- Email: [email protected]
1229 DEVELOPING A RISK CALCULATOR TO PREDICT FUTURE PENILE PROSTHESIS IMPLANTATION IN PATIENTS DIAGNOSED WITH ERECTILE DYSFUNCTION
Vol. 189, No. 4S, Supplement, Monday, May 6, 2013
THE JOURNAL OF UROLOGY姞
e503
1229 DEVELOPING A RISK CALCULATOR TO PREDICT FUTURE PENILE PROSTHESIS IMPLANTATION IN PATIENTS DIAGNOSED WITH ERECTILE DYSFUNCTION Robert Segal*, Baltimore, MD; Stephen Camper, Chadds Ford, PA; Arthur Burnett, Baltimore, MD; Larry Ma, Chadds Ford, PA
Source of Funding: American Medical Systems
1228 MRI ANALYSIS OF ANATOMICAL LANDMARKS WITH RESPECT TO INFLATABLE PENILE PROSTHESIS RESERVOIR PLACEMENT John F Sullivan*, Pier L Di Paolo, Christian J Nelson, Oguz Akin, John P Mulhall, New York, NY INTRODUCTION AND OBJECTIVES: Insertion of a threepiece inflatable penile prosthesis (IPP) reservoir is a “blind procedure”. The traditional reservoir placement in the space of Retzius can result in damage to bladder, bowel and femoral blood vessels. A single cadaveric study has delineated pertinent anatomic relationships. We have attempted to evaluate similar anatomical measurements in an in vivo model using magnetic resonance imaging (MRI). METHODS: Endorectal MRI studies in men being evaluated for prostate cancer were reviewed. Prior pelvic surgery, radiation or an in situ urinary catheter were exclusions. Endorectal MRI was performed on a 3 Tesla system with T1 and T2 weighted images reviewed usingboth axial and sagittal planes. Pertinent anatomical landmarks were evaluated by 2 independent readers, blinded to clinical and pathological data. All measurements were defined by an experienced radiologist. Measurements included (i) distance from external inguinal ring(EIR) to external iliac vein(EIV) (ii) superior aspect of pubic symphysis (PS) to bladder and (iii) EIR to nearest bladder point. Correlation was measured between bladder volume and (iii). For distances (i) and (iii) bilateral measurements were obtained and data averaged as no significant differences were observed. Means and standard deviations are presented. Pearson correlations were used to assess the relationship between variables, and regression analysis use to predict changes in (iii) with respect to bladder volume. RESULTS: 24 MRI studies were reviewed. Mean distances: EIR to EIV ⫽ 3.09cm (2.23-3.84);superior aspect of PS to nearest point of bladder (midline) ⫽ 0.86cm (0.37-1.24); EIR to the nearest point of the bladder ⫽1.76cm (0.08-3.66). Correlation between EIR-bladder distance and bladder volume was r⫽-0.36, p⫽0.9. Average bladder volume was 93.04cm3 (34.5-177.6),(SD 36). On regression analysis as bladder volume increases by 10 cm3 the distance to the EIR decreased by 1mm. CONCLUSIONS: This is the first attempt to analyse anatomical landmarks with respect to IPP reservoir placement in an in vivo model. The close proximity of the external iliac vein and bladder should alert surgeons to the potential for damage to these structures during this procedure. This also emphasizes the importance of decompressing the bladder during reservoir placement. Source of Funding: None
INTRODUCTION AND OBJECTIVES: Penile prosthesis (PP) surgery is indicated based on undesirability, contraindication or ineffectiveness of initial management options for Erectile Dysfunction (ED). However, research on patients receiving PPs indicates that there is often an extended period between ED diagnosis and this definitive treatment. Therefore, we sought to determine the extent to which an individual’s medical history could be used to predict his likelihood of ultimately receiving a PP. METHODS: This retrospective analysis used claims data from the MarketScan Commercial and Medicare supplemental databases (2000 - 2010). The inclusion criteria were males, 18 years or older with one year of continuous enrollment at the first diagnosis of ED (index). Patients’ demographics, co-morbidities and ED therapy were derived based on their enrollment, medical and prescription histories. ED patients without PPs were censored at the end of their enrollment. The Cox proportional hazards model with stepwise selection was used to identify factors associated with a future PP implant. Comorbidities and ED therapies up to the index ED diagnosis were analyzed as fixed covariates. RESULTS: Approximately 1% of the dataset’s ED population (n⫽384,618) received a PP. Frequently presenting factors at the time of ED diagnosis in the Commercial (n⫽310,303) and Medicare (n⫽74,315) cohorts, respectively, were hypertension (46%, 67%), receipt of first-line ED therapy (37%, 47%) and diabetes mellitus (19%, 30%) while factors with the greatest predictive strength included prostate cancer (relative risk: 3.8, 2.3), diabetes mellitus (2.3, 1.3) and receipt of first-line therapy (1.4, 1.4), all p values ⬍ 0.01. The relative risks are multiplicative. For example, in the Commercial population, a patient presenting at ED diagnosis with a history of prostate cancer and diabetes mellitus and who had already received first-line therapy is 12.2 (3.8 ⫻ 2.3 ⫻ 1.4) times as likely to receive a PP as the ED patient without these factors. CONCLUSIONS: The presence and extent of specific medical history factors at the time of ED diagnosis significantly predicts an individual’s future likelihood of PP implantation. Calculating a patient’s likelihood of receiving a PP based on these factors can assist clinicians with the development of a care plan and with patient counseling. Source of Funding: None
1230 CLINICAL EFFICACY OF COLLAGENASE CLOSTRIDIUM HISTOLYTICUM IN THE TREATMENT OF PEYRONIE’S DISEASE BY BASELINE PENILE CURVATURE SEVERITY STRATUM: RESULTS FROM TWO LARGE DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED PHASE 3 STUDIES Larry Lipshultz*, Houston, TX; Martin Gelbard, Burbank, CA; Christopher Love, Mentone, VIC, Australia; Ted Smith, James Tursi, Gregory Kaufman, Malvern, PA; Abraham Morgentaler, Brookline, MA INTRODUCTION AND OBJECTIVES: The Investigation for Maximal Peyronie’s Reduction Efficacy and Safety Studies (IMPRESS) I and II examined the clinical efficacy of collagenase clostridium histolyticum (CCH) in subjects with Peyronie’s disease (PD). These large identical phase 3 randomized, double-blind, placebo-controlled studies examined percent change from baseline in penile curvature deformity determined using angular measurement of pharmacologic erection and PD symptom bother score from the PD questionnaire (PDQ) as coprimary endpoints. We examine whether CCH treatment outcomes from baseline to 52 weeks differed by baseline penile curvature severity stratum, 30°-60° versus 61°-90°.
THE JOURNAL OF UROLOGY姞
e503
1229 DEVELOPING A RISK CALCULATOR TO PREDICT FUTURE PENILE PROSTHESIS IMPLANTATION IN PATIENTS DIAGNOSED WITH ERECTILE DYSFUNCTION Robert Segal*, Baltimore, MD; Stephen Camper, Chadds Ford, PA; Arthur Burnett, Baltimore, MD; Larry Ma, Chadds Ford, PA
Source of Funding: American Medical Systems
1228 MRI ANALYSIS OF ANATOMICAL LANDMARKS WITH RESPECT TO INFLATABLE PENILE PROSTHESIS RESERVOIR PLACEMENT John F Sullivan*, Pier L Di Paolo, Christian J Nelson, Oguz Akin, John P Mulhall, New York, NY INTRODUCTION AND OBJECTIVES: Insertion of a threepiece inflatable penile prosthesis (IPP) reservoir is a “blind procedure”. The traditional reservoir placement in the space of Retzius can result in damage to bladder, bowel and femoral blood vessels. A single cadaveric study has delineated pertinent anatomic relationships. We have attempted to evaluate similar anatomical measurements in an in vivo model using magnetic resonance imaging (MRI). METHODS: Endorectal MRI studies in men being evaluated for prostate cancer were reviewed. Prior pelvic surgery, radiation or an in situ urinary catheter were exclusions. Endorectal MRI was performed on a 3 Tesla system with T1 and T2 weighted images reviewed usingboth axial and sagittal planes. Pertinent anatomical landmarks were evaluated by 2 independent readers, blinded to clinical and pathological data. All measurements were defined by an experienced radiologist. Measurements included (i) distance from external inguinal ring(EIR) to external iliac vein(EIV) (ii) superior aspect of pubic symphysis (PS) to bladder and (iii) EIR to nearest bladder point. Correlation was measured between bladder volume and (iii). For distances (i) and (iii) bilateral measurements were obtained and data averaged as no significant differences were observed. Means and standard deviations are presented. Pearson correlations were used to assess the relationship between variables, and regression analysis use to predict changes in (iii) with respect to bladder volume. RESULTS: 24 MRI studies were reviewed. Mean distances: EIR to EIV ⫽ 3.09cm (2.23-3.84);superior aspect of PS to nearest point of bladder (midline) ⫽ 0.86cm (0.37-1.24); EIR to the nearest point of the bladder ⫽1.76cm (0.08-3.66). Correlation between EIR-bladder distance and bladder volume was r⫽-0.36, p⫽0.9. Average bladder volume was 93.04cm3 (34.5-177.6),(SD 36). On regression analysis as bladder volume increases by 10 cm3 the distance to the EIR decreased by 1mm. CONCLUSIONS: This is the first attempt to analyse anatomical landmarks with respect to IPP reservoir placement in an in vivo model. The close proximity of the external iliac vein and bladder should alert surgeons to the potential for damage to these structures during this procedure. This also emphasizes the importance of decompressing the bladder during reservoir placement. Source of Funding: None
INTRODUCTION AND OBJECTIVES: Penile prosthesis (PP) surgery is indicated based on undesirability, contraindication or ineffectiveness of initial management options for Erectile Dysfunction (ED). However, research on patients receiving PPs indicates that there is often an extended period between ED diagnosis and this definitive treatment. Therefore, we sought to determine the extent to which an individual’s medical history could be used to predict his likelihood of ultimately receiving a PP. METHODS: This retrospective analysis used claims data from the MarketScan Commercial and Medicare supplemental databases (2000 - 2010). The inclusion criteria were males, 18 years or older with one year of continuous enrollment at the first diagnosis of ED (index). Patients’ demographics, co-morbidities and ED therapy were derived based on their enrollment, medical and prescription histories. ED patients without PPs were censored at the end of their enrollment. The Cox proportional hazards model with stepwise selection was used to identify factors associated with a future PP implant. Comorbidities and ED therapies up to the index ED diagnosis were analyzed as fixed covariates. RESULTS: Approximately 1% of the dataset’s ED population (n⫽384,618) received a PP. Frequently presenting factors at the time of ED diagnosis in the Commercial (n⫽310,303) and Medicare (n⫽74,315) cohorts, respectively, were hypertension (46%, 67%), receipt of first-line ED therapy (37%, 47%) and diabetes mellitus (19%, 30%) while factors with the greatest predictive strength included prostate cancer (relative risk: 3.8, 2.3), diabetes mellitus (2.3, 1.3) and receipt of first-line therapy (1.4, 1.4), all p values ⬍ 0.01. The relative risks are multiplicative. For example, in the Commercial population, a patient presenting at ED diagnosis with a history of prostate cancer and diabetes mellitus and who had already received first-line therapy is 12.2 (3.8 ⫻ 2.3 ⫻ 1.4) times as likely to receive a PP as the ED patient without these factors. CONCLUSIONS: The presence and extent of specific medical history factors at the time of ED diagnosis significantly predicts an individual’s future likelihood of PP implantation. Calculating a patient’s likelihood of receiving a PP based on these factors can assist clinicians with the development of a care plan and with patient counseling. Source of Funding: None
1230 CLINICAL EFFICACY OF COLLAGENASE CLOSTRIDIUM HISTOLYTICUM IN THE TREATMENT OF PEYRONIE’S DISEASE BY BASELINE PENILE CURVATURE SEVERITY STRATUM: RESULTS FROM TWO LARGE DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED PHASE 3 STUDIES Larry Lipshultz*, Houston, TX; Martin Gelbard, Burbank, CA; Christopher Love, Mentone, VIC, Australia; Ted Smith, James Tursi, Gregory Kaufman, Malvern, PA; Abraham Morgentaler, Brookline, MA INTRODUCTION AND OBJECTIVES: The Investigation for Maximal Peyronie’s Reduction Efficacy and Safety Studies (IMPRESS) I and II examined the clinical efficacy of collagenase clostridium histolyticum (CCH) in subjects with Peyronie’s disease (PD). These large identical phase 3 randomized, double-blind, placebo-controlled studies examined percent change from baseline in penile curvature deformity determined using angular measurement of pharmacologic erection and PD symptom bother score from the PD questionnaire (PDQ) as coprimary endpoints. We examine whether CCH treatment outcomes from baseline to 52 weeks differed by baseline penile curvature severity stratum, 30°-60° versus 61°-90°.