Effect of Functional Electrical Stimulation on Erectile Dysfunction in Post –Stroke Survivors- A Randomized Cinical Control Trail

IIEF-EF Improvements are more Pronounced with Nutraceuticals Compared to Placebo Medications: A Systematic Review and Meta-analysis

Is Erectile Dysfunction a Reliable Proxy of General Male Health Status? The Case for the International Index of Erectile Function—Erectile Function Domain

The objective of this randomized controlled trial was to investigate the impact of manual therapy (friction massage) and pelvic floor muscle (PFM) training on erectile dysfunction (ED), pelvic floor muscle thickness, and blood flow in the penile arteries and veins in men who have undergone prostatic adenectomy (PA). This study employed a randomized, double-blinded, controlled trial design. Forty patients participated and were divided into two groups: intervention and control (n=20 per group). The intervention group received 10 sessions of pelvic floor muscle training and manual therapy, while the control group solely underwent pelvic floor muscle training. The recovery rate was measured using the International Index of Erectile Function 15 (IIEF-15) questionnaire and Erection Hardness Score (EHS). Sonographic factors were assessed using simple and Doppler ultrasound. The intervention group exhibited significantly higher erectile function scores (F(1,37)=158.04, P < 0.001, η2 P = 0.810) and a higher average total (IIEF-15) score (20.52) (F(1,37)=136.76, P < 0.001, η2 P = 0.787) compared to the control group in the post-test assessment. Comparison between the two groups revealed an increase in ultrasonic parameters such as the thickness of the ischiocavernosus and bulbospongiosus muscles, maximum systolic velocity, and minimum diastolic velocity of the cavernosal artery in the intervention group. However, the maximum blood flow velocity in the posterior vein decreased. PFM training and friction massage play a significant role in managing ED following PA, positioning them as the primary treatment approach for men experiencing ED post-prostatectomy.

Background: Many stroke survivors continue to experience gait deficits. Functional electrical stimulation may be a viable method to improve gait post-stroke. Objective: The purpose of this parallel group controlled clinical trial was to investigate the therapeutic effect of functional electrical stimulation (FES) on gait, motor recovery, and motor cortex activity. Methods: Adults experiencing foot drop <6 months poststroke were allocated to the FES group (physiotherapy and FES stimulation, n = 14) or the control group (physiotherapy, n = 14). Each group received their respective therapy 5 days/week for 12 weeks. Gait, surface electromyography (sEMG) of the tibialis anterior muscle in the affected leg, and electroencephalogram (EEG) signals from the foot motor area were assessed at baseline and again after the 12-week intervention. Results: The results showed that the FES intervention induced significantly more changes in various gait swing parameters such as foot pulling acceleration (measured in unit of gravitational constant G; net between-group difference: 0.11 ± 0.02 G, p = 0.021), swing power (0.11 ± 0.03 G, p = 0.027) and ground impact (0.12 ± 0.04 G, p = 0.046) than the control group. EEG analysis revealed that the FES group had significantly altered beta-3 mean (0.50 ± 0.09, p = 0.021), beta-4 mean (0.60 ± 0.05, p = 0.024) and alpha peak frequency (0.15 ± 0.02, p = 0.035). Finally, analysis of sEMG data showed a significantly greater increase in amplitude (in root mean square; 13.2 ± 2.11 μV, p = 0.033), mean power frequency (5.5 ± 0.80 Hz, p = 0.024) and median power frequency (6.5 ± 0.90 Hz, p = 0.021) of the tibialis anterior muscle on the affected side in the FES group. Conclusion: FES combined with physiotherapy induced better outcomes in the swing phase of the gait cycle, activation of the affected ankle dorsiflexor muscles and cortical function when compared with conventional physiotherapy alone.

Most surgical treatments for male lower urinary tract symptoms and benign prostatic hyperplasia affect erectile and ejaculatory functions negatively, leading to patient dissatisfaction. To determine whether water vapor thermal therapy, when conducted in a randomized controlled trial, would significantly improve lower urinary tract symptoms secondary to benign prostatic hyperplasia and urinary flow rate while preserving erectile and ejaculatory functions. Men at least 50 years old with International Prostate Symptom Scores of at least 13, a peak flow rate of at least 5 to no higher than 15 mL/s, and prostate volume of 30 to 80 cm(3) were randomized 2:1 between Rezūm System thermal therapy and control. Thermal water vapor (103°C) was injected into lateral and median lobes as required for treatment of benign prostatic hyperplasia. The control procedure entailed rigid cystoscopy with simulated active treatment sounds. Blinded group (active= 136, control= 61) comparison occurred at 3 months and the active arm was followed to 12 months for International Prostate Symptom Score, peak flow rate, and sexual function using the International Index of Erectile Function and the Male Sexual Health Questionnaire for Ejaculatory Function. The minimal clinically important difference in erectile function perceived by subjects as beneficial was determined for each erectile function severity category. Subjects not sexually active were censored from sexual function analysis. No treatment- or device-related de novo erectile dysfunction occurred after thermal therapy. International Index of Erectile Function and Male Sexual Health Questionnaire for Ejaculatory Function scores were not different from the control group at 3 months or from baseline at 1 year. Ejaculatory bother score improved 31% over baseline (P=.0011). Also, 32% of subjects achieved minimal clinically important differences in erectile function scores at 3 months, and 27% at 1 year, including those with moderate to severe erectile dysfunction. International Prostate Symptom Score and peak flow rate were significantly superior to controls at 3 months and throughout 1 year (P < .0001). Convective water vapor thermal therapy provides sustainable improvements for 12 months to lower urinary tract symptoms and urinary flow while preserving erectile and ejaculatory functions.

Objective:Phosphodiesterase type-5 inhibitors (PDE5Is) are first-line therapies for erectile dysfunction (ED). Sildenafil (SIL) and vardenafil (VAR) are approved for as-needed (PRN) dosing; tadalafil (TAD) is approved for both PRN and once-a-day (OaD) dosing for ED. Recent evidence suggests that TAD-OaD may be effective as therapy in men with an incomplete response to PRN-PDE5I therapy. This study evaluated whether TAD-OaD provides similar efficacy in men with ED who had previously demonstrated a partial response to PRN-PDE5I therapy.Research design and methods:In this randomized, double-blind, placebo-controlled trial, men with a ≥3 month ED history received SIL 100 mg, TAD 20 mg, or VAR 20 mg during a 4 week open-label lead-in period. Those with International Index of Erectile Function – Erectile Function (IIEF-EF) domain scores <26 following lead-in treatment completed a 4 week washout period, then randomized to TAD 2.5 mg up-titrated to 5 mg, TAD 5 mg, or placebo (PBO) OaD for 12 weeks. Main outcome measures obtained from patients treated with TAD-OaD were compared to PBO-treated patients. Additionally, results of treatment with TAD-OaD were compared to results obtained from 4 week PRN-PDE5I therapy to determine whether OaD and PRN regimens provided comparable efficacy.Clinical trial registration:NCT01130532.Main outcome measures:International Index of Erectile Function (IIEF) domain scores; Sexual Encounter Profile (SEP) questions 2–5.Results:Endpoint data was obtained from 590 men (391 TAD; 199 PBO). Results for all IIEF and SEP measures were significantly better for TAD-OaD (p < 0.001 for all) compared to PBO and were comparable to those observed during PRN-PDE5I treatment. TAD 2.5 mg and TAD 5 mg OaD therapy were safe and generally well tolerated.Conclusion:Tadalafil once daily is a viable alternative to as-needed PDE5I therapy in men with ED. Key limitations include the lack of a PRN PDE5I study group during the double-blind period, and that many more patients took tadalafil than sildenafil or vardenafil during the PRN period.

To report the experience of three highly specialized centres in the vascular evaluation of erectile dysfunction (ED) in teenagers, as there is little information on this topic, and although clinical guidelines support the use of vascular studies in selected cases, our experience is that vascular evaluation aimed at diagnosing organic ED is uncommon in teenagers, and most are designated as having psychogenic ED. In a retrospective multi-institutional analysis of three ED databases (1998-2003) we assessed males aged < or =19 years presenting with ED. The review of these databases focused on demographic characteristics, risk factors for ED, erectile function, results of vascular evaluation, and the causes of ED. In all, 40 males aged 14-19 years were identified. The mean (range) duration of ED at presentation was 22.6 (4-84) months. The major risk factors for ED were antecedent perineal trauma (37%) and penile trauma or surgery (15%). The mean (sd) International Index of Erectile Function 'erectile function' domain score was 15 (4). Information obtained by history taking was not predictive of the cause of ED. Vascular studies were performed in 62% of the patients and 48% of these patients were found to have an underlying vascular pathology; 42% of the latter group were found to be possible candidates for surgical intervention and another 16% needed further angiographic evaluation. ED in teenagers should not be routinely categorized as psychogenic without an adequate vascular evaluation, as a significant percentage have abnormal erectile haemodynamics consistent with vasculogenic ED.

The aim of this study is to present a summary of current evidence concerning the various treatments in the management of penile rehabilitation after radical prostatectomy (RP) and provide recommendations for future research. Randomized controlled trials (RCTs) were identified from electronic databases including PubMed, the Cochrane Library, Embase, and Web of Science from inception through March 2020 with no limitation to language. Comparable data from each study were combined in a meta-analysis where possible, otherwise data were synthesized narratively. The data analysis was completed by Review Manager version 5.3. A total of 39 RCTs were included in this study. At present, phosphodiesterase type 5 inhibitors (PDE5is) remain the first-line treatment for patients with erectile dysfunction (ED) after RP. Compared with the placebo group, patients in regular PDE5is group (mean difference (MD): 0.76; 95% confidence interval (CI): 1.69-4.44; p < 0.0001) and on demand group (MD: 3.92; 95% CI: 2.95-4.88; p < 0.00001) had a significantly higher mean Erectile Function domain of the International Index of Erectile Function (IIEF-EF) scores within 3 months after RP. As for the proportion of IIEF-EF ≥ 22, patients in regular PDE5is group and on demand PDE5is group had significantly higher proportion than those in placebo group 6 months after RP, and the odds ratios were 1.87 (95% CI: 1.32-2.66; p = 0.0005) and 2.17 (95% CI: 1.20-3.93; p = 0.01), respectively. No significant difference was observed between regular PDE5is group and on demand group regardless of mean IIEF-EF score or the proportion of IIEF-EF ≥ 22. Intracorporeal injection therapy seemed to have similar efficacy to PDE5is. The International Index of Erectile Function-5 items (IIEF-5) scores were significantly higher in vacuum constriction devices group than control group at 6-9 months after RP (MD: 6.70, 95% CI: 2.30-11.10, p = 0.003) with great between-study heterogeneity (p = 0.06, I2 = 72%). The other therapeutics including low-intensity extracorporeal shockwave therapy, statin therapy, psychotherapy interventions, and pelvic floor muscle training plus electrical stimulation showed certain improvement on erectile function. We found that the combination therapy showed certain advantages over monotherapy. Currently, PDE5is-based combination therapy remains the mainstream treatment for ED after RP. Intracorporeal injection therapy and vacuum therapy could be served as alternative treatments if PDE5is are ineffective and contraindicated.

Intracavernosal injection therapy (ICI) was the first pharmacologic treatment in the management of erectile dysfunction. ICI allows for customization of medication composition and concentrations, making it a highly effective treatment with an acceptable side effect profile. The objective was to investigate the long-term results of ICI using validated and non-validated instruments. This is a retrospective, single-institution study of 105 patients (mean age 61.6 ± 11.1) patients using ICI. Mean duration of ICI was 8.4 ± 6.25 years. Pre- and post-treatment patient-reported penile rigidity were 41.1% ± 29.3 and 89.6% ± 13.6, respectively (p < 0.05). Statistical changes were also found in the pre and post International Index of Erectile Function (IIEF) scores (33.0 ± 14.4 and 60.0 ± 12.7, p < 0.05), erectile function (11.5 ± 1.3 and 27.3 ± 0.9, p < 0.05) and satisfaction domains (5.3 ± 1.5 and 8.1 ± 1.1, p < 0.05) of the IIEF. There were no statistical differences in questionnaire outcomes between difficult to treat patients (diabetes or radical prostatectomy) and the remainder of queried patients. Complications were rare and included priapism (7.1%), penile curvature (10%; <30°), bruising (7.6%), and mild penile pain (12.4%). Overall, ICI therapy is safe and effective, and compliance may be augmented by patient education, dosing customization, and cost reduction.

Purpose: The aim of this study was to evaluate the efficacy and safety of a herbal formula that mainly consists of Cornus officinalis for treating erectile dysfunction. Materials and Methods: Eighty patients suffering with erectile dysfunction were enrolled in this randomized, double-blinded, placebo-controlled study. The average duration of erectile dysfunction of the herbal formula group (n=40) vs. the placebo group (n=40) were 19.33±18.13 months vs. 19.33±25.62 months, respectively. The safety variables we examined were the history, physical examination, vital signs, EKG, clinical laboratory tests and hormonal tests. Efficacy assessments included the International Index of Erectile Function (IIEF), the sexual encounter profile (SEP) diary and Global Assessment Questions (GAQ). Results: No significant changes in the laboratory values, hormone tests and blood pressure were observed in both groups. In comparison with the placebo group (6.57±11.72), the herbal formula group experienced a significant improvement of the IIEF (11.13±11.83) (p<0.05). When the herbal formula and placebo groups were divided by age and the IIEF score (age: 50 years and IIEF: 42) and then compared, the low IIEF group (IIEF≤ 42) and old age group (age≥50) of the herbal formula group significantly improved their IIEF score (p<0.05). The herbal formula group significantly improved their GAQ score (p<0.05). The herbal formula was well tolerated. The common adverse events were headache (2.5%) and nausea (5%). Conclusions: In conclusion, the herbal formula that mainly consists Cornus officinalis was not only effective at improving erectile function, but it was also safe for the treatment of erectile dysfunction. (Korean J Urol 2007;48: 741-747) 󰠏󰠏󰠏󰠏󰠏󰠏󰠏󰠏󰠏󰠏󰠏󰠏󰠏󰠏󰠏󰠏󰠏󰠏󰠏󰠏

To determine the population dose-response relationship for tadalafil during on-demand (as-needed) administration for treatment of erectile dysfunction (ED). A total of 212 male patients with mild, moderate, or severe ED participated in a multicenter, randomized, double-blind, placebo-controlled, parallel-group study. Patients were randomized to receive placebo or 2, 5, 10, or 25 mg tadalafil, taken on demand over an 8-week period. Efficacy was assessed on the basis of questions 2 and 3 of the Sexual Encounter Profile (SEP) and questions 3 and 4 of the International Index of Erectile Function (IIEF) questionaires. These scores were modeled using logistic regression. A fifth patient response, the IIEF EF (erectile function) domain score, was modeled as a continuous variable. The dose-response relationship for each efficacy variable was best described with an Emax model, in which maximum effect increased with ED severity at baseline. Response scores increased substantially between 10 and 25 mg tadalafil doses, and the dose-response parameter estimates suggested possibly higher responses at even higher doses. Population dose-response modeling of all five oucome measures indicated that efficacy in all ED severity groups in the studied population generally increased across the 2 to 25 mg tadalafil dose range. Estimates of maximal improvement (Emax) in the IIEF EF domain score were 7.5, 11.4, and 16.3 points for patients with mild, moderate, and severe ED, respectively. Corresponding tadalafil doses to attain half-maximal improvement (ED50 estimates) were 4.7 mg, 7.1 mg, and 10.1 mg.

THE ROLE OF SILDENAFIL IN THE TREATMENT OF ERECTILE DYSFUNCTION IN PATIENTS WITH PELVIC FRACTURE URETHRAL DISRUPTION

The cost effectiveness of sildenafil remains controversial, due in part to questions about the magnitude and significance of changes in quality-of-life utility values as a result of its use. Our objective was to measure utilities for present health and hypothetical erectile function scenarios in men with and without erectile dysfunction (ED) and to measure utilities in men with ED before and after treatment with sildenafil. SUBJECTS AND M ethods: Men with and without ED were recruited from a urologist's office. Subjects completed the International Index of Erectile Function (IIEF), the 12-Item Short-Form health survey (SF-12), and utility assessments (visual analogue scale [VAS], time tradeoff [TTO], and standard gamble [SG]) for their own present health and erectile function as well as for hypothetical scenarios of poor and very good erectile function. Exclusion criteria were cardiac illness history, current nitrate use, present sildenafil use, or inability to follow up. Eighty-nine men without ED and 58 men with ED were recruited. Fifteen men with ED (25.9%) were prescribed sildenafil and completed at least one follow-up interview. Utilities for men with ED were significantly lower than men without ED by VAS (0.71 vs 0.84, p < 0.01) and TTO (0.89 vs 0.96, p < 0.01), but not by SG. Men without ED rated the poor erectile function scenario lower than men with ED; both groups rated the very good erectile function scenario similarly. Men without ED rated poor erectile function significantly lower than their present health (utility differences 0.34 for VAS, 0.08 for TTO and SG). In 15 men who gave ratings after sildenafil, significant changes were seen in IIEF scores, but not in utilities. Men with ED had lower VAS and TTO utilities than men without ED. Based on utility differences between present health and a poor erectile function scenario in men without ED, sildenafil would likely be considered cost effective from a societal perspective. However, sildenafil therapy may be less cost effective from a patient perspective, but conclusions are limited by the small group of men providing ratings after sildenafil therapy. Very good erectile function is highly valued by men regardless of their erectile function status.

Objectives Men with erectile dysfunction (ED) are at elevated risk of heart disease. However, data on the prevalence of abnormal cardiac structure and function in ED is scarce. We utilized echocardiography to assess cardiac characteristics in men with ED. Methods In this prospective cohort study of men with ED referred to a tertiary urology clinic, all participants underwent transthoracic echocardiography following a predefined protocol and electrocardiogram. Erectile function was graded according to the International Index of Erectile Function - Erectile Function (IIEF-EF) questionnaire. Participants with neurological disease, a medical history of pelvic surgery or trauma were excluded. Left ventricular (LV) structure was evaluated by ventricular mass index (LVMi). LV diastolic function was evaluated according to early diastolic mitral annular velocity (e'), ratio of early transmitral filling velocity to (E/e’) and left atrial volume index (LAVi). LV systolic function was evaluated by LV ejection fraction (LVEF), and global longitudinal strain (GLS). Results We included 100 patients with a median age of 61 yr (IQR 13) and median IIEF-EF was 15 (IQR 14). Comorbidities included hypertension (43%), dyslipidemia (41%), diabetes mellitus (29%), ischemic heart disease (12%), arrhythmia (12%), and heart failure (3%). Regarding cardiac structure, 25 patients had LV hypertrophy. Signs of LV diastolic dysfunction were a common observation; 21 patients had an E/e' ratio &amp;gt; 9, while 30 patients had reduced septal and/or lateral e' velocities with only 1 patient having left atrial dilation (LAVi &amp;gt; 34 ml/m2). Regarding LV systolic dysfunction, 83 patients had reduced GLS (&amp;lt; 16%) with 14 suffering reduced LVEF &amp;lt; 52%. 4 patients were referred for further evaluation, due to previously undiagnosed left bundle branch block, mitral valve regurgitation, aortic valve regurgitation, and incident heart failure, respectively. Conclusions A majority of patients with ED demonstrated impairment of cardiac structure and function assessed by measures of diastolic dysfunction and myocardial deformation. Conflicts of Interest The authors declare no conflict of interest.

To evaluate once-daily 100-mg sildenafil for the treatment of erectile dysfunction (ED) in men with ED and lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH). This was a 12-week, randomised, double-blind, placebo-controlled (DBPC) trial, with an 8-week open-label (OL) extension, in men > or = 45 years of age who scored < or = 25 on the erectile function (EF) domain of the International Index of Erectile Function (IIEF) and > or = 12 on the International Prostate Symptom Score. At DBPC end of treatment (EOT), the sildenafil group (n = 189, vs. placebo, n = 180) had improved EF (IIEF), improved emotional well-being [Self-Esteem And Relationship questionnaire (SEAR)], and greater treatment satisfaction (Erectile Dysfunction Inventory of Treatment Satisfaction) (p < 0.0001). At OL EOT, IIEF and SEAR scores improved slightly in the group previously randomised to sildenafil (n = 168), but much more in the group previously randomised to placebo (N = 155), such that total improvement over the 20-week trial was comparable between the groups. Erections at baseline were hard enough for penetration on approximately half of occasions and lasted long enough for successful intercourse on less than one quarter of occasions, increasing at sildenafil DBPC and OL EOT to approximately 90% (penetration) and 80% (intercourse success) vs. 61% (penetration) and 39% (intercourse success) for DBPC placebo. At sildenafil DBPC and OL EOT, > or = 90% of men were taking sildenafil 100 mg. Sildenafil was generally well tolerated. In this trial of men with ED and BPH-associated LUTS, sildenafil treatment for ED was efficacious, effective and generally well tolerated.