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1.  Effects of tissue-cultured mountain ginseng (Panax ginseng CA Meyer) extract on male patients with erectile dysfunction 
Asian Journal of Andrology  2009;11(3):356-361.
Korean ginseng and mountain ginseng (Panax ginseng CA Meyer) are important traditional herbal plants whose ginsenosides are generally accepted as serving to improve sexual functions, such as penile erection. We investigated the effects of tissue-cultured mountain ginseng extract (TMGE) on male patients with erectile dysfunction (ED). A double-blind, placebo-controlled study was conducted with 143 patients experiencing ED. Over the course of 8 weeks, one group took 1 000 mg of TMGE twice a day, and the other group took 1 000 mg of placebo twice a day. The effects of the TMGE and the placebo were analyzed using the Korean version of the International Index of Erectile Function (IIEF) questionnaire. A total of 86 patients completed 8 weeks of treatment. The scores on the five domains of the IIEF after medication were significantly higher than the baseline scores in the group treated with TMGE (P < 0.05), whereas no significant improvement was observed in the placebo group (P > 0.05). Erectile function and overall satisfaction scores after medication were significantly higher in the TMGE group than in the placebo group (P < 0.05). Erectile function of patients in the TMGE-treated group significantly improved, suggesting that TMGE could be utilized for improving erectile function in male patients.
doi:10.1038/aja.2008.32
PMCID: PMC3735289  PMID: 19234482
erectile dysfunction; Panax ginseng; tissue-cultured mountain ginseng extract
2.  Evaluation of erectile function after urethral reconstruction: a prospective study 
Asian Journal of Andrology  2009;11(2):209-214.
We conducted a prospective study of erectile dysfunction (ED) after urethral reconstructive surgery, using the 5-item International Index of Erectile Function (IIEF-5), the Sexual Life Quality Questionnaire (SLQQ) and the Quality of Life Questionnaire (QoLQ). Between January 2003 and July 2007, 125 male patients with urethral strictures underwent urethroplasty, and pre- and post-surgery erectile function was assessed using these three questionnaires. A formula to predict the probability of ED after urethroplasty was derived. At 3 months post-operatively, there was a significant decrease in IIEF-5 (16.57 ± 7.98) and SLQQ scores (28.71 ± 14.84) compared with pre-operative scores (P < 0.05). However, the IIEF-5 scores rebounded at 6 months post-operatively (17.22 ± 8.41). Logistical regression analysis showed that the location of the urethral stricture, the recurrence of strictures and the choice of surgical technique were predictive of the post-operative occurrence of ED. This study identified the clinical risk factors for ED after urethroplasty. Posterior urethral stricture and end-to-end anastomosis were found to have a strong relationship with erectile function. The logistical model derived in this study may be applied to clinical decision algorithms for patients with urethral strictures.
doi:10.1038/aja.2008.1
PMCID: PMC3735020  PMID: 19122678
erectile dysfunction; urethroplasty; urethral stricture
3.  Efficacy of Ashwagandha (Withania somnifera Dunal. Linn.) in the management of psychogenic erectile dysfunction 
Ayu  2011;32(3):322-328.
Erectile dysfunction (ED) has been defined as the persistent inability to attain and maintain an erection sufficient to permit satisfactory sexual performance. By 2025, men with ED will be approximately 322 million, an increase of nearly 170 million men from 1995. The present study was aimed to evaluate the efficacy of Ashwagandha (Withania somnifera) in the management of psychogenic erectile dysfunction. In this study, a total of 95 patients with psychogenic erectile dysfunction satisfying the DSM IV TR diagnostic criteria were selected, out of them 86 patients completed the course of treatment. In Trial Group, Ashwagandha root powder and in Control group, Placebo (Wheat powder) were given for 60 days. Treatment selection and its allocation were done by following computerized randomization plan. Criterion of assessment was based on the scoring of International Index of Erectile Function (IIEF) Scale. Paired and Unpaired t test were used for statistical analysis. In Trial group (n=41), 12.6% and in Control group (n=45), 19.11% of improvement was observed with the significance of (P<0.001). There was no significant difference (P>0.05) found in between the two groups. Both Ashwagandha and Placebo provided no relief (<25% improvement on IIEF) in psychogenic erectile dysfunction.
doi:10.4103/0974-8520.93907
PMCID: PMC3326875  PMID: 22529644
Ashwagandha; International Index of Erectile Function; placebo; psychogenic erectile dysfunction
4.  Erectile dysfunction and premature ejaculation in men who have sex with men 
The Journal of Sexual Medicine  2012;9(2):576-584.
Introduction
Quantitative research into sexual function and dysfunction in men who have sex with men (MSM) has been sparse due in large part to a lack of validated, quantitative instruments for the assessment of sexuality in this population.
Aim
To assess prevalence and associations of erectile problems and premature ejaculation in MSM.
Methods
MSM were invited to complete an online survey of sexual function. Ethnodemographic, sexuality, and health related factors were assessed.
Main Outcome Measure
Participants completed a version of the International Index of Erectile Function modified for use in MSM (IIEF-MSM) and the Premature Ejaculation Diagnostic Tool. Total score on the erectile function domain of the IIEF-EF (IIEF-MSM-EF) was used to stratify erectile dysfunction (ED) severity (25–30=no ED, 16–24 mild or mild moderate ED, 11–15 moderate ED, and ≤ 10 severe ED). PEDT scores were used to stratify risk of premature ejaculation (PE, diagnosed as PEDT score ≥9).
Results
Nearly 80% of the study cohort of 2,640 men resided in North America. The prevalence of ED was higher in older men whereas the prevalence of PE was relatively constant across age groups. Multivariate logistic regression revealed that increasing age, HIV seropositivity, prior use of erectogenic therapy, lower urinary tract symptoms (LUTS), and lack of a stable sexual partner were associated with greater odds of ED. A separate multivariate analysis revealed that younger age, LUTS, and lower number of lifetime sexual partners were associated with greater odds of PE.
Conclusions
Risk factors for sexual problems in MSM are similar to what has been observed in quantitative studies of non-MSM males. Urinary symptoms are associated with poorer sexual function in MSM.
doi:10.1111/j.1743-6109.2011.02585.x
PMCID: PMC3271132  PMID: 22214402
5.  Self-Esteem, Confidence, and Relationships in Men Treated with Sildenafil Citrate for Erectile Dysfunction 
Journal of General Internal Medicine  2006;21(10):1069-1074.
BACKGROUND
Men with erectile dysfunction (ED) often have low self-esteem, confidence, and sexual relationship satisfaction.
OBJECTIVE
We evaluated the impact of sildenafil citrate and its generalizability across cultures on self-esteem, confidence, and sexual relationship satisfaction in men with ED using the Self-Esteem And Relationship (SEAR) questionnaire.
DESIGN
Pooled analysis of 2 double-blind, placebo-controlled, flexible-dose trials of sildenafil with identical protocols: 1 was conducted in the United States and the other in Mexico, Brazil, Australia, and Japan.
PATIENTS
Men ≥18 years old with ED.
MEASUREMENTS
The impact of treatment on psychosocial factors associated with ED was determined by patient responses to the SEAR questionnaire. Erectile function was determined using the International Index of Erectile Function (IIEF) and a global efficacy question. Successful sexual intercourse attempts were derived from event logs of sexual activity. Treatment effect sizes were calculated for all study outcomes.
RESULTS
Compared with patients who received placebo (n = 274), patients who received sildenafil (n = 279) reported significantly greater improvements (P<.0001) in self-esteem, confidence, sexual relationship satisfaction, and in all sexual function domains of the IIEF. Treatment effect sizes were large (range, 0.7 to 1.2) for all SEAR components, and improvement in psychosocial measures showed moderate to high correlations (range, 0.50 to 0.83, P<.0001) with improvement in erectile function, percentage of successful intercourse attempts, and global efficacy.
CONCLUSIONS
In men with ED from 5 different nations, sildenafil produced substantial improvements in self-esteem, confidence, and sexual relationship satisfaction. Improvements in these psychosocial factors were observed crossculturally and correlated significantly and tangibly with improvements in erectile function.
doi:10.1111/j.1525-1497.2006.00554.x
PMCID: PMC1831645  PMID: 16836626
erectile dysfunction; impotence; self-esteem; confidence; quality of life; relationship; psychometrics
6.  Sexual Dysfunction Improved in Heroin-Dependent Men after Methadone Maintenance Treatment in Tianjin, China 
PLoS ONE  2014;9(2):e88289.
Objective
To investigate whether methadone maintenance treatment (MMT) is correlated with sexual dysfunction in heroin-dependent men and to determine the prevalence and risk factors of sexual dysfunction among men on MMT.
Methods
The study included a retrospective survey and a cross-sectional survey which contained interviews of 293 men who are currently engaged in MMT. The results of the two surveys were compared. For a subset of 43 participants, radioimmunoassay was additionally conducted using retrospective and prospective blood samples to test the levels of plasma testosterone and luteinizing hormone. Other study evaluations were the International Index of Erectile Function (IIEF-15), and Self-rating Depression Scale.
Results
Sexual dysfunction in all five IIEF-15 domains (erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction) was strongly associated with long-term use of heroin. A decrease in the severity of sexual dysfunction was associated with MMT initiation. Erectile dysfunction, lack of sexual desire, inability to orgasm, and lack of intercourse satisfaction were significantly correlated with increasing age of the participants. Methadone dose and duration of methadone treatment were not found to be associated with sexual dysfunction. The level of plasma testosterone significantly declined during methadone treatment, but results from multivariate analysis indicated low levels of testosterone were not the main cause of sexual dysfunction. No correlation between reported depression status and sexual function was found.
Conclusions
While high levels of sexual dysfunction were reported by heroin-dependent men in our study before and after MMT initiation, MMT appears to be correlated with improved sexual function in the population of the study.
doi:10.1371/journal.pone.0088289
PMCID: PMC3919724  PMID: 24520361
7.  The GAy MEn Sex StudieS: erectile dysfunction among Belgian gay men 
Aim
To determine the prevalence of erectile dysfunction (ED) in a sample of the Belgian men who have sex with men (MSM) population, and to assess the relevance of major predictors such as age, relationship, and education. We investigated the use of phosphodiesterase type 5 (PDE5) inhibitors among Belgian MSM.
Methods
An internet-based survey on sexual behavior and sexual dysfunctions, called GAy MEn Sex StudieS (GAMESSS), was administered to MSM, aged 18 years or older, between the months of April and December 2008. The questionnaire used was a compilation of the Kinsey’s Heterosexual–Homosexual Rating Scale, Erection Quality Scale (EQS), and the shortened version of the International Index of Erectile Function (IIEF-5).
Results
Of the 1752 participants, 45% indicated having some problems getting an erection. In this group of MSM, 71% reported mild ED; 22% mild to moderate ED; 6% moderate ED; and 2% severe ED. Independent predictors for the presence of ED were: age (odds ratio [OR] = 1.04, P < 0.0001), having a steady relationship (OR = 0.59, P < 0.0001), frequency of sex with their partner (OR = 1.22, P < 0.0001), versatile sex role (OR = 1.58, P = 0.016), passive sex role (OR = 3.12, P < 0.0001), problems with libido (OR = 1.15, P = 0.011), ejaculation problems (OR = 1.33, P < 0.0001), and anodyspareunia (OR = 0.87, P < 0.0001). Ten percent of the Belgian MSM used a PDE5 inhibitor (age 43 ± 11 years; mean ± standard deviation) and 83% of them were satisfied with the effects. “Street drugs” were used by 43% of MSM to improve ED.
Conclusion
Forty-five percent of participating Belgian MSM reported some degree of ED and 10% used a PDE5 inhibitor to improve erections. Older MSM reported more ED. MSM, who were in a steady relationship or frequently had sex with a partner, reported less ED. MSM with ejaculation problems indicated having more ED.
doi:10.2147/IJGM.S45783
PMCID: PMC3704453  PMID: 23861591
homosexuality; internet; sexual behavior; erectile dysfunction
8.  Do randomized clinical trials with inadequate blinding report enhanced placebo effects for intervention groups and nocebo effects for placebo groups? 
Systematic Reviews  2014;3:14.
Background
Studies suggest that expectations powerfully shape clinical outcomes. For subjective outcomes in adequately blinded trials, health improvements are substantial and largely explained by non-specific factors.
The objective of this study was to investigate if unblinding in randomized controlled trials (RCTs) is associated with enhanced placebo effects for intervention groups and nocebo effects for placebo groups. For these effects, a secondary objective was to explore potential moderating factors.
Methods
We included RCTs that investigated the efficacy of phosphodiesterase-5 (PDE-5) inhibitors for male erectile dysfunction by comparing one PDE-5 inhibitor to placebo. In addition, to be included studies must have reported scores for change from baseline, or baseline and final International Index of Erectile Functioning-Erectile Functioning domain score (IIEF-EF), and be published in either English, French, Dutch, or German.
We searched for both published and unpublished relevant trials using PUBMED, EMBASE, the Cochrane Central Register of Controlled Trials, a clinical trials register (clinicaltrials.gov) and the Food and Drug Administration clinical reviews through March 2012.
We evaluated the blinding status of trials with the Cochrane Risk of Bias Tool, using the domains of allocation sequence concealment, blinding of participants, healthcare providers and outcome assessors. Across these four domains, studies that scored low risk of bias were judged to be adequately blinded and studies that scored unclear or high risk of bias were judged to be inadequately blinded.
Results
We included 110 studies (205 journal publications and 2 unpublished sources) that involved 23,877 participants; 93 (85%), 51 (46%), 93 (85%) and 93 (85%) studies were assessed with an unclear risk of bias for allocation concealment, blinding of participant, blinding of caregiver and blinding of outcome assessor, respectively. None of the studies reported testing of blinding.
None of the 205 journal publications provided sufficient details to assess allocation concealment, blinding of participants, caregivers and outcome assessors. After contacting authors for additional information, we judged five studies to be adequately (n = 1,202) and 16 to be inadequately (n = 3,006) blinded. The IIEF-EF score for placebo groups in adequately blinded trials versus inadequately blinded trials was 1.92 points (95% CI, 0.64 to 3.20) versus 1.56 (95% CI, 0.93 to 2.20), respectively. The IIEF-EF score for intervention groups in adequately blinded trials versus inadequately blinded trials was 9.40 (95% CI, 6.96 to 11.83) versus 8.33 (95% CI, 7.29 to 9.37), respectively. In a secondary analysis, prior experience with the drug affected the scores; in placebo groups with participants naïve to the intervention the score was 2.89 (95% CI, 2.33 to 3.45) versus -0.11 (95% CI, -2.06 to 1.84) with participants having prior experience. In the intervention groups, these scores were 7.99 (95% CI, 6.85 to 9.14) versus 8.33 (95% CI, 7.51 to 9.16), respectively.
Unblinding lowered placebo scores (creating a nocebo effect) by 19% (0.33 points; 95% CI, -0.96 to 1.62). Unblinding lowered intervention scores by 11% (1.0; 95% CI, -1.35 to 3.47). The results provided no conclusive evidence for nocebo or enhanced placebo effects. Patients taking a PDE-5 inhibitor for the first time experience a larger placebo effect that accounts for 35% of the total effect.
Conclusions
Given the overall poor reporting of blinding in clinical trial reports and the small number of trials that could be rated as adequately or inadequately blinded, we could not draw any robust conclusions about the existence or absence of nocebo and enhanced placebo effects. A large placebo effect was found for patients taking PDE-5 inhibitors for the first time. It was not clear if previous exposure to the drug impacted trial blinding.
We found clear evidence that studies assessing a subjective continuous outcome fail to report on measures taken to secure double blinding. Although we observed a trend for the presence of a nocebo effect, there was insufficient evidence to quantify its impact on expectations. RCTs with patients with no prior experience with PDE-5 inhibitors reported larger placebo effects and possibly these studies were better blinded. Future research should further investigate the factors that contribute to blinding and their impact on health outcomes in randomized trials of subjectively assessed conditions. This research is part of a PhD project and has no external funding. The authors have no competing interests to declare.
doi:10.1186/2046-4053-3-14
PMCID: PMC3939643  PMID: 24555576
Placebo; Nocebo; Phosphodiesterase-5 inhibitor; Randomized controlled trial; Expectancy; Double blind; Bias; Treatment efficacy
9.  Assessment of Erectile and Ejaculatory Function after Penile Prosthesis Implantation 
Korean Journal of Urology  2010;51(3):202-207.
Purpose
We investigated erectile and ejaculatory function after penile prosthesis implantation.
Materials and Methods
A total of 121 patients were enrolled in the surgery group (SG) and 120 patients in the nonsurgery group (NSG). All subjects were evaluated by use of the following questionnaires: the erection function and intercourse satisfaction domains of the International Index of Erectile Function (IIEF) and the ejaculation domain of the Male Sexual Health Questionnaire (MSHQ-EjD). Comparisons were made between the SG and the NSG, by prosthesis types, and of postoperative periods and complication rates for each prosthesis type.
Results
Differences in the erection function and intercourse satisfaction domains of the International Index of Erectile Function (IIEF-EF and IIEF-IS) between before and after treatment were significantly higher in the SG group than in the NSG group (p=0.02, 0.03, respectively). When comparing prosthesis types, differences in the erection confidence and intercourse satisfaction items between before and after surgery were significantly higher in the SG group (p=0.03, 0.04, respectively). In the comparison of each prosthesis type by postoperative period, differences in the IIEF-EF and IIEF-IS between before and after surgery were not statistically significant but the MSHQ-EjD domain after surgery was significantly lower in cases of >5 years (p=0.02, 0.03, respectively).
Conclusions
Subjective symptoms such as erectile confidence and erectile function were improved more in the SG group than in the NSG group, especially in the inflatable group. It appeared that there was no significant difference in improvement in ejaculatory function depending on the treatment method, but that ejaculatory function decreased as time passed.
doi:10.4111/kju.2010.51.3.202
PMCID: PMC2855449  PMID: 20414398
Questionnaires; Penile prosthesis; Penile erection; Ejaculation
10.  The evaluation of sexual dysfunction in male patients with migraine and tension type headache 
Background
Erectile dysfunction (ED), defined as the inability to achieve or maintain an erection sufficient for satisfactory sexual performance, is a common condition. The psychological, hormonal, neurogenic and arterial pathologies, medications, chronic diseases have been reported in the etiology of the ED. This paper aims to study sexual dysfunction in the male patients with migraine and Tension type headache (TTH).
Methods
30 migraine cases (Group M), 31 TTH cases (Group T) and 30 control cases (Group C) were included in the study. Patients were evaluated with medical history, physical examination, body mass index (BMI), Beck Depression Inventory, biochemical analysis and hormone profiles. ED was evaluated via International Index of Erectile Function Scale (IIEF). In statistical analysis, variant analysis, post-hoc tukey test, Pearson correlation test, t-test, and fisher's exact chi-square test were used.
Results
The patients' mean age was 34.96+/−1.30, 35.54+/−1.52 and 32.26+/−1.38 for group M,T and C, respectively. There was no significant difference between the groups in terms of testosterone levels. Mean IIEF scores was 19.83+/−2.2, 20.39+/−1.35 and 27.83+/−0.34 in groups M,T,C. When M and T groups were compared with group C, there were significant differences, and there was no statistical difference when T and M groups were compared to each other. Beck Depression Scores were not significantly different in groups M, T and C.
Conclusion
In this study, it was shown that, migraine and TTH affects the sexual functions negatively in male patients. Chronic diseases may cause sexual disorders in patients because of despair, guilt, and fear of death or pain. Our results suggest that, along with the effect of chronic disease and pain, there must be other complicated factors exist causing the development of SD in patients with migraine and TTH.
doi:10.1186/1129-2377-14-46
PMCID: PMC3671169  PMID: 23718759
Migraine; Tension type headache; Erectile dysfunction; International Index of Erectile Function Scale
11.  Evaluation of a multi-herb supplement for erectile dysfunction: a randomized double-blind, placebo-controlled study 
Background
Evidence is lacking for multi-ingredient herbal supplements claiming therapeutic effect in sexual dysfunction in men. We examined the safety and efficacy of VigRX Plus (VXP) – a proprietary polyherbal preparation for improving male sexual function, in a double blind, randomized placebo-controlled, parallel groups, multi-centre study.
Methods
78 men aged 25–50 years of age; suffering from mild to moderate erectile dysfunction (ED), participated in this study. Subjects were randomized to receive VXP or placebo at a dose of two capsules twice daily for 12 weeks. The international index of erectile function (IIEF) was the primary outcome measure of efficacy. Other efficacy measures were: Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS), Serum testosterone, Semen analysis, Investigator’s Global assessment and Subjects’ opinion.
Results
In subjects receiving VXP, the IIEF-Erectile Function (EF) scores improved significantly as compared to placebo. After 12 weeks of treatment, the mean (sd) IIEF-EF score at baseline increased from 16.08 (2.87) to 25.08 (4.56) in the VXP group versus 15.86 (3.24) to 16.47 (4.25) in the placebo group (P < 0.0001). Similar results were observed in each of the remaining four domains of the IIEF (orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction).There was a significant difference for VXP versus placebo comparison of mean (sd) EDITS scores of patients: 82.31(20.23) vs 36.78(22.53) and partners :(82.75(9.8) vs 18.50(9.44);P < 0.001. Thirty-five out of 39 (90%) subjects from the VXP group and one (3%) from the placebo group wished to continue with the treatment they received. Investigator’s global assessment rated VXP therapy as very good to excellent in more than 50% patients and placebo therapy as fair to good in about 25% of patients. Incidence of side effects and subject’s rating for tolerability of treatment was similar in both groups.
Conclusions
VigRX Plus was well tolerated and more effective than placebo in improving sexual function in men.
Trial Registration
Clinical Trial Registry India, CTRI/2009/091/000099, 31-03-2009
doi:10.1186/1472-6882-12-155
PMCID: PMC3478157  PMID: 22978405
12.  Erectile dysfunction and heart failure: the role of phosphodiesterase type 5 inhibitors 
The phosphodiesterase type 5 (PDE-5) inhibitors are effective in treating erectile dysfunction (ED). ED and heart failure (HF) share similar risk factors, and commonly present together. This association has led to questions ranging from the safety and efficacy of PDE-5 inhibitors in HF patients to a possible role for this class of medication to treat HF patients with or without ED. In addition to endothelial dysfunction, there are causes of ED specific to patients with HF including low exercise tolerance, depression and HF medications. Before treating HF patients with PDE-5 inhibitors, patients should be assessed for their risk of a cardiac event during sexual activity. PDE-5 inhibitors are safe and effective in treating ED in HF patients. An improvement in erectile function by PDE-5 inhibitors was associated with an improvement in quality of life and reduction in depression. Several studies demonstrated the effect of PDE-5 inhibitors on HF per se. PDE-5 inhibitors improved endothelial dysfunction, increased exercise tolerance, decreased pulmonary vascular resistance and pulmonary artery pressure, and increased cardiac index. Several mechanisms whereby PDE-5 inhibitors improve HF have been proposed. PDE-5 inhibitors already have a role in treating primary pulmonary hypertension; however additional studies are needed to determine if they will become a standard therapy for HF patients.
doi:10.1038/ijir.2009.11
PMCID: PMC2834326  PMID: 19387454
heart failure; phosphodiesterase 5 inhibitor; mechanism; safety; efficacy
13.  Effect of Sildenafil on Erectile Dysfunction in Spinal Cord Injured Patients 
Ghana Medical Journal  2009;43(3):132-134.
Summary
Background
Erectile dysfunction is a preoccupying issue, just like motor and bladder disability, in spinal cord injured (SCI) patients. This is particularly so because of the increasing prevalence of paraplegic and tetraplegic subjects and the fact that these patients are younger, and sexually active.
Objective
To determine the effects of Sildenafil (Viagra®) on erectile dysfunction in SCI patients.
Methods
After medical ethics committee approval and informed patient consent, we conducted a prospective inquiry between January and March 2007 in 16 SCI patients who were under Sildenafil treatment for erectile dysfunction. An abridged version of the International Index of Erectile Function (IIEF-5) questionnaire was completed the patients.
Results
The mean age (range) of the patients was 32.75 yrs (21–53 yrs). The mean duration of their disability was 47.75 months (4 yr). Trauma was the etiology in 87.5% of the cases (44% were road accidents). 12/16 patients were paraplegics (10 above T10) and 4 were tetraplegics (1 above C4 and 3 below C5). The mean duration of sildenafil treatment was 18.75 months (17 days–7 yr). 70% of the patients were satisfied with their erection after treatment. However, 10/16 patients had concomitant treatment with alprostadil.
Conclusion
Sildenafil is a vasoactive drug which can be used as a simple, discrete and effective treatment for erectile dysfunction in SCI patients. This approach is compatible with the efforts to improve the quality of life and rehabilitation of these patients.
PMCID: PMC2810242  PMID: 20126326
paraplegia; spinal cord injury; erectile dysfunction; Sildenafil
14.  Unsatisfactory outcomes of prolonged ischemic priapism without early surgical shunts: our clinical experience and a review of the literature 
Asian Journal of Andrology  2012;15(1):75-78.
Ischemic priapism is a rare occurrence which can cause severe erectile dysfunction (ED) without timely treatment. This retrospective study reports our experience in treating prolonged ischemic priapism and proposes our further considerations. In this paper, a total of nine patients with prolonged ischemic priapism underwent one to three types of surgical shunts, including nine Winter shunts, two Al-Ghorab shunts and one Grayhack shunt. During the follow-up visit (after a mean of 21.11 months), all patients' postoperative characters were recorded, except one patient lost for death. Six postoperative patients accepted a 25-mg oral administration of sildenafil citrate. The erectile function of the patients was evaluated by their postoperative 5-item version of International Index of Erectile Function Questionnaire (IIEF-5), which were later compared with their premorbid scores. All patients had complete resolutions, and none relapsed. The resolution rate was 100%. Seven patients were resolved with Winter shunts, one with an Al-Ghorab shunt and one with a Grayhack shunt. The mean hospital stay was 8.22 days. There was only one urethral fistula, and the incidence of postoperative ED was 66.67%. Four patients with more than a 72-h duration of priapism had no response to the long-term phosphodiesterase type 5 (PDE-5) inhibitor treatment. These results suggest that surgical shunts are an efficient approach to make the penis flaccid after prolonged priapism. However, the severe ED caused by prolonged duration is irreversible, and long-term PDE-5 inhibitor treatments are ineffective. Thus, we recommend early penile prosthesis surgeries for these patients.
doi:10.1038/aja.2012.63
PMCID: PMC3739125  PMID: 22922321
erectile dysfunction; PDE-5 inhibitor; penile prosthesis surgery; prolonged ischemic priapism; surgical shunts
15.  Cell phone usage and erectile function 
Introduction
The objective of this pilot study was to report our experience concerning the effects of cell phone usage on erectile function (EF) in men.
Material and Methods
We recruited 20 consecutive men complaining of erectile dysfunction (ED) for at least six months (Group A), and another group of 10 healthy men with no complaints of ED (Group B). Anamnesis, basic laboratory investigations, and clinical examinations were performed. All men completed the German version of the Sexual Health Inventory for Men (SHIM) for evaluation of the International Index of Erectile Function (IIEF), as well as another questionnaire designed by our clinicians that assessed cell phone usage habits.
Results
There was no significant difference between both groups regarding age, weight, height, and total testosterone (Table 1). The SHIM scores of Group A were significantly lower than that of Group B, 11.2 ±5 and 24.2 ±2.3, respectively. Total time spent talking on the cell phone per week was not significantly higher in Group A over B, 17.6 ±11.1 vs. 12.5 ±7 hours. Men with ED were found to carry their ‘switched on’ cell phones for a significantly longer time than those without ED, 4.4 ±3.6 vs. 1.8 ±1 hours per day.
Conclusions
We found a potential correlation with cell phone usage and a negative impact on EF. Further large–scale studies confirming our initial data and exploring the mechanisms involved in this phenomenon are recommended.
doi:10.5173/ceju.2013.01.art23
PMCID: PMC3921848  PMID: 24578997
testosterone; erectile dysfunction
16.  A Placebo-Controlled, Multicenter, Randomized, Double-Blind, Flexible-Dose, Two-Way Crossover Study to Evaluate the Efficacy and Safety of Sildenafil in Men With Traumatic Spinal Cord Injury and Erectile Dysfunction 
Background/Objective:
To show the efficacy, safety, and tolerability of sildenafil in men with erectile dysfunction (ED) associated with complete or incomplete spinal cord injury (SCI) and to assess its effects on quality of life (QoL) using the Life-Satisfaction Check List.
Methods:
This was a placebo-controlled, multicenter, randomized, double-blind, flexible-dose, 2-way crossover study with a 2-week washout period between each phase. Patients with ED attributable to SCI (Sexual Health Inventory—Male score ≤21) received 50 to 100 mg sildenafil (n = 24) or placebo (n = 26).
Results:
Compared with placebo, sildenafil produced higher levels of successful sexual stimulation, intercourse success, satisfaction with sexual life and sexual relationship, erectile function, overall sexual satisfaction, and an improved Erectile Dysfunction Inventory of Treatment Satisfaction score, with no clinically relevant effects on vital signs. Sildenafil seemed more effective in patients with incomplete SCI than in those with complete SCI, producing significant improvements, compared with placebo, in a number of measures only in patients with incomplete SCI. All patients who expressed a preference selected sildenafil over placebo, although the drug had no effect on patient QoL. Sildenafil was well tolerated, with a profile comparable to that of placebo.
Conclusions:
Compared with placebo, treatment with oral sildenafil safely and effectively improved erectile function in patients with ED attributable to SCI, especially in those with incomplete injury, and was the agent of choice in those who expressed a preference.
PMCID: PMC2607124  PMID: 19086709
Sildenafil; Spinal cord injuries; Tetraplegia; Paraplegia; Erectile dysfunction; Impotence
17.  Relation between Intracavernosal Dose of Prostaglandin Pge 1 and Mean Duration of Erection in Men with Different Underlying Causes of Erectile Dysfunction 
Croatian medical journal  2007;48(1):76-80.
Aim
To analyze differences in effect of intracavernosally applied alprostadil (prostaglandin PGE 1) on men with different underlying causes of erectile dysfunction.
Methods
Forty eight men with erectile dysfunction lasting for at least six months were stratified according to the etiology of erectile dysfunction into one of 4 groups comprising 12 patients. The groups were the following: psychogenic, arteriogenic, veno-occlusive, and neurological erectile dysfunction group. All men filled out International Index of Erectile Function (IIEF)-5 questionnaire, which is a 5-question version of International Index of Erectile Function Questionnaire, underwent clinical examination including neurological assessment, were tested for nocturnal penile tumescence, and had Doppler color sonography of penile arteries. Intracavernosal alprostadil was then applied to the patients, starting with a 5 μg dose and then increased in 5 μg increments until the final dose of 20 μg was reached. We measured the time from the moment of application until the start of erection and time of erection duration. For statistical analysis, non-parametric Friedman test for significant differences between repeated measurements in small groups and Wilcoxon test for differences between doses were used.
Results
Significant relation was found between the applied dose of intracavernosal alprostadil and the duration of erection in all 4 groups of men with erectile dysfunction. In patients with arteriogenic erectile dysfunction, mean (±standard deviation) duration of erection for consecutive doses of alprostadil 5 μg, 10 μg, 15 μg, and 20 μg were 40.0 ± 20.6, 54.6 ± 23.6, 65.0 ± 29.6, and 82.1 ± 35.4 minutes, respectively, with significant increase for each dose. In patients with veno-occlusive dysfunction, mean durations of erection significantly increased from 8.2 ± 7.8 minutes at 10 μg to 17.3 ± 9.5 minutes at 20 μg. In patients with neurogenic erectile dysfunction, mean durations of erection were 40.4 ± 16.6, 61.7 ± 24.7, 82.5 ± 34.4, and 101.0 ± 28.5 minutes respectively, with significant increase for each dose. In patients with psychogenic erectile dysfunction, mean durations of erection were 32.4 ± 15.4, 45.8 ± 15.1, 69.9 ± 23.5, and 98.3 ± 37.9 minutes respectively, with a significant increase for each dose.
Conclusion
Men with different underlying cause of erectile dysfunction show different response to the intracavernosally applied alprostadil. In order to achieve the optimal result, the treatment should be started with the smallest doses which are gradually increased until the maximum effect is reached.
PMCID: PMC2080498  PMID: 17309142
18.  Lower Urinary Tract Symptoms and Erectile Dysfunction in Men With Type 2 Diabetes Mellitus 
Purpose
To assess the prevalence of lower urinary tract symptoms (LUTS) and erectile dysfunction (ED) and the relationships between LUTS, ED, depression, and other factors in Korean men with type 2 diabetes mellitus (T2DM).
Methods
This cross-sectional study included 124 male patients with T2DM who attended a university hospital diabetes clinic between October 2010 and April 2012. Data were collected using structured interviews and chart reviews. LUTS were measured using the International Prostate Symptom Score (IPSS), ED using the five-item Korean version of the International Index of Erectile Function (IIEF), depression using the Center for Epidemiologic Studies Depression Scale, and glycosylated hemoglobin level from clinical data.
Results
The IPSS score was 9.2±6.6. The total IPSS scores indicated that 53.3% of the subjects had either moderate or severe symptoms. The mean IIEF score was 7.3±8.6, indicating the severity of ED to be mild, mild to moderate, moderate, and severe in 10.5%, 9.7%, 1.6%, and 66.9% of the participants, respectively. LUTS showed a significant negative correlation with ED (r=-0.26, P=0.003) and a significant positive correlation with depression (r=0.33, P<0.001). ED was negatively correlated with age (r=-0.44, P<0.001), duration of diabetes (r=-0.26, P=0.004), and depression (r=-0.24, P=0.008).
Conclusions
LUTS and ED were found to have a high prevalence among Korean men with T2DM. More severe ED was associated with worse LUTS, whereas more severe depressive symptoms were found to be associated with more severe ED and LUTS.
doi:10.5213/inj.2013.17.4.180
PMCID: PMC3895510  PMID: 24466465
Lower urinary tract symptoms; Erectile dysfunction; Type 2 diabetes mellitus; Depression
19.  Avanafil for the Treatment of Erectile Dysfunction: A Multicenter, Randomized, Double-Blind Study in Men With Diabetes Mellitus 
Mayo Clinic Proceedings  2012;87(9):843-852.
Objective
To prospectively assess the safety and effectiveness of the investigational phosphodiesterase 5 inhibitor avanafil to treat erectile dysfunction in men with diabetes mellitus.
Patients and Methods
This 12-week, multicenter, double-blind, placebo-controlled study conducted between December 15, 2008, and February 11, 2010, randomized 390 men with diabetes and erectile dysfunction 1:1:1 to receive avanafil, 100 mg (n=129), avanafil, 200 mg (n=131), or placebo (n=130). Coprimary end points assessed changes in the percentage of sexual attempts in which men were able to maintain an erection of sufficient duration to have successful intercourse (Sexual Encounter Profile [SEP] 3), percentage of sexual attempts in which men were able to insert the penis into the partner's vagina (SEP 2), and International Index of Erectile Function erectile function domain score.
Results
Compared with placebo, least-squares mean change from baseline to study end in SEP 3, SEP 2, and International Index of Erectile Function erectile function domain score were significantly improved with both avanafil, 100 mg (P≤.002), and avanafil, 200 mg (P<.001). Additional analyses indicated that successful intercourse could be initiated in 15 minutes or less through more than 6 hours after avanafil dosing. Adverse events most commonly reported with avanafil treatment were headache, nasopharyngitis, flushing, and sinus congestion.
Conclusion
Avanafil was safe and effective for treating erectile dysfunction in men with diabetes and was effective as early as 15 minutes and more than 6 hours after dosing. The adverse events seen with avanafil were similar to those seen with other phosphodiesterase 5 inhibitors.
Trial Registration
clinicaltrials.gov Identifier NCT00809471.
doi:10.1016/j.mayocp.2012.06.016
PMCID: PMC3498142  PMID: 22857780
AE, adverse event; BP, blood pressure; ED, erectile dysfunction; IIEF-EF, International Index of Erectile Function erectile function; LS, least square; PDE, phosphodiesterase; SEP, Sexual Encounter Profile
20.  Relationship between Sexual Function and Quality of Life in Obese Persons Seeking Weight Reduction 
Obesity (Silver Spring, Md.)  2013;21(10):1966-1974.
Objective
This study investigated sexual functioning in persons with obesity and seeking weight loss, and the associations of sexual functioning with relevant demographic and clinical variables as well as quality of life.
Design and Methods
Participants were enrolled in a two-year randomized clinical trial. Participants were obese and had at least two components of metabolic syndrome. Male and female sexual functioning was assessed by the International Index of Erectile Function (IIEF) and the Female Sexual Function Index (FSFI) respectively.
Results
The rate of female sexual dysfunction was 29%. The rate of erectile dysfunction (ED) was 45%. Of the characteristics considered, FSD was associated with age (p=0.002). ED was significantly associated with age and physical functioning (both p <0.01).
Conclusions
A large minority of patients with obesity reported sexual dysfunction. The occurrence of sexual dysfunction was associated with age, but, surprisingly, not weight-related comorbidities. This may be the result of the nature of the study sample or the methods used to administer the questionnaires that assessed sexual functioning.
doi:10.1002/oby.20398
PMCID: PMC3735672  PMID: 23512339
21.  Effects of Aerobic Exercise in the Management of Erectile Dysfunction: A Meta Analysis Study on Randomized Controlled Trials 
Background
Penile erection is a hemodynamic process involving increased arterial inflow and restricted venous outflow, coordinated with corpus cavernosum and penile arterial smooth muscle relaxation. Any problem in this mechanism results in Erectile Dysfunction and its etiology is generally multifactorial. This study is aimed at determining the objective outcome of aerobic training in the management of Erectile Dysfunction of arterogenic origin using Meta analysis.
Methods
Relevant publications were searched up to November 2010 in the MEDLINE (PubMed) database. The citation lists of randomized controlled trials on the effect of aerobic training and Erectile Dysfunction management using the International Index of Erectile Function (IIEF) as treatment outcome measure. Studies on different operative techniques on the effects of aerobic training for men with Erectile Dysfunction due to arterogenic Erecile Dysfunction were selected. Data on participants' characteristics, study quality, population, intervention, treatment outcome were collected and analyzed.
Results
There were 5 randomized controlled studies using the International Index of Erectile Function as measure of treatment outcome. A total of 385 subjects were involved in 5 studies; results indicated significant effect of aerobic training on Erecile Dysfunction (t=5.856, p= .000) at p< 0.05.
Conclusion
Subjects with arterogenic Erectile Dysfunction might benefit from aerobic training. More randomized controlled studies in this area are warranted
PMCID: PMC3275865  PMID: 22435000
Erectile dysfunction; Impotence; Exercise; Index of erectile function
22.  An Unappreciated Correlation : Surgical Treatment of Lumbosacral Disc Disease and Erectile Dysfunction 
Objective
The aim of the present study was to assess the effect of lumbar disc herniation surgery for low back pain on the erectile functioning.
Methods
Thirty-eight patients, with age ranging from 22 to 56 years, who had presented with pain due to herniated lumbar discs were included in the study. International Index of Erectile Function (IIEF) Short Form questionnaire was used to evaluate the erectile functioning. Patient visits on the 1st week,1st month and 3rd month postoperatively were analyzed. Pain scores were also noted together with side effects and the complications of the surgery.
Results
Of the 38 patients, 18 patients had reported erectile dysfunction; 10 patients mild and 8 patients moderate erectile dysfunction. Twenty patients did not report erectile problems. The herniation levels mostly were L5-S1 in 12 (31.6%). Overall, erectile dysfunction rates have improved in 31.7% of those previously with erectile dysfunction in a 3 month period after the surgery. Best results were obtained in those patients with mild erectile dysfunction preoperatively.
Conclusion
Mild erectile dysfunction together with radiculopathy tends to improve after lumbosacral disc surgery. Moderate and severe erectile dysfunction may be related to a more severe nerve injury or to vascular and/or psychiatric factors. An evaluation of erectile functioning should routinely be performed in patients with lumbosacral disc disease both for data accumulation and for medico legal causes since the documentation of the correlation between erectile dysfunction and lumbosacral disc disease is still lacking.
doi:10.3340/jkns.2010.47.4.282
PMCID: PMC2864821  PMID: 20461169
Erectile dysfunction; Lumbar disc herniation; Herniation levels; International Index of Erectile Function questionnaire
23.  Sexual dysfunction (Kṛcchra Vyavāya) in obesity (Sthaulya): Validation by an observational study 
Ancient Science of Life  2012;32(2):76-81.
Objective:
The present study intends to evaluate the relationship between Sthaulya (obesity) and Kṛcchra Vyavāya (sexual dysfunction) with respect to different phases of sexual intercourse through a single-centered, observational study in male patients of obesity.
Materials and Methods:
The study involved 33 obese males from the outpatient department of the Institution whose sexual functioning was assessed using an International Index of Erectile Function questionnaire, which was meant to assess five specific areas of sexual functioning.
Results:
A varying degree of sexual dysfunction was observed in four out of five areas of sexual functioning viz. erectile function (P < 0.02), orgasmic function (P < 0.02), sexual desire (P < 0.08), and overall satisfaction (P < 0.000) in obese individuals. Statistically significant dysfunction was not observed in intercourse satisfaction.
Conclusions:
Varying degree of sexual dysfunction is present in obese males, suggesting that obesity has a possible role in reducing the quality of sexual functioning in males as indicated in the classical ayurvedic literature.
doi:10.4103/0257-7941.118535
PMCID: PMC3807961  PMID: 24167331
Erectile dysfunction; Kṛcchra Vyavāya; obesity; Sthaulya; Vyavāya
24.  Sildenafil citrate can improve erectile dysfunction among chronic hemodialysis patients 
Indian Journal of Nephrology  2010;20(3):142-145.
Erectile dysfunction (ED) is common among patients with end-stage renal disease (ESRD), who undergo hemodialysis (HD). The aim of this study was to evaluate the safety and effectiveness of sildenafil in male HD patients with ED. Twenty-seven HD patients were recruited for this prospective, randomized, double-blind, placebo-controlled, clinical trial study of sildenafil during a period of 1 week. Efficacy was assessed by using the International Index of Erectile Function (IIEF) before and 1 week after treatment. Baseline demographic and clinical features were similar in both the groups. There was a weak correlation between ED and duration of undergoing dialysis (P = 0.073). There was significant relationship between sildenafil usage and improvement in erectile function (P < 0.0001). Placebo improved significantly the erectile function (P = 0.016), perhaps by psychological way. However, sildenafil had a more significant effect than placebo in increasing IIEF score among HD patients (P = 0.00 compared to 0.016). Sildenafil is effective and safe for treating ED among HD patients.
doi:10.4103/0971-4065.70845
PMCID: PMC2966980  PMID: 21072154
Erectile dysfunction; hemodialysis; sildenafil citrate
25.  Macrostructural Alterations of Subcortical Grey Matter in Psychogenic Erectile Dysfunction 
PLoS ONE  2012;7(6):e39118.
Psychogenic erectile dysfunction (ED) has been defined as the persistent inability to attain and maintain an erection sufficient to permit sexual performance. It shows a high incidence and prevalence among men, with a significant impact on the quality of life. Few neuroimaging studies have investigated the cerebral basis of erectile dysfunctions observing the role played by prefrontal, cingulate, and parietal cortices during erotic stimulation. In spite of the well-known involvement of subcortical regions such as hypothalamus and caudate nucleus in male sexual response, and the key role of nucleus accumbens in pleasure and reward, poor attention was paid to their role in male sexual dysfunction. In this study, we determined the presence of grey matter (GM) atrophy patterns in subcortical structures such as amygdala, hippocampus, nucleus accumbens, caudate nucleus, putamen, pallidum, thalamus, and hypothalamus in patients with psychogenic ED and healthy men. After Rigiscan evaluation, urological, general medical, metabolic and hormonal, psychological and psychiatric assessment, 17 outpatients with psychogenic ED and 25 healthy controls were recruited for structural MRI session. Significant GM atrophy of nucleus accumbens was observed bilaterally in patients with respect to controls. Shape analysis showed that this atrophy was located in the left medial-anterior and posterior portion of accumbens. Left nucleus accumbens volumes in patients correlated with low erectile functioning as measured by IIEF-5 (International Index of Erectile Function). In addition, a GM atrophy of left hypothalamus was also observed. Our results suggest that atrophy of nucleus accumbens plays an important role in psychogenic erectile dysfunction. We believe that this change can influence the motivation-related component of sexual behavior. Our findings help to elucidate a neural basis of psychogenic erectile dysfunction.
doi:10.1371/journal.pone.0039118
PMCID: PMC3377616  PMID: 22723943

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