PDE5i Use Research Articles

PIH18 Characterizing the IMPACT of PDE5I Use on the Health and Economic Burden of Erectile Dysfunction in the US, JAPAN, and China

PIH18 Characterizing the IMPACT of PDE5I Use on the Health and Economic Burden of Erectile Dysfunction in the US, JAPAN, and China

P-02-17 Efficacy of Low-Intensity Extracorporeal Shockwaves Treatment in Erectile Dysfunction

Evaluate efficacy of LISWT to improve erectile function in ED patients. 20 consecutive non-vascular mild ED patients (mean IIEF-15 EF domain = 19,4 ± 2.1); mean age 56.3 years, range 39-68) underwent 6 LISWT sessions, each session delivering 1500-4000 shocks. For 2 weeks before, during the treatment period and four weeks after LISWT patients were asked to refrain form PDE5i use. Once PDE5i treatment was re-introduced (Tadalafil 2.5 mg daily), patients were evaluated at 1, 2 and 6 months follow-up by using IIEF-15 erectile function domain and EHS questionnaires. Penile color-Doppler parameters in the flaccid state were evaluated before, during and after treatment according with standardized procedure. Collected data were analyzed using T-test and Wilcoxon test. No statistically significative difference in IIEF-15 EF domain, EHS and flow parameters was found when baseline and follow-up parameters were compared. EF-domain showed an improvement at both 2 and 6 months follow-up visit (mean 19.4 ± 2.1 vs 14.3 ± 1.3, p= 0.06) compared with baseline. Moreover, percentage of patients showing EF improvement increased during the treatment: 25 % at 6th treatment session vs 43.75 % at 2 months follow-up and 62.5 % at 6 months follow-up, respectively. Compared with baseline, EHS score improved in 7/20 patients at the end of the treatment session, in 8/16 patients at 1 months follow-up, and in 8/16 at 2 and 6 months follow-up (p < 0.05).

PDE5i Use in Renal Transplant Recipients

PDE5i Use in Renal Transplant Recipients

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.

156 Development of Nomograms to Predict Erectile Function After Radiation Therapy

Erectile dysfunction (ED) is a well-recognized complication of radiation therapy (RT) with numerous factors impacting upon erectile function (EF) preservation. Nomograms have been used as aids to counsel patients prior to radical prostatectomy. The aim of this study was to develop nomograms to predict the likelihood of EF recovery in patients following RT.(EFD) Study population included: men with PC who received RT; with baseline and follow-up IIEF EF domain scores, and PDE5i use documented. Parameters entered into the model were: patient age, number of vascular comorbidities (diabetes, hypertension, dyslipidemia, coronary artery disease, stroke, sleep apnea), treatment type (external beam, brachytherapy, or combination therapy), baseline EFD score, baseline PDE5i use (sometimes/regularly vs never), and cumulative PDE5i use. The predictive ability of these covariates on the respective outcomes were assessed with internal validation. Logistic regression was used to predict the probability that a patient will have EFD ≤10 (severe ED), and EFD ≥24 (functional erections) at 12, 24, and 36 months from baseline.

160 Predictors of Worsening Erectile Function in Men With Functional Erections Early After Radical Prostatectomy

Prior data suggest that men with good erectile function (EF) early after radical prostatectomy (RP) can worsen their EF over the first 6 months postoperatively. We aimed to determine the prevalence and predictors of worsening EF after RP. 1,655 men who (i) underwent RP (ii) completed IIEF EF domain (EFD) pre-RP and (iii) serially post-RP constituted the population. Functional erections (FE) were defined as EFD score ≥24. We analyzed factors predicting FE at 3 months post-RP as well as factors predicting a decrease in FE between 3-6 months, defined as a two point drop or more in EFD score. Multivariable logistic regression (MVA) models were used with the following predictors: patient age at RP, baseline and 3-month EFD scores, PDE5i use at 3m (always vs other), diabetes, hypertension, hyperlipidemia, sleep apnea, cigarette smoking status (never vs current vs former), and nerve-sparing status (NSS; none vs unilateral vs bilateral).

Erectile Dysfunction Medications and Skin Cancer: An Analysis in US Veterans

ObjectiveTo examine the relationship between phosphodiesterase 5 inhibitor drugs (PDE5i) and skin cancers in a large-scale study of Veterans. MethodsThis was a retrospective database review using the Department of Veterans Affairs Informatics and Computing Infrastructure database. Veterans Affairs Informatics and Computing Infrastructure was searched 19 years for Veterans who received PDE5i treatment of erectile dysfunction. A non-PDE5i group of Veterans was selected for comparison analysis. Follow-up time, outpatient clinic visits and incidence of malignant melanoma (MM), and basal cell carcinoma (BCC) were measured in both groups. ResultsA total of 2.55 million Veterans were included in this study (1.27 million in each group). Mean age of the PDE5i group and non-PDE5i group was 59.2 years (standard deviation [SD] ± 10.8) and 58.7 (SD ± 10.8), respectively. Mean follow-up time for the PDE5i group was 8.9 years (SD ± 4.2) and 8.5 years (SD ± 4.3) for non-PDE5i group. Odds ratio for malignant melanoma and BCC in the PDE5i group was 1.25 (confidence interval 95%, 1.22-1.28, P <.0001) and 1.49 (confidence interval 95%, 1.46-1.51, P <.0001), respectively. PDE5i users showed more mean outpatient visits/year (8.9 SD ± 9.50) compared to non-PDE5i users (5.9 SD ± 10.0; P <.0001). ConclusionVeterans prescribed PDE5is to treat erectile show a minimal increased risk of MM and a greater risk of BCC compared to non-PDE5i users. PDE5i users visited outpatient VA clinics at a higher rate than non-PDE5i users in this study. These findings suggest confounding variables are likely involved in the relationship between skin cancers and PDE5i use. PDE5i drugs remain a safe treatment for erectile dysfunction.

Is there a relationship between phosphodiesterase type 5 inhibitors and biochemical recurrence after radical prostatectomy: a systematic review and meta-analysis

Conduct a systematic review and meta-analysis of studies to evaluate the association between the use of PDE5I and biochemical recurrence (BCR) after radical prostatectomy (RP). We searched Embase (from 1996 to Feb 2018), PubMed (from 1996 to Feb 2018), and Cochrane library (from 1999 to Feb 2018), then manually searched the reference lists of key retrieved articles. Original studies that reported the risk of postoperative BCR for PDE5I users, as compared with non-PDE5I users, were included. Data including the characteristic of participants, the risk of BCR after RP and key criteria of study quality were collected. The pooled relative risks (RRs) were calculated with random-effects model. A total of 5 cohort studies and 1 case-control study were conducted for data analysis (a total of 17752 participants). Only 1 cohort study reported adjusted RR greater than 1 (range for all derived RRs, 0.7-1.47). The meta-analysis revealed that the PDE5I users had no higher risk of BCR after RP (RR = 1.04, 95% confidence interval [CI], 0.79-1.36). Sensitivity analysis showed that the remaining pooled RR and 95% CI were not changed significantly by omitting each study. In addition, the 5-year BCR rate had no significant difference between PDE5I users and non-PDE5I users. Our meta-analysis indicated that PDE5I treatment in men following RP did not increase the risk of BCR. The results preliminarily suggested that the use of PDE5I for erectile dysfunction after RP was oncologically safe. Nevertheless, more large sample cohort studies are needed to validate this conclusion.

Oral L-citrulline and Transresveratrol Supplementation Improves Erectile Function in Men With Phosphodiesterase 5 Inhibitors: A Randomized, Double-Blind, Placebo-Controlled Crossover Pilot Study.

IntroductionPhosphodiesterase type 5 inhibitors (PDE5i) are first-line therapy for most men with erectile dysfunction (ED). If ineffective, vacuum erection devices, intracavernous injections, and penile prosthesis implantation are suitable as second- or third-line therapies. However, very few patients select these therapies. It is critically important to improve erectile function with oral administration of effective agents. Administration of L-citrulline or transresveratrol in animal experiments has been reported to improve erectile function, but few such experiments have been performed on humans with ED.AimWe aimed to investigate the efficacy of combination therapy of L-citrulline and transresveratrol in patients with ED despite their use of PDE5i.MethodsIn this randomized, double-blind, placebo-controlled crossover pilot study, men with ED (Sexual Health Inventory for Men [SHIM] score below 16) despite on-demand use of PDE5i received a placebo for 1 month or the active treatment (L-citrulline 800 mg/day and transresveratrol 300 mg/day) for another month. Patients continued on-demand use of PDE5i.Main Outcome MeasureThe SHIM score, Erection Hardness Score (EHS), Aging Male Symptoms Scale-sexual domain (AMS-SD), and adverse events were examined.Results20 patients ages 29–78 years were enrolled, and after 6 men withdrew, 13 concluded the study without adverse events. Mean SHIM score for the active treatment increased significantly (10.96 ± 1.21) compared with baseline (8.32 ± 1.21) and placebo (8.31 ± 1.23) (both P < .05). Mean EHS score for the active treatment (2.56 ± 0.26) also increased from baseline (2.31 ± 0.26), but not significantly (P = .79). Mean AMS-SD score was not significantly different in either group.ConclusionTo our knowledge, this is the first study to show that combination therapy of L-citrulline and transresveratrol is effective for ED treatment in men with added on-demand use of PDE5i. This combination supplement may be added if PDE5i is insufficient.Shirai M, Hiramatsu I, Aoki Y, et al. Oral L-citrulline and Transresveratrol Supplementation Improves Erectile Function in Men With Phosphodiesterase 5 Inhibitors: A Randomized, Double-Blind, Placebo-Controlled Crossover Pilot Study. Sex Med 2018;6:291–296.

Comparison of impact of monopolar versus bipolar resection of the prostate on erectile function in patients with benign hyperplasia of the prostate

Introduction and ObjectiveThe incidence of erectile dysfunction (ED) after TURP for BPH is still debated. Current study aims at comparing the impact of monopolar and bipolar TURP on the sexual function of male patients with LUTS, using the IIEF EF-domain score (questions 1–5, 15) and to identify statistical risk factors associated with development of post-operative ED. Patients and methodsBetween April 2014 and May 2015, 102 patients underwent TURP for symptomatic BPH. Sixty on underwent TURP by the monopolar technique and 41 by the bipolar technique. Patients were assessed on the day before the surgery by IIEF and followed up 3 and 6 months postoperatively, using the same scoring system. ResultsOn a 6 month follow up,13 patients (22.4%) in the monopolar group and 12 (30%) in the bipolar group, experienced clinical change in their EF score. Among risk factors studied, only diabetes, intraoperative capsular perforation and preoperative use of PDE5I had a statistically significant impact on the EF score.No statistically significant difference in IIEF score and EF domain score was observed between the patients who underwent TURP by the monopolar technique, compared to those patients in which the bipolar one was used; whether at three months (p value 0.33) or at six months (p value 0.397). ConclusionNo statistical difference could be detected between monopolar and bipolar TURP, regarding the risk of developing post-operative ED. However, a higher incidence of ED should be anticipated in patients with DM, intraoperative capsular perforation and preoperative use of PDE5I.

Salvage robotic-assisted radical prostatectomy: oncologic and functional outcomes from two high-volume institutions

While no consensus on the optimal salvage treatment exists, only 3% of these patients will get salvage radical prostatectomies due to the assumed technical challenges of this procedure. Our goal is to analyze the perioperative, oncologic and functional outcomes of patients undergoing salvage robotic-assisted radical prostatectomy (sRARP) after primary treatment failure. Data were prospectively collected and retrospectively reviewed from a combined database of more than 14,800 patients who had undergone RARP. We identified 96 patients who underwent sRARP after RT or ablative techniques. Primary cancer characteristics, surgical data, pathology results, perioperative complications, oncologic and functional outcomes were analyzed. Sixty-eight patients (70.8%) received some source of RT as a primary treatment. The remaining 28 patients: 18 (18.75%) received cryotherapy, seven (7.92%) HIFU, one electroporation, one microwave and one Tookad. complication was seen in 25 (26%) patients (21 minor and 4 major complications). Anastomotic leak was the most common complication, found in 14 (14.6%) of the cases. No rectal injuries occurred. Fourteen (15%) patients had a biochemical failure after a median follow-up of 14 (IQR 5-24)months. Fifty-five (57.3%) of them self-reported to be pad-free at 12months. Seventeen (55%) of 31 pre-operative potent patients (SHIM score > 21), were potent with or without the use of PDE5i at 12months. sRARP is a feasible alternative for PCa recurrence. Technically the procedure is challenging and should be performed by experienced PCa surgeons. Major complications are uncommon. Continence and potency recovery is possible, but at lower rates than for non-salvage patients.

Risk of Melanoma With Phosphodiesterase Type 5 Inhibitor Use Among Patients With Erectile Dysfunction, Pulmonary Hypertension, and Lower Urinary Tract Symptoms

BackgroundPhosphodiesterase type 5 inhibitors (PDE5is), a treatment for erectile dysfunction, pulmonary hypertension (pHTN), and lower urinary tract symptoms (LUTS), have been implicated in melanoma development. AimWe sought to determine the association between PDE5i use and melanoma development among patients with erectile dysfunction, pHTN, and LUTS. MethodsThis was a retrospective cohort study of subjects contained within the Truven Health MarketScan claims database, which provides information on insurance claims in the United States for privately insured individuals, from 2007–2015. Individuals taking PDE5i were identified through pharmacy claims. A comparison group of men diagnosed with conditions for which PDE5i are prescribed was assembled. OutcomesCox proportional hazard models were used to estimate the hazard ratio (HR) (95% CI) of incident melanoma, basal cell carcinoma, and squamous cell carcinoma. ResultsOf 610,881 subjects prescribed PDE5i, 636 developed melanoma (0.10%). The control group had 8,711 diagnoses of melanoma. There was an association between increased PDE5i tablet use and melanoma (HR 1.05, 95% CI 1.05–1.09). This association was also present between PDE5i use and basal cell carcinoma (HR 1.04, 95% CI 1.02–1.07) and squamous cell carcinoma (HR 1.04, 95% CI 1.01–1.07). In patients with pHTN and LUTS prescribed PDE5is, there was no relationship between exposure and melanoma incidence (HR 0.74, 95% CI 0.48–1.13; and HR 1.03, 95% CI 0.97–1.10, respectively). Clinical ImplicationsThere is little evidence for a clinically relevant association between PDE5i use and melanoma incidence. Strengths & LimitationsOur current work represents the largest study to date evaluating the relationship between PDE5i use and melanoma risk, and the first to examine all current indications of PDE5i use among men and women. Limitations include a patient population limited to commercially insured individuals, unknown patient medication compliance, and lack of information on patient skin type, lifestyle, and sun-exposure habits. ConclusionThere is a slight association between higher-volume PDE5i use and development of melanoma, basal cell carcinoma, and squamous cell carcinoma. This association among all skin cancers implies that confounding may account for the observed association.Shkolyar E, Li S, Tang J, et al. Risk of Melanoma With Phosphodiesterase Type 5 Inhibitor Use Among Patients With Erectile Dysfunction, Pulmonary Hypertension, and Lower Urinary Tract Symptoms. J Sex Med 2018;15:982–989.

The Association Between Phosphodiesterase Type 5 Inhibitor Use and Risk of Non-Arteritic Anterior Ischemic Optic Neuropathy: A Systematic Review and Meta-Analysis.

IntroductionPhosphodiesterase type 5 inhibitors (PDE5-Is) are first-line drugs for erectile dysfunction. Non-arteritic anterior ischemic optic neuropathy (NAION) has been linked with PDE5-I use. However, no meta-analysis or conclusive review has explored the association between NAION and PDE5-I use.AimTo investigate the association between PDE5-I use and risk of NAION.MethodsA comprehensive literature search was conducted using online databases in October 2017 to obtain studies researching the association between PDE5-I application and occurrence of NAION. Summarized unadjusted risk ratios (RRs) with 95% CIs were calculated for the strength of this association. This study was conducted in accordance to Meta-analysis of Observational Studies in Epidemiology (MOOSE) guidelines and registered in PROSPERO under number CRD42017080865.Main Outcome MeasuresThe strength of association between PDE5-I use and risk of NAION was assessed through pooled unadjusted RRs and 95% CIs.Results5 original articles with 6 clinical observations were included in the meta-analysis. No significant higher risk of NAION was observed after the use of PDE5-Is within a 1-month period (RR = 1.16, 95% CI = 0.98-1.39, P = .09). Subgroup analyses indicated 2 PDE5-Is were significantly related to NAION (tadalafil: RR = 2.14, 95% CI = 1.20–3.84, P = .01; sildenafil: RR = 2.25, 95% CI = 1.29–3.94, P = .004).ConclusionsAlthough we found no association between NAION and PDE5-I use, our results should be interpreted cautiously because we included only observational studies and could not control for potential confounders. Because NAION is a rare ocular disease and difficult to diagnose, this association should be confirmed in prospective comparative studies with larger samples and more rigorous designs.Liu B, Zhu L, Zhong J, et al. The Association Between Phosphodiesterase Type 5 Inhibitor Use and Risk of Non-Arteritic Anterior Ischemic Optic Neuropathy: A Systematic Review and Meta-Analysis. Sex Med 2018;6:185−192.

Use of phosphodiesterase type 5 inhibitors and risk of melanoma: a meta-analysis of observational studies.

BackgroundPhosphodiesterase type 5 inhibitor (PE5i) administration may stimulate the proliferation and survival of melanocytes. However, discrepancies remain regarding the association between PDE5i use and melanoma risk in observational studies in humans.AimTo evaluate the association between PDE5i use and melanoma in a meta-analysis.Materials and methodsStudies were identified by searching the PubMed and Embase databases. A random-effects model was applied to synthesize the data. A stratified study was performed to evaluate the influence of study characteristics on outcomes.ResultsFour prospective cohort studies and three case–control studies with 1,534,615 male participants and 16,053 melanoma cases were incorporated. Patients who received a PDE5i had a significantly increased risk for melanoma (adjusted risk ratio [RR] =1.12, 95% CI =1.03–1.33, P=0.008) with moderate heterogeneity (I2=54%). Cohort studies (adjusted RR =1.22, 95% CI =1.02–1.46, P=0.03) largely contributed to this result rather than case–control studies. Subsequent stratified analyses revealed that sildenafil was associated with an increased risk of melanoma (adjusted RR =1.26, 95% CI =1.07–1.50, P=0.007), but tadalafil and vardenafil were not. Also, PDE5i use was associated with a significantly increased risk of in situ melanoma (adjusted RR =1.31, 95% CI =1.01–1.69, P=0.04), but not of localized or nonlocalized melanoma.ConclusionPDE5i use may be associated with a significantly increased risk for melanoma in men. However, further research is needed to determine whether the association is causative.

Stem cell therapy for erectile dysfunction: Preliminary results from a single-center pilot study in Greece

Introduction: Stem cell therapy is a novel therapy that aims in regenerating tissues and organs and therefore, improves their condition or treats current diseases. The use of stem cell therapy in organic erectile dysfunction is a new alternative to the till now used treatments for erectile dysfunction. Material-Methods: This is a pilot study to evaluate the safety and the efficacy of adipose derived stem cell therapy in erectile dysfunction (ED). Fifteen patients (aged 45-75) will be enrolled and divided in three groups: group A will be treated with adipose derived stem cells (ADSCs) plus Platelet Lysate Plasma (PLP), group B with ADSCs and group C with PLP. In each patient blood samples will be taken for hormonal and metabolic evaluation and CT scans of the abdomen, thorax and brain will be performed to rule out other pathologies. ED evaluation will be performed at the entry visit and then at 1st, 3rd, 6th and 12th month visit through IIEF questionnaire and penile triplex. ADSCs will be collected from subcutaneous abdomen fat through punch biopsy or liposuction and after processing will be injected to the penis. Results: Five patients have been enrolled in group A and they have completed three months of follow up. In all patients there is a significant improvement in erectile function. Morning erections have reappeared or improved in all patients. Unassisted hard erections or erections with the use of oral PDE-5i are present in patients that needed Intracavernous injections (ICI) before treatment or were unable to have erections at all. No side effects or complications are noted so far. Conclusion: Stem cell therapy with ADSCs for ED seems a promising therapy with encouraging results. Further studies and long follow up period is needed to fully evaluate this experimental treatment.

Meta-Analysis of the Association Between Phosphodiesterase Inhibitors (PDE5Is) and Risk of Melanoma.

The US Food and Drug Administration recently announced the need to evaluate the association between PDE5is and melanoma. We performed a meta-analysis on the association between PDE5i and melanoma using random effects models and examined whether it met Hill's criteria for causality. A systematic search of Medline, EMBASE, and the Cochrane Library from 1998 to 2016 identified three case-control studies and two cohort studies, including a total of 866 049 men, of whom 41 874 were diagnosed with melanoma. We found a summary estimate indicating an increased risk of melanoma in PDE5i users (relative risk = 1.11, 95% confidence interval = 1.02 to 1.22). However, the association was only statistically significant among men with low PDE5i exposure (not high exposure) and with low-stage melanoma (not high stage), indicating a lack of dose response and biological gradient. PDE5i use was also associated with basal cell cancer, suggesting a lack of specificity and likely confounding by ultraviolet exposure. Thus, although this meta-analysis found a statistically significant association between PDE5i and melanoma, it did not satisfy Hill's criteria for causality.

027 Is There a Relationship Between Phosphodiesterase Type 5 Inhibitors (PDE5i) and Prostate Cancer Biochemical Recurrence?

There have been conflicting studies looking at an association between prostate cancer biochemical recurrence (BCR) after radical prostatectomy (RP) and PDE5i use. Patients completed a 1 – 5 assessment of PDE5i use pre-RP and serially after RP in a prospective, quality of life study evaluating men post-RP. Men who had data on PDE5i use at 3m, 6m, 9m, and 12m in the first year following RP were included in the analysis. The tested predictors of BCR were: age, PSA, Gleason score (G), surgical margin status (SMS), seminal vesicle involvement (SVI), extra capsular extension (ECE), and lymph node involvement (LNI). Predictive nomograms have established these as the important predictors of BCR. PDE5i groups were: low use (never/sometimes) vs high use (regularly/routinely/more than once a day). Risk groups were low risk (G 6/7 and organ confined disease) or intermediate/high risk (all others). Mean age of the 655 men was 61±7 years. 117 men (18%) had BCR. The mean time to BCR was 1.4±1.4 years. PDE5i groups: 55% low use, 45% high use. There were 16% in the low use PDE5i group with BCR vs 20% in the high use PDE5i group with BCR (RR=1.3: 95% CI: 0.84-1.86, p=0.28). On multivariable analysis, G, SMS, SVI, ECE, and LNI were all associated with BCR (p=0.05 to p=0.001). Age (OR: 1.02, 95% CI: 0.99-1.06, p=0.22), PSA (OR: 1.02, 95% CI: 0.98-1.06, p=0.31), and PDE5i group assignment (OR: 1.52, 95% CI: 0.95-2.43, p=0.08) were not significant predictors in the model. Risk groups were low risk (178 men) and intermediate/high risk (476 men) disease. We could not replicate the analysis with the low risk group since only 5 men had BCR. In the high risk group, there were 112 (23%) who had BCR. The pattern of results for disease characteristics were similar as above. The PDE5i variable, on univariate analysis the group assignment was not significant. There were 22% in the low use PDE5i group with BCR vs 26% in the high use PDE5i group with BCR (RR=1.3: 95% CI: 0.81-1.90, p=0.33). In multivariable analysis, PDE5i group assignment was again not a significant predictor of BCR (OR: 1.37, 95% CI: 0.84-2.22, p=0.20).

Penile Low-Intensity Shock Wave Therapy for Erectile Dysfunction: Personal Experience

Objective: Penile extracorporeal low-intensity shock wave therapy (LIST) to the penis has recently emerged as a novel and promising modality in the treatment of erectile dysfunction. LIST can improve penile blood flow and endothelial function by stimulating angiogenesis in the penis. Design and Method: We applied LIST to patients with mild to moderate vasculogenic ED who responded well to the use of PDE5i. The treatment protocol consisted of one treatment sessions per week for 6 weeks, a 6 -week no-treatment interval. Each session comprised the application of 3000 shock waves (energy intensity of 4 mJ/mm3) to each penile shaft and 1000 shock waves for each crura. Results: The results showed that 6 weeks after treatment, erectile function improved in the 85% of the cases, good result was achieved in 10% and no results in 5% of the patients. The average increase in the IIEF-EF domain score was 8.8 points. Furthermore, erectile function and penile blood flow were measured using nocturnal penile tumescence (NPT) and color-power Doppler of the penis. All NPT parameters improved as recorded by significant increases in the duration of the erections and penile rigidity. Conclusions: The treatment options for ED have greatly expanded and include PDE5i, intracavernosal injections, and penile prostheses. Our experience presented here demonstrate that LIST of the corpora cavernosa is a novel therapeutic option for ED. LIST may have a fundamental effect on penile endothelial function, increasing penile blood flow, and improving erectile function and consequently sexual satisfaction.

AB085. Systematic review and meta-analysis of phosphodiesterase type 5 inhibitors for the treatment of female sexual dysfunction

ObjectiveTo obtain systematic and comprehensive evidence regarding the benefits and safety of PDE5i compared to those of placebo.MethodsAll randomized controlled trials (RCTs) reporting on the effectiveness of PDE5i in FSD were identified through comprehensive searches of PubMed, the Cochrane Library and Embase, and a meta-analysis and systematic review of these studies were conducted.ResultsFourteen studies were included for meta-analysis. Because RCTs included in our study adopted different questionnaires for the measurement of sexual function, most of the data had to be separated rather than pooling the results. Summarizing the results of each comparison, we found that the use of PDE5i resulted in a significant improvement in sexual functioning compared with placebo in most studies, except for a few sporadic negative results. However, pooled data for adverse events showed significantly higher rates of headache, flushing, and vision changes in PDE5i treatment group [risk ratio (RR) 2.59, 95%95% confidence interval (CI), 1.93–3.47, P<0.00001; RR 5.74, 95% CI, 3.60–9.14, P<0.00001; and RR 4.64, 95% CI, 2.16–9.98, P<0.0001, respectively]. However, no one reported the need of any additional therapy for these adverse events.ConclusionsOur results indicate that PDE5i would be effective for female sexual dysfunction. Though there were significantly higher rates of adverse events, use of PDE5i was still relatively safe. More well-designed, double-blind, crossover RCTs reporting results from standardized questionnaires should be conducted to accurately solve this issue.

AB023. Penile rehabilitation with phosphodiesterase type 5 inhibitors in men after nerve-sparing radical prostatectomy

Post-radical prostatectomy (RP) erectile dysfunction (ED) remains a challenge for the urologist. Despite the improvements in surgical technique, ED occurs between 20% and 90% in patients treated with bilateral nerve-sparing RP. Patient factors, cancer selection, type of surgery, surgical techniques, and surgeon factors represent the key significant contributors to erectile function recovery. The aim of a penile rehabilitation program is to preserve the functional smooth-muscle content of the corpus cavernosum during the neuropraxia period. Phosphodiesterase type 5 (PDE5) inhibitors are commonly used in rehabilitation programs. In animal models, such an approach could promote erectile function recovery, improve smooth muscle-to-collagen penile ration, reduce penile apoptotic index, preserve penile endothelial function and promote neuroprotection during nerve damage. Despite the strong basic science support from animal studies, discordant results have been reached in humans. The previous randomized trials comparing chronic versus on-demand PDE-5 inhibitors use after RP may be affected by improper patients’ selection in that only men at low risk of postoperative ED were included. These patients would recover erectile function regardless of the type of PDE5 inhibitor administration because of their excellent baseline profile. Prospective, randomized trials have shown a significant benefit of daily PDE5-I administration as compared with placebo in terms of postoperative EF recovery. Patients with intermediate risk of ED after surgery are the best candidates for daily treatment with PDE5 inhibitor after bilateral nerve-sparing RP. The maximal effect of penile rehabilitation may be found in those men with a certain (but not high) degree of systemic and erectile impairment preoperatively. In conclusion, penile rehabilitation could achieve faster and better natural erectile function after RP and should be started as early as possible. Chronic use of PDE5-I may confer the maximal gain as compared to the on-demand administration schedule. Attention should be pained to the observation that rehabilitation protocols are beneficial even in men with spontaneous erections postoperatively because further improvement in such patients was reported.