2095 SIX WEEKS OF FLUOROQUINOLONE ANTIBIOTIC FOR PATIENTS WITH ELEVATED PSA IS NOT CLINICALLY BENEFICIAL: A RANDOMIZED CONTROLLED CLINICAL TRIAL

2095 SIX WEEKS OF FLUOROQUINOLONE ANTIBIOTIC FOR PATIENTS WITH ELEVATED PSA IS NOT CLINICALLY BENEFICIAL: A RANDOMIZED CONTROLLED CLINICAL TRIAL

e814 THE JOURNAL OF UROLOGY姞 Vol. 183, No. 4, Supplement, Wednesday, June 2, 2010 IPSS 8-19) (OR 2.834; p⫽0.047). As for SUI, preoperative PVR was ...

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IPSS 8-19) (OR 2.834; p⫽0.047). As for SUI, preoperative PVR was the only independent predictor and PVR of ⱖ 90 ml was associated with a 3.5 times higher risk of transient SUI after the HoLEP compared to that of ⬍ 90 ml (OR 3.481; p⫽0.043). As for UUI, symptom severity by IPSS and intraoperative bladder mucosal injury during morcellation were the independent predictors of postoperative UUI (OR 8.639; p⫽0.046, OR 4.530; p⫽0.041, respectively). CONCLUSIONS: Our data suggest that HoLEP is effective in improving micturition but postoperative transient UI occurred in a minority of patients, which was usually self-limiting within 6 months. The present study indicates that severe LUTS by IPSS was an independent predictor of transient postoperative UI after HoLEP. Source of Funding: None

2093 HOLMIUM LASER ENUCLEATION OF THE PROSTATE (HOLEP): THE INITIAL RESULTS OF A MULTI-INSTITUTIONAL ADOPTION OF THE TECHNIQUE Rafael Nunez-Nateras*, Phoenix, AZ; Davis P. Viprakasit, Nicole L. Miller, Nashville, TN; Mitchell R. Humphreys, Phoenix, AZ INTRODUCTION AND OBJECTIVES: Holmium laser enucleation of the prostate (HoLEP) has demonstrated its effectiveness on the treatment of BPH. However, one of the major barriers preventing widespread application has been attributed to the steep learning curve of the procedure. The purpose of this study is to examine the results associated with the initial application of HoLEP at two separate training institutions and critically examine the functional outcomes and complications. METHODS: After obtaining IRB approval, we retrospectively analyzed all patients that have undergone a HoLEP at MCA and VUMC. All cases were performed by a single surgeon (MRH and NLM) at each institution, with resident participation and training. Patient data included: demographics, transrectal ultrasound prostate volume measurement, PSA, uroflow with postvoid residual, AUA SS, tissue pathology, length of hospitalization and catheterization, and complications. No cases were excluded from the study to ensure inclusion of the initial learning curve. RESULTS: A total of 193 patients were available for analysis with a mean follow up of 10 months (1-25). Patient age was 72 years (53 – 90), BMI was 29 kg/m2 (21 – 45), ASA was 2.4 (2-4), prostate size was 87 cm3 (22 - 243), and pretreatment PSA was 6.9 ng/dL (0.3 – 91.2). HoLEP universally resulted in significant improvements in voiding symptoms and parameters (Table 1). Blood loss was 60 ml (10 300), decrease in PSA was 81%, hospital stay was 1.3 days (1-12). Median catheterization time was 1 day. There was no significant difference in the functional outcomes or complications from either institution over their respective first 20 cases. Regarding complications there were 2 UTIs, 2 bladder injuries and 1 bulbar stricture, as well as 11 patients that received transfusions. There was 1 death due to cardiac arrest at post – op day number 7. CONCLUSIONS: HoLEP is a safe and effective minimally invasive treatment for BPH. The well publicized concerns over the steep learning curve do not seem to be a detriment to patient outcomes at centers that are naive to the procedure. Our results demonstrate that the introduction of HoLEP into a urology practice can be done safely and efficiency with excellent patient outcomes. Table 1. Urinary parameters associated with HoLEP. Before HoLEP After HoLEP Mean Mean Peak flow (ml/s) 11.5 ( 2– 49 ) 22 ( 0 – 51 )

p-value 0.001

Average flow (ml/s)

6.3 ( 2 – 60 )

12 ( 0 – 34 )

0.021

Post-void Residual (ml)

326 ( 5 – 900 )

45 ( 0 – 257 )

0.001

21 ( 4 – 35 )

8 ( 0 – 27 )

0.001

4 (0 – 6 )

2(0–6)

0.001

AUA symptom score Bother score

Source of Funding: None

2094 CLASSIFICATION OF HOLMIUM LASER ENUCLEATION OF PROSTATE COMPLICATIONS USING THE MODIFIED CLAVIEN GRADING SYSTEM Hemendra Shah*, Manju Jain, Rajesh Verma, Manish Bansal, Mumbai, India INTRODUCTION AND OBJECTIVES: A classification (modified Clavien system) has been proposed to grade perioperative complications. We reviewed our experience with Holmium laser enucleation of prostate (HoLEP), grading the complications according to this new classification. METHODS: From April 2003 to September 2009, 603 HoLEP were performed at our institute by a single surgeon for management of bladder outlet obstruction. All patients data was retrospectively reviewed focusing on intraoperative and postoperative complications. According to the modified Clavien classification system, perioperative complications were stratified into five grades. Grade 1 defined all events that, if left untreated, would have a spontaneous resolution or needed a simple bedside intervention (eg- intraoperative covered capsular perforation, superficial bladder mucosal &/or ureteric orifice injury, mild postoperative hematuria). Grade 2 complications required specific medication, including antibiotics and blood transfusion (eg- intraoperative or postoperative significant hemorrhage, transient urinary incontinence, urinary tract infection, & epididymitis). Grade 3 complications necessitated surgical, endoscopic, or radiologic intervention (3a without general anesthesia eg- dilatation for meatal or submeatal stenosis, recatheterization,: 3b under general anesthesia eg- cystoscopic clot evacuation, holmium laser incision for bulbar urethral stricture or bladder neck stenosis, ureteric stenting for ureteric injury with resultant hydronephrosis). Neighboring organ injuries and organ failures were classified as grade 4 (eg- permanent incontinence, transmural bladder perforation, acute myocardial infarct, fluid extravasation with paralytic ileus), and death was considered a grade 5 complication. Sexual related complications were not included in present study. RESULTS: A total of 210 perioperative complications were observed in 173 (28.68%) patients. There were 80 grade 1 (13.26 %), 84 grade 2 (13.93 %), 26 grade 3a (4.31 %), 18 grade 3b (2.98 %), 5 grade 4 (0.82 %) complications, and one death (0.16 %). Most complications were related to intraoperative superficial mucosal or ureteric orifice injury or transient urinary incontinence. CONCLUSIONS: HoLEP is associated with acceptable morbidity. The present classification scheme for reporting the complications of HoLEP may be useful for monitoring and reporting outcomes. However, larger studies with necessary modifications in present pilot study are needed in future. Source of Funding: None

Prostate Cancer: Detection and Screening IV Podium 59 Wednesday, June 2, 2010

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2095 SIX WEEKS OF FLUOROQUINOLONE ANTIBIOTIC FOR PATIENTS WITH ELEVATED PSA IS NOT CLINICALLY BENEFICIAL: A RANDOMIZED CONTROLLED CLINICAL TRIAL Robin Bhavsar*, Ahmed El-Zawahry, Susan Caulder, Jeanette Byers, John Tissot, Charleston, SC; Jeffrey Springer, New Orleans, LA; Thomas Keane, Harry Clarke, Stephen Savage, Charleston, SC INTRODUCTION AND OBJECTIVES: It is common practice for practitioners to reflexively give an extended course of fluoroquinolones in patients who present with an elevated prostate specific antigen

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(PSA). We sought to determine whether a six week course of a fluoroquinolone would reduce PSA sufficiently to eliminate potentially excessive prostate biopsies in these patients. METHODS: All patients referred to the urology clinic for an initial evaluation of an elevated PSA between 4.0 ng/ml and 20.0 ng/ml were eligible for this study. Patients on 5-alpha reductase inhibitors were excluded. Patients were randomized to either 6 weeks of ciprofloxacin 500 mg twice daily or 6 weeks of observation alone. PSA levels were redrawn 8 weeks after randomization. Those patients with an elevated PSA or prostate nodule were recommended to proceed with biopsy. Those with a reduced PSA were offered a biopsy but were not required to do so after discussion with their urologist and could opt to continue to be monitored closely. RESULTS: A total of 135 patients have enrolled, and 120 have completed the 8 week study period and are available for analysis. The mean and median pre-intervention PSA for treatment (tx) patients was 6.21 ng/mL and 5.31 ng/mL, respectively, and 5.56 ng/mL and 5.00 ng/mL among observation patients, respectively. At baseline, this did not represent a statistically significant difference of the means between arms (p⫽0.115). The mean and median post-intervention PSA was 5.54 ng/mL and 5.01 ng/mL among antibiotic patients and 5.79 ng/mL and 5.17 ng/mL among observation patients. Post-intervention, the two arms did not differ significantly in mean PSA (p⫽0.567). The mean PSA decreased 0.67 ng/mL (-10.8%, p⫽0.178) in the tx arm, and increased 0.23 ng/mL (⫹4.0%; p⫽0.582) in the observation arm. Neither group had statistically significant changes. Of the 120 patients, 30 patients’ PSA decreased to ⬍4 ng/mL (16 in Cipro arm, 14 in observation arm). Prostate cancer was found in 16 patients in the tx arm and 11 patients in the observation arm. CONCLUSIONS: We concluded that in men who present with a PSA above 4.0 ng/mL, a 6 week trial of fluoroquinolones does not reduce PSA significantly when compared to observation. Therefore, in this randomized, controlled trial, it did not reduce the need for prostate biopsy, and is not supported as a routine clinical practice. Source of Funding: None

2096 HOW SAFE IS PROSTATE BIOPSY? RATE OF COMPLICATIONS REQUIRING HOSPITALIZATION FOLLOWING PROSTATE BIOPSY IN SEER-MEDICARE Stacy Loeb*, H. Ballentine Carter, Baltimore, MD; Sonja Berndt, Bethesda, MD; Winnie Ricker, Rockville, MD; Edward M. Schaeffer, Baltimore, MD INTRODUCTION AND OBJECTIVES: Prostate biopsy is a common procedure, with age-adjusted rates of 1580 and 1851 per 100,000 Caucasian and African American Medicare beneficiaries, respectively. Moreover, among Medicare participants with no cancer found on first biopsy, the risk of a subsequent biopsy was 12% at 1 year and 38% at 5 years. Given the frequency with which this procedure is performed, the risk of serious complications is of great interest. Our hypothesis is that with the emergence of multi-drug resistant organisms, there may be an increasing risk for infection after prostate biopsy. METHODS: In a 5% random sample of male Medicare participants living in SEER regions from 1991 to 2007, we used CPT/HCPCS codes to identify 17,472 men who underwent at least one transrectal ultrasound-guided prostate biopsy. Procedural morbidity was then ascertained using the primary ICD-9 diagnosis codes for hospital admissions within 30 days of prostate biopsy. Multivariable Poisson regression was used to examine the rate and predictors of serious infectious and non-infectious complications over time. RESULTS: The median age in the study population was 72 years and the majority of men were Caucasian (81.9%). Prostate cancer was diagnosed in 6981 (40.0%). Overall, 1209 (6.9%) men were hospitalized within 30 days. Infectious complications were the primary diagnosis in 67 (0.38%), and other serious biopsy-related complications were the primary diagnosis in 53 (0.30%) men. The risk of infectious complications requiring hospitalization (but not non infectious

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complications) was significantly greater in more recent years (Figure1). Year of biopsy and race (non –white) were significantly associated with the risk of an infectious complication requiring hospitalization. CONCLUSIONS: There is a non-trivial risk of serious complications requiring hospitalization within 30 days of prostate biopsy. The risk of infectious complications after prostate biopsy has increased in recent years, while the rate of serious non-infectious complications has remained relatively stable.

Source of Funding: None

2097 RISING HOSPITAL ADMISSION RATES FOR UROLOGIC COMPLICATIONS AFTER TRANSRECTAL ULTRASOUND-GUIDED PROSTATE BIOPSY Robert Nam*, Laurence Klotz, Andrew Loblaw, John Trachtenberg, Andrew Simor, Aleksandra Stanimirovic, Steven Narod, Toronto, Canada INTRODUCTION AND OBJECTIVES: Transrectal ultrasound (TRUS)-guided prostate biopsy is widely used to confirm the diagnosis of prostate cancer. The technique has been associated with significant morbidity in a small proportion of patients. METHODS: We conducted a population-based study of 75,190 men who underwent a TRUS-guided biopsy in Ontario, Canada, between 1996 and 2005. We used hospital and cancer registry administrative databases to estimate the rates of hospital admission and mortality due to urologic complications associated with the procedure. RESULTS: Of the 75,190 men who underwent a TRUS biopsy, 33,508 (44.6%) were diagnosed with prostate cancer and 41,682 (55.4%) did not have prostate cancer. The hospital admission rate for urologic complications within 30 days of the procedure for men without cancer was 1.9% (781/41,482). The 30-day hospital admission rate rose from 1.0% in 1996 to 4.1% in 2005 (p-value for trend ⬍0.0001). The majority of hospital admissions (72%) were for infection-related reasons. The probability of being admitted to hospital within 30 days of having the procedure rose four-fold between 1996 and 2005 (odds ratio ⫽ 3.7; 95% C.I.: 2.0 – 7.0, p⬍0.0001). The overall 30-day mortality rate was 0.09%, but did not change over the study period. CONCLUSIONS: The hospital admission rates for complications following a TRUS-guided prostate biopsy have risen dramatically over the last ten years, primarily due to an increasing rate of infectionrelated complications. Source of Funding: None