There are few published guidelines for the management of sexual dysfunctions in men and women, despite the prevalence and lack of attention to these problems. Disorders of sexual function in men ...include erectile dysfunction, orgasm/ejaculation disorders, priapism, and Peyronie's disease.
To provide evidence based and expert opinion consensus guidelines for the clinical management of men's sexual dysfunctions.
An International Consultation in collaboration with major urological and sexual medicine societies assembled over 200 multidisciplinary experts from 60 countries into 17 consultation committees. Committee members established the scope and objectives for each chapter. Following intensive review of available data and publications, committees developed evidence based guidelines in each area.
New algorithms and guidelines for assessment and treatment of men's sexual dysfunction were developed. The Oxford system of evidence based review was systematically applied. Expert opinion was based on systematic grading of the medical literature, in addition to cultural and ethical considerations.
Recommendations and guidelines for men's sexual dysfunction are presented. These guidelines were developed as evidence based, patient centered, and multidisciplinary in focus. For the clinical assessment and diagnosis of ED, a basic evaluation was recommended for all patients, with optional and specialized testing reserved for special cases. A new treatment algorithm is proposed. This algorithm provides a clinically relevant guideline for managing ED in the large majority of men. New treatment guidelines and algorithms are provided for men's orgasm and ejaculation disorders, including premature ejaculation, retrograde and delayed ejaculation. Finally, expert opinion based guidelines for the clinical management of priapism and Peyronie's disease are provided.
Additional research is needed to validate and extend these guidelines. Nonetheless, this summary encompasses the recommendations concerning men's sexual dysfunctions presented at the 2nd International Consultation on Sexual Medicine in Paris, France, June 28–July 1, 2003.
After bilateral nerve-sparing radical retropubic prostatectomy (BNSRRP), nocturnal and sexually mediated erections may help to preserve normal erectile function (EF).
To investigate nocturnal penile ...tumescence and rigidity (NPTR) in a subset (N=54 men) from a randomized, double-blind trial (N=76) of nightly sildenafil after BNSRRP.
Inclusion required preoperative “normal” EF (defined as a combined score of ≥8 for International Index of Erectile Function questions 3 (penetration) and 4 (maintained erection after penetration) and NPTR testing (≥10 continuous minutes of ≥55% rigidity R≥55% at the base). Postoperative assessments were at weeks 4 (pretreatment), 16, 28, 40 (during 36 weeks of nightly prophylaxis: sildenafil 50mg N=17, 100mg N=18 or placebo N=19), and 48 (after 8weeks of no erectile dysfunction therapy, when “responders” were delineated by the defined normal EF and a “yes” response to “Over the past 4weeks, have your erections been good enough for satisfactory sexual activity?”). Base and tip rigidity and tumescence were measured using penile plethysmography.
Duration of R≥55% and area under the curves for rigidity and tumescence.
Postoperatively, rapid profound reduction in nocturnal EF was noted in all groups. There was a gradual dose-dependent improvement in base and tip rigidity in the sildenafil groups but little improvement in the placebo group. Eight weeks after treatment termination (48 weeks postoperatively), 24% (4/17) of 50-mg sildenafil recipients, 33% (6/18) of 100-mg sildenafil recipients, and 5% (1/19) of placebo recipients were responders. Tip R≥55% was the most discriminating NPTR measure between nonresponders and responders to sildenafil, in whom it regained baseline (preoperative) levels (whereas base R≥55% did not). It was most prolonged in responders to sildenafil 100mg.
In our subset analysis, nightly sildenafil for 9 months post-BNSRRP objectively improved nocturnal erections and pharmaceutically unassisted EF. McCullough AR, Levine LA, and Padma-Nathan H. Return of nocturnal erections and erectile function after bilateral nerve-sparing radical prostatectomy in men treated nightly with sildenafil citrate: Subanalysis of a longitudinal randomized double-blind placebo-controlled trial.
To examine the therapeutic effects of tadalafil on erectile dysfunction (ED) at 24 and 36 hours after dosing.
A multicenter, randomized, double-blind, placebo-controlled, parallel-group study of 348 ...men (mean age 57 years) with ED was conducted in Europe and the United States. Patients were stratified by baseline severity of ED using the Erectile Function domain score of the International Index of Erectile Function and then randomly allocated within the severity group to receive tadalafil 20 mg (n = 175) or placebo (n = 173). Subsequently, participants were randomly assigned to two 4-week treatment intervals, during which they were requested to attempt sexual intercourse approximately 24 or 36 hours after tadalafil or placebo dosing. The primary outcome measure was the proportion of successful sexual intercourse attempts (completed to ejaculation) according to patient self-report using the Sexual Encounter Profile diary.
Of the 348 patients, 327 (94%) completed the trial (163 of 175 in the tadalafil group and 164 of 173 in the placebo group). Thirty-six hours after tadalafil dosing, 59.2% of intercourse attempts were successful versus 28.3% in the placebo group (
P <0.001). The proportion of successful intercourse attempts at approximately 24 hours after treatment was also significantly greater with tadalafil (52.9%) than with placebo (29.1%;
P <0.001). Tadalafil was well tolerated. The incidences of four treatment-emergent adverse events were significantly greater in the tadalafil group than in the placebo group (all
P <0.05): headache, flushing, dyspepsia, and myalgia.
Tadalafil 20 mg is an effective and well-tolerated treatment for ED that has a period of responsiveness of up to 36 hours.
Female sexual dysfunction is highly prevalent but not well defined or understood. We evaluated and revised existing definitions and classifications of female sexual dysfunction.
An interdisciplinary ...consensus conference panel consisting of 19 experts in female sexual dysfunction selected from 5 countries was convened by the Sexual Function Health Council of the American Foundation for Urologic Disease. A modified Delphi method was used to develop consensus definitions and classifications, and build on the existing framework of the International Classification of Diseases-10 and
DSM-IV: Diagnostic and Statistical Manual of Mental Disorders of the American Psychiatric Association, which were limited to consideration of psychiatric disorders.
Classifications were expanded to include psychogenic and organic causes of desire, arousal, orgasm and sexual pain disorders. An essential element of the new diagnostic system is the “personal distress” criterion. In particular, new definitions of sexual arousal and hypoactive sexual desire disorders were developed, and a new category of noncoital sexual pain disorder was added. In addition, a new subtyping system for clinical diagnosis was devised. Guidelines for clinical end points and outcomes were proposed, and important research goals and priorities were identified.
We recommend use of the new female sexual dysfunction diagnostic and classification system based on physiological as well as psychological pathophysiologies, and a personal distress criterion for most diagnostic categories.
Advances in molecular biology and protein chemistry, along with increasing understanding of the mechanisms of penile erection, have spurred development of pharmacologic approaches to the treatment of ...erectile dysfunction (ED). The next generation of oral agents includes tadalafil, a potent, highly selective phosphodiesterase 5 inhibitor. In vitro studies have shown that tadalafil enhances relaxation of trabecular smooth muscle, and clinical trials have supported its efficacy and tolerability in a broad population of men with ED. The effect of tadalafil in enhancing the erectile response to sexual stimulation is relatively rapid in onset and lasts for ≥24 hours. The ability of patients with ED treated with tadalafil to achieve improved erectile function is demonstrated by significantly increased subjective measures of penetration ability, successful intercourse, and sexual satisfaction. Partners have expressed similar or higher levels of satisfaction with the results of treatment. Men with ED of psychogenic, organic, or mixed etiology and in a range from mild to severe have experienced significant improvment with tadalafil treatment. Response to treatment in men with diabetes has been robust and not affected by disease severity. Tadalafil has been well tolerated. Adverse events have generally been mild or moderate and have abated with continued treatment. Headache and dyspepsia have been most frequently reported. Changes in color vision have been rare (<0.1%) with tadalafil across all clinical trials. Tadalafil appears to be a safe and effective treatment for men with ED.
Tadalafil is a phosphodiesterase 5 (PDE5) inhibitor used for the treatment of erectile dysfunction (ED). The minimal time to onset of erectogenic effect in the at‐home setting has not been evaluated.
...The goal was to determine the earliest time to erectogenic effect leading to successful intercourse within 30 minutes after taking tadalafil 10 and 20 mg.
The multicenter, randomized, double‐blind, placebo‐controlled, parallel‐group, phase‐2 study enrolled men at least 21 years old with a minimum 3‐month history of ED. Four single doses each of placebo, tadalafil 10 mg, or 20 mg were taken at home once every 8–10 days. Using a stopwatch, couples recorded in Sexual Encounter Profile diaries the earliest time within 30 minutes after dosing to the first erection adequate for vaginal penetration, and whether the erection led to successful intercourse.
The primary analysis compared the percentage of erections resulting in successful intercourse between tadalafil groups and placebo at one‐minute intervals using a step‐down procedure. A secondary analysis compared the overall distribution of time to erectogenic effect between treatment groups using the Cox Regression Method.
Compared to placebo, a significant erectogenic response to tadalafil 20 mg was found from 30 minutes down to 16 minutes after dosing (P = 0.012). Response to tadalafil 10 mg approached significance (P = 0.054) at 30 minutes. As analysed by the Cox Regression Method, a significant erectogenic response was found from 30 minutes down to 15 minutes after dosing for tadalafil 20 mg (P = 0.020), and from 30 minutes down to 26 minutes for tadalafil 10 mg (P = 0.042). Fifty‐two percent of men taking tadalafil 20 mg had at least one successful intercourse attempt within 30 minutes compared to 35.1% of men taking placebo (P = 0.038).
This stopwatch‐based study demonstrated a pharmacodynamic effect within 30 minutes after dosing for tadalafil 10 and 20 mg.
The ability of oral phosphodiesterase type 5 (PDE5) inhibitor therapy to restore erectile function to normal is an important attribute to men with erectile dysfunction (ED).
To assess the ability of ...vardenafil to restore normal erectile function in men with general ED.
In two fixed‐dose, parallel‐group, double‐blind, placebo‐controlled, pivotal studies, patients received vardenafil (5, 10, or 20mg) or placebo for 12/26weeks.
In this retrospective analysis, the percentage of patients “returning to normal” erectile function at week 12 (as defined by scores ≥26 on erectile function domain of International Index of Erectile Function IIEF‐EF) was determined, with further stratification by baseline ED severity, etiology, age, and duration of ED.
Vardenafil 5, 10, and 20mg returned 32%, 43%, and 49% of patients, respectively, to normal erectile function after 12weeks, compared with 10% of patients receiving placebo (P<0.0001). Return to normal IIEF‐EF domain scores was noted irrespective of severity, etiology, age, and duration of ED, and was observed even in challenging‐to‐treat subgroups. With vardenafil 20mg, 39% of men with severe ED at baseline, 45–49% of men with ED of mixed or organic etiology, 35% of men aged ≥65years, and 43% of men with ED of ≥3years of duration returned to normal erectile function at week 12. Mean per‐patient SEP3 (question 3 on the Sexual Encounter Profile) success rates in patients achieving IIEF‐EF domain scores ≥26 ranged from 87% to 95%.
Vardenafil improves the IIEF‐EF domain score to the normal range in a substantial proportion of men with ED. Padma‐Nathan H, Montorsi F, Giuliano F, Meuleman E, Auerbach S, Eardley I, McCullough A, Homering M, and Segerson T for the North American and European Vardenafil Study Group. Vardenafil restores erectile function to normal range in men with erectile dysfunction. J Sex Med 2007;4:152–161.
We aimed to determine whether erectile function (EF) and assessments of erection hardness correlate positively with measures of psychosocial outcomes (ie, emotional well-being, sexual satisfaction, ...and satisfaction with erectile dysfunction ED treatment) in men treated with sildenafil citrate (Viagra
®; Pfizer Inc, New York, NY). Data were collected from 33 worldwide phase 2, 3, and 4 sildenafil clinical trials, which included almost 10,000 men with ED. Most of these trials were randomized, double-blind, and placebo-controlled (n = 27) and were undertaken to assess doses of 50 mg adjustable to 25 mg or 100 mg, depending on efficacy and tolerability (n = 32). Doses were taken approximately 1 hour before anticipated sexual activity but not more often than once daily. EF was assessed with use of the EF domain of the International Index of Erectile Function (IIEF) and with assessments of erection hardness (Erection Hardness Grading Scale EHGS and IIEF Q2 the frequency of erections hard enough for penetration). Change (baseline to end point) in emotional well-being in men treated for ED was assessed with the Self-Esteem and Relationship (SEAR) questionnaire, which consisted of the Confidence domain (ie, the Self-Esteem subscale and Overall Relationship subscale) and the Sexual Relationship domain. End point treatment satisfaction (overall, speed of onset, and duration of action) was assessed with the Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS). The IIEF was used to assess change and end point sexual satisfaction by means of the Intercourse Satisfaction domain, Q7 (frequency of satisfactory sexual intercourse), and the Overall Satisfaction domain (ie, Q13, satisfaction with sex life, and Q14, satisfaction with sexual relationship). In men treated with sildenafil for ED, scores for measures of EF (IIEF EF domain, IIEF Q2) and the percentage of erections graded completely hard and fully rigid (EHGS grade 4) correlated positively with scores for measures of psychosocial outcomes (SEAR emotional well-being, IIEF sexual satisfaction, and EDITS ED treatment satisfaction), indicating that when EF improved and erection hardness increased, these measures of psychosocial function also improved.
