Bilateral Nerve-sparing Radical Prostatectomy Research Articles

Changes in Penile Length After Robot-Assisted Laparoscopic Radical Prostatectomy

Radical prostatectomy is commonly performed for the treatment of patients with prostate cancer. Several studies have demonstrated a reduction in penile size after open radical retropubic prostatectomy. The objective of this study is to describe changes in penile length after after robot-assisted laparoscopic radical prostatectomy (RALRP). We performed a randomized, open label, multicenter study in men with normal erectile function who underwent bilateral nerve-sparing radical prostatectomy. We evaluated changes in measured stretched penile length (SPL), a secondary end point of the study, in a subset of men from a single site who underwent RALRP by one surgeon. They were randomized to either intraurethral alprostadil 125 to 250 μg daily or oral sildenafil citrate 50 mg daily for 9 months. SPL was measured from pubic bone to coronal sulcus using a semirigid ruler before surgery and at 1, 3, 6, 9, 10, and 11 months. A total of 127 patients were enrolled and 94 completed the 11-month follow-up. The mean patient age was 56.5 years. Baseline mean SPL (cm) before surgery was 11.77 and decreased to 11.13 at 1 month (P<0.0001). A trend toward recovery of SPL was seen at 3 and 6 months. Mean SPL was not significantly different from baseline at 9, 10, and 11 months. This report describes changes in SPL over time after RALRP for prostate cancer. The expected decrease in length was observed shortly after surgery, but, by 9 months, penile length had returned to the preoperative measurement.

Bilateral vs unilateral laparoscopic intrafascial nerve‐sparing radical prostatectomy: evaluation of surgical and functional outcomes in 457 patients

Study Type - Therapy (case series). 4. What's known on the subject? and What does the study add? Bilateral nerve-sparing radical prostatectomy still represents an issue for urologists as the indications to perform it depend oft from the personal clinical experience. Moreover, until now data concerning bilateral and unilateral laparoscopic nerve-sparing radical prostatectomy have been limited. This study states that bilateral laparoscopic intrafascial nerve-sparing technique results in superior functional outcomes when compared with unilateral nsLRP and it suggests to prefer a bilateral nerve-sparing technique in younger patients with low-risk, organ-confined prostate cancer. To evaluate the surgical and functional outcomes in bilateral and unilateral nerve-sparing laparoscopic radical prostatectomy (nsLRP). Between January 2005 and May 2009, 457 nsLRP were performed at our clinic. In all, 250 patients underwent a bilateral nsLRP and 207 patients underwent an unilateral nsLRP. One surgeon performed all the operations. All patients presented at biopsy a localized prostate cancer. Demographic data and perioperative and postoperative measurements and outcomes were compared. The operative times for bilateral nsLRP and unilateral nsLRP were 165 ± 45 min and 130 ± 25 min, respectively. The mean intra-operative blood loss was 450 ± 300 mL and 270 ± 160 mL in the bilateral and unilateral nsLRP groups with a transfusion rate of 3% and 1%, respectively (P = 0.013). Conversion to open surgery was never deemed necessary. Postoperatively, the mean Gleason Score after nsLRP and distribution of tumour stages was similar in the two groups, and the frequency of positive margins in both groups did not present any statistically significant difference. At 12 months, a complete continence was reported in 97% of patients who underwent a bilateral nsLRP and in 88% of patients of the unilateral nsLRP group. At that time, 69% in the bilateral nsLRP and 43% in the unilateral nsLRP groups reported the ability to engage in sexual intercourse. The bilateral laparoscopic intrafascial nerve-sparing technique results in superior functional outcomes with regard to urinary continence and sexual potency, when compared with unilateral nsLRP, reporting similar oncological outcomes.

The 5-year functional outcomes after radical prostatectomy: a real-life experience in Korea

We investigated the functional outcomes regarding erectile function and urinary continence up to 5 years following radical prostatectomy (RP) in a cohort of Korean men. We retrospectively analyzed the clinicopathologic data of 85 Korean men who received open uni- or bilateral nerve-sparing RP for clinically localized prostate cancer and were followed up for at least 5 years postoperatively. From medical records, patients' status regarding urinary and erectile function at baseline and postoperative followups after RP was assessed. At 24 and 60 months after RP, proportions of subjects continent (no pads used) were 89.4% and 97.6%, respectively (P = 0.007). Excluding subjects (n = 24) who preoperatively reported having severe erectile dysfunction or lacked relevant informations, proportions of subjects capable of having vaginal intercourse regardless of erectile aid usage were 47.5% and 37.7% at 24 and 60 months from RP, respectively (P = 0.022). Patient's age at surgery (P = 0.047) and salvage radiation therapy (P = 0.026) were observed to be significant predictors of having erections sufficient for intercourse at 60 months from RP in multivariate analysis. Our results showed that while patients' postoperative status regarding urinary continence at 2 years from RP is generally maintained or improved at 5 year point, erectile function was observed to significantly declined from 2 years to 5 years following RP. Such decline in erectile function following RP may be more significant among men who were relatively older at surgery or those who received salvage therapy during postoperative follow-ups.

Characteristics and management of erectile dysfunction after various treatments for prostate cancer

Preface Currently, there are many wellestablished therapeutic options for early prostate cancer, and therefore, it is difficult for both urologists and patients to choose the optimal treatment. It is essential for urologists to counsel their patients according to reliable information about the advantages and disadvantages of each therapeutic option. We picked the topic for this issue, “Characteristics and management of erectile dysfunction after various treatments for prostate cancer,” because erectile dysfunction (ED) is one of the most frequent adverse events encountered in the management of prostate cancer. We invited six specialists to review each therapeutic option: radical prostatectomy, laparoscopic radical prostatectomy, robot-assisted laparoscopic radical prostatectomy, external beam radiotherapy, brachytherapy, and androgen deprivation therapy (ADT). Among these modalities, surgical interventions tend to induce a quick drop in erectile function with slow postoperative recovery. Early postoperative rehabilitation has been introduced, aiming at the early recovery of ED. On the contrary, radiation therapy tends to maintain the patient’s erectile function for a while after treatment but it gradually decreases. ADT may compromise not only the erectile function but also the libido level, and may result in significant deterioration of the patient’s quality of life. We hope these reviews will help urologists to counsel their patients with regards to decision-making in the management of early prostate cancer.

Predicting Erectile Function Recovery after Bilateral Nerve Sparing Radical Prostatectomy: A Proposal of a Novel Preoperative Risk Stratification

No multivariable model is currently available for the prediction of erectile function (EF) recovery after bilateral nerve sparing radical prostatectomy (BNSRP). The aim of this study was to develop a novel preoperative risk stratification aimed at assessing the probability of EF recovery after BNSRP. The International Index of Erectile Function (IIEF) was used to evaluate EF after BNSRP. This study included 435 patients treated with retropubic BNSRP between 2004 and 2008 at a single Institution. Preoperative data, including age, IIEF, Charlson comorbidity index (CCI), and body mass index (BMI) were available for all patients. Moreover, all patients were assessed postoperatively every 3 months and were asked to complete the IIEF during each visit. Cox regression models tested the association between preoperative predictors (age at surgery, preoperative IIEF-EF domain score, CCI, BMI) and EF recovery. Independent predictors of EF recovery were then used to stratify patients into three groups according to the risk of erectile dysfunction (ED) after surgery: low (age <or= 65 years, IIEF-EF >or= 26, CCI <or= 1; n = 184), intermediate (age 66-69 years or IIEF-EF 11-25,CCI <or= 1; n = 115), and high (age >or= 70 years or IIEF-EF <or= 10 or CCI >or= 2; n = 136). Kaplan-Meier curves assessed the time to EF recovery (defined as IIEF-EF score >or= 22). Predictive accuracy of our proposed classification was quantified using the AUC method. Of 435 patients, 242 (55.6%) received phosphodiesterase type 5 inhibitors (PDE5-I) either on demand or every day for a period of 3-6 months. Overall, EF recovery rate was 58% at 3-year follow-up. Patients treated with PDE5-I had significantly higher 3-year EF recovery rate as compared with patients left untreated after surgery (73 vs. 37%; P < 0.001). Except for BMI (P = 0.7), all preoperative covariates showed a significant association with EF recovery (all P <or= 0.04). The 3-year EF recovery rate significantly differed between the three groups, being 85, 59, and 37% in patients with low, intermediate, and high risk of postoperative ED, respectively (P < 0.001). Multivariable Cox regression analysis confirmed a highly significant association between the risk classification and EF recovery (P < 0.001). The proposed patient stratification tool showed a 69.1% accuracy. Similar results were achieved when patients were stratified according to the use of ED treatment after surgery (all P < 0.001). We report the first preoperative risk stratification tool aimed at assessing the probability of EF recovery after BNSRP. It is based on routinely available baseline data such as patient age, preoperative erectile function, and comorbidity profile.

Recovery of Erectile Function After Nerve Sparing Radical Prostatectomy and Penile Rehabilitation With Nightly Intraurethral Alprostadil Versus Sildenafil Citrate

To our knowledge we report the first large, randomized, prospective penile rehabilitation clinical trial to compare the effectiveness of nightly intraurethral alprostadil vs sildenafil citrate after nerve sparing prostatectomy. We performed a prospective, randomized, open label, multicenter American study in men with normal erectile function who underwent bilateral nerve sparing radical prostatectomy. The International Index of Erectile Function erectile function domain was the primary end point. Subjects initiated nightly treatment within 1 month of surgery with intraurethral alprostadil or oral sildenafil citrate (50 mg) for 9 months. After 1-month washout and before sexual activity subjects self-administered sildenafil citrate (100 mg) for a total of 6 attempts in 1 month. Secondary end points were the global assessment question, sexual encounter profile, Erectile Dysfunction Inventory of Treatment Satisfaction and measured stretched penile length. Of 139 men who started intraurethral alprostadil and 73 who started sildenafil citrate, 97 and 59, respectively, completed the trial. There were no statistically significant differences in International Index of Erectile Function erectile function domain and intercourse success rates to intraurethral alprostadil. The global assessment question was significantly better only at 6 months for intraurethral alprostadil (p <0.028). At completion there were no differences between treatments for any of the end points. This is the first study to directly compare the ability of alprostadil and a phosphodiesterase-5 inhibitor to enhance penile recovery subsequent to bilateral nerve sparing radical prostatectomy. The use of nightly subtherapeutic intraurethral alprostadil is well tolerated after radical prostatectomy. The benefit to return of erectile function of nightly sildenafil citrate and subtherapeutic intraurethral alprostadil appears to be comparable within the first year of surgery.

1491 IF A PRO-ERECTILE PHARMACOLOGICAL APPROACH IS CONSIDERED AFTER BILATERAL NERVE SPARING RADICAL PROSTATECTOMY, THIS SHOULD BE INITIATED SOON AFTER SURGERY

You have accessJournal of UrologySexual Function/Dysfunction/Andrology: Medical and Non-Surgical Therapy II1 Apr 20101491 IF A PRO-ERECTILE PHARMACOLOGICAL APPROACH IS CONSIDERED AFTER BILATERAL NERVE SPARING RADICAL PROSTATECTOMY, THIS SHOULD BE INITIATED SOON AFTER SURGERY Andrea Gallina, Alberto Briganti, Andrea Salonia, Luigi Barbieri, Manuela Tutolo, Fabio Castiglione, Lorenzo Rocchini, Giulio Gadda, Antonino Saccà, Patrizio Rigatti, and Francesco Montorsi Andrea GallinaAndrea Gallina More articles by this author , Alberto BrigantiAlberto Briganti More articles by this author , Andrea SaloniaAndrea Salonia More articles by this author , Luigi BarbieriLuigi Barbieri More articles by this author , Manuela TutoloManuela Tutolo More articles by this author , Fabio CastiglioneFabio Castiglione More articles by this author , Lorenzo RocchiniLorenzo Rocchini More articles by this author , Giulio GaddaGiulio Gadda More articles by this author , Antonino SaccàAntonino Saccà More articles by this author , Patrizio RigattiPatrizio Rigatti More articles by this author , and Francesco MontorsiFrancesco Montorsi More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2010.02.1228AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES Controversy exists with regards to the optimal timing of pro-erectile treatments administration after bilateral nerve sparing radical prostatectomy (BNSRP). While animal evidences support the association between early prophylaxis and erectile function (EF) recovery, the correlation between timing of drug administration and EF recovery has been poorly assessed in humans. We hypothesized that the earlier a pro-erectile treatment is given, the higher rates of EF recovery can be expected after BNSRP METHODS The study included 154 patients treated with BNSRP between 2005 and 2009 at a single tertiary referral center. Complete pre-op data, including age and International Index of Erectile Function (IIEF) were available for all patients. Patients were assessed post-op every 3 months and were asked to complete the IIEF during each visit. Post-op EF recovery was defined as an IIEF-EF ≥22. All patients received therapy for ED either as on-demand (n=96; 62.43%) or as rehabilitation treatment (n=58; 37.7%). Patients were sub-divided into 2 groups according to time to treatment initiation (namely ≤60 days, or >60 days, after BNSRP). Kaplan-Meier curves assessed the time to EF recovery in both the overall patient population and in each group. The association between time to treatment initiation and EF recovery was tested in multivariable Cox regression analyses after accounting for age and pre-op EF RESULTS Mean age was 59.8 yrs (median 59.8; range 46-72 yrs). Pre-op IIEF-EF domain score assessment showed severe, moderate, mild to moderate, mild and no ED in 14.5, 4.8, 4.8, 18.5 and 57.3% of patients, respectively. Overall, 105/154 (68.2%) reached a IIEF-EF ≥22 after a mean follow-up of 24.2 months (median 19; range: 2-51). The 1 and 2yrs EF recovery rates were significantly higher for patients initiating EF treatment '60 days as compared to those treated after 60 days from BNSRP (81 and 81% vs 50 and 71%, respectively; p=0.01). At multivariable Cox regression analyses time to treatment initiation was significantly inversely associated with EF recovery (p=0.002) even after accounting for patient age and pre-op EF. Patients treated within 60 days from BNSRP had a 2.8 fold higher chance of EF recovery as compared with patients treated >60 days from BNSRP (p=0.002) CONCLUSIONS We demonstrated that patients treated within 2 months after BNSRP have better EF outcome as compared those treated later, regardless of the type of treatment administered. Therefore, if a post-op treatment is planned this should be initiated soon after surgery Milan, Italy© 2010 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 183Issue 4SApril 2010Page: e575 Advertisement Copyright & Permissions© 2010 by American Urological Association Education and Research, Inc.MetricsAuthor Information Andrea Gallina More articles by this author Alberto Briganti More articles by this author Andrea Salonia More articles by this author Luigi Barbieri More articles by this author Manuela Tutolo More articles by this author Fabio Castiglione More articles by this author Lorenzo Rocchini More articles by this author Giulio Gadda More articles by this author Antonino Saccà More articles by this author Patrizio Rigatti More articles by this author Francesco Montorsi More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...

1206 PRE-OPERATIVE URINARY AND ERECTILE FUNCTION REPRESENT SIGNIFICANT PREDICTORS OF POST-OPERATIVE URINARY CONTINENCE RECOVERY IN PATIENTS TREATED WITH NERVE SPARING RADICAL PROSTATECTOMY

You have accessJournal of UrologySexual Function/Dysfunction/Andrology: Evaluation1 Apr 20101206 PRE-OPERATIVE URINARY AND ERECTILE FUNCTION REPRESENT SIGNIFICANT PREDICTORS OF POST-OPERATIVE URINARY CONTINENCE RECOVERY IN PATIENTS TREATED WITH NERVE SPARING RADICAL PROSTATECTOMY Andrea Gallina, Alberto Briganti, Luigi Barbieri, Andrea Salonia, Renzo Colombo, Francesco Sozzi, Zanni Giuseppe, Federico Pellucchi, Valerio Di Girolamo, Patrizio Rigatti, and Francesco Montorsi Andrea GallinaAndrea Gallina More articles by this author , Alberto BrigantiAlberto Briganti More articles by this author , Luigi BarbieriLuigi Barbieri More articles by this author , Andrea SaloniaAndrea Salonia More articles by this author , Renzo ColomboRenzo Colombo More articles by this author , Francesco SozziFrancesco Sozzi More articles by this author , Zanni GiuseppeZanni Giuseppe More articles by this author , Federico PellucchiFederico Pellucchi More articles by this author , Valerio Di GirolamoValerio Di Girolamo More articles by this author , Patrizio RigattiPatrizio Rigatti More articles by this author , and Francesco MontorsiFrancesco Montorsi More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2010.02.708AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES Pre-op erectile function (EF) represents an important determinant of EF recovery after bilateral nerve sparing radical prostatectomy (BNSRP). However, poor data is available on the association between baseline EF or urinary function and urinary continence (UC) recovery after BNSRP. The aim of this study was to address the association between pre-op functional data and post-operative UC recovery in patients treated with BNSRP METHODS The study included 752 patients treated with BNSRP at a single tertiary referral center between June 2003 and June 2009. All patients had complete pre-op data including pre-op EF assessed by the International Index of Erectile Function (IIEF-EF) and urinary function evaluated with the International Prostatic Symptoms score (IPSS). All patients post-op completed the International Consultation on Incontinence questionnaire (ICIQ) every 3 months during the first year after surgery and every 6 months thereafter. UC recovery was defined as an ICIQ score ≤6 (no pads). Univariable and multivariable Cox regression models addressed the rates of UC. Covariates consisted of pre-op EF and urinary function, age, body mass index (BMI), pathological stage and pre-op PSA RESULTS Mean and median age at surgery was 62.4 and 62.5 yrs, respectively. Pre-op IIEF-EF showed severe, moderate, mild to moderate, mild and no ED in 23.6, 6.2, 6.2, 17.4 and 46.6% of patients, respectively. IPSS scores were 0-7 (no/mild symptoms), 8-19 (moderate), ≥ 20 (severe) in 49.4, 39.8 and 10.8%, respectively. Mean and median BMI was 25.8 and 25.6 kg/m2, respectively. At univariable Cox regression analyses, patient age, pre-op IIEF-EF and IPSS scores were significantly associated with UC after surgery (all p'0.002). These data were confirmed at multivariable analyses, where age and pre-op IPSS scores maintained their significant inverse association with UC recovery while IIEF-EF domain showed a significant direct association with UC after BNSRP (all p≤0.04). Patients with full EF prior to surgery (≥26) had a 1.5 higher probability of UC recovery as compared to patients with severe ED, even after accounting for the effects of the other predictors (p=0.02) CONCLUSIONS We demonstrated that pre-op EF and urinary functions represent significant predictors of UC after surgery. We speculate that pre-op ED might be a marker of pelvic vascular disease which may affect the external urinary sphincter. Pre-op functional parameters should be also considered for UC prediction after BNSRP Milan, Italy© 2010 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 183Issue 4SApril 2010Page: e467 Advertisement Copyright & Permissions© 2010 by American Urological Association Education and Research, Inc.MetricsAuthor Information Andrea Gallina More articles by this author Alberto Briganti More articles by this author Luigi Barbieri More articles by this author Andrea Salonia More articles by this author Renzo Colombo More articles by this author Francesco Sozzi More articles by this author Zanni Giuseppe More articles by this author Federico Pellucchi More articles by this author Valerio Di Girolamo More articles by this author Patrizio Rigatti More articles by this author Francesco Montorsi More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...

Preoperative Criteria to Select Patients for Bilateral Nerve-sparing Robotic-assisted Radical Prostatectomy

To date, no study has analyzed the predictors of potency recovery in a robot-assisted laparoscopic radical prostatectomy (RALP) series. A novel risk stratification for erectile function recovery after retropubic radical prostatectomy (RRP) has been proposed recently by Briganti et al. from the University Vita-Salute San Raffaele in Milan, Italy. To evaluate the potency rate in a series of consecutive patients who underwent bilateral nerve-sparing RALP, to identify the preoperative predictors of erectile function recovery, and to validate the risk-group stratification of Briganti et al. The clinical records of all patients who underwent RALP for clinically localized prostate cancer between April 2005 and April 2009 were prospectively collected in the Prostate Cancer Padua Database. For the present study, we extracted all consecutive cases receiving a bilateral nerve-sparing technique with a minimum follow-up > or =12 months. Twelve-month potency rate after RALP, defined as an International Index of Erectile Function 6 (IIEF-6) score > or =18. Data showed that 129 out of 208 enrolled patients (62%) were potent 12 months after surgery. Age (hazard ratio [HR]: 2.8; P < 0.001), Charlson score (HR: 2.9; P = 0.007), and baseline IIEF-6 score (HR: 0.8; P < 0.001) were independent predictors of potency recovery at multivariate analysis. According to Briganti et al.'s risk-group stratification, the 12-month potency rate following RALP was 81.9% in the low-risk group, 56.7% in the intermediate-risk group, and 28.6% in the high-risk group (P < 0.001). In the era of robotic surgery, the key point for the success of the nerve-sparing technique remains the accurate selection of patients. Age < or =65 years, absence of associated comorbidities, and good preoperative erectile function are the most important preoperative factors to select those patients for whom bilateral nerve-sparing RALP can achieve the best results.

Vardenafil can Improve Continence Recovery after Bilateral Nerve Sparing Prostatectomy: Results of a Randomized, Double Blind, Placebo-Controlled Pilot Study

Phosphodiesterase type 5 inhibitors (PDE5-I) have acquired an established role in the treatment of post-prostatectomy erectile dysfunction (ED). Several trials in men with ED and lower urinary tract symptoms associated with benign prostatic hyperplasia suggest that PDE5-I could improve both erectile function and urinary symptoms. To assess the role of vardenafil in continence recovery after bilateral nerve sparing radical prostatectomy (BNS-RP). Thirty-nine patients with prostate cancer were recruited. After BNS-RP, patients were double-blinded assigned to three arms: a) vardenafil on demand; b) vardenafil nightly; and c) placebo. Urinary function (UF) and urinary bother (UB) of University of California-Los Angeles Prostate Cancer Index questionnaire were assessed preoperatively and at 1, 3, 6, 9, 10, and 12 months. Twelve-month outcomes were compared to 1 month with a t-test. The differences in UF and UB (at 3, 6, 9, 10, and 12 months) between the three treatment arms were calculated by an analysis of variance. With ALLFIT we estimated half-maximal recovery times (ER50) and maximal recovery (R(max)) in three groups. The improvement of UF and UB between 1 and 12 months was significant in all arms except for placebo (UF: P = 0.125; UB: P = 0.089). Nightly resulted in greater UF at 3, 6, and 9 months and greater UB at 6 months compared with placebo (P = 0.042, P = 0.044 and P = 0.039); after nightly administration, patients presented higher UB than after on-demand use, 3 and 6 months postoperatively (P = 0.036 and P = 0.017). ALLFIT demonstrated a similar ER50 in all groups (2.6 months for both UF and UB) and indicated that nightly administration induced significant improvements in R(max) compared with placebo (both <0.0001). Vardenafil can improve continence recovery after BNS-RP compared with placebo. The daily use of vardenafil seems to provide better continence rate, although it does not seem to influence the timing needed to achieve full continence.

Penile rehabilitation therapy following radical prostatectomy

Purpose. To compare erectile function (EF) recovery of patients treated by early penile rehabilitation therapy (PRT) with sildenafil and with control group.Method. Forty men treated by bilateral nerve sparing radical prostatectomy (NSRP) and with a normal pre-operative EF were enrolled. Fourteen days after surgery, they were randomised to a flexible-dose sildenafil group and to a control group. The International Index of Erectile Function (IIEF) questionnaire was completed before surgery and at 3, 6, 12 and 24 weeks after NSRP.Results. In the group treated, the mean IIEF score before surgery was 26.2 and 14.1, 16.2, 22.5 and 25.2 at 3, 6, 12 and 24 weeks after NSRP, respectively. In the control group, the respective scores were 26.5 and 12.4, 15.8, 15.3 and 17.4. There was a significant difference in IIEF mean score (25 ± 6 vs. 17 ± 9, p < 0.05) and in the potency rate (87% vs. 56%) between the groups at 24 weeks after NSRP. The percentage of patients who were capable of having medication-unassisted intercourse was 54% vs. 21%; 34% vs. 18% of patients had a normal EF with 72% vs. 32% of responders to sildenafil.Conclusions. PRT with PDE-5 inhibitors should be offered early after RP to allow the recovery of EF.

The timing of penile rehabilitation after bilateral nerve‐sparing radical prostatectomy affects the recovery of erectile function

To define if erectile function (EF) outcomes were better in men with early institution of penile rehabilitation after radical prostatectomy (RP), as one of the mechanisms by which patients fail to recover EF after RP is collagenization of corporal smooth muscle with subsequent venous leak development, and rehabilitation is aimed at preventing these structural alterations. The study population comprised patients who: (i) had clinically organ-confined prostate cancer; (ii) had fully functional erections, corroborated by the partner; (iii) had bilateral nerve-sparing RP; and (iv) committed to pharmacological penile rehabilitation. Patients completed the International Index of Erectile Function (IIEF) serially after RP. Patients were instructed to obtain three erections/week using initially sildenafil, and if unsuccessful, then intracavernous injections. Patients were subdivided into those starting rehabilitation at < 6 months after RP (early) and those starting at > or = 6 months after RP (delayed). There were 48 patients in the early group and 36 in the delayed group; patients in both groups were matched for age, comorbidity status and baseline EF. The mean duration after RP at the time of starting penile rehabilitation was 2 and 7 months in the early and delayed groups, respectively (P < 0.01). At 2 years after surgery there was a highly statistically significant difference in IIEF EF domain score between the early and delayed groups (22 vs 16, P < 0.001). There were also statistically significant differences between the groups in the percentage of men at 2 years after RP who had unassisted functional erections and sildenafil-assisted functional erections (58% vs 30%, P < 0.01; 86% vs 45%, P < 0.01, respectively). These data suggest that delaying the start of penile rehabilitation after RP is associated with poorer outcomes for EF.

Quantitative and qualitative analysis of the recovery of potency after radical prostatectomy: effect of unilateral vs bilateral nerve sparing

To analyse the impact of a approximately 50% reduction of cavernous nervous tissue on the qualitative and quantitative recovery of sexual function after unilateral (UNS) and bilateral (BNS) nerve-sparing robotic radical prostatectomy (RALP), by evaluating these differences in two groups treated with cautery and a cautery-free technique (CFT). UNS was defined as wide-excision of one neurovascular bundle (NVB). Only men aged < or =65 years with preoperative International Index of Erectile Function (IIEF-5) scores of > or =22 were included. The cautery group comprised 42 men (of case numbers 1-125) undergoing RALP with cautery, and the CFT group (62 men of cases 151-350) had a cautery-free technique along the NVB. Data were collected prospectively using validated self-administered questionnaires. Potency was defined as two affirmative answers to: do you have erections 'adequate for vaginal penetration?' and 'Are they satisfactory?'. Patient-reported IIEF-5 scores and quality of erections (i.e. an estimate of erection as 0%, 25%, 50%, 75% or 100% of preoperative fullness) were obtained after surgery. In the cautery group, doubling the nerve volume increased potency by 1.36 times (UNS 50% vs BNS 68%). The results were similar in the CFT group as doubling nerve tissue increased potency by 1.15 times (UNS 80% and BNS 93%). At 24 months, comparing IIEF-5 scores, there was no difference between UNS and BNS for the cautery group, at 19.6 (95% confidence interval 15.7-23.5) vs 18.9 (16.6-21.0), or the CFT group, at 22.0 (20.2-23.8) vs 21.0 (19.8-22.1). Doubling the nerve volume only increased potency by 1.15-1.36 times for both the CFT and cautery groups. Furthermore, the quality of erections and IIEF-5 scores did not vary appreciably with doubling of nerve tissue.

Bulbocavernosus reflex testing: a preliminary study on the prognostic factors for potency and response to sildenafil citrate after bilateral nerve-sparing radical prostatectomy

Erectile dysfunction (ED) following radical prostatectomy is of major concern for both patients and caring physicians. We evaluated the bulbocavernosus reflex latency (BCRL) and amplitude (BCRA) following bilateral nerve-sparing radical retropubic prostatectomy (NS-RRP) to predict the response to sildenafil citrate (SC). Patients were recruited in our ED clinic following NS-RRP. Exclusion criteria included preoperative significant ED, neurological disease, and nitrates treatment. Patients were defined as non-responders only after four consecutive unsuccessful trials of 100 mg SC. Twenty patients at least 3 months after surgery were included in this study. Five patients (25%) regained spontaneous erections, although insufficient for vaginal penetration. All of them had normal BCRL and normal BCRA as well as good response to 100 mg SC. Three patients (15%) lacked spontaneous erections and had prolonged BCRL with normal BCRA. This subgroup eventually regained erections using SC. Twelve patients (60%) lacked spontaneous erections and had prolonged BCRL and low BCRA. They failed SC trials and achieved erections using intra-cavernosal injections (ICI) of 10 microg PGE(1). Neurophysiologic evaluation consisting of BCRL and BCRA was found to be useful in the prediction of the response to SC following bilateral NS-RRP. Patients who do not regain an erection, and have abnormal BCRL and BCRA 6 months after surgery, will probably be SC non-responders and may benefit from ICI. A subset of patients with preserved BCRA and prolonged latencies has been shown to have a better chance to respond to SC.

79 PREDICTING ERECTILE FUNCTION RECOVERY AFTER BILATERAL NERVE SPARING RADICAL PROSTATECTOMY: A PROPOSAL OF A NOVEL RISK STRATIFICATION

Introduction. No multivariable model is currently available for the prediction of erectile function (EF) recovery after bilateral nerve sparing radical prostatectomy (BNSRP). Aim. The aim of this study was to develop a novel preoperative risk stratification aimed at assessing the probability of EF recovery after BNSRP. Main Outcome Measure. The International Index of Erectile Function (IIEF) was used to evaluate EF after BNSRP. Methods. This study included 435 patients treated with retropubic BNSRP between 2004 and 2008 at a single Institution. Preoperative data, including age, IIEF, Charlson comorbidity index (CCI), and body mass index (BMI) were available for all patients. Moreover, all patients were assessed postoperatively every 3 months and were asked to complete the IIEF during each visit. Cox regression models tested the association between preoperative predictors (age at surgery, preoperative IIEF-EF domain score, CCI, BMI) and EF recovery. Independent predictors of EF recovery were then used to stratify patients into three groups according to the risk of erectile dysfunction (ED) after surgery: low (age 65 years, IIEF-EF 26, CCI 1; n = 184), intermediate (age 66–69 years or IIEF-EF 11-25,CCI 1; n = 115), and high (age 70 years or IIEF-EF 10 or CCI 2; n = 136). Kaplan-Meier curves assessed the time to EF recovery (defined as IIEF-EF score 22). Predictive accuracy of our proposed classification was quantified using the AUC method. Results. Of 435 patients, 242 (55.6%) received phosphodiesterase type 5 inhibitors (PDE5-I) either on demand or every day for a period of 3–6 months. Overall, EF recovery rate was 58% at 3-year follow-up. Patients treated with PDE5-I had significantly higher 3-year EF recovery rate as compared with patients left untreated after surgery (73 vs. 37%; P < 0.001). Except for BMI (P = 0.7), all preoperative covariates showed a significant association with EF recovery (all P 0.04). The 3-year EF recovery rate significantly differed between the three groups, being 85, 59, and 37% in patients with low, intermediate, and high risk of postoperative ED, respectively (P < 0.001). Multivariable Cox regression analysis confirmed a highly significant association between the risk classification and EF recovery (P < 0.001). The proposed patient stratification tool showed a 69.1% accuracy. Similar results were achieved when patients were stratified according to the use of ED treatment after surgery (all P < 0.001). Conclusions. We report the first preoperative risk stratification tool aimed at assessing the probability of EF recovery after BNSRP. It is based on routinely available baseline data such as patient age, preoperative erectile function, and comorbidity profile. Briganti A, Gallina A, Suardi N, Capitanio U, Tutolo M, Bianchi M, Passoni N, Salonia A, Colombo R, Di Girolamo V, Guazzoni G, Rigatti P, and Montorsi F. Predicting erectile function recovery after bilateral nerve sparing radical prostatectomy: A proposal of a novel preoperative risk stratification. J Sex Med 2010;7:2521–2531.

Effect of Nightly versus On-Demand Vardenafil on Recovery of Erectile Function in Men Following Bilateral Nerve-Sparing Radical Prostatectomy

Effect of Nightly versus On-Demand Vardenafil on Recovery of Erectile Function in Men Following Bilateral Nerve-Sparing Radical Prostatectomy

Bilateral Nerve-Sparing Extraperitoneal Video Laparoscopic Radical Prostatectomy: Potency Rates after 1 Year Follow Up

Wide variations exist in the methods for reporting potency following radical prostatectomy. In this group we used a validated questionnaires pre and post operatively to access relative return to normal sexual function after bilateral nerve-sparing visual laser ablation radical prostatectomy (VLAP). One hundred and twenty four patients with ages ranging from 45 to 70 years old were evaluated in the period between January 2004 and March 2007. Sexual function was evaluated using the IIEF questionnaire pre operatively and 3, 6, 9, and 12 months after the surgery. All the procedures were performed by the same surgeon using bilateral nerve-sparing technique. No thermal energy devices were utilized for coagulation and clipping was minimal in order to better preserve the neurovascular bundles. Preoperatively one hundred and four patients had no sexual dysfunction and a 28.2 average according to IIEF score. Thirteen patients were classified in the mild category with 21.8 average score. Five patients were in the mild to moderate group and scored an average of 17 points in the IIEF. Two patients were classified moderate group and scored 10. None were classified in the severe group preoperatively. After 1 year 85 patients were classified in the no dysfunction group and scored an average of 25.3. Eleven patients were in the mild erectile dysfunction group scored 16.9. Sixteen patients in the mild to moderate group scored 12. Eight patients in the moderate group scored seven. Four patients migrated to the severe dysfunction group, scoring two points. 29% of the patients that have had sexual intercourse used medication to improve or obtain erection. Careful preservation of the neurovascular bundles provides good potency recovery rates, but no final conclusion should be established before one year of follow-up.

Randomized, double-blind, placebo-controlled study of postoperative nightly sildenafil citrate for the prevention of erectile dysfunction after bilateral nerve-sparing radical prostatectomy

Four weeks after bilateral nerve-sparing radical retropubic prostatectomy, men with normal erectile function before surgery were randomized to double-blind sildenafil (50 or 100 mg) or placebo nightly for 36 weeks, followed by an 8-week drug-free period before assessment of erectile function. Enrollment was prematurely ceased and only 76 men completed because, assuming a placebo response rate similar to the published literature (for example, 34% in meta-analysis), the 25% response at blinded interim review suggested a lack of treatment effect. On the contrary, spontaneous erectile function (a combined score of >or=8 for questions 3 and 4 of the International Index of Erectile Function and a positive response to 'Were erections good enough for satisfactory sexual activity?') occurred in only 4% of the placebo group (n=1 of 25) versus 27% (n=14 of 51, P=0.0156, Fisher's exact test) of the sildenafil group. Nightly sildenafil administration for 36 weeks after surgery markedly increased the return of normal spontaneous erections.

Effect of Nightly versus On-Demand Vardenafil on Recovery of Erectile Function in Men Following Bilateral Nerve-Sparing Radical Prostatectomy

BackgroundTo date, no data have been available from large, well-designed trials comparing on demand and nightly dosing of phosphodiesterase type 5 (PDE5) inhibitors on recovery of erectile function in postprostatectomy patients with erectile dysfunction (ED). ObjectiveTo investigate the effect of early postoperative dosing with vardenafil, administered either nightly or on demand, compared with placebo on recovery of erectile function in men with ED following bilateral nerve-sparing radical prostatectomy (NSRP) surgery. Design, setting, and participantsA randomised, 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 ≥26 at screening. A total of 628 men, aged 18–64 yr, were randomised 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. InterventionPatients received placebo, nightly vardenafil, or on demand vardenafil. MeasurementsPrimary outcome measure was the percentage of subjects with an IIEF-EF score of ≥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 limitationsNo statistically significant differences were observed among treatment groups in the proportion of patients with an IIEF-EF score of ≥22 or in SEP3 success rates after the washout period. On-demand vardenafil treatment resulted in significantly greater IIEF-EF scores and better SEP3 response rates than placebo over the entire treatment period. ConclusionsIn this study of men with ED following bilateral NSRP, vardenafil was efficacious when used on demand, supporting a paradigm shift towards on demand dosing with PDE5 inhibitors in this patient group. Trial registrationEuropean clinical trials database (EudraCT; available at http://eudract.emea.europa.eu/). Trial registration number: 11336.

Return of Nocturnal Erections and Erectile Function after Bilateral Nerve-sparing Radical Prostatectomy in Men Treated Nightly with Sildenafil Citrate: Subanalysis of a Longitudinal Randomized Double-blind Placebo-controlled Trial

After bilateral nerve-sparing radical retropubic prostatectomy (BNSRRP), nocturnal and sexually mediated erections may help to preserve normal erectile function (EF). To investigate nocturnal penile tumescence and rigidity (NPTR) in a subset (N = 54 men) from a randomized, double-blind trial (N = 76) of nightly sildenafil after BNSRRP. Inclusion required preoperative "normal" EF (defined as a combined score of >/=8 for International Index of Erectile Function questions 3 (penetration) and 4 (maintained erection after penetration) and NPTR testing (>/=10 continuous minutes of >/=55% rigidity [R >/= 55%] at the base). Postoperative assessments were at weeks 4 (pretreatment), 16, 28, 40 (during 36 weeks of nightly prophylaxis: sildenafil 50 mg [N = 17], 100 mg [N = 18] or placebo [N = 19]), and 48 (after 8 weeks of no erectile dysfunction therapy, when "responders" were delineated by the defined normal EF and a "yes" response to "Over the past 4 weeks, have your erections been good enough for satisfactory sexual activity?"). Base and tip rigidity and tumescence were measured using penile plethysmography. Duration of R >/= 55% and area under the curves for rigidity and tumescence. Postoperatively, rapid profound reduction in nocturnal EF was noted in all groups. There was a gradual dose-dependent improvement in base and tip rigidity in the sildenafil groups but little improvement in the placebo group. Eight weeks after treatment termination (48 weeks postoperatively), 24% (4/17) of 50-mg sildenafil recipients, 33% (6/18) of 100-mg sildenafil recipients, and 5% (1/19) of placebo recipients were responders. Tip R >/= 55% was the most discriminating NPTR measure between nonresponders and responders to sildenafil, in whom it regained baseline (preoperative) levels (whereas base R >/= 55% did not). It was most prolonged in responders to sildenafil 100 mg. In our subset analysis, nightly sildenafil for 9 months post-BNSRRP objectively improved nocturnal erections and pharmaceutically unassisted EF.