1 January 2011 Recent Literature in Sexual Medicine/ Andrology (except JSM) Publications of the Month: CDC Updates Its Guidelines on Sexually Transmitted Diseases The CDC (Centers for Disease Control and Prevention) has issued an update to its 2006 Guidelines for Treatment of Sexually Transmitted Diseases. The latest material includes: • evaluation for cervicitis and trichomoniasis; • recommendations for treating bacterial vaginosis; • diagnostic evaluation following sexual assault; • approaches to preventing sexually transmitted diseases. The update also emphasizes the importance of taking a patient's sexual history "routinely and regularly" and offers guidance for doing so. Editorial Comment : These new guidelines and recommendations for the management of STS comprises 110 pages with 489 references and represents to date the most updated and comprehensive scientific work regarding all established STDs and Venereal Diseases as well as other diseases related to affections of the genital region suc has Proctitis,Ectoparasitic infections such as Pediculosis and Scabies. This marvellous scientifc work also address in comprehensive chapters special topics such as: Sexual Assault and STDs, Partner Management, Prevention Methods, STDs in Special populatios such as children, pregnant women etc. The authors (lead author Kimberly A Workowski,MD from the Division of STD Prevention, National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, 10 Corporate Square, Corporate Square Blvd, MS E02, Atlanta, GA 30333. have to be congratulated for that work. This comprehensive paper is a must for every physician who is dealing in his daily practice with patients suffering from any STDs and related diseases. And now the good news for all of us: you can download for free these 110 pages under LINK(S): 2 MMWR Recommendations and Reports guideline (Free) Analysis of Overall Level of Evidence Behind Infectious Diseases Society of America Practice Guidelines Dong Heun Lee, MD; Ole Vielemeyer, MD Arch Intern Med. 2011;171(1):18-22 Background Clinical practice guidelines are developed to assist in patient care. Physicians may assume that following such guidelines means practicing evidence-based medicine. However, the quality of supporting literature can vary greatly. Methods We analyzed the strength of recommendation and overall quality of evidence behind 41 Infectious Diseases Society of America (IDSA) guidelines released between January 1994 and May 2010. Individual recommendations were classified based on their strength of recommendation (levels A through C) and quality of evidence (levels I through III). Guidelines not following this format were excluded from further analysis. Evolution of IDSA guidelines was assessed by comparing 5 recently updated guidelines with their earlier versions. Results In the 41 analyzed guidelines, 4218 individual recommendations were found and tabulated. Fourteen percent of the recommendations were classified as level I, 31% as level II, and 55% as level III evidence. Among class A recommendations (good evidence for support), 23% were level I ( 1 randomized controlled trial) and 37% were based on expert opinion only (level III). Updated guidelines expanded the absolute number of individual recommendations substantially. However, few were due to a sizable increase in level I evidence; most additional recommendations had level II and III evidence. Conclusions More than half of the current recommendations of the IDSA are based on level III evidence only. Until more data from well-designed controlled clinical trials become available, physicians should remain cautious when using current guidelines as the sole source guiding patient care decisions. Editorial Comment: Reading these data related to guidelines/recommendations for infectious diseases that more than half ( 55%) of the studies considered only reached a level of evidence III and that among class A recommendations 37 % were based on expert opinion only,i.e. they have reached at best a level of evidence III justified doubts may raise how valid and useful those guidelines finally are for the practicing physicians , the health insurances and the patients, whose treatment should follow evidence based medicine guidelines. Male Sexual Dysfunktion: Erectile Dysfunction Question for a questionnaire: the International Index of Erectile Function M İ Öztürk, O Koca, M O Keleş, M Güneş, C Kaya and M I Karaman 3 International Journal of Impotence Research , (13 January 2011 Int J Impotence Res. 2010,publ. online Dec. 30,2010 Abstract The aim of this study was to analyze the impact of patient age and education level on the comprehension of the Turkish version of Index of Erectile Function (IIEF), and to determine the patient characteristics that make this questionnaire less reliable. In this study, 238 male patients presenting to our clinic were enrolled. The patients were asked to complete the Turkish version of the IIEF questionnaire upon arrival by themselves and then once again during their second visit with the assistance of a physician. ‘Accurate’ comprehension of the IIEF was considered to be the consistency between the ‘self-administered’ and ‘physician- assisted’ IIEF scores. The impact of patient age and education level on the ‘accurate’ comprehension of the IIEF was analyzed. There was a significant difference between the ‘self-administered’ and ‘physician-assisted’ IIEF scores in patients 60 years of age (P=0.045) and primary school graduates (P=0.015). Age 60 years and being primary school graduate are factors lowering the comprehension of the Turkish version of the IIEF by the patients. Older patients and patients with lower education could benefit from the assistance of a physician while completing this questionnaire. Pistachio diet improves erectile function parameters and serum lipid profiles in patients with erectile dysfunction M Aldemir, E Okulu, S Neşelioğlu, O Erel and Ö Kayıgil Abstract We investigated the effects of Antep pistachio on International Index of Erectile Function (IIEF) scores, penile color Doppler ultrasound (PCDU) parameters and serum lipid levels in patients with ED. A total of 17 married male patients with ED for at least 12 months were included in this prospective study. Patients were put on a 100 g pistachio nuts diet for 3 weeks. IIEF and PCDU were evaluated before and after the pistachio diet. In addition, plasma total cholesterol (TC), low-density lipoprotein (LDL), high-density lipoprotein (HDL) and triglyceride were measured before and after dietary modifications from all subjects. Mean IIEF-15 score was 36±7.5 before the diet and 54.2±4.9 after the diet (P=0.001). Similarly, an increase in all five domains of IIEF was observed after the diet (P<0.05). Mean peak systolic velocity values before and after the pistachio diet were 35.5±15.2 and 43.3±12.4 cm s–1, respectively (P=0.018). After the pistachio diet, TC and LDL levels decreased significantly, whereas HDL level increased (P=0.008, 0.007 and 0.001, respectively). We demonstrated that a pistachio diet improved IIEF scores and PCDU 4 parameters without any associated side effects in patients with ED. Furthermore, the lipid parameters showed statistically significant improvements after this diet. Long-Term Infection Outcomes After Original Antibiotic Impregnated Inflatable Penile Prosthesis Implants: Up to 7.7 Years of Followu Culley C. Carson III John J. Mulcahy Manya R. Harsch J.Urol 2010, published online 21 December 2010. Abstract Purpose Although some studies suggest that most infections associated with inflatable penile prosthesis implantation develop within year 1 after surgery, device related infections have been reported 5 years after implantation or later and the infection risk with time is not well characterized. We previously reported a statistically significantly lower infection rate for original inflatable penile prostheses impregnated with antibiotic treatment with minocycline and rifampin vs nonimpregnated inflatable penile prostheses at 1-year followup. Long-term data are now available on infection revision after initial implantation of antibiotic impregnated vs nonimpregnated prostheses. Materials and Methods We retrospectively reviewed patient information forms voluntarily filed with the manufacturer after the initial implantation of more than 39,000 inflatable penile prostheses to compare the revision rate due to infection for antibiotic impregnated vs nonimpregnated implants between May 1, 2001 and December 31, 2008. Life table analysis was used to evaluate device survival from revision surgery. Results On life table survival analysis initial revision events due to infection were significantly less common in the impregnated vs the nonimpregnated group (log rank p <0.0001). At up to 7.7 years of followup 1.1% of 35,737 vs 2.5% of 3,268 men with impregnated vs nonimpregnated implants underwent initial revision due to infection. Conclusions To our knowledge this long-term outcome analysis provides the first substantial clinical evidence of a decrease in costly infection related revision using an antibiotic impregnated inflatable penile prosthesis. Key Words: penis, penile prosthesis, antibiotic prophylaxis, infection, reoperation 5 SAbbreviations and Acronyms: AMS, American Medical Systems, ED, erectile dysfunction, FDA, United States Food and Drug Administration, IPP, inflatable penile prosthesis, M/R, minocycline and rifampin, PIF, patient information form , The Prevalence of Erectile Dysfunction and Its Relation to Chronic Prostatitis in Chinese Men Zong-Yao Hao , Hong-Jun Li , Zhi-Ping Wang , Jun-Ping Xing , Wei-Lie Hu , Tao-Fu Zhang , Xian-Sheng Zhang , Jun Zhou , Sheng Tai , and Chao-Zhao Liang * J.Amdrol. 2011,publ.online 13 January Objective: This study was performed to evaluate the prevalence of erectile dysfunction and to explore its correlation to chronic prostatitis in China. Methods: A cross-sectional investigation from a large cohort study of Chinese men was used in this survey. A questionnaire consisting of general information regarding socio-demographics, chronic disease history, sexual function, National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI) and International Index of Erectile Function-5 (IIEF-5) was administered to 15,000 Chinese men aged from 15 to 60. The prevalence of erectile dysfunction was determined from the patient's self-evaluation and International Index of Erectile Dysfunction (IIEF-5) score. The eligible individual was both married and had intercourse experience. Results: Totally, there were 12743 respondents, giving a response rate of 84.95%. Among 7372 eligible men, erectile dysfunction prevalence of self-reported and IIEF-5 score was 12.0% and 17.1%, respectively. Among 771 men with prostatitis-like symptoms, erectile dysfunction prevalence of self-reported and IIEF-5 score was 39.3% and 30.1%, respectively. Among 370 men suffering from chronic prostatitis, erectile dysfunction prevalence of self- reported and IIEF-5 score was 40.5% and 35.1%, respectively. The prevalence of self- reported and IIEF-5 score had high correlation with increasing age among all eligible men, men with prostatitis-like symptoms, and men with chronic prostatitis groups (P < 0.05, P < t s 0.05, P < 0.05). Erectile dysfunction prevalence of both self-reported and IIEF-5 score was cp higher in men with prostatitis-like symptoms and with chronic prostatitis than the general group (P < 0.05, P < 0.05). Conclusion: The prevalence of erectile dysfunction was higher s cp in the prostatitis population than in the general population with either self-reported or IIEF-5 score assessment. The prevalence was higher with self-reported than with IIEF-5 assessment in men with prostatitis. Estimates of erectile dysfunction prevalence among men with prostatitis group should not rely on self-reporting alone in that it is likely to overestimate the true prevalence. Key words: Erectile Dysfunction • Prostate • Chinese • prevalence • prostatitis-like symptoms Patients’ preference in the treatment of erectile dysfunction: a critical review of the literature A Martin Morales, M Casillas and C Turbi International Journal of Impotence Research , (30 December 2010) 6 Abstract The increase in the number of safe and effective ED treatments highlights the importance of patients’ preference when choosing a therapeutic option. Several studies assessing these preferences are now available in published literature. This article aims to review and discuss the studies on patients’ preference and the data concerning the reasons for preference for one PDE-5 inhibitor over another. A PubMed search was conducted for manuscripts published within the last 10 years containing the search items ED, preference, sildenafil, tadalafil or vardenafil. Selected articles were discerningly reviewed and summarized (design, limitations and relevance). The articles selected were peer reviewed publications on patients’ preference and ED published in medical literature since 2000. Preference studies that include either two (tadalafil and sildenafil) or three PDE-5 inhibitors (tadalafil, sildenafil and vardenafil), showed that the majority of the patients preferred tadalafil versus either vardenafil or sildenafil. As the treatment of ED has evolved, patients’ preference has become an important aspect of ED therapy, 52–65% of patients prefer tadalafil versus 12–20% vardenafil or 8–30% sildenafil. All founded studies have serious limitations, particularly in terms of dosing differences. Preference for tadalafil was mainly because of the longer duration of action that increases patients’ freedom in sexual life. There is a consistency in patients’ preference for tadalafil over sildenafil or vardenafil across the studies reviewed. Intraprostatic botulinum toxin type A administration: evaluation of the effects on sexual function João Silva1, Rui Pinto1, Tiago Carvalho1, Francisco Botelho1, Pedro Silva1, Carlos Silva1,2,3, Francisco Cruz1,2,3,*, Paulo Dinis1 BJU International 2010, publ.online 24 Nov. 2011 Keywords:botulinum toxin;benign prostatic enlargement;prostate;sexual dysfunctionStudy Type – Therapy (case series) Level of Evidence 4 OBJECTIVE To evaluate the consequences on male sexual function of intraprostatic injection of botulinum toxin type A (BoNT/A) as a treatment for benign prostatic hyperplasia (BPH). Although BoNT/A is effective in decreasing symptoms of BPH, neuronal impairment caused by the neurotoxin might affect emission/ejaculation. These aspects have not been evaluated before. PATIENTS AND METHODS In all, 16 sexually active men aged >60 years with BPH/benign prostatic enlargement (BPE), International Prostate Symptom Score (IPSS) ≥8 and a maximum urinary flow rate (Qmax) <15 mL/s refractory to standard medical therapy volunteered for the study. Patients were injected transrectally, under ultrasonographic control, with 200 U of BoNT/A in the prostate. Evaluation was carried out at baseline and 1, 3 and 6 months post-treatment. Erectile function was evaluated using the International Index of Erectile Function – Short Form (IIEF-5) questionnaire. Orgasmic/ejaculatory function and libido were evaluated using questions 9, 10, 11 and 12 of the IIEF – Long Form. Total testosterone, luteinizing hormone (LH), follicle-stimulating hormone (FSH) and prolactin were also investigated. RESULTS 7 The mean age was 73 ± 6 years. The IIEF-5 score was 16.5 ± 6 at baseline, 15.7 ± 6 at 1 month, 16.6 ± 6 at 3 months and 15.7 ± 5 at 6 months (differences nonsignificant). The score for ejaculatory/orgasmic function (questions 9 and 10) remained fairly constant from baseline to the sixth month, 8.3 ± 1.9 and 8 ± 2.1 respectively. The sexual desire score (questions 11 and 12 of the IIEF) also remained little changed from baseline (5.9 ± 1.6) to month 6 (6.1 ± 2). Total serum testosterone, LH, FSH and prolactin did not change during the study. CONCLUSIONS Intraprostatic injection of BoNT/A in patients with BPE does not impair erectile, orgasmic or ejaculatory functions and does not change libido. The male hormonal profile is not altered by BoNT/A injection. This facilitates the acceptance of BoNT/A as a treatment for BPH/BPE lower urinary tract symptoms (LUTS) refractory to standard medical management. Effect of Tipranavir/Ritonavir Combination on the Pharmacokinetics of Tadalafil in Healthy Volunteers. Garraffo R, Lavrut T M, Ferrando S, Durant J, Rouyrre N, Macgregor TR, Sabo JP, Dellamonica P. J Clin Pharmacol. 2011 Jan 5. (Epub ahead of print) Abstract This study evaluated the effects of single-dose administration and steady-state concentrations of tipranavir 500 mg and ritonavir 200 mg (TPV/r) combination on the pharmacokinetics of tadalafil 10 mg (TAD) in an open-label study. Seventeen healthy male volunteers received sequential dosing of the studied product: TAD (day 1) alone in a single dose for 7 days followed by TAD (day 8) in a single dose with TPV/r (500/200 mg twice daily, days 8-18). Pharmacokinetic parameters were determined in a non-compartmental analysis. The geometric mean ratio and 90% confidence interval were used to evaluate drug interactions. The effect of a single dose of TAD on the pharmacokinetics of TPV/r resulted in a small decrease in exposure after either first-dose or steady-state TPV/r (geometric mean ratios [90% confidence interval]: area under the concentration-time curve, 0.85 [0.74-0.97]). In contrast, coadministration of TAD exposure was increased significantly (2.33 [2.02-2.69]) when administered with the first dose of TPV/r but not when TPV/r steady state was reached (1.01 [0.83-1.21]). Antiretroviral activity may not be reduced, but the dose of TAD should be reduced at the start of TPV/r therapy and then a full dose can be resumed after steady state is reached. 8 The correlation between international prostate symptoms score and sexual health inventory in men with lower urinary tract symptoms Abdul R. Nasir, Ali Akbar Zehri, Farhat Abbas and M. Hammad Ather Int J Urol Nephrol 2011,publ. online 13 Jan 2011 Abstract Objective Lower urinary tract symptoms (LUTS) are common in aging men and are often associated with erectile dysfunction (ED). The International Prostate Symptoms Score (IPSS) and the Sexual Health Inventory for Men (SHIM) are commonly used validated instruments for LUTS and ED, respectively. We explored the correlation between LUTS (assessed by IPSS) and ED (assessed by SHIM) in men over 40 years of age. Methods A total of 585 men, 40 years and above, who presented with LUTS were prospectively enrolled into the study at single tertiary academic center. All patients were evaluated using SHIM and IPSS questionnaires. The self-administered IPSS and SHIM questionnaires were translated in the local language (not validated yet) as well. The data were analyzed using SPSS version 13.0. The correlation coefficient between IPSS and SHIM scores were determined, and the scatter diagram was made. Results and limitations The mean age (SD) of the group was 59.61 ± 11.75 years. The correlation between age and ED was statistically significant (P value < 0.001) with coefficient of 0.376. The correlation between age and LUTS was statistically significant (P value < 0.001) with coefficient of 0.312. Additionally, the correlation between ED and LUTS was statistically significant (P value < 0.001) with coefficient of 0.336. Conclusions We noted a significant correlation between the severity of LUTS and ED, while confirming the earlier established correlation between age, LUTS, and ED. The exact nature of this relationship and its pathophysiology needs to be determined by further studies. Keywords IPSS – SHIM – Lower urinary tract symptoms and erectile dysfunction 9 Tadalafil administered once daily for lower urinary tract symptoms secondary to benign prostatic hyperplasia: a 1- year, open-label extension study. Donatucci CF, Brock GB, Goldfischer ER, Pommerville PJ, Elion-Mboussa A, Kissel JD, Viktrup L. Department of Surgery, Division of Urology, Duke University, Durham, NC, Hudson Valley Urology Center, Poughkeepsie, NYLilly Research Laboratories, Eli Lilly and Co., Indianapolis, IN, USADepartment of Surgery, Division of Urology, St Joseph's Health Care London, University of Western Ontario, London, OntarioCan-Med Clinical Research Inc., Victoria, BC, Canada. BJU International 2011, epub ahead of print Jan 18, 2011 Abstract Study Type - Therapy (cohort study) Level of Evidence 2b OBJECTIVES: To evaluate the 1-year safety of 5 mg of tadalafil once daily in men with lower urinary tract symptoms secondary to benign prostatic hyperplasia (BPH-LUTS); efficacy measures were included to evaluate the maintenance of efficacy after an additional year of treatment. PATIENTS AND METHODS: In total, 427 men who completed a 12-week, placebo- controlled, dose- finding study assessing once-daily tadalafil (2.5, 5, 10 or 20 mg) or placebo elected to continue into the open-label extension period. Safety and efficacy parameters were assessed after 1 month and every 3 months. RESULTS: In total, 299 patients (69.9%) completed the 1-year, open-label extension period. Treatment-emergent adverse events (TEAEs) were reported by 57.6% of patients, with most TEAEs being mild (44%) or moderate (45%) in severity; the most common TEAEs (≥2%) were dyspepsia, gastro-oesophageal reflux disease, back pain, headache, sinusitis, hypertension and cough. Twenty-two patients (5.2%) discontinued as a result of AEs. During the open-label extension period, mean prostate-specific antigen increased from 1.6 ± 1.3 ng/mL to 1.8 ± 1.4 ng/mL. Mean post-void residual volume was 61.1 ± 60.4 mL at study entry and 42.2 ± 64.1 mL after the open-label extension period. Changes in the 10 total International Prostate Symptom Score (IPSS), IPSS irritative and obstructive subscores, IPSS health-related quality of life and BPH Impact Index were maintained after 1 year. In sexually-active patients with erectile dysfunction, improvements in the International Index of Erectile Function-Erectile Function domain were maintained after 1 year. CONCLUSIONS: In men with BPH-LUTS, 5 mg of tadalafil once daily during 1 year of treatment was well tolerated and efficacy changes were maintained. © 2011 THE AUTHORS. BJU INTERNATIONAL © 2011 BJU INTERNATIONAL Ejaculatory Disorders The link between penile hypersensitivity and premature ejaculation Michael G. Wyllie, Wayne J.G. Hellstrom BJU International 2011 , 107, 452–457 Keywords: premature ejaculation (PE);,hypersensitivity;,topical desensitizing agents;,PSD502 Study Type – Aetiology (case control) Level of Evidence 3b What’s known on the subject? and What does the study add? Very little is known about the aetiology of premature ejaculation. This analysis shows that many PE patients have a heightened penile sensitivity. This information could result in the design and development of new drugs. OBJECTIVES To investigate the correlation between penile hypersensitivity and premature ejaculation (PE), as defined by the criteria identified by the International Society of Sexual Medicine (ISSM). Penile hypersensitivity as a cause of PE is based on historical clinical neurophysiological data and clinical efficacy of the topical desensitizing agent PSD502 in the treatment of PE. PSD502 is a eutectic-like mixture of two local anaesthetics, lidocaine and prilocaine, whose primary action is to reduce neuronal conduction in sensory afferents. METHODS Historical neurophysiological data was reviewed, together with data from the recent PSD502 clinical trials, including the first published double-blind clinical trial data evaluating a topical