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