madman
Super Moderator
https://www.urologytimes.com/urolog...tline-must-see-presentations-chicago/page/0/4
MP27-06: IMMEDIATE PREOPERATIVE BLOOD GLUCOSE AND HEMOGLOBIN A1C LEVELS ARE NOT PREDICTIVE OF POST-OPERATIVE INFECTIONS IN DIABETIC MEN UNDERGOING PENILE PROSTHESIS PLACEMENT
Abstract
INTRODUCTION AND OBJECTIVES:
Recent reports have suggested that pre-operative diabetic control may be predictive of infection rates following penile prosthesis (PP) implantation. In this study, we sought to investigate whether immediate pre-operative serum blood glucose (PBG) levels were associated with PP infection rates in diabetic patients.
METHODS:
We conducted a retrospective review of 716 diabetic patients undergoing primary PP (inflatable and malleable) implantation from April 2003 to May 2018 across 15 institutions. PBG levels (within 6 hours of surgery) and Hemoglobin A1c (HbA1c) levels were recorded for each patient, along with clinical and demographic variables. Measured outcomes were rates of post-operative infection, revision and explantation. The impact of pre-operative glucose and HbA1c levels on post-operative infection rates was assessed using ANOVA and univariate analyses. The effects of age, diabetes type, diabetes related complications, body mass index, Charlson Comorbidity Index (CCI), history of immunosuppression, previous radical prostatectomy, and PP type were adjusted for, using logistic regression models.
RESULTS:
Median age was 61 years (range 34-86). Median follow-up was 7 months (range 0-157). Median and mean pre-operative glucose levels were 134.0 mg/dL (range 54-344) and 143.3 mg/dL ± 45.9, respectively, and median and mean pre-operative HbA1c levels were 7.2 % (range 4.8-15.2) and 7.5% ± 1.5, respectively. Most PP were inflatable (98.6%). Devices used were AMS 700 (43.2%), AMS Ambicor (0.1%), Coloplast Titan (55.3%), and Coloplast Genesis (1.3%). Surgical approach used was penoscrotal in 74.4%, subcoronal in 23.8%, and infrapubic in 1.8%. Post-operative infection, revision, and explantation rates were 3.8%, 5.9%, and 4.5%, respectively. There was no association between PBG levels and post-operative infection rates: continuous, p=0.413; cut-off >165 mg/dL, 75th percentile, p=0.500; cut-off >201 mg/dL, 90th percentile, p=0.393. Additionally, there was no association between pre-operative HbA1c levels and post-operative infection rates: continuous, p=0.430; cut-off >6.5%, p=0.611; cut-off> 8%, p=0.241. Similarly, there were no associations between explantation and revision rates with PBG levels (p=0.567 and 0.517, respectively), nor with HbA1c levels (p=0.219 and 0.160, respectively). On multivariate analysis, a higher CCI was a significant predictor of higher infection rates (p=0.040).
CONCLUSIONS:
In this large multi-institutional cohort of diabetic men undergoing PP implantation, neither PBG nor HbA1c levels were predictive of device infection. A higher CCI in diabetic patients predicts PP infection.
MP40-07: THE PREDICTIVE EFFECT OF FREE TESTOSTERONE ON SEXUAL FUNCTION INCREASES WITH AGE
Abstract
INTRODUCTION AND OBJECTIVES:
While the impacts of age and testosterone on sexual function have been well-studied, the additive relationship of these three variables has seldom been mentioned. In the present study, we seek to assess the impact of testosterone and age on baseline sexual function in men with prostate cancer.
METHODS:
We retrospectively reviewed 850 patients who presented for primary treatment of prostate cancer between December 2009 and June 2018. Preoperative sexual function was measured via the International Index of Erectile Function-5 (IIEF-5). Total and free testosterone (FT and TT) were collected and calculated preoperatively in 822 patients. To assess the impact of age, patients were stratified patients by decade of life and the most predictive cut-off was determined to be at 60 years of age. Univariate and multivariate analyses were conducted to assess impact of FT, TT, age, Body Mass Index (BMI), and pathological grade on sexual function.
RESULTS:
Overall, 822 patients were included, of which 35.4% (291/822) were <60 years. Mean FT was significantly higher in the <60 aged cohort (6.74±4.24 ng/dL) vs. the >60 aged cohort (5.6±2.52 ng/dL), (p<0.001). In multivariate analysis, FT was only an independent predictor of IIEF-5 scores for patients >60 years old (p=0.018), but not in patients younger than 60 (p=0.69). Similarly, BMI was not significantly correlated with sexual function in younger men (<60 years old) (p>0.05), but was an independent predictor in the older cohort (p<0.001). Age was an independent predictor of sexual function in both cohorts (p=0.001 for <60; p<0.001 for >60).
CONCLUSIONS:
Our results show that lower FT levels do not impact IIEF-5 scores in patients <60 years old, but have a negative effect on IIEF-5 scores in patient >60 years old. In this group, that effect worsens with age. A FT level should be obtained in all patients over the age of 60 undergoing radical prostatectomy to assess postoperative sexual function recovery.
MP40-09: RE-ENGINEERING THE INTERNATIONAL INDEX OF ERECTILE FUNCTION: EVALUATION OF A LARGE CLINICAL DATA SET
Abstract
INTRODUCTION AND OBJECTIVES:
The six-item version of the International Index of Erectile Function (IIEF6) is the predominant method of assessing erectile function in urology. There are, however, three obvious and immediate problems with using the IIEF6 in the clinic to evaluate an individual patient: i) no account of the use of erectile aids such as intracavernosal injections; ii) a man not engaging in sexual intercourse cannot reach the accepted threshold for erectile function (24+); iii) a man reporting no sexual activity is assigned a very low score (<6). We analyzed a large data set taken as part of routine care as well as a systematic comparison of the IIEF and EPIC sexual domain.
METHODS:
Data were from close to 25,000 IIEF questionnaires completed by radical prostatectomy patients as part of routine clinical follow-up at our institution, and 1550 surveys from patients who completed both an IIEF6 and an EPIC questionnaire in a prospective study. We examined results before and after adding a question concerning use of erectile aids along with instruction that the IIEF6 was to reflect experience without use of the aid. We also added a question for men who reported no intercourse, asking for the reason why. EPIC sexual function scores were analyzed for men who reported no sexual activity on the IIEF6.
RESULTS:
Of 16,753 surveys including data on erectile aide usage, 15% reported use, predominately injections (89%). A simple modeling analysis demonstrated that before introduction of the erectile aid question, some men using erectile aids would report IIEF6 scores with use of the aid, whereas other would not. Of men reporting not attempting sexual intercourse, 46% (95% C.I. 43%, 49%) gave a reason other than erectile dysfunction including lack of a partner, sexual orientation, sexual preference and health problems of the female partner. In men who did have sexual intercourse, doubling the first 3 questions on the IIEF6 gave almost perfect scores compared to the full IIEF6 (mean difference -0.1, limits of agreement was -3.3, 3.1). In 251 men reporting no sexual activity, 13% reported erections sufficient for sexual activity and 5.6% reported scores of at least 65 on the EPIC sexual function domain.
CONCLUSIONS:
Patient-reported outcome instruments for erectile function should include a question about erectile aids with patients asked to report experience without the use of aids. Lack of sexual activity and, more specifically, lack of sexual intercourse, cannot be taken as being indicative of erectile dysfunction.
MP58-06: ASSESSMENT OF ERYTHROCYTOSIS FOLLOWING LONG-ACTING TESTOSTERONE SUPPLEMENTATION
Abstract
INTRODUCTION AND OBJECTIVES:
Testosterone supplementation is known to stimulate erythropoiesis and can lead to erythrocytosis, which may be associated with adverse cardiovascular events. The mechanism by which erythrocytosis occurs is multifactorial, but long-acting formulations are believed to be associated with a lower risk of erythrocytosis compared to short-acting injections. We evaluated the available long-acting formulations of testosterone, subcutaneous testosterone pellets (TP) and testosterone undecanoate (TU), and their comparative risk of erythrocytosis.
METHODS:
A retrospective review of 127 patients treated with TP or TU for hypogonadism (total testosterone < 300 ng/dL) over a 5-year period was conducted. Men with hematopoietic disorders were excluded. Testosterone (T), free testosterone (FT), estradiol (E2), PSA, hemoglobin (Hgb), and hematocrit (Hct) were evaluated. Descriptive statistics (Pearson chi-square and t-test) and multivariate logistic regression were performed to evaluate variables associated with erythrocytosis, defined by Hct > 50%.
RESULTS:
Of 127 men reviewed, 79 received TP and 48 received TU. Baseline characteristics were similar between the groups, including age, BMI, and proportion of patients with diabetes, hypertension, hyperlipidemia, or history of cardiovascular disease. Pre-treatment mean total T (TP 188 ng/dL, TU 214 ng/dL, p = 0.063), FT (TP 38 ng/dL, TU 36 ng/dL, p = 0.60), PSA (TP 1.54 ng/mL, TU 1.70 ng/mL, p = 0.59), Hgb (TP 14.8 g/dL, TU 14.9 g/dL, p = 0.80), and Hct (TP 43.6%, TU 42.5%, p = 0.23) were similar between groups. Post-treatment T levels were higher in the TP group (mean T: TP 658 ng/dL, TU 530 ng/dL, p = < 0.01; mean peak T: TP 1039 ng/dL, TU 665 ng/dL, p < 0.01). Mean peak E2 levels were higher in the TP group (TP 59.7 pg/mL, TU 36.8 pg/mL, p < 0.01). Men on TP had a higher Hct (TP 48.6%, TU 46.4%, p < 0.01) and rate of erythrocytosis (TP 36.7%, TU 18.8%, p = 0.03). Longer duration on therapy was observed in the TP group (TP 40.1 mo., TU 18.5 mo., p = < 0.01) but no significant difference in the time to erythrocytosis (TP 13.1 mo., TU 7.4 mo., p = 0.11) was observed. On multivariate analysis, only pre-treatment hemoglobin was independently associated with increased risk of erythrocytosis (OR 1.92, 95% CI 1.24 - 2.98, p < 0.01).
CONCLUSIONS:
Erythrocytosis following long-acting testosterone supplementation was observed more often in men receiving TP with higher mean and peak T levels. The most important factor associated with erythrocytosis appears to be baseline hemoglobin concentration. Patients at risk for erythrocytosis may be more appropriate candidates for TU.
MP58-10: BIOCHEMICAL RECURRENCE RATES IN MEN WITH HIGH GRADE PROSTATE CANCER ON TESTOSTERONE THERAPY
Abstract
INTRODUCTION AND OBJECTIVES:
Testosterone therapy (TTH) in men with prostate cancer is controversial especially in men with high risk prostate cancer. This study assessed biochemical recurrence (BCR) rates in men with high risk prostate cancer.
METHODS:
We reviewed men who underwent radical prostatectomy (RP) with high risk prostate cancer (HRPC), defined as having a Gleason (GS) score of GS 6-7 with positive surgical margins (SMS+), lymph node involvement (LNI+), seminal vesicle involvement (SVI+) or GS ≥8 with any pathology status. BCR was defined as a prostate specific antigen (PSA) level of ≥ 0.1ng/mL. Low T was defined as an early morning total T (TT) <300nd/dl. Men were divided into 3 groups based on T levels and TTH: those with normal TT levels and no TTH (NT); men with low TT who did not receive TTH; men with low TT who received TTH. Clinical and pathological data were analyzed. Chi-square and ANOVA were performed for group comparisons. A series of proportional hazards models were estimated to assess the unadjusted and adjusted associations of predictors to time-to-BCR. Each predictor was fitted in an unadjusted model, then significant predictors from unadjusted models were included in a single adjusted model.
RESULTS:
1,407 men with HRPC were analyzed. Mean age = 61.7±7 years. 793 (56%) had normal TT (NT) levels with a mean TT of 481±156 ng/dL. 614 men had low TT levels (mean TT 136.2 ± 113.5 ng/dL), 590 not on TTH (LTNT), and 24 on TTH (LTT). Among men with low TT levels, those on TTH did not differ significantly from those not on TTH, by pathology status, but had lower Gleason scores (p=0.010) and were less likely to be LNI positive (17% LTT, 41% LTNT, p =0.041). Of the men on TTH, 25% were ≥ GS 8; of the GS 6-7 patients, 63% were SMS+, 42% SVI+, 17% LNI+. In our cohort, a total of 906 (64%) patients experienced BCR within 0.1-15.3 years. 57% of the NT group, 75% in the LTNT group and 46% of men in the LTT group (LTNT compared to LTT p=0.001). Older age, higher Gleason score, LNI+, SVI+, receipt of chemotherapy, radiation, or ADT, low T and TTH were associated with faster BCR rates in unadjusted models. After adjustment, low T and TTH were not associated with BCR after covariate adjustment.
CONCLUSIONS:
Men with HRPC with low T levels on TTH did not show an increased incidence of BCR when compared to men with HRPC who were not on TTH and men with normal TT levels.
MP65-18: PRELIMINARY OUTCOMES OF A NOVEL PENILE TRACTION DEVICE (RESTOREX) IN MEN WITH PEYRONIE’S DISEASE: A RANDOMIZED, CONTROLLED TRIAL
Abstract
INTRODUCTION AND OBJECTIVES:
Penile traction therapy (PTT) is a common treatment used in the management of Peyronie’s disease (PD). However, existing PTT devices require daily utilization for ≥5 hours and data regarding penile curvature and length improvements are inconsistent and of unclear clinical benefit. Given these limitations, a novel PTT device, RestoreX, was developed specifically as a primary or adjunctive therapy for PD. Here, we sought to assess the safety and efficacy of the RestoreX PTT device in men with PD.
METHODS:
A randomized, controlled trial (NCT03389854) is ongoing to evaluate the impact of PTT with RestoreX in 120 men with PD. Men are randomized to one of four groupings: no therapy (control) or treatment with Restorex for 30 minutes 1x, 2x, or 3x daily for 3 months. All men then enter an open label phase for an additional 3 months. Inclusion criteria are no current or recent PD therapies and ≥30 degrees curvature. The primary outcome is safety, and secondary outcomes include penile length, curvature, and subjective responses to standardized (IIEF, PDQ) and non-standardized questionnaires. Assessments are obtained at baseline and 3 and 6 months after starting therapy.
RESULTS:
A total of 117 men have been enrolled to date, with 3-month data available on 85 patients (control, n=19, PTT, n=66). Baseline clinicopathologic characteristics include a mean age of 58.4 (SD 7.8) years, mean PD duration 45.0 (42.0) months, mean primary curvature 45.7 (11.7) degrees, and mean stretched penile to coronal length of 11.5 (1.4) cm, all non-significant between PTT and controls. After 3 months of treatment, PTT significantly improved penile length (+1.4 cm [+9.9%] vs +0.3 cm [2.1%], p<0.01), and primary penile curvature (-9 degrees [-18.9%] vs -1.0 degrees [-2.4%], p<0.01) compared to controls. Results from the PD Questionnaire demonstrated significant improvements in the psychological/physical domain (PTT -2.6 vs -0.5, p=0.01). Of those who could not penetrate at baseline, 38% reported restored ability to penetrate (vs 0%, p<0.01), and 19% indicated that therapy negated a need for surgery. Adverse events with PTT were all mild and resolved within 5 minutes of completing therapy: mild discomfort (44%), erythema (39%), and sensory changes (15%).
CONCLUSIONS:
Based on preliminary results, in a cohort of PD men, PTT with RestoreX for 30-90 minutes daily resulted in statistically significant improvements in penile length and curvature at 3 months compared to controls with no significant adverse events.
PD44-02: A MULTI-INSTITUTIONAL ASSESSMENT OF MULTIMODAL ANALGESIA IN PENILE IMPLANT RECIPIENTS DEMONSTRATES DRAMATIC NARCOTICS REDUCTION
Abstract
INTRODUCTION AND OBJECTIVES:
Increasing regulations are being placed on providers in an effort to combat the growing opioid epidemic in the United States. Although implantation of an inflatable penile prosthesis (IPP) is associated with significant post-operative pain, there have been few rigorous attempts at describing non-opioid based pain management strategies for implant recipients. Here, we present results of a multi-institutional assessment of a multimodal analgesic (MMA) regimen in patients (pts) undergoing IPP surgery to a matched cohort of pts treated with a traditional opioid-based (OB) regimen.
METHODS:
We performed a multicenter comparison of pts undergoing IPP implantation by high-volume implanters whose pain was managed using a recently described, novel MMA protocol (Table 1) to a matched, historic cohort of pts managed via an OB protocol. Patients were excluded if they underwent any additional procedure or had a history of narcotic dependence. Both groups were compared with respect to visual analog pain scale (VAS), and opioid usage (total morphine equivalents, TME) in the post-anesthesia care unit (PACU), post-operative days (POD) zero and one, and in immediate post-discharge period. Narcotics usage on discharge and follow up were assessed and compared between both groups.
RESULTS:
91 pts were eligible for final analysis: 53 (58%) in MMA arm and 38 (42%) in the OB arm. There were no differences between groups with regards to age, race, BMI, or medical comorbidities. VAS was significantly lower in the MMA group in PACU (mean 1.1 vs 2.9, p=0.002), POD0 (mean 2.8 vs 4.7, p=0.001), and POD1 (mean 3.02 vs 4.00, p=0.04). Patients in the MMA group used fewer narcotics in the PACU (mean 1.6 vs 4.3 TME, p=0.002), POD0 (mean 5.8 vs 13.8 TME, p<0.001), and POD1 (mean 10.8 vs 25.1 TME, p=0.001). Despite being discharged with substantially fewer narcotics (mean 14.9 vs 51.3 tabs, p<0.001), a smaller proportion of MMA pts required narcotic refills (7.5% vs 47.4%, p<0.001). No pts in either group experienced significant medication-related side-effects.
CONCLUSIONS:
To our knowledge, this is the first multicenter pain management investigation in penile implant recipients. The use of a multimodal analgesic protocol not only demonstrates excellent durability in significantly reducing post-operative pain but further reduces inpatient and outpatient narcotic usage without any discernable side-effects.
PD44-09: ADHERENCE TO THE AUA ANTIBIOTIC PROPHYLAXIS GUIDELINES IN DIABETIC PATIENTS IS ASSOCIATED WITH SIGNIFICANTLY HIGHER RISKS OF PENILE PROSTHESIS INFECTION
Abstract
INTRODUCTION AND OBJECTIVES:
The most devastating complication following penile prosthesis (PP) implantation is an infection requiring device explantation. Current AUA guidelines recommend antibiotic prophylaxis before PPI with an aminoglycoside and either a 1st/2nd generation cephalosporin or vancomycin. We conducted a multi-institutional study to examine infection rates in diabetic patients undergoing PP implantation with different prophylactic antibiotic regimens, and compared outcomes based on adherence to AUA guidelines.
METHODS:
Between April 2003 and May 2018, data was collected from 15 different institutions, and charts of 710 patients with diabetes receiving primary PP implantation were reviewed. Demographic data including age, race, Body Mass Index (BMI), and type of diabetes were collected for each patient. Pre-operative antibiotic regimen was recorded for each patient and primary outcomes were post-operative infection, explantation, and revision rates. Patients were included in the analysis only if they had complete information regarding perioperative antibiotics and outcomes. Univariate comparisons of proportions were completed for rates of infection, explantation, and revision between different antibiotic regimens.
RESULTS:
Overall, 603 patients had complete records and were included in this study. Median follow up was 7 months (range: 0 - 157). The total number of infections, explantations, and revisions for all patients included were 23 (3.8%), 29 (4.8%), and 33 (5.5%), respectively. The AUA prophylaxis guidelines were followed in 282 patients, 220 (36.5%) received Gentamicin + Vancomycin as prophylaxis and 62 (10.3%) received Gentamicin + Cephalosporin (Cefazolin), while 321 (53.2%) received prophylaxis that differed from guidelines. The number of infections in the AUA guidelines group was 17 (6.0%) vs. 6 (1.9%) for the non-AUA guidelines group, p = 0.008. The number of explantations in the AUA guidelines group was 23 (8.2%) vs. 6 (1.9%) in the non-AUA guidelines group, p < 0.001. There was no significant difference in revision rates between the two groups (p = 0.360). On further analysis, the infection rate for patients treated with Gentamicin + Vancomycin (7.73%) dropped significantly when a Quinolone (1.04%) was added to the regimen, p=0.001. Similar reductions were seen with explantation (9.6% to 1.0%, p < 0.001) and revision (8.2% to 3.1%, p = 0.028) rates. Adding an anti-fungal in combination with Gentamicin + Vancomycin non-significantly lowered the infection (0%), explantation (2.9%), and revision (0%) rates.
CONCLUSIONS:
Adherence to the AUA penile prosthesis antibiotic prophylaxis guidelines confers a higher rate of device infection in diabetic patients. A high rate of infection was noted in patients receiving the most commonly prescribed antibiotic regimen of Gentamicin + Vancomycin. The AUA guidelines should be amended to reflect findings of this and other device infection related studies.
MP27-06: IMMEDIATE PREOPERATIVE BLOOD GLUCOSE AND HEMOGLOBIN A1C LEVELS ARE NOT PREDICTIVE OF POST-OPERATIVE INFECTIONS IN DIABETIC MEN UNDERGOING PENILE PROSTHESIS PLACEMENT
Abstract
INTRODUCTION AND OBJECTIVES:
Recent reports have suggested that pre-operative diabetic control may be predictive of infection rates following penile prosthesis (PP) implantation. In this study, we sought to investigate whether immediate pre-operative serum blood glucose (PBG) levels were associated with PP infection rates in diabetic patients.
METHODS:
We conducted a retrospective review of 716 diabetic patients undergoing primary PP (inflatable and malleable) implantation from April 2003 to May 2018 across 15 institutions. PBG levels (within 6 hours of surgery) and Hemoglobin A1c (HbA1c) levels were recorded for each patient, along with clinical and demographic variables. Measured outcomes were rates of post-operative infection, revision and explantation. The impact of pre-operative glucose and HbA1c levels on post-operative infection rates was assessed using ANOVA and univariate analyses. The effects of age, diabetes type, diabetes related complications, body mass index, Charlson Comorbidity Index (CCI), history of immunosuppression, previous radical prostatectomy, and PP type were adjusted for, using logistic regression models.
RESULTS:
Median age was 61 years (range 34-86). Median follow-up was 7 months (range 0-157). Median and mean pre-operative glucose levels were 134.0 mg/dL (range 54-344) and 143.3 mg/dL ± 45.9, respectively, and median and mean pre-operative HbA1c levels were 7.2 % (range 4.8-15.2) and 7.5% ± 1.5, respectively. Most PP were inflatable (98.6%). Devices used were AMS 700 (43.2%), AMS Ambicor (0.1%), Coloplast Titan (55.3%), and Coloplast Genesis (1.3%). Surgical approach used was penoscrotal in 74.4%, subcoronal in 23.8%, and infrapubic in 1.8%. Post-operative infection, revision, and explantation rates were 3.8%, 5.9%, and 4.5%, respectively. There was no association between PBG levels and post-operative infection rates: continuous, p=0.413; cut-off >165 mg/dL, 75th percentile, p=0.500; cut-off >201 mg/dL, 90th percentile, p=0.393. Additionally, there was no association between pre-operative HbA1c levels and post-operative infection rates: continuous, p=0.430; cut-off >6.5%, p=0.611; cut-off> 8%, p=0.241. Similarly, there were no associations between explantation and revision rates with PBG levels (p=0.567 and 0.517, respectively), nor with HbA1c levels (p=0.219 and 0.160, respectively). On multivariate analysis, a higher CCI was a significant predictor of higher infection rates (p=0.040).
CONCLUSIONS:
In this large multi-institutional cohort of diabetic men undergoing PP implantation, neither PBG nor HbA1c levels were predictive of device infection. A higher CCI in diabetic patients predicts PP infection.
MP40-07: THE PREDICTIVE EFFECT OF FREE TESTOSTERONE ON SEXUAL FUNCTION INCREASES WITH AGE
Abstract
INTRODUCTION AND OBJECTIVES:
While the impacts of age and testosterone on sexual function have been well-studied, the additive relationship of these three variables has seldom been mentioned. In the present study, we seek to assess the impact of testosterone and age on baseline sexual function in men with prostate cancer.
METHODS:
We retrospectively reviewed 850 patients who presented for primary treatment of prostate cancer between December 2009 and June 2018. Preoperative sexual function was measured via the International Index of Erectile Function-5 (IIEF-5). Total and free testosterone (FT and TT) were collected and calculated preoperatively in 822 patients. To assess the impact of age, patients were stratified patients by decade of life and the most predictive cut-off was determined to be at 60 years of age. Univariate and multivariate analyses were conducted to assess impact of FT, TT, age, Body Mass Index (BMI), and pathological grade on sexual function.
RESULTS:
Overall, 822 patients were included, of which 35.4% (291/822) were <60 years. Mean FT was significantly higher in the <60 aged cohort (6.74±4.24 ng/dL) vs. the >60 aged cohort (5.6±2.52 ng/dL), (p<0.001). In multivariate analysis, FT was only an independent predictor of IIEF-5 scores for patients >60 years old (p=0.018), but not in patients younger than 60 (p=0.69). Similarly, BMI was not significantly correlated with sexual function in younger men (<60 years old) (p>0.05), but was an independent predictor in the older cohort (p<0.001). Age was an independent predictor of sexual function in both cohorts (p=0.001 for <60; p<0.001 for >60).
CONCLUSIONS:
Our results show that lower FT levels do not impact IIEF-5 scores in patients <60 years old, but have a negative effect on IIEF-5 scores in patient >60 years old. In this group, that effect worsens with age. A FT level should be obtained in all patients over the age of 60 undergoing radical prostatectomy to assess postoperative sexual function recovery.
MP40-09: RE-ENGINEERING THE INTERNATIONAL INDEX OF ERECTILE FUNCTION: EVALUATION OF A LARGE CLINICAL DATA SET
Abstract
INTRODUCTION AND OBJECTIVES:
The six-item version of the International Index of Erectile Function (IIEF6) is the predominant method of assessing erectile function in urology. There are, however, three obvious and immediate problems with using the IIEF6 in the clinic to evaluate an individual patient: i) no account of the use of erectile aids such as intracavernosal injections; ii) a man not engaging in sexual intercourse cannot reach the accepted threshold for erectile function (24+); iii) a man reporting no sexual activity is assigned a very low score (<6). We analyzed a large data set taken as part of routine care as well as a systematic comparison of the IIEF and EPIC sexual domain.
METHODS:
Data were from close to 25,000 IIEF questionnaires completed by radical prostatectomy patients as part of routine clinical follow-up at our institution, and 1550 surveys from patients who completed both an IIEF6 and an EPIC questionnaire in a prospective study. We examined results before and after adding a question concerning use of erectile aids along with instruction that the IIEF6 was to reflect experience without use of the aid. We also added a question for men who reported no intercourse, asking for the reason why. EPIC sexual function scores were analyzed for men who reported no sexual activity on the IIEF6.
RESULTS:
Of 16,753 surveys including data on erectile aide usage, 15% reported use, predominately injections (89%). A simple modeling analysis demonstrated that before introduction of the erectile aid question, some men using erectile aids would report IIEF6 scores with use of the aid, whereas other would not. Of men reporting not attempting sexual intercourse, 46% (95% C.I. 43%, 49%) gave a reason other than erectile dysfunction including lack of a partner, sexual orientation, sexual preference and health problems of the female partner. In men who did have sexual intercourse, doubling the first 3 questions on the IIEF6 gave almost perfect scores compared to the full IIEF6 (mean difference -0.1, limits of agreement was -3.3, 3.1). In 251 men reporting no sexual activity, 13% reported erections sufficient for sexual activity and 5.6% reported scores of at least 65 on the EPIC sexual function domain.
CONCLUSIONS:
Patient-reported outcome instruments for erectile function should include a question about erectile aids with patients asked to report experience without the use of aids. Lack of sexual activity and, more specifically, lack of sexual intercourse, cannot be taken as being indicative of erectile dysfunction.
MP58-06: ASSESSMENT OF ERYTHROCYTOSIS FOLLOWING LONG-ACTING TESTOSTERONE SUPPLEMENTATION
Abstract
INTRODUCTION AND OBJECTIVES:
Testosterone supplementation is known to stimulate erythropoiesis and can lead to erythrocytosis, which may be associated with adverse cardiovascular events. The mechanism by which erythrocytosis occurs is multifactorial, but long-acting formulations are believed to be associated with a lower risk of erythrocytosis compared to short-acting injections. We evaluated the available long-acting formulations of testosterone, subcutaneous testosterone pellets (TP) and testosterone undecanoate (TU), and their comparative risk of erythrocytosis.
METHODS:
A retrospective review of 127 patients treated with TP or TU for hypogonadism (total testosterone < 300 ng/dL) over a 5-year period was conducted. Men with hematopoietic disorders were excluded. Testosterone (T), free testosterone (FT), estradiol (E2), PSA, hemoglobin (Hgb), and hematocrit (Hct) were evaluated. Descriptive statistics (Pearson chi-square and t-test) and multivariate logistic regression were performed to evaluate variables associated with erythrocytosis, defined by Hct > 50%.
RESULTS:
Of 127 men reviewed, 79 received TP and 48 received TU. Baseline characteristics were similar between the groups, including age, BMI, and proportion of patients with diabetes, hypertension, hyperlipidemia, or history of cardiovascular disease. Pre-treatment mean total T (TP 188 ng/dL, TU 214 ng/dL, p = 0.063), FT (TP 38 ng/dL, TU 36 ng/dL, p = 0.60), PSA (TP 1.54 ng/mL, TU 1.70 ng/mL, p = 0.59), Hgb (TP 14.8 g/dL, TU 14.9 g/dL, p = 0.80), and Hct (TP 43.6%, TU 42.5%, p = 0.23) were similar between groups. Post-treatment T levels were higher in the TP group (mean T: TP 658 ng/dL, TU 530 ng/dL, p = < 0.01; mean peak T: TP 1039 ng/dL, TU 665 ng/dL, p < 0.01). Mean peak E2 levels were higher in the TP group (TP 59.7 pg/mL, TU 36.8 pg/mL, p < 0.01). Men on TP had a higher Hct (TP 48.6%, TU 46.4%, p < 0.01) and rate of erythrocytosis (TP 36.7%, TU 18.8%, p = 0.03). Longer duration on therapy was observed in the TP group (TP 40.1 mo., TU 18.5 mo., p = < 0.01) but no significant difference in the time to erythrocytosis (TP 13.1 mo., TU 7.4 mo., p = 0.11) was observed. On multivariate analysis, only pre-treatment hemoglobin was independently associated with increased risk of erythrocytosis (OR 1.92, 95% CI 1.24 - 2.98, p < 0.01).
CONCLUSIONS:
Erythrocytosis following long-acting testosterone supplementation was observed more often in men receiving TP with higher mean and peak T levels. The most important factor associated with erythrocytosis appears to be baseline hemoglobin concentration. Patients at risk for erythrocytosis may be more appropriate candidates for TU.
MP58-10: BIOCHEMICAL RECURRENCE RATES IN MEN WITH HIGH GRADE PROSTATE CANCER ON TESTOSTERONE THERAPY
Abstract
INTRODUCTION AND OBJECTIVES:
Testosterone therapy (TTH) in men with prostate cancer is controversial especially in men with high risk prostate cancer. This study assessed biochemical recurrence (BCR) rates in men with high risk prostate cancer.
METHODS:
We reviewed men who underwent radical prostatectomy (RP) with high risk prostate cancer (HRPC), defined as having a Gleason (GS) score of GS 6-7 with positive surgical margins (SMS+), lymph node involvement (LNI+), seminal vesicle involvement (SVI+) or GS ≥8 with any pathology status. BCR was defined as a prostate specific antigen (PSA) level of ≥ 0.1ng/mL. Low T was defined as an early morning total T (TT) <300nd/dl. Men were divided into 3 groups based on T levels and TTH: those with normal TT levels and no TTH (NT); men with low TT who did not receive TTH; men with low TT who received TTH. Clinical and pathological data were analyzed. Chi-square and ANOVA were performed for group comparisons. A series of proportional hazards models were estimated to assess the unadjusted and adjusted associations of predictors to time-to-BCR. Each predictor was fitted in an unadjusted model, then significant predictors from unadjusted models were included in a single adjusted model.
RESULTS:
1,407 men with HRPC were analyzed. Mean age = 61.7±7 years. 793 (56%) had normal TT (NT) levels with a mean TT of 481±156 ng/dL. 614 men had low TT levels (mean TT 136.2 ± 113.5 ng/dL), 590 not on TTH (LTNT), and 24 on TTH (LTT). Among men with low TT levels, those on TTH did not differ significantly from those not on TTH, by pathology status, but had lower Gleason scores (p=0.010) and were less likely to be LNI positive (17% LTT, 41% LTNT, p =0.041). Of the men on TTH, 25% were ≥ GS 8; of the GS 6-7 patients, 63% were SMS+, 42% SVI+, 17% LNI+. In our cohort, a total of 906 (64%) patients experienced BCR within 0.1-15.3 years. 57% of the NT group, 75% in the LTNT group and 46% of men in the LTT group (LTNT compared to LTT p=0.001). Older age, higher Gleason score, LNI+, SVI+, receipt of chemotherapy, radiation, or ADT, low T and TTH were associated with faster BCR rates in unadjusted models. After adjustment, low T and TTH were not associated with BCR after covariate adjustment.
CONCLUSIONS:
Men with HRPC with low T levels on TTH did not show an increased incidence of BCR when compared to men with HRPC who were not on TTH and men with normal TT levels.
MP65-18: PRELIMINARY OUTCOMES OF A NOVEL PENILE TRACTION DEVICE (RESTOREX) IN MEN WITH PEYRONIE’S DISEASE: A RANDOMIZED, CONTROLLED TRIAL
Abstract
INTRODUCTION AND OBJECTIVES:
Penile traction therapy (PTT) is a common treatment used in the management of Peyronie’s disease (PD). However, existing PTT devices require daily utilization for ≥5 hours and data regarding penile curvature and length improvements are inconsistent and of unclear clinical benefit. Given these limitations, a novel PTT device, RestoreX, was developed specifically as a primary or adjunctive therapy for PD. Here, we sought to assess the safety and efficacy of the RestoreX PTT device in men with PD.
METHODS:
A randomized, controlled trial (NCT03389854) is ongoing to evaluate the impact of PTT with RestoreX in 120 men with PD. Men are randomized to one of four groupings: no therapy (control) or treatment with Restorex for 30 minutes 1x, 2x, or 3x daily for 3 months. All men then enter an open label phase for an additional 3 months. Inclusion criteria are no current or recent PD therapies and ≥30 degrees curvature. The primary outcome is safety, and secondary outcomes include penile length, curvature, and subjective responses to standardized (IIEF, PDQ) and non-standardized questionnaires. Assessments are obtained at baseline and 3 and 6 months after starting therapy.
RESULTS:
A total of 117 men have been enrolled to date, with 3-month data available on 85 patients (control, n=19, PTT, n=66). Baseline clinicopathologic characteristics include a mean age of 58.4 (SD 7.8) years, mean PD duration 45.0 (42.0) months, mean primary curvature 45.7 (11.7) degrees, and mean stretched penile to coronal length of 11.5 (1.4) cm, all non-significant between PTT and controls. After 3 months of treatment, PTT significantly improved penile length (+1.4 cm [+9.9%] vs +0.3 cm [2.1%], p<0.01), and primary penile curvature (-9 degrees [-18.9%] vs -1.0 degrees [-2.4%], p<0.01) compared to controls. Results from the PD Questionnaire demonstrated significant improvements in the psychological/physical domain (PTT -2.6 vs -0.5, p=0.01). Of those who could not penetrate at baseline, 38% reported restored ability to penetrate (vs 0%, p<0.01), and 19% indicated that therapy negated a need for surgery. Adverse events with PTT were all mild and resolved within 5 minutes of completing therapy: mild discomfort (44%), erythema (39%), and sensory changes (15%).
CONCLUSIONS:
Based on preliminary results, in a cohort of PD men, PTT with RestoreX for 30-90 minutes daily resulted in statistically significant improvements in penile length and curvature at 3 months compared to controls with no significant adverse events.
PD44-02: A MULTI-INSTITUTIONAL ASSESSMENT OF MULTIMODAL ANALGESIA IN PENILE IMPLANT RECIPIENTS DEMONSTRATES DRAMATIC NARCOTICS REDUCTION
Abstract
INTRODUCTION AND OBJECTIVES:
Increasing regulations are being placed on providers in an effort to combat the growing opioid epidemic in the United States. Although implantation of an inflatable penile prosthesis (IPP) is associated with significant post-operative pain, there have been few rigorous attempts at describing non-opioid based pain management strategies for implant recipients. Here, we present results of a multi-institutional assessment of a multimodal analgesic (MMA) regimen in patients (pts) undergoing IPP surgery to a matched cohort of pts treated with a traditional opioid-based (OB) regimen.
METHODS:
We performed a multicenter comparison of pts undergoing IPP implantation by high-volume implanters whose pain was managed using a recently described, novel MMA protocol (Table 1) to a matched, historic cohort of pts managed via an OB protocol. Patients were excluded if they underwent any additional procedure or had a history of narcotic dependence. Both groups were compared with respect to visual analog pain scale (VAS), and opioid usage (total morphine equivalents, TME) in the post-anesthesia care unit (PACU), post-operative days (POD) zero and one, and in immediate post-discharge period. Narcotics usage on discharge and follow up were assessed and compared between both groups.
RESULTS:
91 pts were eligible for final analysis: 53 (58%) in MMA arm and 38 (42%) in the OB arm. There were no differences between groups with regards to age, race, BMI, or medical comorbidities. VAS was significantly lower in the MMA group in PACU (mean 1.1 vs 2.9, p=0.002), POD0 (mean 2.8 vs 4.7, p=0.001), and POD1 (mean 3.02 vs 4.00, p=0.04). Patients in the MMA group used fewer narcotics in the PACU (mean 1.6 vs 4.3 TME, p=0.002), POD0 (mean 5.8 vs 13.8 TME, p<0.001), and POD1 (mean 10.8 vs 25.1 TME, p=0.001). Despite being discharged with substantially fewer narcotics (mean 14.9 vs 51.3 tabs, p<0.001), a smaller proportion of MMA pts required narcotic refills (7.5% vs 47.4%, p<0.001). No pts in either group experienced significant medication-related side-effects.
CONCLUSIONS:
To our knowledge, this is the first multicenter pain management investigation in penile implant recipients. The use of a multimodal analgesic protocol not only demonstrates excellent durability in significantly reducing post-operative pain but further reduces inpatient and outpatient narcotic usage without any discernable side-effects.
PD44-09: ADHERENCE TO THE AUA ANTIBIOTIC PROPHYLAXIS GUIDELINES IN DIABETIC PATIENTS IS ASSOCIATED WITH SIGNIFICANTLY HIGHER RISKS OF PENILE PROSTHESIS INFECTION
Abstract
INTRODUCTION AND OBJECTIVES:
The most devastating complication following penile prosthesis (PP) implantation is an infection requiring device explantation. Current AUA guidelines recommend antibiotic prophylaxis before PPI with an aminoglycoside and either a 1st/2nd generation cephalosporin or vancomycin. We conducted a multi-institutional study to examine infection rates in diabetic patients undergoing PP implantation with different prophylactic antibiotic regimens, and compared outcomes based on adherence to AUA guidelines.
METHODS:
Between April 2003 and May 2018, data was collected from 15 different institutions, and charts of 710 patients with diabetes receiving primary PP implantation were reviewed. Demographic data including age, race, Body Mass Index (BMI), and type of diabetes were collected for each patient. Pre-operative antibiotic regimen was recorded for each patient and primary outcomes were post-operative infection, explantation, and revision rates. Patients were included in the analysis only if they had complete information regarding perioperative antibiotics and outcomes. Univariate comparisons of proportions were completed for rates of infection, explantation, and revision between different antibiotic regimens.
RESULTS:
Overall, 603 patients had complete records and were included in this study. Median follow up was 7 months (range: 0 - 157). The total number of infections, explantations, and revisions for all patients included were 23 (3.8%), 29 (4.8%), and 33 (5.5%), respectively. The AUA prophylaxis guidelines were followed in 282 patients, 220 (36.5%) received Gentamicin + Vancomycin as prophylaxis and 62 (10.3%) received Gentamicin + Cephalosporin (Cefazolin), while 321 (53.2%) received prophylaxis that differed from guidelines. The number of infections in the AUA guidelines group was 17 (6.0%) vs. 6 (1.9%) for the non-AUA guidelines group, p = 0.008. The number of explantations in the AUA guidelines group was 23 (8.2%) vs. 6 (1.9%) in the non-AUA guidelines group, p < 0.001. There was no significant difference in revision rates between the two groups (p = 0.360). On further analysis, the infection rate for patients treated with Gentamicin + Vancomycin (7.73%) dropped significantly when a Quinolone (1.04%) was added to the regimen, p=0.001. Similar reductions were seen with explantation (9.6% to 1.0%, p < 0.001) and revision (8.2% to 3.1%, p = 0.028) rates. Adding an anti-fungal in combination with Gentamicin + Vancomycin non-significantly lowered the infection (0%), explantation (2.9%), and revision (0%) rates.
CONCLUSIONS:
Adherence to the AUA penile prosthesis antibiotic prophylaxis guidelines confers a higher rate of device infection in diabetic patients. A high rate of infection was noted in patients receiving the most commonly prescribed antibiotic regimen of Gentamicin + Vancomycin. The AUA guidelines should be amended to reflect findings of this and other device infection related studies.
