Fernando J. Bianco

Posterior Rhabdosphincter Reconstruction During Robotic Assisted Radical Prostatectomy: Results From a Phase II Randomized Clinical Trial

PURPOSE Posterior rhabdosphincter reconstruction following radical prostatectomy was designed to improve early urinary continence. We executed a randomized clinical trial to test this conjecture in men undergoing robotic radical prostatectomy. MATERIALS AND METHODS We conducted a phase II randomized clinical trial intended to detect a 25% difference in 3-month continence outcomes defined by a patient response of 0 or 1 to question 5 of the Expanded Prostate Cancer Index Composite questionnaire urinary domain, comparing standard running vesicourethral anastomosis (controls) to posterior rhabdosphincter reconstruction followed by standard running vesicourethral anastomosis (posterior rhabdosphincter reconstruction treated). Patients had clinically localized prostate cancer and were blinded. Surgeons were notified of computer randomization after prostate excision. Further continence outcomes were assessed by analysis of Expanded Prostate Cancer Index Composite questionnaire questions 1 and 12, International Prostate Symptom Score and 24-hour pad weights. Statistical significance was defined as p <0.05 RESULTS A total of 94 patients were randomized, 47 to each arm. Preoperative clinical and functional variables were equivalent between study arms. There were no complications associated with either anastomotic technique. Of the 87 evaluable patients 62 (71.3%) met our 3-month continence definition. The null hypothesis was not rejected as 33 (81%) controls and 29 (63%) posterior rhabdosphincter reconstruction treated patients were continent at 3 months (chi-square p = 0.07, Fisher exact p = 0.1). Likewise there was no significant difference between arms in 24-hour pad weights (p = 0.14), International Prostate Symptom Score (p = 0.4), absence of daily leaks (p = 0.4) or perception of urinary function (p = 0.4). CONCLUSIONS In this randomized clinical trial posterior rhabdosphincter reconstruction offered no advantage for return of early continence after robotic assisted radical prostatectomy.

Comparison of models to predict clinical failure after radical prostatectomy

Models are available to accurately predict biochemical disease recurrence (BCR) after radical prostatectomy (RP). Because not all patients experiencing BCR will progress to metastatic disease, it is appealing to determine postoperatively which patients are likely to manifest systemic disease.

Prospective intermediate follow-up of carcinoma in situ involving the distal ureter at cystectomy: is there a role for ureteroscopy?

BACKGROUND AND PURPOSE The presence of urothelial carcinoma in situ (CIS) at the distal ureteral margin has been identified as a risk factor for upper tract recurrence after radical cystectomy. Management of this finding is controversial. The objective of this study was to determine if follow-up with ureteroscopy could aid in early detection of recurrences in these patients. PATIENTS AND METHODS We collected prospective clinical-pathologic data for all patients who underwent radical cystectomy between 1999 and 2004. Patients with CIS at the distal ureteral margin were followed with endoscopy of the urinary diversion and bilateral ureteroscopy in addition to standard imaging and cytologic evaluation every 6 months. Recurrence was defined as detection of any malignant urothelial cells. RESULTS In 250 consecutive cystectomies, eight patients were identified with CIS that involved a ureteral margin of 12 renal units. Ureteroscopy was successful in all cases, and there were no complications. Imaging was diagnostic in one patient, all cytologic examinations from the diversion were nondiagnostic, and ureteroscopy was positive in all recurrences. Six patients had recurrences at a median follow-up of 52.7 months; five needed laparoscopic nephroureterectomy, and one had disease controlled with percutaneous mitomycin C. Five patients were disease free at last follow-up, and one patient died with brain metastasis at 30 months. CONCLUSIONS Patients with CIS that involves the ureteral margin are at increased risk for upper tract recurrence and progression. Aggressive follow-up with scheduled ureteroscopy may identify recurrences at an earlier stage. Development of additional markers for risk stratification and protocols for adjuvant treatment are needed.