e532 THE JOURNAL OF UROLOGY� Vol. 191, No. 4S, Supplement, Monday, May 19, 2014

all patients had normal erections documented with RigiScan� definedas greater than 60% rigidity for at least 10 minutes. Fourteen of 34(41.2%) patients had normal erections in the placebo group versus14 of36 (38.9%) patients in the Sildenafil group at the conclusion of the study(13 months). Multivariable generalized estimating equations (GEE)used to model sexual function over time, revealed that both IIEF (p-value<0.0001) and RigiScan� (p-value¼0.0005) scores improved overtime, but scores were not affected by treatment intervention. African-American men were found to be less likely than Caucasiansto demonstrate higher RigiScan� scores over time (OR: 0.44,p-value¼0.0167).

CONCLUSIONS: This study demonstrates that nightly use ofSildenafil citrate does not provide therapeutic benefit in the erectilefunction recovery post-prostatectomy. Regardless of therapy, bothsubjective and objective measurements of erectile function improveover time. Differences in objective recovery parameters based on pa-tients’ ethnicity may warrant further investigation.

Source of Funding: none

MP48-13EFFECTS OF TADALAFIL TREATMENT POST BILATERAL NERVE-SPARING RADICAL PROSTATECTOMY (NSRP): QUALITY OF LIFE(QOL), PSYCHOSOCIAL OUTCOMES AND TREATMENTSATISFACTION

Hitendra R. Patel*, Tromso, Norway; Nimish Shah, Cambridge, UnitedKingdom; Jonas Lundmark, Solna, Sweden; Jane Cooper Jones,Basingstoke, United Kingdom; Hartwig B€uttner, Carsten Henneges, BadHomburg, Germany; Julia Branicka, Warsaw, Poland; Dapo Ilo, ErlWood Manor, Windlesham, United Kingdom

INTRODUCTION AND OBJECTIVES: We report secondaryoutcomes on QoL and treatment satisfaction data from a multicenter,randomized, double-blind, double-dummy, placebo-controlled trial(NCT01026818) primarily evaluating the efficacy of tadalafil once-daily(OaD) or on-demand (pro re nata, PRN) treatment started earlypost-nsRP.

METHODS: Patients �68 years with adenocarcinoma of theprostate (Gleason �7, normal preoperative erectile function [EF]) wererandomized post-nsRP 1:1:1 to 9-month treatment with tadalafil 5mgOaD, tadalafil 20mg PRN, or placebo, followed by 6-week drug-freewashout and 3month open-label tadalafil OaD treatment. Secondaryoutcomes reported include changes in patients’ and partners’ ExpandedProstate Cancer Index Composite (EPIC26) and Erectile DysfunctionInventory of Treatment Satisfaction (EDITS), and Self-Esteem andRelationship (SEAR) questionnaires (pairwise comparisons, MMRM,adjusting for treatment, visit, treatment-by-visit interaction, age group,country, baseline score). LS means (95%CI) are reported.

RESULTS: 423 patients were randomized to tadalafil OaD(N¼139), PRN (N¼143), or placebo (N¼141); 57 (41.0%), 58 (40.6%),and 50 (35.5%) aged 61-68 years. At the end of double-blind treatment(EDT), patients’ EPIC sexual domain scores improved significantly withtadalafil OaD versus placebo (Table; treatment effect [95%CI]: 9.6[3.1,16.0]; p¼0.004); comparisons of PRN versus placebo at EDT, andboth comparisons versus placebo after open-label OAD treatment(EOL) were not significant. Only in older patients (61-68 years), EPICurinary incontinence domain scores also improved significantly withtadalafil OaD versus placebo (overall treatment effect across all visits8.3 [0.4,16.1]; p¼0.040). Treatment satisfaction increased significantlyin both tadalafil groups at EDT, EDITS total scores increased signifi-cantly with OaD and PRN versus placebo (p¼0.005 and 0.041). At EOL,improvement was significant for tadalafil OaD versus placebo only(p¼0.035). No significant differences were observed for SEAR.

CONCLUSIONS: These QoL data complement previously re-ported positive effects of tadalafil OaD on EF recovery at EDT.

Table: LS mean changes [95% CI] in EPIC and EDITS scores with tadalafil

OaD, tadalafil PRNand placebo from baseline to end of double-blind and

open-label treatment periods (EDT, EOL)

Tadalafil OaD

Tadalafil PRN Placebo

EPIC sexual domain score

(age-group by treatment

interaction: p = 0.083)

EDT

þ27.5 [21.6, 33.4]** þ20.7 [15.3, 26.1] þ18.0 [12.1, 23.8]

EOL

þ36.6 [30.0, 43.1] þ32.6 [26.6, 38.6] þ33.4 [27.0, 39.8]

Men � 60 years

þ30.1 [23.2, 36.9] þ31.2 [24.8, 37.6] þ24.9 [18.2, 31.6]

Men 61-68 years

þ34.0 [26.0, 42.0] þ22.1 [14.6, 29.5] þ26.5 [18.5, 34.4]

EPIC urinary incontinence

domain score (age-group by

treatment interaction: p = 0.084)

EDT

þ34.1 [29.3, 38.9] þ31.1 [26.7, 35.5] þ30.6 [25.9, 35.3]

EOL

þ37.4 [32.6, 42.3] þ35.5 [31.1, 40.0] þ35.4 [30.7, 40.2]

Men � 60 years

þ33.0 [27.7, 38.3] þ34.6 [29.6, 39.7] þ35.8 [30.5, 41.1]

Men 61-68 years

þ38.5 [32.2, 44.8]* þ32.0 [26.2, 37.9] þ30.2 [24.0, 36.5]

EPIC urinary irritative/obstructive

domain score

EDT

þ13.8 [11.5, 16.1] þ13.3 [11.2, 15.4] þ12.3 [10.0, 14.5]

EOL

þ13.9 [11.5, 16.2] þ13.8 [11.7, 15.9] þ12.3 [10.0, 14.6]

EPIC bowel domain score

EDT

þ5.9 [3.7, 8.2] þ6.3 [4.2, 8.3] þ6.5 [4.3, 8.7]

EOL

þ6.9 [4.7, 9.1] þ6.5 [4.5, 8.5] þ6.8 [4.6, 8.9]

EPIC hormonal domain score

EDT

þ1.7 [-0.8, 4.3] þ2.7 [0.4, 5.1]* -0.2 [-2.7, 2.3]

EOL

þ2.5 [0.1, 4.9] þ2.9 [0.8, 5.1] þ3.0 [0.7, 5.4]

EDITS total score

EDT

þ2.2 [2.0, 2.4]** þ2.1 [1.9, 2.3]* þ1.9 [1.7, 2.1]

EOL

þ2.5 [2.3, 2.8]* þ2.4 [2.2, 2.6] þ2.3 [2.0, 2.5]

Data are from mixed model for repeated measures (MMRM), including baselinescore, treatment, country, visit (EDT, EOL), age group (men � 60yrs, men 61-68yrs), and visit-by-treatment interaction. Age-group-by-treatment interaction wasincluded only if significant at the 10% level. For men � 60 years and 61-68 years,the overall treatment effect presented includes all visits from baseline to EOL.** p< 0.01, * p<0.05 versus placebo (MMRM)

Source of Funding: The study was funded by Eli Lilly andCompany.

MP48-14ONCE DAILY ADMINISTRATION OF UDENAFIL 50MG AND 75MGSAFELY IMPROVES ERECTILE DYSFUNCTION: THE OUTCOMEFROM A PHASE III MULTICENTER RANDOMIZED DOUBLE-BLINDCLINICAL TRIAL

Phil Hyun Song*, Young-Hwii Ko, Yoon Seob Ji, Bong Gi Ok,Ki Hak Moon, Hee Chang Jung, Daegu, Korea, Republic of

INTRODUCTION AND OBJECTIVES: To evaluate the efficacyand safety of different doses of Udenafil (50 mg and 75 mg) once perday for the patient with erectile dysfunction (ED), in comparison with aplacebo group.

METHODS: A phase III placebo-controlled, randomized, dou-ble-blind clinical trial was conducted for 346 Korean ED patients (114 forplacebo, 115 for Udenafil 50mg, and 117 for Udenafil 75mg). The in-clusion criteria were male adult with a history of a minimum of sixmonths of ED, which was defined as over 50% failure on sexual inter-course and below 25 on the International Index of Erectile Function(IIEF)-EF domain. Enrolled patients took a pill once per day at the sametime for 24 consecutive weeks. The primary end points were IIEF-EFdomain at 24 weeks and development of an adverse event (AE).

RESULTS: Regardless of dosage of Udenafil, it significantlyincreased IIEF-EF in comparison with placebo at both 12 and 24 weeks(Table). Global Assessment Question (GAQ) which was assessed at 24weeks showed a significant increase for both the Udenafil 50 mg and75mg groups (83.5% for both) in comparison with placebo group(40.7%). After administration for 24 weeks, the proportion of patientswho reported return to normal erectile function (IIEF-EF domainscore�26) was significantly increased in the Udefanil 50 mg (39.1%)and 75 mg (47.0%) groups, compared with 8.8% in the placebo group.

In terms of safety, AEs were observed in 27.2%, 37.9%, and 44.4%,respectively. Most of them had mild to moderate grade events,

Vol. 191, No. 4S, Supplement, Monday, May 19, 2014 THE JOURNAL OF UROLOGY� e533

dominantly consisting of flushing and headache. Seven patients in theplacebo group (6.1%), 15 patients (12.9%) in the Udenafil 50 mg group,and 21 patients (17.9%) in the Udenafil 75mg group experienced morethan one AE, with statistically higher occurrence in the Udenafil 75mggroup. Vital signs and the outcome of clinical laboratory tests weremaintained within normal range.

CONCLUSIONS: Our data suggest Udenafil as a novel daily5-phosphodiesterase inhibitor.

Placebo(n¼144)

Udenafil 50mg(n¼115)

Udenafil 75mg(n¼117)

Baseline (0 weeks) 14.68 � 4.39 14.87 � 4.7 14.09 � 4.53

12 weeks 16.82 � 5.88 22.42 � 5.73 21.97 � 6.24

24 weeks 17.25 � 6.07 22.77 � 5.59 22.92 � 6.47

Change from baseline(at 24 weeks)

2.56 � 5.78 7.9 � 6.15* 8.83 � 6.45*

Source of Funding: Dong-A Pharmaceutical Co., Ltd.

MP48-15EFFECTS OF SILODOSIN ON SEXUAL FUNCTION e REALISTICPICTURE FROM THE EVERYDAY CLINICAL PRACTICE

Andrea Salonia*, Paolo Capogrosso, Alessandro Serino, Luca Boeri,Michele Colicchia, Eugenio Ventimiglia, Giulia Castagna,Fabio Castiglione, Andrea Russo, Giovanni La Croce,Umberto Capitanio, Alberto Briganti, Milan, Italy; Francesco Cantiello,Rocco Damiano, Catanzaro, Italy; Francesco Montorsi, Milan, Italy

INTRODUCTION AND OBJECTIVES: We sought to determinethe effects of silodosin 8 mg, a highly selective once-daily dosinga1-adrenoceptor blocker, on sexual function, ejaculation, orgasm,sexual desire, erectile function, in sexually active men with lower urinarytract symptoms (LUTS) suggestive of BPH (LUTS/BPH).

METHODS: Sociodemographic and clinical data from 137consecutive patients treated with silodosin 8 mg for LUTS/BPH wereanalysed. Patients were interviewed about potential treatment-emer-gent adverse events (TEAEs) as taken from the patient informationleaflet of silodosin, along with some specific questions regarding sexualfunctioning. Moreover, all patients filled in the International ProstateSymptom Score (IPSS) at baseline and at the time of survey. Patientscompleted a remembered International Index of Erectile Function (IIEF)-Orgasmic Function (OF) domain (IIEF-Q9 [ejaculatory frequency] andQ10 [orgasmic frequency]), which targeted sexual function regarding aperiod preceding the treatment with silodosin and a real-time IIEF-OF,targeting the 4 weeks prior to the survey. Descriptive statistics and lo-gistic regression models tested the association between sexual functionand potential predictors.

RESULTS: Of all, 22 (16.1%) and 15 (10.9%) individualsrefused to participate to the survey and did not even start silodosin,respectively. Complete data were available for 100 patients [mean (SD)age: 63.2 (12) yrs; range 44-77]. Silodosin resulted highly effective inimproving IPSS total [16.3 (7.5) vs 10.7 (6.4); p<0.01], IPSS storage[7.1 (4.0) vs 4.5 (3.0); p<0.01], and IPSS voiding [9.2 (5.0) vs 6.1 (4.4);p<0.01]. Anejaculation, hypospermia, reduced or absent orgasmicfeeling, low sexual desire, and erectile dysfunction were subjectivelyreported by 48 (48%), 23 (23%), 11 (11%), 6 (6%), 7 (6%), and 10 (%)patients, respectively. Subjective feeling of reduced masculinity wasreported by 5 (5%) patients. Both IIEF-Q9 [4.3 (1.6) vs 2.0 (1.7);p¼0.001] and IIEF-Q10 [4.3 (1.6) vs 3.7 (1.7); p<0.01] significantlydecreased with silodosin. Anejaculation emerged as cause of discon-tinuation from silodosin in only 6% of the whole cohort. At logisticregression models, no independent predictors for either anejaculation,orgasmic function impairment or any other sexual dysfunctionwere observed.

CONCLUSIONS: Silodosin is a highly effective treatment forpatients with LUTS/BPH. Of them, roughly 70% report anejaculation orhypospermia. A more or less severe OF impairment is recorded in 17%

of the cases. Anejaculation is the cause of silodosin drop-off in only 6%of the patients.

Source of Funding: None

MP48-16EMPIRICAL VS. RISK-BASED APPROACH TOINTRACAVERNOSAL INJECTION THERAPY: A PROSPECTIVESTUDY

Robert Segal, Brian Le*, Kristen Burns, Arthur L. Burnett,Trinity Bivalacqua, Baltimore, MD

INTRODUCTION AND OBJECTIVES: Intracavernosal injection(ICI) therapy is widely used for ED. Employing it in practice is largelyempirical and has not been validated with evidence-based approaches.This study compares two strategies for ICI to determine whether a risk-based approach is more efficacious, increases satisfaction and/or re-sults in fewer treatment complications.

METHODS: After obtaining IRB approval, a prospective data-base of patients enrolled in the ICI program at the Johns HopkinsHospital from May 2012-present was amassed. Demographic informa-tion, treatment outcomes and subjective patient evaluations of sexualfunction (IIEF, QEQ, SQoL and EDITS questionnaires) were obtained atbaseline, 3 and 6 months. Two approaches were compared. Group 1consisted of empiric ICI treatment. Patients were treated with Prosta-glandin E1 10mcg, irrespective of ED etiology or severity, and only ifpoor response noted at test injection, then initiated on bimix or trimix.Group 2 was a risk-based approach, where using an algorithm thatfactored in: organic vs. neurogenic ED, number of ED risk factors,prostatectomy, nerve-sparing status, time from surgery and radiationstatus, patients were treated with either bimix, low- or high-dose trimix.Dose titration was permitted in both groups. Statistical analysis wascarried out using t-test and chi-squared analysis.

RESULTS: 156 patients were enrolled (55 in Group 1, 101 inGroup 2) with 3 and 6 month f/u at 57% and 35% respectively, andsimilar between groups. Baseline patient characteristics and sexualfunction questionnaire responses were similar between groups 1 and 2,(mean age 62 vs. 61.3 p¼0.73, IIEF-EF 8.25 vs. 7.30 p¼0.20, andSQoL 37.8 vs. 39.8 p¼0.27), though Group 1 reported higher qualityerections at baseline (QEQ 14.59 vs. 7.36 p¼0.02) and had a lowerproportion of post-prostatectomy patients 56% vs. 72% (p¼0.02). Inboth groups, quality of erections (QEQ) improved with treatment (mean10.98 vs. 60.24, p<0.05), SQoL improved (38.77 vs. 50.60, p<0.05),and IIEF-EF improved (7.78 vs. 18.85, p<0.05). However, betweengroups at 3 and 6 months, there were no statistically significant differ-ences in responses for IIEF, QEQ, SQoL or EDITS, and no difference infailure or medication switch rates. There were no significant differencesin complication rates, though at 3 months group 2 reported a higherincidence of priapism and pain (23% vs. 7.4% p¼0.08).

CONCLUSIONS: Both approaches resulted in significant im-provements across multiple domains of sexual function. Complicationsrates, satisfaction and efficacy overall were similar between bothapproaches.

Source of Funding: None

MP48-17PELVIC FLOOR MUSCLE REHABILITATION FOR PATIENTS WITHLIFELONG PREMATURE EJACULATION: A NOVEL THERAPEUTICAPPROACH.

Antonio Luigi Pastore, Giovanni Palleschi*, Luigi Silvestri,Andrea Fuschi, Yazan Al Salhi, Davide Moschese, Cristina Maggioni,Andrea Ripoli, Antonio Carbone, Latina, Italy

INTRODUCTION AND OBJECTIVES: Premature ejaculation(PE) is the most common male sexual disorder.In the present study,men with lifelong PE underwent pelvic floor muscle (PFM) rehabilitation