Bilateral Nerve-sparing Radical Research Articles

Predictors of corporo-venocclusive dysfunction in men with bilateral nerve-sparing radical prostatectomy.

Erectile dysfunction (ED) is seen in some men who have undergone bilateral nerve-sparing surgery. Corporo-venocclusive dysfunction (CVOD) is the major pathway to permanent ED after radical prostatectomy (RP). To identify comorbidity factors that are associated with the presence of CVOD in men who had undergone bilateral nerve-sparing RP. We included patients who had no ED before RP, underwent bilateral nerve-sparing RP, were unresponsive to pharmacotherapy, and had a penile Duplex Doppler Ultrasound (PDDU) with a diagnosis of CVOD. PDDU was performed with a redosing vasoactive agent protocol. A logistic regression model was created to define predictors of CVOD, defined as end-diastolic velocity (EDV) ≥5cm/s bilaterally. CVOD diagnosis. 135 patients with a median age of 60 (IQR 54, 64) years were included. 45% reported ≥2 comorbidities, 10% diabetes, 28% obstructive sleep apnea (OSA), and 44% were current or former smokers. At PDDU, 34% had less than penetration hardness erections, and 43% received 100units of vasoactive agent. 44% were diagnosed with CVOD. Increased age at RP (OR 2.12 per 10years, 95% CI 2.35, 3.73, P= .007) and OSA (OR 2.44, 95% CI 1.07, 5.73, P= .036) were associated with a diagnosis of CVOD. Comorbidities, especially OSA, have a role in erection recovery after surgery. The study used a well-established institutional RP nerve-sparing score, a strict PDDU vasoactive agent redosing protocol, validated cut-offs for CVOD diagnosis, and a validated erectile function questionnaire both pre- and post-operatively. The major limitation is that this is a cohort of men seeking treatment at a sexual medicine clinic for post-operative ED, which limits the generalizability of the results to patients without ED symptoms or who decided not to seek treatment. The dichotomous definition of comorbidities is also a limitation since patients can have differing degrees of comorbidities' severity. Older patients and the presence of OSA were associated with the presence of CVOD.

Early and late urinary continence outcomes after unilateral and bilateral nerve-sparing robot-assisted radical prostatectomy: A retrospective multicentre cohort study in Japan (the MSUG94 group).

The impact of unilateral and bilateral nerve-sparing robot-assisted laparoscopic radical prostatectomy (NS-RARP) procedures on continence and the time to continence recovery have not been established. We retrospectively reviewed a total of 2801 patients who underwent RARP in 9 institutions. Procedures were classified as NS or non-NS; NS procedures were further classified as unilateral or bilateral. The recovery of continence was analysed using propensity score matching method. The pad-free rates at 12months after surgery were higher in the NS group (95% confidence interval of odds ratio, 1.06-1.51). Pad-free rates at all time points within 12months of surgery did not significantly differ between the unilateral and bilateral NS groups. NS-RARP resulted in better urinary continence outcomes than non-NS-RARP in the first 12months after surgery. Urinary recovery rates did not significantly differ between unilateral and bilateral NS-RARP.

PJY16 - Bilateral nerve-sparing robotic-assisted radical cystectomy with Y-shape intracorporeal bladder: Perioperative and functional outcomes in a tertiary care center

PJY16 - Bilateral nerve-sparing robotic-assisted radical cystectomy with Y-shape intracorporeal bladder: Perioperative and functional outcomes in a tertiary care center

(343) Predictors of Corporo-venocclusive Dysfunction (CVOD) in Men with Bilateral Nerve-sparing Radical Prostatectomy (RP)

Abstract Introduction Nerve-sparing status (NSS) during RP is a significant predictor of erectile function recovery (EFR). Poor nerve sparing is associated with collagenization of cavernosal smooth muscle and CVOD development with typically poor response to PDE5 inhibitors (PDE5i) and intracavernosal injection therapy (ICI). Objective This study aimed to define factors predictive of CVOD in men with bilateral NS RP. Methods Study population consisted of (i) men who underwent bilateral NS (defined by the surgeon using an institutional grading system) RP (ii) with poor response to PDE5i and ICI (iii) ≥2 years post-RP (iv) who underwent penile duplex Doppler ultrasound (DUS) (v) using a vasoactive agent redosing schedule. CVOD diagnosis was made with end-diastolic velocity (EDV) values ≥5 cm/sec bilaterally. ADT and radiation therapy were exclusions. We used multivariable modeling to define factors predictive of CVOD. Factors included in the model: patient age, history of diabetes, history of obstructive sleep apnea, number of vascular comorbidities, baseline EF, peri-RP total testosterone (T) level, and total T at DUS (within 3 months). Results 201 men with a mean age of 66 ± 7 years. 25% of the patients reported 3 or more vascular comorbidities, 17% had diabetes, 36% obstructive sleep apnea, 39% were current or former smokers. Mean baseline PSA and pre-RP total T was 6.7 ± 6 ng/mL and 410 ± 211 ng/dL, respectively. Median baseline EFD score was 24 (13, 29). 49% of the men had an erection less than penetration rigidity during the DUS procedure with a mean total dose administered of 87 ± 21 units of trimix. 69% received 100 units. CVOD was diagnosed in 76%. Mean total T at DUS was 386 ± 177 ng/dL. 32% had low T. Significant predictors of CVOD after RP in men with BL NSS were: OSA (OR = 3.8, 95% CI = 1.7-8.7), ≥ 3 vascular comorbidities (OR = 5.0, 95% CI = 1.7-14.8), age at the time of DUS (per 10 years increase, OR = 1.9, 95% CI = 1.2-3.0), and pre-RP EF domain score (per 1 unit increase, OR = 0.93, 95% CI 0.88-0.98). There was a signal that in a larger sample size, diabetes may be a significant predictor of CVOD in this group of patients (OR = 2.7, 95% 0.9-8.0). Conclusions Baseline clinical comorbidities pre-RP have a significant impact on EFR post-RP, in particular, the presence of venous leak. Despite BL NSS, older patients, men with OSA, higher number of comorbidities pre-RP, and lower pre-RP EF increased the likelihood of developing CVOD post-RP. Disclosure No

PE23 - Extended pelvic lymph node dissection does not affect functional outcomes during bilateral nerve-sparing radical prostatectomy

PE23 - Extended pelvic lymph node dissection does not affect functional outcomes during bilateral nerve-sparing radical prostatectomy

Extended Pelvic Lymph Node Dissection Does Not Affect Functional Outcomes during Bilateral Nerve-Sparing Radical Prostatectomy

Introduction: A possible association between extended pelvic lymph node dissection (ePLND) in radical prostatectomy (RPE) and functional outcomes such as erectile function (EF) and continence recovery has been previously considered. This association stems from the direct proximity of ePLND to the pelvic plexus. In this paper, we aimed to critically examine an association of ePLND with functional outcomes in patients who underwent bilateral nerve-sparing RPE. Methods: 272 out of 782 patients from a randomized, patient-blinded, multicenter trial were retrospectively classified into two groups based on the D’Amico criteria: 114 had no PLND and 158 had ePLND. Continence (no pad/safety pad) and EF (Index of Erectile Function-5 [IIEF-5] questionnaire ≥17; sufficient erection for sexual intercourse) were assessed at 3, 6, and 12 months as well as postsurgical complications (Clavien-Dindo Classification). Results: After 12 months of follow-up, no significant difference for potency could be found between men without and subjected to ePLND: IIEF-5 ≥17 (23.2% vs. 27.2%; p = 0.55) and sufficient erection for intercourse (44.1% vs. 45.6%; p = 0.84). A multiple linear regression analysis demonstrated that while preoperative EF (p < 0.001), pathological tumor stage (p = 0.027), and robot-assisted bilateral nerve-sparing RPE (p < 0.001) were independent predictors of EF recovery, the same did not apply to ePLND. No association was detected for continence recovery (94.2% vs. 89.7%; p = 0.22) and complications of any grade after surgery (11.4% vs. 16.5%; p = 0.24). Conclusion: ePLND is not associated with increased risk of erectile dysfunction, incontinence or complications after bilateral nerve-sparing RPE.

Linear Low-Intensity Extracorporeal Shockwave Therapy as a Method for Penile Rehabilitation in Erectile Dysfunction Patients after Radical Prostatectomy: A Randomized, Single-Blinded, Sham-Controlled Clinical Trial

Introduction: The objective of this study was to investigate the effect and feasibility of linear low-intensity extracorporeal shockwave therapy (LI-LiESWT) as a penile rehabilitation method for erectile dysfunction (ED) after bilateral nerve-sparing (NS) radical prostatectomy (RP). Methods: Patients who had undergone bilateral NS RP (either radical retropubic prostatectomy or robot-assisted laparoscopic RP), 3 or more months prior to the study, and who had no ED preoperatively and were suffering from mild to severe postoperative ED were included in the study. Four treatments were given over a 4-week period, using the PiezoWave2 device with a linear shockwave applicator and the linear shockwave tissue coverage (LSTC-ED®) technique. If the improvement in erectile function was still considered insufficient (less than an IIEF-5 score of 22–25) at 2 months after the start of LI-LiESWT, penile rehabilitation was supplemented by pharmacological penile rehabilitation. The final effect of treatment was evaluated after 12 months. The main outcome measure was changes in the five-item International Index of Erectile Function (IIEF-5) score. Results: Between September 2019 and September 2020, a total of 40 patients were included in the study and randomly divided into 2 groups: treatment group and sham group. Eight patients were excluded from the study and were not evaluated due to other conditions which required additional treatment (COVID-19 disease, postoperative incontinence, urethral stricture, and ischemic stroke). Thirty-two patients were included in the final analysis: 16 in the control group and 16 in the intervention group. At 6 months from the end of treatment, patients in both the treatment and the sham group achieved physiological IIEF-5 values, and the beneficial effect persisted for 12 months after the end of treatment. Conclusions: LI-LiESWT using the LSTC-ED® technique is a suitable and safe method for penile rehabilitation in patients with ED after bilateral NS RP, not only because of the vasculogenic effect of LI-LiESWT but also because of its neuroprotective and/or regenerative effects.

32 - Predictors of Corporo-Venocclusive Dysfunction (cvod) in men with bilateral nerve-sparing Radical Prostatectomy (rp)

32 - Predictors of Corporo-Venocclusive Dysfunction (cvod) in men with bilateral nerve-sparing Radical Prostatectomy (rp)

Comparison of the efficacy of the early LI-SWT plus daily tadalafil with daily tadalafil only as penile rehabilitation for postprostatectomy erectile dysfunction

This study compares the efficacy of the early low-intensity shock wave therapy (LI-SWT) plus daily tadalafil with daily tadalafil only therapy as penile rehabilitation for postprostatectomy erectile dysfunction in patients with prostate cancer who underwent bilateral interfascial nerve-sparing radical prostatectomy (robotic or open). From April 2019 to March 2021, 165 patients were enrolled, and 80 of them successfully completed this prospective study. Daily tadalafil were administered to all the patients. LI-SWT consisted of a total of six sessions. Each session was performed on days 4, 5, 6, and 7, and on the second and fourth weeks after surgery. Each LI-SWT session consisted of 300 shocks at an energy density of 0.09 mJ/mm2 and a frequency of 120 shocks per minute that were delivered at each of the five treatment points for 15 min. Thirty-nine patients were treated with tadalafil-only (group A) while 41 were treated with tadalafil and LI-SWT simultaneously (group B). At postoperative 6 months, the proportion of patients with erection hardness scores (EHS) ≥ 3 (4/39 vs. 12/41) was significantly higher in group B (p = 0.034), and LI-SWT was the only independent factor for predicting EHS ≥ 3 (OR, 3.621; 95% CI, 1.054–12.437; p = 0.041). There were no serious side effects related to early LI-SWT. Early LI-SWT plus daily tadalafil therapy as penile rehabilitation for postprostatectomy erectile dysfunction is thought to be more efficacious than tadalafil only. Further large-scaled randomized controlled trials will be needed to validate these findings.

Long term erectile function results of radical perineal prostatectomy

Although many patients are being treated by radical prostatectomy (RP), there is still insufficient information about the changes in long-term erectile function after RP. Our aim is to examine long term, up to 5 year erectile function status of patients after Radical Perineal Prostatectomy (RPP). One hundred and thirty-two patients, who underwent bilateral nerve-sparing Radical Perineal Prostatectomy (RPP) in between January 2012 and January 2017, with preoperative age≤70, prostate volume<80g, transrectal ultrasound (TRUS) guided biopsy Gleason score (GS)<7, prostate specific antigen (PSA) value<10ng/mL, and cT stage≤2 (N0, M0) were included into this study. Exclusion criteria were previous cardiovascular diseases, serious chronic renal and/or hepatic insufficiency, neurological diseases, uncontrolled diabetes mellitus, and severe lung diseases. Patients who received additional treatment (hormonal and/or radiotherapy) after RPP were also excluded from the study group. Erectile function was evaluated before surgery and at postoperative 3rd, 12th, and 60th months. Patients with an "International Index of Erectile Function (IIEF) - 5" score of ≥21 and patients whose IIEF-5 scores were between 16 and 20 but responded as "yes" to the "Sexual Encounter Profile (SEP) - 2" and "SEP-3" questions were accepted as having normal erectile function. Out of the 132 patients, 96 (72.7%) of the patients were found to be potent in the first postoperative year. A total of 118 patients were evaluated at the end of 5 years. Eighty seven (73.7%) patients had normal erectile function according to our criteria. According to the results of our study, short term and long term erectile function outcomes of patients undergoing RPP were favorable and there was no statistically significant difference between short and long term results.

Efficacy and Safety of Udenafil Once Daily in Patients with Erectile Dysfunction after Bilateral Nerve-Sparing Robot-Assisted Laparoscopic Radical Prostatectomy: A Randomized, Double-Blind, Placebo-Controlled Study.

To evaluate the efficacy and safety of udenafil 75 mg once daily in patients with erectile dysfunction following bilateral nerve-sparing robot-assisted laparoscopic radical prostatectomy (BNS-RALP). A multi-center, prospective, randomized, controlled, double-blind study was conducted. Among patients with localized prostate cancer with international index of erectile function-erectile function domain (IIEF-EF) score of 18 or higher before BNS-RALP, those who developed postoperative erectile dysfunction (IIEF-EF score 14 or less at 4 weeks after BNS-RALP) were enrolled. Enrolled patients were randomly assigned to the udenafil 75 mg daily group or the placebo group in a 2:1 ratio. Each subject was followed up at 8 weeks (V2), 20 weeks (V3), and 32 weeks (V4) to evaluate the efficacy and safety of udenafil. In all, 101 patients were screened, of whom 99 were enrolled. Of the 99 patients, 67 were assigned to the experimental group and 32 to the control group. Ten (14.93%) patients in the experimental group and 10 (31.25%) in the control group dropped out of the study. After 32 weeks of treatment, IIEF-EF score of 22 or higher was seen in 36.51% (23/63) of patients in the experimental group and 13.04% (3/23) patients in the control group (p=0.021). The proportion of patients with IIEF-EF improvement of 25% or more compared to the baseline was 82.54% (52/63) in the experimental group and 62.96% (17/27) in the control group (p=0.058). Udenafil 75 mg once daily after BNS-RALP improved the erectile function without any severe adverse effects.

Patient- and Surgeon-Level Variation in Patient-Reported Sexual Function Outcomes Following Radical Prostatectomy Over 2 Years

Of patient-reported outcomes for individuals undergoing radical prostatectomy, sexual function outcomes are among the most reported and the most detrimental to quality of life. Understanding variations at the patient and surgeon level may inform collaborative quality improvement. To describe patient- and surgeon-level sexual function outcomes for patients undergoing radical prostatectomy in the Michigan Urological Surgery Improvement Collaborative (MUSIC) and to examine the correlation between surgeon case volume and sexual function outcomes. This is a prospective cohort study using the MUSIC registry and patient-reported sexual function outcome data. Patient- and surgeon-level variation in sexual function outcomes were examined among patients undergoing radical prostatectomy from May 2014 to August 2019. Sexual function outcome data were collected using validated questionnaires, which were completed before surgery and at 3, 6, 12, and 24 months' follow-up following surgery. All participants were male. Race and ethnicity data were self-reported and were included to examine potential variation in outcomes by race and/or ethnicity. Data were analyzed from January 2021 to March 2021. There were 4 outcomes in this study, including the 26-item Expanded Prostate Cancer Index Composite (EPIC-26) sexual function scores at 3, 6, 12, and 24 months' follow-up; patient-level sexual function recovery at 12- and 24-month follow-up; surgeon-level variation in sexual function outcomes at 12- and 24-month follow-up; and correlation between surgeon case volume and sexual function outcomes. A total of 1426 male patients met inclusion criteria for this study. The median (IQR) age was 64 (58-68) years. A total of 115 participants (8%) were Black, 1197 (84%) were White, 25 (2%) were of another race or ethnicity (consolidated owing to low numbers), and 89 (6%) were of unknown race or ethnicity. Among patients undergoing bilateral nerve-sparing radical prostatectomy, mean (SD) EPIC-26 sexual function scores at 12- and 24-month follow-up (12 months, 39 [28]; 24 months, 63 [29]) did not return to baseline levels. There was wide variation in EPIC-26 sexual function scores at both 12-month follow-up (range, 23-69; P < .001) and 24-month follow-up (range, 27-64; P < .001). Similar variations were found in EPIC-26 sexual function scores and recovery of sexual function by surgeon. Recovery rates ranged from 0% to 40% of patients at 12-month follow-up (18 surgeons; P < .001) and 3% to 44% of patients at 24-month follow-up (12 surgeons; P < .001). Surgeon case volume and sexual function outcomes were not significantly correlated. On multivariable analysis, the following variables were associated with better recovery at 24-month follow-up: younger age (P < .001), lower baseline EPIC-26 sexual function score (P < .001), lower Gleason score (P = .05), and nonobesity (P = .03). In this study, there was significant patient- and surgeon-level variation in sexual function recovery over 2 years following radical prostatectomy. Variation in surgeon-level sexual function outcomes presents an opportunity and model for surgical collaborative quality improvement.

Клинико-морфологическая оценка результатов стандартной робот-ассистированной нервосберегающей радикальной простатэктомии и с применением техники с сохранением Ретциева пространства

Objective To compare the perioperative, functional, clinical and morphological results of a standard robot-assisted nerve-sparing radical prostatectomy and with the use of the Retzius-sparing technique. Materials and methods A prospective analysis was performed of two groups of patients (n=54) who underwent nerve-sparing robot-assisted radical prostatectomy (period from 2017 to 2018). The first group included 29 patients who underwent nerve-sparing robot-assisted radical prostatectomy with Retzius-sparing technique, the second - 25 patients operated on according to the standard method of bilateral nerve-sparing radical prostatectomy. All patients were comparable in baseline characteristics. In all cases, patients had histologically verified localized prostate cancer pT2a-2c. Results In cases with use Retzius-sparing technique there is no statistically significant difference in the operation time (243.60 min vs 236.64 min, in groups 1 and 2, p>0.05) and intraoperative blood loss (131.20 ml vs 122.57 ml , in groups 1 and 2, p>0.05). Regarding the dynamics of the urinary continence recovery, the Retzius-sparing technique demonstrates advantages in speed and frequency at all follow-up periods (54.13% vs 41.81%; 68.12% vs 59.21%; 94.15% vs 90 , 63%; 98.54% vs 97.12%; 98.62% vs 97.31%; 98.83% vs 97.82% - in one week after removal of the urethral catheter, 1, 3, 6, 9, and 12 months in the first and second group, respectively). The frequency of erectile function recovery after 12 months was 82.17% and 71.14% in the first and second groups, respectively. Conclusions Retzius-sparing robot-assisted prostatectomy superior to standard operation in the speed and timing of recovery of urine continence and erectile function.

MP45-11 EFFECT OF ERYTHROPOIETIN ON ERECTILE FUNCTION AFTER RADICAL PROSTATECTOMY: THE ERECT RANDOMIZED CLINICAL TRIAL

Erectile dysfunction significantly impacts quality of life for men undergoing radical prostatectomy for prostate cancer. Erythropoietin is a promising neurotrophic factor for neurogenic erectile dysfunction based on preclinical and retrospective data. ERECT (NCT00737893) is a phase 2, double-blinded, randomized, placebo-controlled trial (July 2017-December 2019) evaluating the impact of perioperative erythropoietin on recovery of erectile function and other patient-reported, health-related quality of life outcomes after bilateral nerve-sparing radical prostatectomy (3, 6, 9, and 12 months). Erythropoietin (20,000 units) or saline placebo was injected subcutaneously the day before, day of, and day after surgery for 3 total doses. Of 63 patients assessed for eligibility, 56 patients were randomized. Arms (29 erythropoietin, 27 placebo) were well balanced (89.3% robotic, median age 55.5 years). International Index of Erectile Function-Erectile Function Domain (IIEF-EF) scores increased from median 12.5 at 3 months to 24.5 at 12 months. Median 2-week serum hemoglobin was higher for the erythropoietin arm compared to placebo (14.7 vs 13.6, p=0.02). There was no statistically significant difference in IIEF-EF scores at 6 months comparing erythropoietin to placebo (p=0.50) or at other time points (mixed model regression coefficient: -1.7, 95% CI -6.1-2.7, p=0.45). Excellent nerve-sparing rating (10/10) was associated with improved IIEF-EF recovery (+5.2, p=0.022). Other patient-reported, health-related quality of life domains as well as oncologic outcome and complications were similar between arms during followup. In the context of brief perioperative dosing, erythropoietin did not improve recovery of erectile function for men undergoing radical prostatectomy for prostate cancer compared to placebo. Further research to identify effective adjuncts to improve health-related quality of life for these men is needed.

The Phosphodiesterase-5 Inhibitors and Prostate Cancer – What We Rely Know About It?

Abstract Phosphodiesterase-5 inhibitors (PDE5Is) represent a group of drugs that are registered for the treatment of erectile dysfunctions predominantly, but recently also for treatment of pulmonary hypertension and benign prostatic hypertrophy. However, more and more research deals with possible antitumor potential of PDE5Is in different types of cancers, including prostate cancer. Prostate cancer represents the one of the most common carcinoma in the male population, whose incidence is continuously increasing. Early detection combined with radical prostatectomy increases the survival rate, but also it is necessary to keep in mind the quality of life of patients undergoing prostatectomy in light of bladder control and erectile function. Authors of various clinical studies presented the results that often lead to totally opposing conclusions. For example, Chavez and colleagues have shown that use of PDE5Is in men with erectile dysfunction decreases the risk of developing prostate cancer, while, on the other hand, Michl and colleagues pointed out the adversely effect of PDE5Is on biochemical recurrence after bilateral nerve sparing radical prostatectomy. In that sense, the aim of this review was to present as many as possible of existing results dealing with of action of PDE5Is in the field of prostatic carcinoma. Taking into account all presented data, it can be concluded that eff ect of PDE5Is on formation, development and outcome of treatment in patients with prostate carcinoma is very intriguing question, whose response requires additional both experimental and clinical research.

Re: A Randomized, Double-Blind, Placebo-Controlled Trial to Assess the Utility of Tacrolimus (FK506) for the Prevention of Erectile Dysfunction following Bilateral Nerve-Sparing Radical Prostatectomy.

Re: A Randomized, Double-Blind, Placebo-Controlled Trial to Assess the Utility of Tacrolimus (FK506) for the Prevention of Erectile Dysfunction following Bilateral Nerve-Sparing Radical Prostatectomy.

Effect of Tadalafil on Erectile Function in Patients after Robotic-Assisted Radical Prostatectomy with Unilateral or Bilateral Nerve Sparing

Objective: Erectile dysfunction (ED) is a major complication of radical prostatectomy. Despite advances in surgical techniques, the postoperative continence and potency rates are still not satisfactory. Many studies have reported experiences with penile rehabilitation using tadalafil for patients receiving nerve-sparing robotic-assisted radical prostatectomy, but similar reports are still lacking in Taiwan. Patients and Methods: We collected 163 patients that had undergone unilateral or bilateral nerve-sparing robotic-assisted radical prostatectomy from January 2013 to December 2014 in Tungs' Hospital. One month after operation, 5 mg tadalafil once daily was prescribed for 54 patients whose Foley's catheter had been removed and who had ED. We recorded the International Index of Erectile Function (IIEF-5) score at the 12th month after surgery. We defined postsurgery IIEF-5 ≥22 as potency or no ED. We compared the differences in clinical parameters and postsurgery potency rates between patients with or without tadalafil treatment. Results: The postsurgery potency rates of those with tadalafil treatment were significantly higher than that of those without tadalafil treatment (55.6% vs. 32.1%) after a 1-year follow-up observation. The mean (standard deviation) of IIEF-5preamong those with and without tadalafil treatment was 21.3 (4.5) and 19.2 (4.2), respectively. There were no significant differences in baseline clinical condition parameters between patients with potency with or without tadalafil treatment. The results indicated that the tadalafil-treated patients had a higher odds ratio (OR) of potency (adjusted OR = 2.58, 95% confidence interval [CI] = 1.28–5.22) than the nontadalafil-treated patients. However, those ≥65 years old were associated with a lower potency rate (adjusted OR = 0.94, 95% CI = 0.89-0.99). Conclusion: Starting penile rehabilitation with tadalafil 5 mg daily 1 month after nerve-sparing radical prostatectomy is safe for patients. Patients with mild-to-moderate ED should use tadalafil 5 mg daily after receiving nerve-sparing robotic-assisted laparoscopic prostatectomy due to its significant benefit in erectile function recovery.

A Randomized, Double-Blind, Placebo-Controlled Trial to Assess the Utility of Tacrolimus (FK506) for the Prevention of Erectile Dysfunction Following Bilateral Nerve-Sparing Radical Prostatectomy

Radical prostatectomy (RP) is associated with erectile dysfunction, largely mediated through cavernous nerve injury. There are robust pre-clinical data supporting a potential role for neuromodulatory agents in this patient population. This study assessed tacrolimus in improving erectile function recovery rates after RP (ClinicalTrials.gov number, NCT00106392). To define the utility of oral tacrolimus in improving erectile function recovery after nerve sparing radical prostatectomy. A randomized, double-blind trial compared tacrolimus 2-3 mg daily and placebo in men undergoing RP. Patients had localized prostate cancer and excellent baseline erectile function, underwent bilateral nerve-sparing RP, and were followed up for at least 18 months after RP. Patients received study drug for 27 weeks and completed the International Index of Erectile Function erectile function domain (EFD) questionnaire at baseline and serially after surgery. International Index of Erectile Function erectile function domain score. Data were available for 124 patients (59 tacrolimus, 65 placebo); mean age was 54.6 ± 6.2 years. No patient experienced permanent creatinine or potassium elevation. At baseline, mean EFD scores were 28.6 ± 2.1 (tacrolimus group) and 29 ± 1.5 (placebo group). By week 5, mean EFD scores had dropped to 8 ± 9.4 (tacrolimus) and 9 ± 10.7 (placebo). At 18 months, mean EFD scores were 16.0 ± 11.3 (tacrolimus) and 20.2±9.0 (placebo) (P= .09). Tacrolimus failed to meet significance (hazard ratio= 0.83; P= .50), with no difference in: (i) percentage of patients achieving normal spontaneous erectile function (EFD score ≥24), (ii) time to normalization of EFD score (≥24), (iii) percentage of patients capable of intercourse in response to phosphieserase type 5 inhibitor (PDE5i), and (iv) time to achieve response to PDE5i. Despite positive animal data, oral tacrolimus as used in this trial failed to improve erectile function after nerve sparing radical prostatectomy. The study is limited by a high attrition rate. The strengths include a randomized, placebo controlled design, extensive patient monitoring, use of medication diaries and a validated instrument as the primary outcome measure. Despite supportive animal data, tacrolimus used in this fashion in the RP population failed to demonstrate any superiority over placebo. Mulhall JP, Klein EA, Slawin K, etal. A Randomized, Double-Blind, Placebo-Controlled Trial to Assess the Utility of Tacrolimus (FK506) for the Prevention of Erectile Dysfunction Following Bilateral Nerve-Sparing Radical Prostatectomy. J Sex Med 2018;15:1293-1299.

Low-Intensity Extracorporeal Shockwave Therapy – A New Approach in the Treatment of Erectile Dysfunction after Radical Prostatectomy

Summary The experience accumulated with low-intensity extracorporeal shock wave therapy (LI-ESWT) from international clinical trials has demonstrated its safety, efficacy and good tolerance in treatment of erectile dysfunction (ED). The aim of this retrospective study was to investigate the effect of LI-ESWT in patients with ED after bilateral nerve sparing radical surgery for prostate cancer. Twenty-seven patients underwent bilateral nerve sparing radical retropubic prostatectomy (BNSRRP) at the clinic of urology of the university hospital in Pleven between January 2016 and December 2016. Twenty-one of these patients had pre-operative preserved erectile function (EF), as reported according to the International Index of Erectile Function (IIEF-5). Postoperatively, these 21 patients experienced a mild (18-21 points) impairment of EF. In 10 patients (group 1), LI-ESWT was performed. The procedure was performed once a week for 6 weeks with a LI-ESWT (BTL 6000 SWT Topline) instrument. The reading was obtained with IIEF-5 on the third and sixth month after the end of therapy. The other 11 patients (group 2) were used as a control group and did not receive treatment. In 5 patients in group 1, a recovery of EF (&gt; 21 points) as per IIEF-5 was recorded at the third month after treatment. In two patients, the same score was recorded at the sixth month. No improvement was seen in three men in group 1. In the controls (group 2), a spontaneous EF improvement in four patients at sixth month was registered. Despite the small number of patients and their short-term follow-up, our initial results indicate that LI-ESWT is effective, safe and well-tolerated. It could be an alternative for early penis rehabilitation in patients who have undergone BNSRRP.

Preoperative Evaluation of Sexual Function in Patients Undergoing Bilateral Nerve-Sparing Radical Retropubic Prostatectomy

Summary During the last few years, prostate cancer is more frequently diagnosed in young patients. This lays emphasis on the necessity to preoperatively evaluate the sexual function in patients undergoing bilateral nerve sparing radical retropubic prostatectomy (BNSRRP). The aim of our study was to make an objective evaluation of the basic sexual function in patients with clinically localized prostate cancer and candidates for BNSRRP, using internationally validated questionnaires. We also tried to find a correlation between these questionnaires and the individual assessment of candidates, on one hand, and between comorbidities of the patients and degree of erectile dysfunction (ED), on the other hand. From January 2014 to March 2017, at the urology clinic of University Hospital – Pleven, 64 patients opted BNSRRP and reported to have preserved erectile function (EF), wishing to maintain this function after surgery. The patients’ histories and comorbidities were recorded on the day of hospitalization. The subjective assessment of the patients’ potency was compared with International Index of Erectile Function (IIEF). According to the EF domain of the IIEF, baseline EF was assessed in 28 patients. Twelve patients had mild ED, 9 patients had mild to moderate ED, seven patients had moderate, and eight had severe ED. The results showed that a significant number of patients with clinically localized prostate cancer who were candidates for BNSRRP reported to be fully potent but actually had impaired EF preoperatively. There was also a pronounced correlation between concomitant diseases and EF.