment in the efficacy population (all randomized subjects with a negative entry prostate biopsy as determined by the central pathology laboratory and who received q1 dose of study treatment). The distribution of Gleason scores for subjects diagnosed with prostate cancer, as well as the occurrence of adverse events in the safety population (all subjects randomized to study drug), will also be reported. CONCLUSIONS: The results of the REDUCE study will help to determine the value of dual 5A-reductase inhibition with dutasteride in reducing the risk of biopsy-detectable prostate cancer in men at elevated risk of developing the disease. Source of Funding: GlaxoSmithKline
LBA2 A PHASE 2 STUDY - TENGION AUTOLOGOUS NEO-BLADDER AUGMENT™ (NBA) FOR AUGMENTATION CYSTOPLASTY IN SUBJECTS WITH NEUROGENIC BLADDER SECONDARY TO SPINA BIFIDA David Joseph*, Birmingham, AL; Joseph Borer, Boston, MA; Roger De Filippo, Los Angeles, CA; Gordon McLorie, Salem, NC; Lisa Goldberg, Michael Tillinger, Elyse Seltzer, East Norriton, PA INTRODUCTION AND OBJECTIVES: The ability to use an autologous cell-seeded biodegradable scaffold for bladder augmentation was demonstrated in patients with neurogenic bladder (NB) due to spina bifida (SB) at Children’s Hospital Boston (CHB) [1]. We conducted a confirmatory prospective multicenter Phase 2 study of the Tengion NBA