The long-term effect of doxazosin, finasteride, and combination therapy on the clinical progression of benign prostatic hyperplasia.

BACKGROUND: Benign prostatic hyperplasia is commonly treated with alpha-adrenergic-receptor antagonists (alpha-blockers) or 5alpha-reductase inhibitors. The long-term effect of these drugs, singly or combined, on the risk of clinical progression is unknown. METHODS: We conducted a long-term, double-blind trial (mean follow-up, 4.5 years) involving 3047 men to compare the effects of placebo, doxazosin, finasteride, and combination therapy on measures of the clinical progression of benign prostatic hyperplasia. RESULTS: The risk of overall clinical progression--defined as an increase above base line of at least 4 points in the American Urological Association symptom score, acute urinary retention, urinary incontinence, renal insufficiency, or recurrent urinary tract infection--was significantly reduced by doxazosin (39 percent risk reduction, P<0.001) and finasteride (34 percent risk reduction, P=0.002), as compared with placebo. The reduction in risk associated with combination therapy (66 percent for the comparison with placebo, P<0.001) was significantly greater than that associated with doxazosin (P<0.001) or finasteride (P<0.001) alone. The risks of acute urinary retention and the need for invasive therapy were significantly reduced by combination therapy (P<0.001) and finasteride (P<0.001) but not by doxazosin. Doxazosin (P<0.001), finasteride (P=0.001), and combination therapy (P<0.001) each resulted in significant improvement in symptom scores, with combination therapy being superior to both doxazosin (P=0.006) and finasteride (P<0.001) alone. CONCLUSIONS: Long-term combination therapy with doxazosin and finasteride was safe and reduced the risk of overall clinical progression of benign prostatic hyperplasia significantly more than did treatment with either drug alone. Combination therapy and finasteride alone reduced the long-term risk of acute urinary retention and the need for invasive therapy.

Pathologic variables and recurrence rates as related to obesity and race in men with prostate cancer undergoing radical prostatectomy.

PURPOSE: To determine if obesity is associated with higher prostate specific antigen recurrence rates after radical prostatectomy (RP), and to explore racial differences in body mass index (BMI) as a potential explanation for the disparity in outcome between black and white men. PATIENTS AND METHODS: A retrospective, multi-institutional pooled analysis of 3,162 men undergoing RP was conducted at nine US military medical centers between 1987 and 2002. Patients were initially categorized as obese (BMI > or = 30 kg/m(2)), overweight (BMI 25 to 30 kg/m(2)), or normal (BMI < or = 25 kg/m(2)). For analysis, normal and overweight groups were combined (BMI < 30 kg/m(2)) and compared with the obese group (BMI > or = 30 kg/m(2)) with regard to biochemical recurrence (prostate-specific antigen > or = 0.2 ng/mL) after RP. RESULTS: Of 3,162 patients, 600 (19.0%) were obese and 2,562 (81%) were not obese. BMI was an independent predictor of higher Gleason grade cancer (P <.001) and was associated with a higher risk of biochemical recurrence (P =.027). Blacks had higher BMI (P <.001) and higher recurrence rates (P =.003) than whites. Both BMI (P =.028) and black race (P =.002) predicted higher prostate specific antigen recurrence rates. In multivariate analysis of race, BMI, and pathologic factors, black race (P =.021) remained a significant independent predictor of recurrence. CONCLUSION: Obesity is associated with higher grade cancer and higher recurrence rates after RP. Black men have higher recurrence rates and greater BMI than white men. These findings support the hypothesis that obesity is associated with progression of latent to clinically significant prostate cancer (PC) and suggest that BMI may account, in part, for the racial variability in PC risk.

Transobturator versus transabdominal mid urethral slings: a multi-institutional comparison of obstructive voiding complications.

PURPOSE: In the last year TO slings have become an increasingly popular alternative to TA slings for the surgical treatment of SUI. Proposed advantages of the transobturator approach include improved speed, safety and the reduction of obstructive complications. We assessed outcomes of TO and TA slings in a large series of women treated at several institutions to compare the rate of obstructive complications from these procedures. MATERIALS AND METHODS: We reviewed the charts of 504 consecutive women who had synthetic mid urethral sling procedures (154 TO or 350 TA) performed by 24 different urologists for SUI at 8 institutions from 2002 to 2004. Obstructive complications were defined as increased PVR (greater than 100 cc), or the need for CIC, prolonged Foley catheter drainage or urethrolysis. RESULTS: While TO and TA sling procedures appeared to be similarly efficacious in eliminating the need for incontinence pad use (TO 89%, TA 86%, p = 0.36), the transobturator approach was associated with fewer obstructive complications (TO 11.0%, TA 18.3%, p < 0.05). Urethrolysis was required in none of the 154 TO cases and 8 of 350 (2.3%) TA cases. Concomitant pelvic surgery did not significantly increase the likelihood of obstructive voiding complications in either group. CONCLUSIONS: Although TO and TA sling procedures had similar short-term results for decreasing pad use in patients with stress urinary incontinence, the transobturator approach is associated with fewer obstructive voiding complications.

Drain-free simple retropubic prostatectomy with fibrin sealant.

PURPOSE: We present our preliminary experience with liquid fibrin sealant during simple retropubic prostatectomy. MATERIALS AND METHODS: We reviewed 18 consecutive simple retropubic prostatectomies performed for symptomatic advanced benign prostatic hyperplasia at our institution between 1997 and 2001. Adenoma enucleation was performed via transverse anterior prostatic capsulotomy. In the first 13 cases (group 1) a Jackson-Pratt suction drain was placed in the pelvis after prostatic capsular closure. In the remaining 5 cases (group 2) 2 ml. liquid fibrin sealant were administered over the closed prostatic capsule instead of a pelvic drain. RESULTS: The 2 groups were matched for age and prostate size. Average time to drain removal in control group was 3.92 days, while the fibrin sealant group had no clinically apparent adverse sequelae despite the lack of pelvic drainage. Average hospitalization in group 1 was 4.38 days, while all group 2 patients were discharged home after 2 days (p = 0.001). In addition, a trend toward earlier resumption of a full diet was noted in the sealant group (2.61 versus 1 day, p = 0.075). CONCLUSIONS: Liquid fibrin sealant appears to expedite recovery and shorten hospitalization when used as an adjunct during simple prostatectomy.

Fibrin sealant for the management of genitourinary injuries, fistulas and surgical complications.

PURPOSE: We report our preliminary experience with the use of fibrin sealant to manage iatrogenic urinary tract injuries, complex urinary fistulas, and urological surgical complications. MATERIALS AND METHODS: Topical fibrin sealant was used in 19 patients for iatrogenic urinary tract injury during gynecological or general surgical procedures (7), complex urinary fistulas (5) or urological surgical complications (7). RESULTS: Successful resolution of the injury, fistula or complication was attained after a single application of fibrin sealant in the 18 patients (94.7%) in whom a direct injection technique was used. The only failure (formation of a vesicovaginal fistula) occurred with the air driven sprayed sealant delivery technique after sutured closure of iatrogenic cystotomy during vaginal hysterectomy. CONCLUSIONS: Liquid fibrin sealant appears to be safe and prudent for use in urological "damage control" from trauma, fistulas or surgical complications. Direct injection over a sutured urinary anastomosis appears to be highly effective in preventing urinary drainage. Additional study is needed to define further the role and best use of tissue adhesives in urology.

Single dose levofloxacin prophylaxis for prostate biopsy in patients at low risk.

PURPOSE: We determine if a single 500 mg. oral tablet of levofloxacin represents adequate prophylaxis for patients at low risk who undergo transrectal prostate biopsy. MATERIALS AND METHODS: From April 2000 to May 2001 we prospectively evaluated 400 consecutive men who underwent transrectal needle biopsy of the prostate after a single 500 mg. oral dose of levofloxacin. Under an institutional review board approved protocol the drug was issued under a standing order by a clinic nurse 30 to 60 minutes before the procedure. Patients were issued 2 additional daily doses of levofloxacin if they were deemed at increased risk for infectious complications, that is if they had a large prostate more than 75 cc, diabetes mellitus, recent steroid use, severe voiding dysfunction or immune compromise. No patient received a cleansing enema before the procedure. Complications, the number of biopsy cores, prostate size and cancer detection rates were assessed. RESULTS: Only 1 of the 377 patients at low risk in whom biopsy was completed experienced a symptomatic urinary tract infection (0.27%). None of the 23 men at high risk who received additional doses of levofloxacin experienced a complication. Thus, the overall infection rate was 1 of 400 cases (0.25%) in this series. A mean of 7 biopsy cores (range 2 to 16) was obtained per patient and mean prostate volume was 49.75 cc (range 12 to 150). Prostate cancer was present in 93 patients (23%). CONCLUSIONS: A single 500 mg. dose of levofloxacin before transrectal needle biopsy of the prostate is effective and safe in patients at low risk. The administration of prophylaxis by a clinic nurse under a standing order optimizes patient compliance and physician efficiency. In patients at higher risk for infection additional antibiotic administration appears to provide adequate prophylaxis.

Limited value of bone scintigraphy and computed tomography in assessing biochemical failure after radical prostatectomy.

OBJECTIVES: To define the utility of bone scan and computed tomography (CT) in the evaluation of patients with biochemical recurrence after radical prostatectomy. METHODS: A retrospective analysis of the Center for Prostate Disease Research database was undertaken to identify patients who underwent radical prostatectomy between 1989 and 1998. Patients who developed biochemical recurrence (two prostate-specific antigen [PSA] levels greater than 0.2 ng/mL) and underwent either bone scan or CT within 3 years of this recurrence were selected for analysis. The preoperative clinical parameters, pathologic findings, serum PSA levels, follow-up data, and radiographic results were reviewed. RESULTS: One hundred thirty-two patients with biochemical recurrence and a bone scan or CT scan were identified. Of the 127 bone scans, 12 (9.4%) were positive. The patients with true-positive bone scans had an average PSA at the time of the bone scan of 61.3 +/- 71.2 ng/mL (range 1.3 to 123). Their PSA velocities, calculated from the PSA levels determined immediately before the radiographic studies, averaged 22.1 +/- 24.7 ng/mL/mo (range 0.14 to 60.0). Only 2 patients with a positive bone scan had a PSA velocity of less than 0.5 ng/mL/mo. Of the 86 CT scans, 12 (14.0%) were positive. On logistic regression analysis, PSA and PSA velocity predicted the bone scan result (P <0.001 each) and PSA velocity predicted the CT scan result (P = 0.047). CONCLUSIONS: Patients with biochemical recurrence after radical prostatectomy have a low probability of a positive bone scan (9.4%) or a positive CT scan (14.0%) within 3 years of biochemical recurrence. Most patients with a positive bone scan have a high PSA level and a high PSA velocity (greater than 0.5 ng/mL/mo).