Nocturnal tumescence: a parameter for postoperative erectile integrity after nerve sparing radical prostatectomy. Effects of three-times-per-week versus on-demand tadalafil treatment on erectile function and continence recovery following bilateral nerve sparing radical prostatectomy: results of a prospective, randomized, and single-center study. Effect of nightly versus on-demand vardenafil on recovery of erectile function in men following bilateral nerve-sparing radical prostatectomy. Hypogonadal men nonresponders to the PDE5 inhibitor tadalafil benefit from normalization of testosterone levels with a 1% hydroalcoholic testosterone gel in the treatment of erectile dysfunction (TADTEST study). Effect of statin therapy on early return of potency after nerve sparing radical retropubic prostatectomy. Sildenafil: an orally active type 5 cyclic GMP-specific phosphodiesterase inhibitor for the treatment of penile erectile dysfunction. A return to normal erectile function with tadalafil once daily after an incomplete response to as-needed PDE5 inhibitor therapy. Safety and efficacy of vardenafil for the treatment of men with erectile dysfunction after radical retropubic prostatectomy. Efficacy and safety of combined oral therapy with tadalafil and alfuzosin: an integrated approach to the management of patients with lower urinary tract symptoms and erectile dysfunction. Preliminary report. Potency following robotic radical prostatectomy: a questionnaire based analysis of outcomes after conventional nerve sparing and prostatic fascia sparing techniques. A prospective trial comparing consecutive series of open retropubic and robot-assisted laparoscopic radical prostatectomy in a centre with a limited caseload. Treatment of erectile dysfunction after radical prostatectomy with sildenafil citrate (Viagra). Randomized comparison between laparoscopic and robot-assisted nerve-sparing radical prostatectomy. Efficacy and safety of dapoxetine in men with premature ejaculation and concomitant erectile dysfunction treated with a phosphodiesterase type 5 inhibitor: randomized, placebo-controlled, phase III study. Effects of daily low-dose treatment with phosphodiesterase type 5 inhibitor on cognition, depression, somatization and erectile function in patients with erectile dysfunction: a double-blind, placebo-controlled study Effects of tadalafil treatment on erectile function recovery following bilateral nerve-sparing radical prostatectomy: a randomised placebo-controlled study (REACTT). Sildenafil citrate after radical retropubic prostatectomy. Decision tree analyses of key patient characteristics in Middle Eastern/North African and Latin American men treated with long-acting and short-acting PDE5 inhibitors for erectile dysfunction Vardenafil improved patient satisfaction with erectile hardness, orgasmic function and sexual experience in men with erectile dysfunction following nerve sparing radical prostatectomy. An open-label, multicenter, randomized, crossover study comparing sildenafil citrate and tadalafil for treating erectile dysfunction in Chinese men naïve to phosphodiesterase 5 inhibitor therapy PDE5 inhibitors blunt inflammation in human BPH: a potential mechanism of action for PDE5 inhibitors in LUTS. The multinational Men's Attitudes to Life Events and Sexuality (MALES) Study Phase II: understanding PDE5 inhibitor treatment seeking patterns, among men with erectile dysfunction. Single institution 2-year patient reported validated sexual function outcomes after nerve sparing robot assisted radical prostatectomy.
PURPOSE The exact process and time required for rehabilitation of erectile function after nerve sparing prostatectomy remain unclear to date . Different theories of the pathophysiology of postoperative erectile dysfunction are currently being discussed . In a prospect i ve study we performed recordings of nocturnal penile tumescence and rigidity during the acute phase after nerve sparing radical prostatectomy , ie in the first night after removal of the catheter , to assess the organic penile integrity . MATERIAL S AND METHODS In 27 patients with local prostate carcinoma who had been sexually active before the intervention , we performed unilateral or bilateral nerve sparing radical prostatectomy . Preoperative sexual function of all patients was evaluated by the International Index of Erectile Function-5 question naire . On the day of catheter removal ( postoperative day 7 to 14 ) an  NPTR recording  was performed on the following night with an erectometer ( RigiScan ) . RESULTS All patients had a preoperative IIEF score greater than 18 . After removal of the catheter 25 of 27 patients ( 93 % ) showed 1 to 5 nocturnal rigidity increases by greater than 70 % for at least 10 minutes . In a control group of 4 patients who underwent radical prostatectomy without nerve sparing , no nocturnal erections were recorded . CONCLUSIONS NPTR recording during the acute phase after nerve sparing radical prostatectomy showed residual erectile function as early as the first night after catheter removal . These results are significant for selecting adequate pharmacological treatment for optimal therapy and rehabilitation of satisfactory erections and sexual function . In cases of early nocturnal tumescence , application of a PDE5 inhibitor can support successive organ rehabilitation . However , if tumescence does not occur , penile injection therapy is recommended Erectile dysfunction ( ED ) and urinary incontinence after bilateral nerve-sparing radical prostatectomy ( BNSRP ) still remain major causes of morbidity . Phosphodiesterase type 5 inhibitors ( PDE5-Is ) have a role in the treatment of ED after BNSRP . Several studies in patients with ED and lower urinary tract symptoms demonstrated that PDE5-Is could improve both erectile function and urinary symptoms . The aim of this study was to compare the efficacies of two dosing regimens of 20 mg tadalafil ( on-dem and and 3 times per week ) and to assess the role of tadalafil in recovery of erectile function and continence after BNSRP . We conducted a single-center , prospect i ve , r and omized controlled trial of three times per week versus on-dem and tadalafil 20 mg and a control group after BNSRP . A total of 129 preoperatively potent and continent patients were included in the study . The patients were evaluated at 6 weeks and 12 months postoperatively for erectile function and continence status . There was no significant difference between all three groups with respect to erectile function at 6 weeks after the surgery . Twelve months after the surgery , the International Index of Erectile Function score was significantly higher in the group using tadalafil 20 mg three times per week . However , there was no significant difference between the treated groups and the control group with respect to the continence status at 12 months after the surgery . There was no correlation between incontinence and ED after the surgery in all groups . Tadalafil 20 mg three times per week is an efficacious and well-tolerated treatment option for ED after BNSRP . Treatment with 20 mg tadalafil either three times per week or on dem and can not improve continence recovery after BNSRP compared with the control group BACKGROUND To date , no data have been available from large , well- design ed trials comparing on dem and and nightly dosing of phosphodiesterase type 5 ( PDE5 ) inhibitors on recovery of erectile function in postprostatectomy patients with erectile dysfunction ( ED ) . OBJECTIVE To investigate the effect of early postoperative dosing with vardenafil , administered either nightly or on dem and , compared with placebo on recovery of erectile function in men with ED following bilateral nerve-sparing radical prostatectomy ( NSRP ) surgery . DESIGN , SETTING , AND PARTICIPANTS A r and omised , double-blind , double-dummy , multicentre , parallel group study conducted at 87 centres across Europe , Canada , South Africa , and the United States . For inclusion , patients had to be scheduled to undergo bilateral NSRP within 1 mo of screening and have a normal International Index of Erectile Function erectile function domain ( IIEF-EF ) score of > or = 26 at screening . A total of 628 men , aged 18 - 64 yr , were r and omised to treatment . Study design consisted of a 9-mo double-blind treatment period , a 2-mo single-blind washout period , and an optional 2-mo open-label period . INTERVENTION Patients received placebo , nightly vardenafil , or on dem and vardenafil . MEASUREMENTS Primary outcome measure was the percentage of subjects with an IIEF-EF score of > or = 22 after the 2-mo washout period . Secondary variables included mean per-patient success rates for Sexual Encounter Profile ( SEP ) questions 2 and 3 . RESULTS AND LIMITATIONS No statistically significant differences were observed among treatment groups in the proportion of patients with an IIEF-EF score of > or = 22 or in SEP3 success rates after the washout period . On-dem and vardenafil treatment result ed in significantly greater IIEF-EF scores and better SEP3 response rates than placebo over the entire treatment period . CONCLUSIONS In this study of men with ED following bilateral NSRP , vardenafil was efficacious when used on dem and , supporting a paradigm shift towards on dem and dosing with PDE5 inhibitors in this patient group . TRIAL REGISTRATION European clinical trials data base ( EudraCT ; available at http://eudract.emea.europa.eu/ ) . TRIAL REGISTRATION NUMBER 11336 INTRODUCTION Addition of testosterone ( T ) may improve the action of phosphodiesterase type 5 inhibitors ( PDE5-Is ) in patients with erectile dysfunction not responding to PDE5-Is with low or low-normal T levels . AIMS To confirm this add-on effect of T in men optimally treated with PDE5-Is  and to specify the baseline T levels at which such an effect becomes significant . METHODS A multicenter , multinational , double-blind , placebo-controlled study of 173 men , 45 - 80 years , nonresponders to treatment with different PDE5-Is , with baseline total T levels ≤ 4 ng/mL or bioavailable T ≤ 1 ng/mL. Men were first treated with tadalafil 10 mg once a day ( OAD ) for 4 weeks ; if not successful , they were r and omized in a double-blind , placebo-controlled design to receive placebo or a 1 % hydroalcoholic T gel ( 50 mg/5 g gel ) , to be increased to 10 mg T if results were clinical ly unsatisfactory . Main Outcomes Measures . Mean change from baseline in the Erectile Function Domain Score of the International Index of Erectile Function and rate of successful intercourses ( Sexual Encounter Profile 3 question ) . RESULTS Erectile function progressively improved over a period of at least 12 weeks in both the placebo and T treatment groups . In the overall population with a mean baseline T level of 3.37 ± 1.48 ng/mL , no additional effect of T administration to men optimally treated with PDE5-Is was encountered . The differences between the T and placebo groups were significant for both criteria only in the men with baseline T ≤ 3 ng/mL. CONCLUSIONS The maximal beneficial effects of OAD dosing with 10 mg tadalafil may occur only after as many as 12 weeks . Furthermore , addition of T to this PDE5-I regimen is beneficial , but only in hypogonadal men with baseline T levels ≤ 3 PURPOSE We prospect ively investigated whether postoperative statin use would contribute to earlier recovery of erectile function in men who underwent bilateral nerve sparing radical retropubic prostatectomy for clinical ly localized prostate cancer . MATERIAL S AND METHODS A total of 50 potent men without hypercholesterolemia undergoing bilateral nerve sparing radical retropubic prostatectomy for clinical ly localized prostate cancer were prospect ively r and omized into 2 equal groups . Group 1 patients were instructed to ingest only 50 mg sildenafil per day if needed following hospital discharge after radical retropubic prostatectomy . Group 2 patients were prescribed atorvastatin at a dose of 10 mg daily from postoperative days 1 to 90 and they were also instructed to ingest sildenafil , as in group 1 . Patient status regarding potency and adverse events were assessed 6 months after surgery . RESULTS The 2 groups demonstrated no significant differences regarding various baseline factors , including International Index of Erectile Function-5 scores . Group 2 had a significantly higher postoperative International Index of Erectile Function-5 score than group 1 at 6 months postoperatively ( p = 0.003 ) . Meanwhile , as judged by a preset definition , the incidence of potent patients 6 months after prostatectomy was 26.1 % in group 1 and 55 % in group 2 ( p = 0.068 ) . Also , 17.4 % and 40 % of the men reported achieving intercourse by vaginal penetration without a phosphodiesterase 5 inhibitor in groups 1 and 2 , respectively ( p = 0.172 ) . No serious adverse events associated with medication were reported . CONCLUSIONS Postoperative treatment with atorvastatin in men who report normal erectile function preoperatively may contribute to earlier recovery of erectile function after nerve sparing radical retropubic prostatectomy Sildenafil ( Viagra , UK-92,480 ) is a novel oral agent under development for the treatment of  penile erectile dysfunction .  Erection is dependent on nitric oxide and its second messenger , cyclic guanosine monophosphate ( cGMP ) . However , the relative importance of phosphodiesterase ( PDE ) isozymes is not clear . We have identified both cGMP- and cyclic adenosine monophosphate-specific phosphodiesterases ( PDEs ) in human corpora cavernosa in vitro . The main PDE activity in this tissue was due to PDE5 , with PDE2 and 3 also identified . Sildenafil is a selective inhibitor of PDE5 with a mean IC50 of 0.0039 microM. In human volunteers , we have shown sildenafil to have suitable pharmacokinetic and pharmacodynamic properties ( rapid absorption , relatively short half-life , no significant effect on heart rate and blood pressure ) for an oral agent to be taken , as required , prior to sexual activity . Moreover , in a clinical study of 12 patients with erectile dysfunction without an established organic cause , we have shown sildenafil to enhance the erectile response ( duration and rigidity of erection ) to visual sexual stimulation , thus highlighting the important role of PDE5 in human penile erection . Sildenafil holds promise as a new effective oral treatment for penile erectile dysfunction INTRODUCTION An optimal outcome of an erectile dysfunction ( ED ) treatment is to enable a return to normal erectile function ( as defined by an International Index of Erectile Function-Erectile Function [ IIEF-EF ] domain score ≥ 26 ) . As-needed ( PRN ) phosphodiesterase type 5 ( PDE5 ) inhibitor treatment does not always result in a return-to-normal erectile function . AIM The combined studies evaluated whether treatment with tadalafil once daily would allow men to return to normal erectile function who had less than normal IIEF-EF domain scores while using a maximum dose of a PRN PDE5 inhibitor treatment . METHODS Men were ≥ 18 years of age , sexually active , reported a ≥ 3-month history of ED , and had been taking the maximum dose of sildenafil citrate , vardenafil , or tadalafil PRN . R and omization to once-daily therapy with tadalafil 2.5 mg to 5 mg ( N = 207 ) , tadalafil 5 mg ( N = 207 ) , or placebo  ( N = 209 ) for 12 weeks followed a 4-week maximum dose PRN PDE5 treatment and 4-week nondrug lead periods . Two identical double-blind , r and omized , placebo-controlled studies were conducted ; combined results are reported . MAIN OUTCOME MEASURE The main outcome measure was the percentage of subjects with a return-to-normal erectile function ( IIEF-EF domain score ≥ 26 ) when treated with tadalafil once daily compared with placebo . RESULTS In subjects not achieving normal erectile function with the maximum dose of a PRN PDE5 inhibitor , a higher percentage of subjects treated with tadalafil  had an IIEF-EF domain score ≥ 26 at end point ( tadalafil 2.5- to 5-mg group [ 39 % ] ; tadalafil 5-mg group [ 40 % ] ) compared with the placebo group ( 12.1 % ; P < 0.001 ) . Tadalafil was generally well tolerated and adverse events observed were consistent with previous reports of tadalafil once daily . CONCLUSIONS Treatment with tadalafil once daily significantly improved erectile function in men with mild to mild-moderate impairments in erectile function following PRN PDE5 inhibitor treatment PURPOSE More than one-third of men may experience erectile dysfunction ( ED ) after nerve sparing radical retropubic prostatectomy . The efficacy and safety of vardenafil , a potent , selective , phosphodiesterase 5 inhibitor , was assessed for the treatment of ED after radical prostatectomy . MATERIAL S AND METHODS In this double-blind study 440 men with ED after nerve sparing radical prostatectomy were r and omized to take placebo , or 10 or 20 mg vardenafil .  Efficacy was measured after 12 weeks using the erectile function domain of the International Index of Erectile Function , diary questions measuring vaginal penetration and intercourse success rates , and a global assessment question ( GAQ ) on erection . RESULTS Of the intent to treat population 70 % had severe ED ( erectile function less than 11 ) at baseline . After 12 weeks both vardenafil doses were significantly superior to placebo ( p < 0.0001 ) for all efficacy variables . Improved erections ( based on GAQ ) were reported by 65.2 % and 59.4 % of patients on 20 and 10 mg vardenafil , respectively , and by only 12.5 % of patients on placebo ( p < 0.0001 ) . Among men with bilateral neurovascular bundle sparing , positive GAQ responses were reported by 71.1 % and 59.7 % of patients on 20 and 10 mg vardenafil , respectively , versus 11.5 % of those on placebo ( p < 0.0001 ) . The average intercourse success rate per patient receiving 20 mg vardenafil was 74 % in men with mild to moderate ED and 28 % in men with severe ED , compared to 49 % and 4 % for placebo , respectively . Few adverse events were observed . They were generally mild to moderate headache , flushing and rhinitis . CONCLUSIONS In men with severe ED after nerve sparing radical retropubic prostatectomy , vardenafil significantly improved key indices of erectile function INTRODUCTION Alpha1-blockers ( AB ) are the first-line monotherapy for lower urinary tract symptoms ( LUTS ) .  Phosphodiesterase type 5 ( PDE5 ) inhibitors are the first-line treatment for erectile dysfunction ( ED ) . Numerous studies have supposed a significant association between ED and LUTS , but a causal relationship can not be established . AIM The aim was to evaluate the efficacy of a combined therapy with an AB ( alfuzosin ) and PDE5 inhibitors ( tadalafil ) in patients with LUTS and ED . METHODS This was a r and omized , open-label , three-arm study . A total of 66 men complaining of ED and LUTS were included in the study . Patients were assessed at baseline and after 12 weeks of study treatment , and then underwent r and omized allocation to either alfuzosin 10 mg once a day ( 22 patients ) or tadalafil 20 mg on alternative days ( 21 patients ) , or a combination of both ( 23 patients ) . MAIN OUTCOME MEASURES All participants completed the erectile function domain of the International Index of Erectile Function ( IIEF-EF ) and the International Prostatic Symptom Score ( IPSS ) . Other efficacy variables included maximum urinary flow rate ( Qmax ) and medium urinary flow rate ( Qave ) . RESULTS IIEF-EF tended to improve with alfuzosin alone ( + 15 % ) , while it was clearly improved with tadalafil alone ( + 36.3 % ) . The greatest improvement was experienced with the combination therapy ( + 37.6 % ) . Improvement in Qmax was observed in all groups , but patients receiving combination therapy had greater improvement ( 29.6 % ) than patients receiving either only alfuzosin ( 21.7 % ) or only tadalafil ( 9.5 % ) . IPSS was significantly improved in alfuzosin group ( 27.2 % ) , was more marked with the combination therapy ( 41.6 % ) , and a small increase , although not significant , was also observed with tadalafil ( 8.4 % ) . CONCLUSIONS Combined therapy improved ED and LUTS as demonstrated by the significant improvement in uroflowmetry measures and in IPSS and IIEF-EF scores . A significant improvement was also observed in quality of life assessment s. The beneficial effects of tadalafil on LUTS similar to the benefits of alfuzosin on ED , although present , were smaller PURPOSE Anatomical nerve sparing radical prostatectomy provides excellent cancer control , although the recovery of sexual function is variable . We recently described a technique to preserve the prostatic fascia ( veil of Aphrodite ) that appears to enhance the quality of nerve preservation during robotic prostatectomy . In January 2003 we initiated a prospect i ve study comparing patients undergoing prostatic fascia preservation with those undergoing conventional nerve sparing robotic radical prostatectomy .  We report results at 12 months of followup MATERIAL S AND METHODS From January to August 2003 , 58 potent men with a Sexual Health Inventory for Men score ( SHIM ) of greater than 21 without phosphodiesterase 5 inhibitors underwent Vattikuti Institute prostatectomy , including 35 with preservation of the prostatic fascia ( study ) and 23 with conventional nerve sparing ( control ) .  Potency was assessed with self-administered SHIM question naires 12 months after surgery . The primary end point was achievement of erections strong enough for penetration with or without oral medications . The secondary end point was the ability to achieve normal erections ( SHIM greater than 21 ) with and without medications . RESULTS At 12 months of followup 17 of 23 control ( 74 % ) and 34 of 35 study ( 97 % ) patients achieved erections strong enough for intercourse ( p = 0.002 ) . Four control ( 17 % ) and 18 study ( 51 % ) patients achieved normal erections ( SHIM greater than 21 ) without medication ( p < 0.0001 ) . Six control ( 26 % ) and 30 study ( 86 % ) patients achieved normal erections with or without phosphodiesterase 5 inhibitors ( p < 0.0001 ) . CONCLUSIONS Potency rates after radical prostatectomy vary with the measure used to define potency . Irrespective of the definition used patients undergoing prostatic fascia preserving radical prostatectomy have significantly better potency outcomes than patients undergoing conventional nerve sparing robotic prostatectomy at 12 months of followup BACKGROUND Robot-assisted radical prostatectomy ( RALP ) is performed worldwide , even in institutions with limited caseloads . However , although the results of large RALP series are available , oncologic and functional outcomes as well as complications from low-caseload centres are lacking . OBJECTIVE To compare perioperative , oncologic , and functional outcomes from two consecutive series of patients with localised prostate cancer treated by retropubic radical prostatectomy ( RRP ) or recently established RALP in our hospital , which has a limited caseload . DESIGN , SETTING , AND PARTICIPANTS One hundred fifty consecutive patients were enrolled . Their data and outcomes were collected and extensively evaluated . INTERVENTION Seventy-five consecutive patients underwent RRP , and 75 consecutive patients underwent RALP , including all patients of the learning curve . MEASUREMENTS Patient baseline characteristics , perioperative and postoperative outcomes , and complications were evaluated . End points were oncologic data ( positive margins , prostate-specific antigen [ PSA ] ) , perioperative complications , urinary continence , and erectile function at 3- and 12-mo follow-up . RESULTS AND LIMITATIONS The preoperative parameters from the two groups were comparable . The positive surgical margin ( PSM ) rates were 32 % for RRP and 16 % for RALP ( p=0.002 ) . For RRP and RALP , the PSA value was < 0.2 ng/ml in 91 % and 88 % of patients 3 mo postoperatively ( p=0.708 ) and in 87 % and 89 % of patients 12 mo postoperatively ( p=0.36 ) , respectively . Continence rates for RRP and RALP were 83 % and 95 % at 3-mo follow-up ( p=0.003 ) and 80 % and 89 % after 12-mo follow-up ( p=0.092 ) , respectively . Among patients who were potent without phosphodiesterase type 5 inhibitors ( PDE5-I ) before RRP and RALP , recovery of erectile function with and without PDE5-Is was achieved in 25 % ( 12 of 49 patients ) and 68 % ( 25 of 37 patients ) 3 mo postoperatively ( p=0.009 ) and in 26 % ( 12 of 47 patients ) and 55 % ( 12 of 22 patients ) 12 mo postoperatively ( p=0.009 ) , respectively . Minimal follow-up for RRP was 12 mo ; median follow-up for the RALP group was 12 mo ( range : 3 - 12 ) . According to the modified Clavien system , major complication rates for RRP and RALP were 28 % and 7 % ( p=0.025 ) , respectively ; minor complication rates were 24 % and 35 % ( p=0.744 ) , respectively . CONCLUSIONS Despite a limited caseload and including the learning curve , RALP offers slightly better results than RRP in terms of PSM , major complications , urinary continence , and erectile function OBJECTIVES To determine whether the response to the new oral medication , sildenafil citrate ( Viagra ) , was influenced by the presence or absence of the neurovascular bundles , as recent reports on its success did not specify the efficacy of the drug in patients with erectile dysfunction after radical prostatectomy . METHODS Baseline and follow-up data from 28 healthy patients presenting with erectile dysfunction after radical prostatectomy were obtained . Patients receiving any neoadjuvant/adjuvant hormones or adjuvant radiation therapy were excluded . Patients reported what their erectile status was before surgery , before sildenafil therapy , and after using a minimum of four doses of sildenafil . Both the patients and their spouses were interviewed using the Clevel and Clinic post-prostatectomy question naire , which includes questions about response to therapy , duration of intercourse , spousal satisfaction , side effects , and related topics . The patients were compared on the basis of the type of surgical procedure they had undergone-nerve sparing or non-nerve sparing . A positive response to sildenafil was defined as erection sufficient for vaginal penetration . RESULTS Of the 15 patients who had bilateral nerve-sparing procedures , 12 ( 80 % ) had a positive response to sildenafil , with a mean duration of 6.92 minutes of vaginal intercourse . These 12 patients also reported a spousal satisfaction rate of 80 % . All 12 of the responders had a positive response within the first three doses , and 10 of the 12 responded with the first or second dose . None of the 3 patients who had undergone a unilateral nerve-sparing procedure responded , nor did any of the 10 patients who had undergone a non-nerve-sparing procedure . The two most common side effects of the drug were transient headaches ( 39 % ) and abnormal color vision ( 11 % ) . No patients discontinued the medication because of side effects . CONCLUSIONS Successful treatment of erectile dysfunction in a patient after prostatectomy with sildenafil citrate may depend on the presence of bilateral neurovascular bundles . No patient who had undergone a non-nerve-sparing procedure responded . Whether patients who undergo unilateral nerve-sparing procedures will respond to sildenafil is still unclear because of the small number of patients in our study . These findings should encourage urologists to continue to perform and perfect the nerve-sparing approach . The ability to restore potency with an oral medication after radical prostatectomy will impact our discussion with the patient on the surgical morbidity of radical prostatectomy INTRODUCTION Lack of r and omized controlled trials ( RCTs ) that compare pure laparoscopic radical prostatectomy ( LRP ) with robot-assisted laparoscopic radical prostatectomy ( RALRP ) is an important gap of the literature related to the surgical treatment of the clinical ly localized prostate cancer ( PCa ) . AIM To provide the first prospect i ve r and omized comparison on the functional and oncological outcomes of LRP and RALRP for the treatment of the clinical ly localized PCa . METHODS Between 2007 and 2008 , 128 consecutive male patients were r and omized in two groups and treated by a single experienced surgeon with traditional LRP ( Group I-64 patients ) or RALRP ( Group II-64 patients ) in all cases with intent of bilateral intrafascial nerve sparing . MAIN OUTCOME MEASURES Primary end point was to compare the 12 months erectile function ( EF ) outcomes . Complication rates , continence outcomes , and oncological results were also compared . The sample size of our study was able , with an adequate power ( 1-beta > 0.90 ) , to recognize as significant large differences ( above 0.30 ) between incidence proportions of considered outcomes . RESULTS No statistically significant differences were observed for operating time , estimated blood loss , transfusion rate , complications , rates of positive surgical margins , rates of biochemical recurrence , continence , and time to continence . However , the 12-month evaluation of capability for intercourse ( with or without phosphodiesterase type 5 inhibitors ) showed a clear and significant advantage of RALRP ( 32 % vs. 77 % , P < 0.0001 ) . Time to capability for intercourse was significantly shorter for RALRP . Rates of return to baseline International Index of Erectile Function ( IIEF-6 ) EF domain score question naires ( questions 1 - 5 and 15 ) ( 25 % vs. 58 % ) and to IIEF-6 > 17 ( 38 % vs. 63 % ) were also significantly higher for RALRP ( P = 0.0002 and P = 0.008 , respectively ) . CONCLUSIONS Our study offers the first high-level evidence that RALRP provides significantly better EF recovery than LRP without hindering the oncologic radicality of the procedure . Larger RCTs are needed to confirm if a new gold-st and ard treatment in the field of RP has risen INTRODUCTION Men with comorbid erectile dysfunction ( ED ) and premature ejaculation ( PE ) may be concomitantly prescribed a phosphodiesterase type 5 ( PDE5 ) inhibitor and dapoxetine . AIM Evaluate efficacy and safety of dapoxetine 30 mg and 60 mg on dem and ( prn ) in men with PE and ED who were being treated with PDE5 inhibitors . METHODS This r and omized , double-blind , placebo-controlled , flexible-dose , multicenter study enrolled men ≥18 years who met diagnostic criteria for PE including intravaginal ejaculatory latency time ( IELT ) of ≤2 minutes in ≥75 % of sexual intercourse episodes ; were on stable regimen of a PDE5 inhibitor ; and had International Index of Erectile Function-erectile function domain score ≥21 . Subjects received placebo , dapoxetine 30 mg , or dapoxetine 60 mg prn ( 1 - 3 hours before intercourse ) for 12 weeks . MAIN OUTCOME MEASURE Stopwatch-measured average IELT , Clinical Global Impression of Change ( CGIC ) in PE , Premature Ejaculation Profile ( PEP ) , and treatment-emergent adverse events ( TEAEs ) . RESULTS Of 495 subjects r and omized , 429 completed the study . Arithmetic mean average IELT significantly increased with dapoxetine vs. placebo at end point ( 5.2 vs. 3.4 minutes ) and weeks 4 , 8 , and 12 ( P ≤ 0.002 for all ) . Men who described their PE at least " better " using the CGIC were significantly greater with dapoxetine vs. placebo at end point ( 56.5 % vs. 35.4 % ) and weeks 4 , 8 , and 12 ( P ≤ 0.001 for all ) . Significantly better outcomes were also reported with dapoxetine vs.  placebo on PEP measures . Incidence of TEAEs was 20.0 % and 29.6 % in placebo- and dapoxetine-treated subjects , respectively ( P = 0.0135 ) . TEAEs led to discontinuation in 1.6 % of subjects in both groups . Most frequent TEAEs were known adverse drug reactions of dapoxetine treatment including nausea ( 9.2 % ) , headache ( 4.4 % ) , diarrhea ( 3.6 % ) , dizziness ( 2.4 % ) , and dizziness postural ( 2.4 % ) . CONCLUSIONS In men with PE and comorbid ED on a stable regimen of PDE5 inhibitor , dapoxetine provided meaningful treatment benefit and was generally well tolerated Phosphodiesterase type 5 ( PDE5 ) inhibitors have recently been shown to have cognitive-enhancing effects in animal models and in our previous pilot study . To investigate the efficacy of daily low-dose treatment with a PDE5 inhibitor on cognitive function , depression and somatization in patients with erectile dysfunction ( ED ) , 8-week , double-blind , placebo-controlled study enrolled 60 male patients with ED for ≥3 months without cognitive impairment . Forty-nine patients completed the study . Patients were r and omized to receive either daily low-dose udenafil 50 mg or placebo for 2 months . The International Index of Erectile Function-5 ( IIEF-5 ) , the Korean version of the Mini-Mental State Examination ( K-MMSE ) for general cognitive function and the Seoul Neuropsychological Screening Battery for comprehensive neuropsychological examination , the Physical Health Question naire-9 ( PHQ-9 ) for depression and the Physical Health Question naire-15 ( PHQ-15 ) for somatization were administered at baseline and at 2 months . The change in the mean IIEF-5 was significantly higher in the udenafil group than the placebo group ( 6.08±4.72 vs 2.20±3.50 , P=0.008 ) . The changes in the PHQ-9 and PHQ-15 were −2.04±3.14 and −2.17±2.87 in the udenafil group , and 1.20±1.63 and 0.56±2.48 in the placebo group ( both , P<0.001 ) . The changes in the K-MMSE and Digit Span Forward were 1.25±1.26 and 0.92±1.02 in the udenafil group , and −0.52±1.19 and −0.24±1.13 in the placebo group ( both , P<0.001 ) . However , there were no differences in the other neuropsychological tests . Daily dosing with a PDE5 inhibitor seems to improve cognitive function , depression and somatization , as well as erectile function , in patients with ED BACKGROUND The potential rehabilitative and protective effect of phosphodiesterase type 5 inhibitors ( PDE5-Is ) on penile function after nerve-sparing radical prostatectomy ( NSRP ) remains unclear . OBJECTIVE The primary objective was to compare the efficacy of tadalafil 5 mg once daily and tadalafil 20 mg on dem and versus placebo taken over 9 mo in improving unassisted erectile function ( EF ) following NSRP , as measured by the proportion of patients achieving an International Index of Erectile Function-Erectile Function domain ( IIEF-EF ) score ≥ 22 after 6-wk drug-free washout ( DFW ) . Secondary measures included IIEF-EF , Sexual Encounter Profile question 3 ( SEP-3 ) , and penile length . DESIGN , SETTING , AND PARTICIPANTS R and omised , double-blind , double-dummy , placebo-controlled trial in men ≤ 68 yr of age with adenocarcinoma of the prostate ( Gleason ≤ 7 ) and normal preoperative EF who underwent NSRP at 50 centres from nine European countries and Canada . INTERVENTIONS 1:1:1 r and omisation to 9 mo of treatment with tadalafil 5 mg once daily , tadalafil 20 mg on dem and , or placebo followed by a 6-wk DFW and 3-mo open-label tadalafil once daily ( all patients ) . OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS Logistic regression , mixed-effects model for repeated measures , and analysis of covariance , adjusting for treatment , age , and country , were applied to IIEF-EF scores ≥ 22 , SEP-3 , and penile length . RESULTS AND LIMITATIONS Four hundred twenty-three patients were r and omised to tadalafil once daily ( n=139 ) , on dem and ( n=143 ) , and placebo ( n=141 ) . The mean age was 57.9 yr of age ( st and ard deviation : 5.58 yr ) ; 20.9 % , 16.9 % , and 19.1 % of patients in the tadalafil once daily , on dem and , and placebo groups , respectively , achieved IIEF EF scores ≥ 22 after DFW ; odds ratios for tadalafil once daily and on dem and versus placebo were 1.1 ( 95 % confidence interval [ CI ] , 0.6 - 2.1 ; p=0.675 ) and 0.9 ( 95 % CI , 0.5 - 1.7 ; p=0.704 ) . At the end of double-blind treatment ( EDT ) , least squares ( LS ) mean IIEF-EF score improvement significantly exceeded the minimally clinical ly important difference ( MCID : ΔIIEF-EF ≥ 4 ) in both tadalafil groups ; for SEP-3 ( MCID ≥ 23 % ) , this was the case for tadalafil once daily only . Treatment effects versus placebo were significant for tadalafil once daily only ( IIEF-EF : p=0.016 ; SEP-3 : p=0.019 ) . In all groups , IIEF-EF and SEP-3 decreased during DFW but continued to improve during open-label treatment . At month 9 ( EDT ) , penile length loss was significantly reduced versus placebo in the tadalafil once daily group only ( LS mean difference 4.1 mm ; 95 % CI , 0.4 - 7.8 ; p=0.032 ) . CONCLUSIONS Tadalafil once daily was most effective on drug-assisted EF in men with erectile dysfunction following NSRP , and data suggest a potential role for tadalafil once daily provided early after surgery in contributing to the recovery of EF after prostatectomy and possibly protecting from penile structural changes . Unassisted EF was not improved after cessation of active therapy for 9 mo . TRIAL REGISTRATION Clinical Trials.gov identifier NCT01026818 PURPOSE Erectile dysfunction continues to be a significant problem for men after radical retropubic prostatectomy  despite nerve sparing techniques . Sildenafil citrate ( Viagra ) has proved effective for erectile dysfunction in many men . We determine the efficacy of sildenafil in men with erectile dysfunction after radical retropubic prostatectomy  and examine variables that may impact the response to treatment . MATERIAL S AND METHODS A total of 84 men were prescribed sildenafil after radical retropubic prostatectomy  and asked to complete a series of question naires , including the International Index of Erectile Function ( IIEF ) , on erectile function before and after sildenafil administration . The importance of factors , such as patient age , time since surgery , degree of cavernous nerve sparing , preoperative prostate specific antigen , Gleason score , clinical and pathological stage , and baseline postoperative erectile function , was examined . RESULTS Of the 84 patients 45 ( 53 % ) had improved erections and 34 ( 40 % ) had improved ability for intercourse while taking sildenafil .  Mean IIEF score for the erectile function domain increased from 9 to 14 ( p < 0.001 ) . Orgasmic function ( p = 0.004 ) and intercourse satisfaction ( p = 0.009 ) also significantly improved . The degree of nerve sparing and baseline postoperative erectile dysfunction had a significant impact on the ability of sildenafil to improve erectile function ( p = 0.010 and p < 0.001 , respectively ) and total IIEF question naire responses ( p = 0.031 and p < 0.001 , respectively ) . Age and pathological stage also appeared to have a significant effect . CONCLUSIONS Sildenafil improved erectile function and the ability to have intercourse in more than half of men after radical retropubic prostatectomy . Baseline postoperative erectile function , which is dependent on the degree of nerve sparing technique , significantly impacts the likelihood that patients will respond to sildenafil Abstract Background : Phosphodiesterase type 5 ( PDE5 ) inhibitors have discontinuation rates as high as 60 % in men with erectile dysfunction . Treatment satisfaction has been significantly associated with treatment continuation . Underst and ing key characteristics in terms of treatment preference , relationship , and lifestyle issues could provide direction on how to improve compliance with PDE5 inhibitor treatment globally . Objective : The objective was to identify subgroups of interest in the pooled data base of two observational studies conducted in Latin America ( LA ) and Middle East/North Africa ( MENA ) exploring patient characteristics and prescription of either a long- or short-acting PDE5 inhibitor at baseline . Methods : Two identical prospect i ve , non-interventional , observational , studies in MENA ( N = 493 ) and LA ( N = 511 ) treated men with an ‘ on dem and ’ ( pro re nata , PRN ) PDE5 inhibitor ( sildenafil , tadalafil , vardenafil , or lodenafil ) during 6 months . In this post-hoc meta- analysis of two observational studies with equal design , pooled data were analyzed to determine patient characteristics and PDE5 inhibitor prescribed/used most likely to be associated with patient expectations , satisfaction , self-esteem , and patient – partner relationships . Decision tree analyses , with and without weighting , were used to identify and describe key features . Results : In each analysis of patient expectations , patient – partner relationship , and self-esteem , we describe the two major subgroups at baseline for each decision tree . Analyses of patient expectations and sexual self-esteem revealed that patients prescribed long-acting PDE5 inhibitors ( 59 % ) highlighted the importance of treatment effect duration , second to partner satisfaction with treatment , while patients prescribed short-acting PDE5 inhibitors ( 32 % ) placed less importance on treatment effect duration but considerable importance on treatment effect lasting until intercourse completion . Further insights regarding patients , partner relationship characteristics , and treatment expectations were identified . Conclusion : Our analyses have described key characteristics , such as self- and partner perceptions , sexual attitudes , and treatment expectations in relation to the patients ’ country and prescribed treatment , which might guide treatment decisions in MENA and LA men with ED PURPOSE Nerve sparing radical retropubic prostatectomy ( NS-RRP ) results in erectile dysfunction in a significant number of patients . Vardenafil , a potent and selective phosphodiesterase type 5 inhibitor , is generally safe . It improves International Index of Erectile Function erectile function domain scores , and penetration and erection maintenance success rates in patients who have undergone NS-RRP . We report additional parameters important to patient perceptions regarding erection quality and satisfaction with sexual experience following NS-RRP . MATERIAL S AND METHODS A total of 440 men at 58 centers throughout the United States and Canada participated in this r and omized , placebo controlled , double-blind trial with 3 phases , namely baseline ( 4-week untreated period ) , treatment ( 12 weeks ) and followup ( 7 days ) . Participants received placebo ( 145 ) , 10 mg vardenafil ( 146 ) or 20 mg vardenafil ( 149 ) at home on dem and but no more than once per calendar day . Efficacy and satisfaction with erection quality and sexual experience were determined during the trial . RESULTS The 10 and 20 mg vardenafil doses were significantly superior to placebo for the International Index of Erectile Function domains for intercourse satisfaction , orgasmic function and overall satisfaction with sexual experience ( vs placebo p < 0.0009 ) . Significant improvement in the satisfaction rate with erection hardness were demonstrated for each vardenafil dose compared with placebo ( p < 0.0001 ) . Vardenafil was generally well tolerated . Common adverse events were headache , vasodilatation and rhinitis . CONCLUSIONS In this difficult to treat population of men with erectile dysfunction subsequent to NS-RRP on dem and treatment with vardenafil during a 3-month period significantly improved key aspects of the sexual experience important to patient quality of life The study was to compare treatment preference , efficacy , and tolerability of sildenafil citrate ( sildenafil ) and tadalafil for treating erectile dysfunction ( ED ) in Chinese men naοve to phosphodiesterase 5 ( PDE5 ) inhibitor therapies .  This multicenter , r and omized , open-label , crossover study evaluated whether Chinese men with ED preferred 20-mg tadalafil or 100-mg sildenafil . After a 4 weeks baseline assessment , 383 eligible patients were r and omized to sequential 20-mg tadalafil per 100-mg sildenafil or vice versa for 8 weeks respectively and then chose which treatment they preferred to take during the 8 weeks extension . Primary efficacy was measured by Question 1 of the PDE5 Inhibitor Treatment Preference Question naire ( PITPQ ) . Secondary efficacy was analyzed by PITPQ Question 2 , the International Index of Erectile Function ( IIEF ) erectile function ( EF ) domain , sexual encounter profile ( SEP ) Questions 2 and 3 , and the Drug Attributes Question naire . Three hundred and fifty men ( 91 % ) completed the r and omized treatment phase . Two hundred and forty-two per 350 ( 69.1 % ) patients preferred 20-mg tadalafil , and 108/350 ( 30.9 % ) preferred 100-mg sildenafil ( P < 0.001 ) as their treatment in the 8 weeks extension . Ninety-two per 242 ( 38 % ) patients strongly preferred tadalafil and 37/108 ( 34.3 % ) strongly the preferred sildenafil . The SEP2 ( penetration ) , SEP3 ( successful intercourse ) , and IIEF-EF domain scores were improved in both tadalafil and sildenafil treatment groups . For patients who preferred tadalafil , getting an erection long after taking the medication was the most reported reason for tadalafil preference . The only treatment-emergent adverse event reported by > 2 % of men was headache . After tadalafil and sildenafil treatments , more Chinese men with ED naοve to PDE5 inhibitor preferred tadalafil . Both sildenafil and tadalafil treatments were effective and safe BACKGROUND Metabolic syndrome ( MetS ) and benign prostate hyperplasia (BPH)/low urinary tract symptoms ( LUTS ) are often comorbid . Chronic inflammation is one of the putative links between these diseases . Phosphodiesterase type 5 inhibitors ( PDE5i ) are recognized as an effective treatment of BPH-related LUTS . One proposed mechanism of action of PDE5 is the inhibition of intraprostatic inflammation . In this study we investigate whether PDE5i could blunt inflammation in the human prostate . METHODS Evaluation of the effect of tadalafil and vardenafil on secretion of interleukin 8 ( IL-8 , a surrogate marker of prostate inflammation ) by human myofibroblast prostatic cells ( hBPH ) exposed to different inflammatory stimuli . We preliminary evaluate histological features of prostatic inflammatory infiltrates in BPH patients enrolled in a r and omized , double bind , placebo controlled study aim ed at investigating the efficacy of vardenafil ( 10 mg/day , for 12 weeks ) on BPH/LUTS . RESULTS In vitro treatment with tadalafil or vardenafil on hBPH reduced IL-8 secretion induced by either TNFα or metabolic factors , including oxidized low-density lipoprotein , oxLDL , to the same extent as a PDE5-insensitive PKG agonist Sp-8-Br-PET-cGMP . These effects were reverted by the PKG inhibitor KT5823 , suggesting a cGMP/PKG-dependency . Treatment with tadalafil or vardenafil  significantly suppressed oxLDL receptor ( LOX-1 ) expression . Histological evaluation of anti-CD45 staining ( CD45 score ) in prostatectomy specimens of BPH patients showed a positive association with MetS severity . Reduced HDL-cholesterol and elevated triglycerides were the only MetS factors significantly associated with CD45 score . In the MetS cohort there was a significant lower CD45 score in the vardenafil-arm versus the placebo-one OBJECTIVE The aim of Phase II of the Men 's Attitudes to Life Events and Sexuality ( MALES ) Study is to explore PDE5 inhibitor treatment seeking among men with erectile dysfunction ( ED ) . METHODS Phase II of the MALES study involved 2,912 men , aged 20 - 75 years , from 8 countries ( U.S. , U.K. , Germany , France , Italy , Spain , Mexico , and Brazil ) , who reported ED . Participants were recruited from the MALES Phase I sample [ 1 ] and via booster methods ( e.g. , physician referral , street interception ) , and completed self-report question naires concerning the characteristics of their ED , their efforts to seek PDE5 inhibitor treatment for their sexual dysfunction , and attitudinal and referent influences that potentially affect treatment-seeking . Statistical analyses focus on identification of correlates of PDE5 inhibitor treatment seeking . RESULTS PDE5 inhibitor utilization is strongly associated with ED sufferers ' assessment of the severity of their sexual dysfunction , with their belief that medication for ED is dangerous , and with their perceptions of whether physicians , other professionals , and spouses or family members are supportive of their seeking treatment . ED sufferers who evaluate their sexual dysfunction as severe , who believe that medication for ED is not dangerous , and who perceive support for treatment seeking from referent others , are more likely to utilize PDE5 inhibitor treatment . CONCLUSION Findings indicate that perceived ED severity , beliefs about ED medication , and referent influences are strongly correlated with utilization of PDE5 inhibitor therapy . These findings aid our underst and ing of factors that may incline men with ED to seek-or to avoid-PDE5 inhibitor therapy for their sexual dysfunction , and provide a basis for clinical and educational interventions to assist men with ED to seek appropriate treatment PURPOSE To identify surgeon specific factors for preserving sexual function ( and minimize patient related factors ) we report 2-year potency outcomes in men 65 years or younger with normal preoperative sexual function undergoing nerve sparing robot assisted laparoscopic radical prostatectomy .  MATERIAL S AND METHODS Between July 2004 and February 2006 , 200 consecutive patients underwent robot assisted laparoscopic radical prostatectomy by 1 surgeon . Inclusion criteria were age 65 years or younger with normal baseline 5-item International Index of Erectile Function score of 22 to 25 and complete 2-year followup . Postoperatively potency was defined by a yes to " erections adequate for vaginal penetration " and " satisfactory erections " on prospect i ve self-administered vali date d question naires with or without phosphodiesterase type 5 medications . Men also reported 5-item International Index of Erectile Function scores and erectile fullness of 0 % to 10 % , 25 % , 50 % , 75 % or 100 % compared to before surgery . RESULTS A total of 62 patients met the inclusion criteria , and of these 3 were lost to followup and 1 was excluded from study due to receiving hormonal therapy . At 3 months 32.1 % reported potency . At 24 months potency was 89.7 % ( 52 of 58 ) overall , 93.0 % ( 40 of 43 ) for bilateral and 80.0 % ( 12 of 15 ) for unilateral nerve sparing . For potent men the mean 5-item International Index of Erectile Function score was 20.4 at 3 months vs 21.3 at 24 months . Mean erectile firmness at 24 months was 91 % compared to preoperative baseline , with 34 of 52 ( 65 % ) reporting 100 % of preoperative fullness . The 5-item International Index of Erectile Function score and fullness at 24 months were equivalent for unilateral nerve sparing and bilateral nerve sparing . CONCLUSIONS Overall 90 % of men reported return of potency at 24 months , and 46 % returned to baseline with normal 5-item International Index of Erectile Function scores and 100 % firmness . Remarkably there was no difference in 5-item International Index of Erectile Function scores or fullness between unilateral nerve sparing and bilateral nerve sparing
By network meta- analysis , sildenafil seems to be the most efficiency with a slightly higher rate of treatment-emergent adverse events ( TEATs ) , whereas tadalafil had the lowest TEATs .
Compared with placebo , PDE5-Is manifested significantly improved treatment outcomes .
Overall , regular regimen demonstrated statistically pronounced better potency than on-dem and .
Phosphodiesterase type-5 inhibitors ( PDE5-Is ) have been recommended as first line therapy for erectile dysfunction for patients received nerve-sparing radical prostatectomy for prostate cancer .
We examed the efficiency of PDE5-Is and considered the optimal application .