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Early and late complications of radical retropubic prostatectomy: experience in a single institution.

BACKGROUND: Radical retropubic prostatectomy is one of the first-line treatments for clinically organ-confined prostatic cancer. However, some studies have reported the morbidity of this procedure. We retrospectively assessed the incidence of complications of radical retropubic prostatectomy in our institution. METHODS: We reviewed 123 consecutive medical charts of prostate cancer patients who underwent radical retropubic prostatectomy between 1988 and 2001 at our institution. We evaluated intraoperative complications, early complications within 1 month postoperatively, and late complications, including anastomotic stricture and urinary incontinence. RESULTS: The median age of patients was 66 years (range, 53 to 74 years) and median follow-up duration was 44.0 months (range, 2 to 157 months). None of the patients died due to surgery-related causes. Intraoperative complications included rectal injuries in six patients (4.9%) and ureteral injury in one patient (0.8%). As for late complications, anastomotic strictures were observed in 16 patients (13.8%), and stress urinary incontinence that persisted for more than 12 months was observed in 13 patients. The estimated continence recovery rate at 12 months was 87.3%. Multivariate analysis did not reveal any predictive factor for anastomotic stricture. However, the blood loss volume and period of surgery were significant predictive factors of continence recovery. CONCLUSIONS: Radical retropubic prostatectomy was safely performed, though there were various intra- or postoperative complications that were adequately managed. Early recovery of continence was related to the blood loss volume and the surgery period. Adequate surgical experience and a meticulous technique to avoid excessive bleeding are important factors for an early recovery.

Aged↗

Health outcomes after prostatectomy or radiotherapy for prostate cancer: results from the Prostate Cancer Outcomes Study.

BACKGROUND: Radical prostatectomy and external beam radiotherapy are the two major therapeutic options for treating clinically localized prostate cancer. Because survival is often favorable regardless of therapy, treatment decisions may depend on other therapy-specific health outcomes. In this study, we compared the effects of two treatments on urinary, bowel, and sexual functions and on general health-related quality-of-life outcomes over a 2-year period following initial treatment. METHODS: A diverse cohort of patients aged 55-74 years who were newly diagnosed with clinically localized prostate cancer and received either radical prostatectomy (n = 1156) or external beam radiotherapy (n = 435) were included in this study. A propensity score was used to balance the two treatment groups because they differed in some baseline characteristics. This score was used in multivariable cross-sectional and longitudinal regression analyses comparing the treatment groups. All statistical tests were two-sided. RESULTS: Almost 2 years after treatment, men receiving radical prostatectomy were more likely than men receiving radiotherapy to be incontinent (9.6% versus 3.5%; P:<.001) and to have higher rates of impotence (79.6% versus 61.5%; P:<.001), although large, statistically significant declines in sexual function were observed in both treatment groups. In contrast, men receiving radiotherapy reported greater declines in bowel function than did men receiving radical prostatectomy. All of these differences remained after adjustments for propensity score. The treatment groups were similar in terms of general health-related quality of life. CONCLUSIONS: There are important differences in urinary, bowel, and sexual functions over 2 years after different treatments for clinically localized prostate cancer. In contrast to previous reports, these outcome differences reflect treatment delivered to a heterogeneous group of patients in diverse health care settings. These results provide comprehensive and representative information about long-term treatment complications to help guide and inform patients and clinicians about prostate cancer treatment decisions.

Aged↗

Gleason grading of prostatic needle biopsies. Correlation with grade in 316 matched prostatectomies.

The automated spring-loaded 18-gauge gun recently introduced for prostatic needle biopsy provides less than half the tissue of the traditional 14-gauge biopsy, possibly influencing the accuracy and predictive ability of biopsy tumor grade. In order to determine the value of tumor grade in contemporary needle biopsy specimens, we compared grade in 316 biopsies with matched whole-mounted radical retropubic prostatectomy specimens according to Gleason primary pattern, Gleason secondary pattern, Gleason score, percent of Gleason patterns 4 and 5, and nuclear grade. Biopsy grading accuracy was correlated with rates of capsular perforation, seminal vesicle invasion, pelvic lymph node metastasis, serum prostate specific antigen level, prostatic volume, prostatic weight, cancer volume, perineural invasion, DNA ploidy, and pathologic stage. The greatest grading error was encountered with low-grade tumors; there was no correlation of grading error with clinical staging error or other pathologic factors. Significant differences were noted between biopsy and prostatectomy for Gleason primary pattern, secondary pattern, and score. The percent of poorly differentiated carcinoma (Gleason patterns 4 and 5) in biopsies and prostatectomies showed a moderate positive correlation. The results indicate that the accuracy of 18-gauge needle biopsy in predicting tumor grade in the prostatectomy is similar to that reported with 14-gauge biopsies. Based on these findings, we recommend that the Gleason score (sum of primary and secondary patterns) be employed in all needle biopsies, recognizing that the accuracy of grade is decreased in cases with low-grade cancer and small amounts of cancer.

Adenocarcinoma↗

Clinical and cost impact of second-opinion pathology. Review of prostate biopsies prior to radical prostatectomy.

Despite numerous studies evaluating second-opinion surgical programs, we are unaware of work evaluating the cost effectiveness of a second opinion for pathology prior to surgery. One of six pathologists reviewed the pathology of the outside needle biopsies of 535 consecutive men referred to Johns Hopkins Hospital for radical prostatectomy over a 12-month period (from October 1993 until October 1994) before the men underwent surgery. Of the 535 needle biopsies initially diagnosed on the outside as adenocarcinoma of the prostate, seven (1.3%) were reclassified as benign upon pathology review at Johns Hopkins Hospital. The most common lesion misinterpreted as adenocarcinoma was adenosis or less pronounced examples of adenosis consisting of foci of crowded glands (five cases). Foci of atrophy in the remaining two cases were misdiagnosed as adenocarcinoma of the prostate. Upon subsequent clinical work up, six of seven men were considered not to have adenocarcinoma, and their surgery was cancelled. The cost for reviewing all 535 preoperative needle biopsies was $44,883, which included the cost of immunohistochemical studies for high-molecular-weight cytokeratin and repeat biopsies and ultrasounds in men whose diagnoses were reversed. The total cost of the radical prostatectomies had the six men undergone surgery was estimated at $85,686, including hospitalization, anesthesia, radical prostatectomy pathology, and surgery. This cost savings did not include other costs resulting from lost wages, morbidity, or potential litigation. Second-opinion pathological evaluation of prostate biopsy before radical prostatectomy is cost effective and has a major impact on clinical treatment for a subset of patients.

Adenocarcinoma↗

Prevalence and distribution of prostatic intraepithelial neoplasia in salvage radical prostatectomy specimens after radiation therapy.

High-grade prostatic intraepithelial neoplasia (PIN) is the most likely precursor of prostate cancer. The effect of radiation therapy (RT) on the prevalence of PIN is uncertain. We studied 86 patients who underwent salvage radical prostatectomy after irradiation failure at the Mayo Clinic. The prevalence, volume, multicentricity, spatial proximity to cancer, and architectural patterns of PIN were evaluated. High-grade PIN was identified in 53 (62%) of 86 prostatectomy specimens. Multiple architectural patterns were usually observed, including tufting in 87%, micropapillary in 66%, cribriform in 38%, and flat in 17%. The mean volume of PIN was 0.12 cm3 (range, 0.05-1.20 cm3). PIN was usually multicentric (70%), with a mean number of PIN foci of 2.5 (range, 1-10). Ninety-four percent of PIN foci were located within 2 mm of invasive cancer. There was no correlation between PIN and pathologic stage, surgical margin, tumor size, DNA ploidy, post-RT Gleason score, time interval from RT to biopsy-proven recurrence, postoperative prostate-specific antigen level, distant metastasis-free survival, or cancer-specific survival. Our examination of salvage radical prostatectomy specimens indicated that the prevalence and extent of PIN appeared to be reduced after RT compared to published studies of prostatectomies without prior RT.

Aged↗

Salvage radical prostatectomy: outcome measured by serum prostate specific antigen levels.

We reviewed our experience with salvage radical prostatectomy for locally recurrent cancer in 40 patients to assess the current complication rate and the results using prostate specific antigen (PSA) as an indicator of treatment outcome and to identify better criteria for the selection of appropriate candidates for this operation. Most recurrent cancers were detected by digital rectal examination (26 patients) or increasing serum PSA levels (10). The operation was technically challenging, with 6 rectal injuries (15%), 2 requiring temporary colostomy. Serious technical complications were more common (31%) among the 29 patients who underwent pelvic lymphadenectomy at the time of initial radiotherapy than among the 11 treated with external irradiation alone (9%). Urinary incontinence persisted in 18 of 31 evaluable patients (58%) and was successfully corrected with an artificial urinary sphincter in 9. A total of 21 patients (54%) had pathologically advanced disease (seminal vesicle invasion and/or lymph node metastases). Preoperative PSA levels but not clinical stage or biopsy grade correlated with pathological stage (p < 0.03). If the PSA was less than 10 ng./ml. only 15% of the patients had an advanced pathological stage, compared to 86% if the PSA was 10 or more. After 2 to 97 months (mean 39) 2 patients died of metastatic prostatic cancer, 5 had distant metastases and none had symptomatic local recurrence. At 5 years the actuarial nonprogression rate measured by PSA was 55 +/- 20%. The only pretreatment factor predictive of progression was the serum PSA level. If the PSA was less than 10 ng./ml. the actuarial rate of progression was significantly lower than if the PSA was greater than 10 (p < 0.05). The best results were in the subset of 18 patients with cancer confined to the prostate or immediate periprostatic tissue: 82% had no progression at 5 years. Within each of these pathological stages the results of salvage prostatectomy were similar to those for standard radical prostatectomy in patients with no prior irradiation. Although technically challenging, salvage prostatectomy provides excellent control of radio-recurrent cancer confined to the prostate or immediate periprostatic tissue and is best performed before the preoperative PSA level increases to greater than 10 to 20 ng./ml.

Aged↗

Prostate cancer detection in candidates for open prostatectomy.

PURPOSE: We determine the incidence of biopsy detectable prostate cancer in men with clinical benign prostatic hyperplasia (BPH) and prostate specific antigen (PSA) elevation who are candidates for open prostatectomy, and the histology of prostatic tissue of men who underwent surgery. MATERIALS AND METHODS: Sextant peripheral zone prostate biopsies were performed in 128 consecutive men with obstructive voiding symptoms who had digital rectal examination not suspicious for cancer, PSA greater than 4.0 ng./ml. and prostate volume 75 ml. or greater. Of the patients 59 also underwent transition zone biopsy. Median PSA was 9.9 ng./ml. (range 4.1 to 80.0), median prostate volume was 92 ml. (range 75 to 220), median PSA density was 0.10 ng./ml./ml. (range 0.03 to 0.80) and median percent free PSA in 43 patients was 23.6 (range 8.8 to 41.3). RESULTS: Of the 128 patients 16 (13%) had malignant biopsy including 1 who had cancer detected with transition zone biopsy only. Gleason score of tumors ranged from 4 to 8 (median 5). Of 57 patients who underwent prostatectomy 6 (11%) had stage T1a and 2 (4%) had stage T1b cancer. Among men without an indwelling urethral catheter due to acute urinary retention mean PSA, PSA density and percent free PSA were not significantly different in those with benign and malignant biopsies and/or prostatectomy specimens. CONCLUSIONS: Greater than 10% of men with PSA elevation who are potential candidates for open prostatectomy will have biopsy detectable prostate cancer. This diagnostic yield, while lower than that reported for unselect men with normal digital rectal examination and PSA elevation, may justify preoperative peripheral zone biopsy to avoid surgical misadventure during open enucleation. Among patients with benign peripheral zone biopsy there is a less than 5% prevalence of large volume tumors that may complicate open enucleation.

Aged↗

Radical prostatectomy: the value of preoperative, individually labeled apical biopsies.

PURPOSE: Involvement of the prostatic apex with adenocarcinoma is a relatively common finding, as is a positive surgical margin at this location. We evaluated whether a positive apical core biopsy provides preoperative information that may be used as a basis for the subsequent surgical approach in individuals. MATERIALS AND METHODS: We evaluated apical prostate cancer in 240 individually labeled, preoperative apical core biopsies and the corresponding prostatectomy specimen in 120 patients who underwent radical prostatectomy for clinically localized prostate cancer. Sensitivity, specificity, and positive and negative predictive values were calculated for the ability of an individual apical core to predict the side of tumor in the surgical specimen using 2 x 2 contingency tables. Moreover, univariate subset analysis was done for positive biopsies to assess the ability of histopathological characteristics, including Gleason score, cancer length, percent of cancer in the core and distance of cancer from the inked rectal core end, to predict a positive surgical margin at the apex. RESULTS: The positive predictive value of a single positive apical core for identifying tumor location correctly in the prostatectomy specimen was 71.1%, while absent cancer in the apical biopsy had a negative predictive value of 75.5%. Sensitivity was 44.5% for a positive biopsy core. In this context the predictive value of an individual positive apical core biopsy was only 28.8% for predicting surgical margin positivity at the apex. CONCLUSIONS: Cancer and its histopathological characteristics in an individual core biopsy failed to predict apical tumor involvement as well as a positive apical margin at subsequent radical prostatectomy.

Adenocarcinoma↗

Perineural invasion as a predictor of biochemical outcome following radical prostatectomy for select men with clinically localized prostate cancer.

PURPOSE: The presence of perineural invasion on the prostate needle biopsy specimen has been suggested to be an independent predictor of prostate specific antigen (PSA) outcome following radical prostatectomy. We evaluated the clinical use of perineural invasion at biopsy for predicting time to PSA failure following radical prostatectomy after controlling for established prognostic factors. MATERIALS AND METHODS: A prospective evaluation using a Cox regression multivariate analysis of 750 men with clinically localized or PSA detected prostate cancer was performed to evaluate the ability of PSA, biopsy Gleason score, perineural invasion on the needle biopsy specimen and the percent of positive prostate biopsies to predict PSA outcome following radical prostatectomy. RESULTS: Multivariate analysis demonstrated that the presence of perineural invasion on the needle biopsy specimen provided additional information regarding 5-year PSA outcome (82% versus 95%, p = 0.04) for patients who were in the low risk group. This difference in PSA outcome could be explained by higher rates of positive surgical margins (25% versus 17%, p = 0.07). Patients whose prostate needle biopsy contained perineural invasion and who had the corresponding neurovascular bundle resected had a significantly lower positive margin rate (11% versus 100%, p = 0.001) compared to those who had the neurovascular bundle spared. The presence of perineural invasion on biopsy was not a significant predictor of PSA outcome following radical prostatectomy for patients in the intermediate or high risk group. CONCLUSIONS: Resection of the neurovascular bundle on the side corresponding to location of perineural invasion on the biopsy may decrease the positive surgical margin rate and improve outcome for low risk patients.

Adenocarcinoma↗

Analysis of apical soft tissue margins during radical retropubic prostatectomy.

PURPOSE: We determine the use of information gained with intraoperative biopsy and frozen section analysis of the apical soft tissue margin during nerve sparing radical retropubic prostatectomy. MATERIALS AND METHODS: A separate 2 to 3 mm. circumferential biopsy was obtained from the apical soft tissue margin, and was sent for frozen and permanent section analysis during radical retropubic prostatectomy in 95 men with clinically localized adenocarcinoma of the prostate. A single pathologist examined the surgical and apical soft tissue margin specimens for evidence and extent of benign or malignant prostate tissue. Urinary continence was evaluated at catheter removal and 3 months postoperatively. RESULTS: Of the patients 26% had positive surgical margins, of which 64% were positive apical margins. Permanent section of the apical soft tissue biopsy revealed no prostate in 39%, benign prostate in 54% and prostate cancer in 7% of patients. Because of the frozen section finding of adenocarcinoma in 3 patients, the apical soft tissue margin was further resected until the specimen was negative for malignancy. The apical soft tissue margin was the only positive margin site in 2 of these 3 patients. Positive surgical and apical margins, and percent tumor volumes greater than 26% on prostatectomy specimen had a significantly higher likelihood for positive apical soft tissue margins. The pathological finding of a positive apical margin on the surgical specimen had sensitivity, specificity, and positive and negative predictive values of 57%, 86%, 25% and 96%, respectively, for detecting prostate cancer on the apical soft tissue biopsy. Of the apical soft tissue biopsies 54% contained an element of benign prostatic tissue, although 92% of them contained benign tissue in less than 25% of the total specimen. Mean continence score in the men with and those without benign prostate tissue on apical soft tissue biopsy was 15.6 and 14.4, respectively (p = 0.15). The percent of men who required no protective pads for urinary continence at 3 months was 53% and 65% for those who had no prostate and those who had benign prostate tissue, respectively, in the apical soft tissue margin. CONCLUSIONS: Excising and submitting an additional 2 to 3 mm. of apical soft tissue margin for permanent section analysis after prostate removal during radical prostatectomy represent an effective method for decreasing residual prostate tissue. Attempts at maximizing urethral length when dividing the prostato-urethral junction likely increases the chance of leaving residual prostate without improving continence.

Adult↗

Adjuvant external radiation therapy following radical prostatectomy for node-negative prostate cancer.

PURPOSE OF REVIEW: The use of adjuvant radiation therapy following prostatectomy is commonplace. The purpose of this review is to summarize completed and ongoing clinical trials and to review recent relevant studies and debates related to this subject. RECENT FINDINGS: The routine use of adjuvant radiation therapy remains a controversial topic. Recent retrospective matched-pair analyses support its use in appropriately selected patients with positive margins, extraprostatic extension or seminal vesicle invasion, but interpretation of these and other data vary. Although the 5-year biochemical recurrence rate using adjuvant radiotherapy may be decreased from approximately 40 to 10% in patients with either positive margins or extraprostatic extension, its effect on cause-specific mortality is unclear. Two prospective randomized trials with cumulative enrollment of over 1400 patients have examined the role of adjuvant radiation therapy compared with observation following prostatectomy: one trial was a National Cancer Institute-sponsored Intergroup study coordinated by the Southwest Oncology Group, and the other was from the European Organization for Research and Treatment of Cancer. Currently, the Radiation Therapy Oncology Group is conducting a three-arm trial, with broadened stratification criteria as compared with previous trials. This ongoing trial examines the use of adjuvant radiotherapy with or without adjuvant androgen deprivation following prostatectomy and also androgen deprivation alone in patients at high risk for disease relapse. SUMMARY: In lieu of data from completed randomized trials, indications for immediate adjuvant radiation therapy following prostatectomy exist and are supported by retrospective data with respect to reducing local and biochemical recurrence rates. However, data demonstrating an overall or cause-specific survival advantage for adjuvant radiotherapy as compared with delayed salvage therapy do not exist.

Humans↗

Laparoscopic radical prostatectomy: functional and oncological outcomes.

PURPOSE OF REVIEW: Laparoscopic radical prostatectomy has become an accepted alternative to open surgery, however data on the functional and oncological outcome are still lacking. In this study we present an analysis based on a survey of the current literature and the first 500 patients treated with the Heilbronn technique. Additionally, we compare the results of laparoscopy with those of open radical prostatectomy. RECENT FINDINGS: We conducted an extensive MEDLINE search of laparoscopic and open radical prostatectomy from 1999 through 2003, focusing on the last 3 years. The articles as well as our own results were analyzed with respect to continence, potency, positive margins, prostatic specific antigen failure, and clinical progression. No significant differences were found between the laparoscopic and open approach with respect to overall continence at 12 months (60-94% versus 61-98%) or at 3 months (51-63% versus 62-69%), varying from 4.1% at pT2, 12% at pT3 to 19% at pT4 stages. We found no significant differences between the two techniques in the recovery of potency (34-67% versus 31-79%), if one excludes the selected series of Walsh with a mean age of 57 years. Furthermore, we did not detect any significant differences in positive margins and short-term prostatic specific antigen recurrence (3 years). SUMMARY: At centers of expertise, laparoscopic radical prostatectomy is able to provide similar functional and oncological results as its open counterpart, however with the advantages of minimally invasive surgery.

Follow-Up Studies↗

Intraoperative nerve stimulation with measurement of urethral sphincter pressure changes during radical retropubic prostatectomy: a feasibility study.

PURPOSE: We evaluated the feasibility of using intraoperative nerve stimulation and real-time urodynamic monitoring to identify the intrapelvic innervation of the urethral sphincter during radical retropubic prostatectomy. MATERIALS AND METHODS: Using an intraurethral balloon pressure transducer and nerve stimulator changes in urethral pressure were measured in response to stimulation of the neurovascular bundles, pelvic side wall, bladder neck, rectus muscle and other structures in 8 patients undergoing nerve sparing radical retropubic prostatectomy. Intraurethral pressure changes were charted on an urodynamic monitor and correlated with the anatomical location of stimulation. RESULTS: Stimulation of the neurovascular bundles resulted in measurable and significant (greater than 10 cm. H(2)O) increases in intraurethral pressure in all 8 patients. The mean pressure increase was 22 cm. H(2)O. Neither control structure, that is the bladder neck or rectus, resulted in pressure changes with stimulation. In 60% of the subjects pelvic side wall stimulation resulted in urethral pressure increases, while in 40% this stimulation caused pelvic contraction floor but no pressure increase. The mean pressure changes with side wall stimulation was 14 cm. H(2)O. CONCLUSIONS: Intraoperative stimulation of pelvic neural structures and measurement of changes in urethral pressure in response to stimulation are feasible during radical retropubic prostatectomy. Stimulating the neurovascular bundle consistently results in significant increases in urethral pressure. The finding of an intrapelvic urethral innervation supports the previously published observation that nerve sparing radical retropubic prostatectomy may result in improved continence postoperatively.

Electric Stimulation↗

Laparoscopic radical prostatectomy: decreasing the learning curve using a mentor initiated approach.

PURPOSE: Laparoscopic radical prostatectomy is being evaluated at several centers in the United States as a treatment option for localized prostate cancer. It is a technically difficult operation to perform with a steep learning curve. It has been stated that 50 procedures are necessary to satisfy the learning curve. To expedite performance and evaluation of laparoscopic radical prostatectomy a surgeon (mentor) who had performed 200 cases was invited to instruct a fellowship trained laparoscopist (trainee). MATERIALS AND METHODS: From March 2001 through September 2001 we performed 30 laparoscopic radical prostatectomies. The mentor performed the first 12 procedures with the trainee acting as assistant (group 1). The subsequent 18 procedures were performed by the trainee with the mentor acting as assistant (group 2). A final set of 20 procedures was performed by the trainee alone using 1 of 3 urological residents as the assistant (group 3). The transperitoneal approach was used and all suturing was intracorporeal. Preoperative data included prostate specific antigen, clinical stage, Gleason grade and median patient age. Intraoperative data included operative time, the blood loss/transfusion rate and intraoperative complications. Postoperative data included pathological stage, prostate specific antigen, the positive margin rate, catheter dwell time and hospital stay. When applicable, statistical significance was determined using the standard paired t test. RESULTS: There was no statistical difference in median operative time in groups 1 and 2 (248 and 258 minutes, respectively, p = 0.15). Similarly there was no difference in groups 2 (trainee and mentor assistant) and 3 (trainee alone) (p = 0.26). There was a difference in operative time in groups 1 and 3 (p = 0.04). Mean estimated blood loss was comparable in groups 1 to 3 and not statistically different (150, 250 and 250 cc, respectively, p = 0.15). Mean organ weight was also comparable (64, 59 and 55 gm., respectively). Hospital stay was 3 days in all groups. Catheter time decreased as confidence was gained with the procedure (range 6 to 33 days). Final pathological stage was compared among the 3 groups. There was an overall increase in positive margins in groups 1 to 3 (16%, 22% and 30%, respectively, p not significant). However, the positive margin rate for stage pT2 disease was similar at 15.5% for groups 1 and 2, and 14% for group 3. CONCLUSIONS: Laparoscopic radical prostatectomy is a technically challenging operation that is in the early stages of evolution and evaluation. We present an intensive, mentor initiated approach to decrease the learning curve and maintain outcomes.

Education, Medical, Continuing↗

The role of pelvic floor exercises on post-prostatectomy incontinence.

PURPOSE: Post-radical prostatectomy incontinence occurs in 0.5% to 87% of patients. This condition may be attributable to intrinsic sphincteric deficiency, and/or detrusor abnormalities. Previous studies of pelvic floor exercise (PFE) for improving post-prostatectomy incontinence have shown mixed results. We determined whether preoperative and early postoperative biofeedback enhanced PFE with a dedicated physical therapist would improve the early return of urinary incontinence. MATERIALS AND METHODS: A total of 38 consecutive patients undergoing radical prostatectomy from November 1998 to June 1999 were randomly assigned to a control or a treatment group. The treatment group of 19 patients was referred to physical therapy and underwent PFE sessions before and after surgery. Patients were also given instructions to continue PFE at home twice daily after surgery. The control group of 19 men underwent surgery without formal PFE instructions. All patients completed postoperative urinary incontinence questionnaires at 6, 12, 16, 20, 28 and 52 weeks. Incontinence was measured by the number of pads used with 0 or 1 daily defined as continence. RESULTS: Overall 66% of the patients were continent at 16 weeks. A greater fraction of the treatment group regained urinary continence earlier compared with the control group at 12 weeks (p <0.05). Three control and 2 treatment group patients had severe incontinence (greater than 3 pads daily) at 16 and 52 weeks. Of all patients 82% regained continence by 52 weeks. CONCLUSIONS: PFE therapy instituted prior to radical prostatectomy aids in the earlier achievement of urinary incontinence. However, PFE has limited benefit in patients with severe urinary incontinence 16 weeks after surgery. There is a minimal long-term benefit of PFE training since continence rates at 1 year were similar in the 2 groups.

Biofeedback, Psychology↗

Correlation of minute (0.5 MM or less) focus of prostate adenocarcinoma on needle biopsy with radical prostatectomy specimen: role of prostate specific antigen density.

PURPOSE: Few studies have examined the radical prostatectomy followup of a minute focus of adenocarcinoma on prostate needle core biopsy. MATERIALS AND METHODS: We searched the surgical pathology data base (1999 to 2000) for patients with a minute focus of Gleason score 6 adenocarcinoma (defined as a single focus less than or equal to a 40 x microscopic field) who subsequently underwent radical retropubic prostatectomy at our institution. Potentially insignificant tumors were defined as those with a radical prostatectomy tumor volume of less than 0.5 cc, Gleason score 6 or less and organ confined disease. RESULTS: A total of 54 patients (mean age 58 years, range 45 to 70) were evaluated. The average number of prostate cores per biopsy was 6.3. All had Gleason score 6 by study design. Mean prostate specific antigen (PSA) was 6.0 (range 0.8 to 15). Average tumor volume at radical prostatectomy was 0.39 cc. Of the 54 tumors 24 (44%) were 0.1 cc or less. Two-thirds of the tumors were clinically potentially insignificant. Using a PSA density (PSAD) cutoff of 0.15 we identified 30 of 36 patients (83%) with potentially insignificant tumors. Of those with a PSAD of 0.15 or less with clinically significant tumors, 5 of 6 still had relatively small, organ confined tumors with Gleason score less than 7. CONCLUSIONS: In the era of PSA screening most patients with a minute focus of Gleason score 6 or less adenocarcinoma on needle biopsy had potentially insignificant tumors. However, one-third of patients had clinically significant tumors warranting definitive therapy. The smallest focus of cancer on needle biopsy is not a guarantee of a clinically insignificant tumor. PSAD may have some value within this group in guiding clinicians and patients as to the likelihood of having clinically insignificant tumors.

Adenocarcinoma↗

Radical perineal prostatectomy: a novel approach for lymphadenectomy from perineal incision.

PURPOSE: A major disadvantage of radical perineal prostatectomy is that lymphadenectomy cannot be performed through the same incision. We developed a novel approach to access the obturator and internal iliac lymph nodes, partially the external iliac lymph nodes, via the perineal incision. We describe the method of lymphadenectomy. MATERIALS AND METHODS: After moving the rectum off of the prostate we separate the levator ani muscle and endopelvic fascia from the lateral prostate with finger dissection. A trocar mounted balloon distention device is inserted toward this space and distended with 200 cc air to create an intrapelvic space. Using several retractors or laparoscopy for viewing we first identify the obturator nerve and then the external iliac vessels next in order of depth. By retracting the obturator nerve with vessel tape we perform lymph node dissection between the obturator nerve and external iliac vessels under direct vision or laparoscopic guidance. RESULTS: We have performed this technique in 20 consecutive patients because of prostate specific antigen greater than 10 ng/ml, Gleason score greater than 7 or bilateral disease. Bilateral lymph node dissection required 15 to 20 minutes. No major bleeding or complications occurred. The number of nodes was similar to that in our retropubic prostatectomy series because of the limited lymphadenectomy that we usually performed. Fecal incontinence and potency results were almost the same as in patients without lymphadenectomy. Although urinary continence was not good at catheter removal on day 7, patients became dry in 1 to 6 months. CONCLUSIONS: This method resolves the major disadvantage of perineal prostatectomy. Radical perineal prostatectomy with lymphadenectomy via the same incision is feasible and reproducible.

Aged↗

Safety and efficacy of vardenafil for the treatment of men with erectile dysfunction after radical retropubic prostatectomy.

PURPOSE: More than one-third of men may experience erectile dysfunction (ED) after nerve sparing radical retropubic prostatectomy. The efficacy and safety of vardenafil, a potent, selective, phosphodiesterase 5 inhibitor, was assessed for the treatment of ED after radical prostatectomy. MATERIALS AND METHODS: In this double-blind study 440 men with ED after nerve sparing radical prostatectomy were randomized to take placebo, or 10 or 20 mg vardenafil. Efficacy was measured after 12 weeks using the erectile function domain of the International Index of Erectile Function, diary questions measuring vaginal penetration and intercourse success rates, and a global assessment question (GAQ) on erection. RESULTS: Of the intent to treat population 70% had severe ED (erectile function less than 11) at baseline. After 12 weeks both vardenafil doses were significantly superior to placebo (p <0.0001) for all efficacy variables. Improved erections (based on GAQ) were reported by 65.2% and 59.4% of patients on 20 and 10 mg vardenafil, respectively, and by only 12.5% of patients on placebo (p <0.0001). Among men with bilateral neurovascular bundle sparing, positive GAQ responses were reported by 71.1% and 59.7% of patients on 20 and 10 mg vardenafil, respectively, versus 11.5% of those on placebo (p <0.0001). The average intercourse success rate per patient receiving 20 mg vardenafil was 74% in men with mild to moderate ED and 28% in men with severe ED, compared to 49% and 4% for placebo, respectively. Few adverse events were observed. They were generally mild to moderate headache, flushing and rhinitis. CONCLUSIONS: In men with severe ED after nerve sparing radical retropubic prostatectomy, vardenafil significantly improved key indices of erectile function.

Double-Blind Method↗