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Biomedical subjects

Francesco Montorsi

Publications and source records attributed to Francesco Montorsi.

At least 73 records · Page 4Linked to original sources
PubMed2005

Bulbar urethroplasty using buccal mucosa grafts placed on the ventral, dorsal or lateral surface of the urethra: are results affected by the surgical technique?

PURPOSE: The use of buccal mucosa graft onlay urethroplasty represents the most widespread method of bulbar urethral stricture repair. The graft may be placed on the ventral or dorsal urethral surface according to surgeon experience and preference. We investigated whether the results are affected by the surgical technique by comparing the outcome of 3 types of bulbar urethroplasty using buccal mucosa graft. MATERIAL AND METHODS: We repaired 50 bulbar urethral strictures with buccal mucosa grafts from 1997 to 2002. Mean patient age was 42 years. The etiology of stricture was ischemia in 12 cases, trauma in 6, instrumentation in 4 and unknown in 28. Patients with lichen sclerosus, failed hypospadias or urethroplasty and stricture extending into the penile urethra were not included. A total of 47 patients (94%) had undergone previous urethrotomy or dilation. The buccal mucosa graft was always harvested from the cheek using a 2 team approach. Mean graft length was 4.2 cm. The graft was placed on the ventral, dorsal and lateral bulbar urethral surface in 17, 27 and 6 cases, respectively. Clinical outcome was considered a success or failure at the time that any postoperative procedure was needed, including dilation. Mean followup was 42 months (range 12 to 76). RESULTS: Of 50 cases 42 (84%) were successful and 8 (16%) failed. The 17 ventral grafts provided success in 14 cases (83%) and failure in 3 (17%). The 27 dorsal grafts provided success in 23 cases (85%) and failure in 4 (15%). The 6 lateral grafts provided success in 5 cases (83%) and failure in 1 (17%). No surgical complications were observed. Failures involved the anastomotic site (distal in 2 and proximal in 3) and the whole grafted area in 3 cases. They were treated with urethrotomy in 5 cases and 2-stage urethroplasty in 3. CONCLUSIONS: In our experience the placement of buccal mucosa grafts into the ventral, dorsal or lateral surface of the bulbar urethra showed the same success rates (83% to 85%) and the outcome was not affected by the surgical technique. Moreover, stricture recurrence was uniformly distributed in all patients.

Adolescent↗
PubMed2005

Vardenafil is effective and well-tolerated for treating erectile dysfunction in a broad population of men, irrespective of age.

OBJECTIVES: To assess the efficacy and safety of vardenafil in the treatment of erectile dysfunction (ED) in men of different age groups. PATIENTS AND METHODS: In a retrospective pooled subgroup analysis of randomized, double-blind, placebo-controlled studies, men from the general population with ED received either placebo or vardenafil 5, 10 or 20 mg over 12 weeks. Efficacy variables included the erectile function (EF) domain score from The International Index of Erectile Function, diary response rates to questions on vaginal penetration and maintenance of erection, and positive responses to the Global Assessment Question (GAQ) "Has the treatment you have been taking over the past 4 weeks improved your erections?'. The 1385 men were grouped by age (< 45, 45-64 and > or =65 years). RESULTS: At 12 weeks the EF domain scores approached 20 with vardenafil and 14 with placebo in men aged > or = 65 years (P < 0.03 vardenafil 5 mg vs placebo, P < 0.001 vardenafil 10 and 20 mg vs placebo). The corresponding scores were 22 and 14 in men aged 45-64 years and up to 24 and 16 in those aged <45 years (P < 0.03 vardenafil 5 mg vs placebo, P < 0.001 vardenafil 10 and 20 mg vs placebo). Vardenafil generated positive GAQ responses in approximately 71%, 76% and 85% of men aged <45, 45-64 and > or = 65 years (P < or = 0.001 vardenafil vs placebo). The corresponding placebo rates were 23%, 25% and 34%. The most common treatment-emergent adverse events were headache, rhinitis, flushing and dyspepsia, which were mild to moderate, transient and unrelated to age. CONCLUSION: Vardenafil is an effective and generally well-tolerated treatment for ED, irrespective of age.

Adult↗
PubMed2005

A prospective evaluation of efficacy and compliance with a multistep treatment approach for erectile dysfunction in patients after non-nerve sparing radical prostatectomy.

OBJECTIVE: To assess the response rate to different erectile aids in a consecutive series of patients treated with non-nerve sparing radical prostatectomy (NNSRP). PATIENTS AND METHODS: Ninety-four potent men were counselled about the different treatment options to restore an assisted erection before they had NNSRP. They were invited to participate in a multiphase protocol involving the sequential use of different erectile aids which aimed at restoring erectile function after surgery. The first proposed treatment was oral apomorphine sublingual. Patients with a positive response to the 1-item overall efficacy question and a minimum score of 3 in both question 3 and 4 of the International Index of Erectile Function were considered responders to oral pharmacotherapy. Treatment with sildenafil was then suggested to those not responding. If patients did not respond to oral pharmacotherapy a trial with a vacuum erectile device was offered; those not responding to this were then offered intracavernosal injection therapy with prostaglandin-E alone as the first option, followed by a mixture of vasoactive agents if needed. In those in whom injections also failed, a penile implant was recommended. At the 1-year follow-up visit all patients were offered a second trial with oral therapy regardless of the treatment currently in use. RESULTS: Seventy-six patients entered the protocol; there was no response to apomorphine. Five of 59 (8%) patients responded to sildenafil when they first used it at a mean of 7 months after NNSRP, while there were three additional responders in 22 patients who tried it for a second time a year later. Of patients achieving at least a complete tumescence sufficient for vaginal penetration, 52% and 60% were considered responders to the vacuum device and intracavernosal injections, respectively. Overall, 44% of patients enrolled in the protocol chose to use an erectile aid for at-home use. At the 1-year follow-up, only 20% of patients were still using an erectile aid, including two who had had a penile implant. CONCLUSIONS: Up to 10% of patients may achieve a clinically significant erection with sildenafil after NNSRP, but 80% will not be using any erectile aid at 1 year after surgery. In the present study protocol the proposed erectile aids were largely inadequate for treating the permanent erectile dysfunction that follows NNSRP.

Administration, Sublingual↗
PubMed2005

Clinical trials in urology: how many patients are required to achieve statistically significant results?

During the clinical validation of a new drug there are several clinical phases. Once phase II studies have defined the efficacy of a new drug, clinical research is used to evaluate its significance in clinical practice, comparing it with other drugs or treatments in use for similar clinical conditions. The group of patients undergoing standard treatment (either untreated or treated with placebo) is thus used as a control; these phase III studies are termed 'controlled clinical studies'. The general condition for comparing patients treated with the new drug is that they do not have characteristics (relevant to the study) that are systematically different from those in the control group. Randomization guarantees comparability between treated and untreated (or otherwise treated) patients. The comparability of the observations of the studied events are guaranteed by blinding and placebo. The fundamental question when designing a controlled clinical study to evaluate whether there are differences between two or more treatments is how many patients are needed. Generally, the smaller the clinically relevant differences in efficacy between treatments, the more patients are required, to provide sufficient statistical power and meaningful clinical results. A group of randomized patients represents the final point of sequential steps. Also of importance is to what kind of 'population' the results from the studied sample can be applied (qualitatively, not necessarily quantitatively), i.e. the general applicability of a study, or whether the findings can be used to treat future patients with the same or similar characteristics as those randomized, or to all patients with the same pathology. Answers to these questions depend on many aspects of the randomized selection mechanisms, the disease characteristics, and knowledge of the biological effects of the drug to be tested.

Clinical Trials as Topic↗
PubMed2005

Perianal and intrarectal anaesthesia for transrectal biopsy of the prostate: a prospective randomized study comparing lidocaine-prilocaine cream and placebo.

OBJECTIVES: To assess the effectiveness of perianal and intrarectal lidocaine-prilocaine cream for prostate biopsy. PATIENTS AND METHODS: In a prospective, randomized, double-blind, placebo-controlled study, 200 consecutive patients were randomized to receive 5 mL lidocaine-prilocaine cream or 5 mL placebo peri-anally and transrectally before transrectal ultrasonography (TRUS)-guided prostate needle biopsy (mean number of cores, 12). The men were asked to grade the pain when the TRUS probe was inserted and during the biopsy procedure using a 10-point linear visual analogue pain scale. RESULTS: At probe insertion, men in the anaesthetic group reported a significantly lower mean pain level than men in the placebo group (0.3 vs 1.6, P < 0.001). Men who had anaesthetic also reported less pain during biopsy punctures (1.8 vs 3.2, P < 0.001). Stratifying results by age, younger men (< 67 years) benefited more from anaesthesia during probe insertion (0.9 vs 1.7; P = 0.04) and biopsy (1.8 vs 4.0, P < 0.001) than older men (1.0 vs 1.1, P = 0.7 and 1.9 vs 2.4, P = 0.3, respectively). There were only minor complications, and these were not significantly different between the groups. CONCLUSION: Topical anaesthesia with prilocaine-lidocaine cream significantly reduced pain at transrectal probe insertion and during the biopsy procedure.

Adult↗
PubMed2005

An open-label, multicentre, randomized, crossover study comparing sildenafil citrate and tadalafil for treating erectile dysfunction in men naïve to phosphodiesterase 5 inhibitor therapy.

OBJECTIVES: To compare treatment preference, efficacy, and tolerability of sildenafil citrate (sildenafil) and tadalafil for treating erectile dysfunction (ED) in men naïve to phosphodiesterase 5 (PDE5) inhibitor therapy. PATIENTS AND METHODS: This was an open-label, crossover study of sildenafil and tadalafil (taken as needed). After a 4-week baseline assessment, 367 men with ED (mean age 54 years) were randomized to receive sildenafil for 12 weeks followed by tadalafil for 12 weeks or vice versa (8-week dose optimization and 4-week assessment phases). During dose optimization, patients started taking 25- or 50-mg sildenafil or 10-mg tadalafil and could titrate to find their optimum dose (25-, 50- or 100-mg sildenafil; 10- or 20-mg tadalafil). After completing both 12-week periods, patients chose which treatment to continue during an 8-week extension. Efficacy was measured with the International Index of Erectile Function (IIEF) and Sexual Encounter Profile (SEP) diary. RESULTS: Of the 291 men who completed both treatments, 85 (29%) chose sildenafil and 206 (71%) chose tadalafil (P < 0.001) for the 8-week extension. The IIEF erectile function domain scores were 14.2 at baseline, 23.9 at endpoint on sildenafil, and 24.3 at endpoint on tadalafil (P = 0.08, sildenafil vs tadalafil). The mean per patient percentage success scores for SEP2 (penetration) were: baseline (46%), sildenafil (post-baseline 82%) and tadalafil (post-baseline 85%; P = 0.06, sildenafil vs tadalafil), and for SEP3 (successful intercourse) were: baseline (19%), sildenafil (post-baseline 72%), and tadalafil (post-baseline 77%; P = 0.003, sildenafil vs tadalafil). The only treatment-emergent adverse events that were reported by >5% of men were headache and flushing. CONCLUSIONS: In men with ED who were naïve to PDE5 inhibitor therapy, sildenafil and tadalafil were both effective and well tolerated. After treatment with sildenafil and tadalafil, 29% of men chose sildenafil and 71% chose tadalafil for ED therapy during an 8-week extension.

Adolescent↗
PubMed2005

Association between erectile dysfunction and coronary artery disease: a case report study.

Evidence is accumulating in favor of classifying erectile dysfunction (ED) as a vascular disorder. There are three main clinical scenarios in which ED and coronary artery disease (CAD) may coexist: the patient with ED who later develops CAD, the patient with overt CAD who is casually found to have ED, and the patient with acute coronary syndrome who has normal sexual function. This study presents three cases and discusses a "putative" pathophysiological mechanism underlying all these clinical presentations. Further studies, coupling functional and structural changes of coronary circulation with those of penile (i.e., dynamic penile test) circulation in each of these situations are mandatory to support this hypothesis.

Aged↗
PubMed2005

Testosterone and sleep-related erections: an overview*.

Sleep-related erections have been reported to occur from the intrauterine life to senescence. It has been speculated that the main function of nocturnal erections is to provide adequate engorgement of the corpora cavernosa, which then leads to increased tissue oxygenation. This is in turn to prevent cavernous fibrosis, the histopathological basis for corporeal venoocclusive dysfunction, which probably is the most common cause of organic erectile dysfunction. It has been suggested that sleep-related erections are triggered by the release of nitric oxide by the nitrergic nerve fibers within the cavernous nerves. Androgens regulate this mechanism as well as some other non-nitrergic processes within the corpora cavernosa and within the central nervous system. By contrast, the erectile response to tactile or visual erotic stimuli in wakefulness predominantly involves an androgen-independent system, although it may, at least to a certain degree, also be influenced by androgen-sensitive mechanisms. No doubt, androgens are key players in the physiology of nocturnal erections, and the availability of new, user-friendly testosterone preparations such as transdermal gel and intramuscularly administered testosterone undecanoate stimulates further investigations on this field. The prospect that the quality of sleep may also be improved by an androgen therapy administered to improve sleep-related erections in hypogonadal men needs further basic research and appropriate clinical studies.

Androgens↗
PubMed2005

Efficacy of sildenafil citrate in men with erectile dysfunction following radical prostatectomy: a systematic review of clinical data.

INTRODUCTION: Radical prostatectomy is a frequently used treatment option for prostate cancer; however, prostatectomy is often associated with significant morbidity, including erectile dysfunction (ED). AIM: To analyze the efficacy of sildenafil citrate in treating ED after radical prostatectomy. MATERIALS AND METHODS: MEDLINE and CANCERLIT (1998 to January 2004) were searched for English language articles using the key words prostatectomy, sildenafil, and phosphodiesterase inhibitors. Eleven studies fulfilled the inclusion criteria: primary, discrete data sets of postprostatectomy patients with ED treated with sildenafil monotherapy. RESULTS: Sample sizes ranged from 13 to 198 (mean age, 61 +/- 3 years). Treatment durations were 4 weeks (or more than four doses) to 1 year, and sildenafil dosing was in the recommended range (25-100 mg). Seven studies reported a response rate (range, 14%-53%) for an end point consistent with the primary analysis outcome (erection sufficient for vaginal intercourse); the combined estimate of probability of response was 35% (95% confidence interval [CI], 24%-48%). There was strong evidence for a lower response rate after non-nerve-sparing (range, 0%-15%) versus nerve-sparing surgery (range, 35%-75%; combined odds ratio [OR] = 12.1; 95% CI, 5.5-26.6) but not after unilateral (range, 10%-80%) versus bilateral nerve-sparing surgery (range, 46%-72%; combined OR = 2.21; 95% CI, 0.75-6.54). CONCLUSIONS: The results of these studies demonstrate that with sildenafil, more than one third of patients with postprostatectomy ED achieved erection sufficient for intercourse. The odds of responding improved 12-fold with preservation of at least one neurovascular bundle. Early treatment failure does not necessarily imply lack of efficacy in the future, and patients should be encouraged to continue trying sildenafil, titrating up to 100 mg as needed.

Erectile Dysfunction↗
PubMed2005

Flexible-dose vardenafil in a community-based population of men affected by erectile dysfunction: a 12-week open-label, multicenter trial.

AIM: To evaluate the efficacy, safety, and tolerability of a flexible-dose regimen of vardenafil in a community-based population of men with erectile dysfunction (ED). METHODS: This was a 12-week, open-label, flexible-dose, multicenter study of unselected men with ED of diverse origins and severity. Unlike previous studies, prostatectomy-induced ED and previous unresponsiveness to sildenafil were not exclusion criteria. After 4 weeks of treatment with 10 mg of vardenafil, the dose could be continued or titrated to 5 mg or 20 mg, depending on efficacy and tolerability. After 8 weeks, another dose change was possible. Efficacy was assessed with International Index of Erectile Function erectile function (IIEF-EF) domain scores, diary questions of the Sexual Encounter Profile (SEP), and a global assessment question (GAQ) about erection improvement during the previous 4 weeks. RESULTS: Safety was evaluated in 497 patients, and 480 were suitable for intention-to-treat analysis. After 12 weeks of treatment, the mean per patient rate of successful intercourse, defined by an affirmative response to SEP questions 1-3, was 72%, and was related to age and ED duration. The overall success rate increased from 66% at week 4 to 77% at week 12. The mean IIEF-EF domain score of the whole population increased from 17.2 (baseline) to 24.4 (endpoint). At week 12, the best scores were obtained by patients taking 5 mg and 10 mg. At week 12, GAQ scores showed improved erection in 97.4%, 94.8%, and 78.8% of patients in the 5 mg, 10 mg, and 20 mg group, respectively. Safety was excellent: no serious drug-related event was reported, and only 2.2% of patients discontinued treatment because of side-effects. CONCLUSIONS: Vardenafil was effective and well tolerated in this community-based ED population that is truly representative of the general ED population. Dose titration meets the patient's needs and optimizes clinical outcome.

Erectile Dysfunction↗
PubMed2005

Vardenafil improves satisfaction rates, depressive symptomatology, and self-confidence in a broad population of men with erectile dysfunction.

INTRODUCTION: Vardenafil is a potent and selective phosphodiesterase 5 (PDE5) inhibitor developed for the treatment of erectile dysfunction (ED). Fixed-dose and flexible-dose studies have previously established the efficacy and tolerability of vardenafil. AIM: To assess, besides the usual measures of efficacy, the quality of erection, satisfaction with the sexual experience, symptoms of depression, and overall confidence. METHODS: This 12-week double-blind, placebo-controlled flexible-dose study assessed patients from the general ED population. Patients underwent a 4-week treatment-free period before randomization to vardenafil or matching placebo. Initial dosage was vardenafil 10 mg for 4 weeks. At 4 weeks, patients could switch to 5 or 20 mg (or corresponding placebo), or remain on 10 mg for an additional 4 weeks; dose switching was also optional for the last 4 weeks. This paper describes per-patient success in satisfaction with hardness of erection, satisfaction with overall sexual experience, effect on overall self-confidence, and an assessment of symptoms of depression using the Center for Epidemiologic Studies Depression Scale. RESULTS: Mean per-patient satisfaction rates with erection hardness increased after vardenafil treatment to 43%, 59%, and 63% at weeks 4, 8, and 12, respectively, compared to placebo with 10%, 21%, and 23% (all P < 0.005 vs. placebo). Vardenafil also improved mean per-patient overall satisfaction 50-65% over the 4-12 week study period compared with 17-28% for placebo (P < 0.005). Symptoms of depression were statistically significantly reduced compared to placebo (P = 0.02); the effect was observed particularly in patients who were depressed at baseline (P = 0.01). Significantly more patients in the vardenafil treatment group reported improved self-confidence than those who received placebo (P < 0.005). CONCLUSIONS: A flexible-dose regimen of vardenafil improved satisfaction rates, symptoms of depression, and self-confidence, providing patients with an effective ED therapy that contributes to overall improvements in sexual function and confidence.

Analysis of Variance↗
PubMed2005

Prevalence of premature ejaculation: a global and regional perspective.

The effort to determine the global burden of premature ejaculation (PE) has been impeded by the lack of a clear and universally accepted definition of the condition. Current diagnostic criteria are variable and rely, to a large degree, on subjective measurements. Moreover, the absence of a clear consensus on what constitutes a normal ejaculatory latency has impeded research into the prevalence of PE, although evidence is gradually accruing that may make this definition easier. Perception of "normal" ejaculatory latency varies by country and can differ when assessed either by the patient or their partner. Despite these limitations, information from the Global Study of Sexual Attitudes and Behaviors and other sources suggests a global prevalence of PE of approximately 30% across all age groups. The etiology underpinning this prevalence remains to be clarified, but current evidence reflects a shift from psychogenic theories to more neurobiological bases. While elucidation of the etiology of PE will undoubtedly aid the development of more effective therapies, it is clear that, whatever the cause of the condition, it is associated with a significant burden on psychological and overall health.

Age Distribution↗
PubMed2005

Safety and tolerability of oral erectile dysfunction treatments in the elderly.

Erectile dysfunction (ED) is a common medical condition that affects the sexual life of millions of men worldwide. It is generally accepted that sexual function tends to decline with aging, which is often associated with a higher prevalence of sexual problems, including ED and loss of libido. As the mean age of men seeking medical help for sexual dysfunction continues to increase, it is important to assess the safety and tolerability of currently available medical treatments in elderly men, who often share other co-morbidities that should be carefully evaluated when any type of ED therapy is considered. With this aim in mind, a MEDLINE search was conducted from 1 January 1998 to 31 May 2004 to identify studies assessing the efficacy, safety and tolerability of treatments for ED in the elderly. Particular care was taken to assess the cardiovascular safety of oral drugs for ED in this subset of patients, who often have multiple cardiovascular risk factors which contribute to a complicated clinical scenario. The most important conclusion of the paper is that the high efficacy, reliability, safety and tolerability of oral ED treatments makes them appropriate first-line therapies for elderly patients with ED.

Administration, Oral↗
PubMed2005

Sustained efficacy and safety of vardenafil for treatment of erectile dysfunction: a randomized, double-blind, placebo-controlled study.

OBJECTIVE: To evaluate the reliability, efficacy, and safety of vardenafil, 10 mg, for patients with erectile dysfunction. PATIENTS AND METHODS: Vardenafil-naive patients completed a 4-week treatment-free run-in phase and a 1-week single-dose vardenafil (10 mg) open-label challenge phase. Responders to vardenafil in the challenge phase were randomized to 12 weeks of double-blind, fixed-dose treatment with vardenafil at 10 mg or placebo. Diary responses to Sexual Encounter Profile (SEP) questions about erections and attempts at sexual activity were collected after 4, 8, and 12 weeks of randomized treatment. Adverse events were monitored throughout the study. RESULTS: During the open-label challenge phase, the proportions of patients with a first-time success for penetration (SEP2) and maintenance of erection (SEP3) were 87% and 74%, respectively. Of 600 patients challenged with a single dose of vardenafil at 10 mg, 260 were randomized to vardenafil and 263 to placebo. During the double-blind phase, the reliability of penetration and maintenance rates for patients successful during the challenge phase were significantly greater with vardenafil compared with placebo (83.4% vs 55.8% [SEP2] and 76.6% vs 42.1% [SEP3], respectively). At week 12, patients in the vardenafil group had a consistently higher least squares mean (SE) on the erectile function domain score of the International Index of Erectile Function than patients in the placebo group (23.5 [0.4] vs 15.8 [0.4], respectively [last observation carried forward]) and a greater proportion of positive responses to the Global Assessment Question (80.8% vs 32.3%, respectively [last observation carried forward]) at each assessment (Pc.001). Vardenafil was generally well tolerated; most adverse events were mild to moderate, with headache and flushing reported most frequently. CONCLUSION: During this 12-week study, vardenafil produced consistently higher reliability of penetration and maintenance of erection rates compared to placebo and was generally well tolerated in patients with erectile dysfunction.

Double-Blind Method↗
PubMed2005

Atypical small acinar proliferation (ASAP) on extended prostatic biopsies: predictive factors of cancer detection on repeat biopsies.

OBJECTIVE: To evaluate the clinical and histopathologic factors that may help to predict cancer detection by means of extended repeated prostate needle biopsies in patients with Jumma atypical small acinar proliferation (ASAP) results on initial prostate biopsy. MATERIALS AND METHODS: From 1998 to September 2003, 105 out of 121 (86%) patients with a diagnosis of ASAP after a first set of 10 to 12 systematic biopsies, were rebiopsied using the same technique plus additional biopsies on the ASAP site (mean number of repeat biopsy samples, 12.6). The median time until a second and third biopsy was 7.04 months (95% confidence interval [CI], 5.5-8.5), and 13.3 months (95% CI, 8.8-17.7; 19 patients), respectively. Each histological slide was reviewed blindly by a single experienced pathologist (M.F) who differentiated highly suspicious (ASAPH) and not highly suspicious (ASAPB) lesions for cancer. RESULTS: On initial biopsy, a concomitant HGPIN was present in 18 patients (17%) with ASAP The overall cancer detection rate in those who underwent two or three sets of biopsies was 39% (41/105); it was 35% (37/105) and 21% (4/19) in second and third biopsies, respectively. The overall cancer detection rate was higher in patients who had ASAP associated with HGPIN (50%) compared with patients who had isolated ASAP (37%) (p = 0.3). Statistical analysis showed that levels of prostate-specific antigen (PSA), PSA density, prostatic volume, digital rectal examination results, transrectal ultrasound findings, time until rebiopsy (less vs. more than 6 months), and histological level of suspicion were not significant predictors of prostate cancer at the time of rebiopsy. In particular, the cancer detection rate was not significantly higher in patients with ASAPH than those with ASAPB (49% vs. 33%, respectively; p = 0.11). In a univariate analysis, the mean prostate volume was statistically different in patients with cancer compared with those without (56.4 +/- 6.3 and 78.9 +/- 5.3 respectively; p = 0.009), but only in the group of patients who had isolated ASAP In these patients, the rate of cancer detection was significantly higher in patients who had a prostatic volume less than 60 mL (56%) than in patients with a prostatic volume greater than or equal to 60 mL (27%) (p = 0.03). CONCLUSIONS: Patients with an initial ASAP diagnosis after extended biopsies had an overall cancer detection rate less than 40% after two sets of extended biopsy. ASAPH lesions did not indicate a significantly higher risk of cancer than ASAPB lesions on repeated extended biopsies. Despite the extended rebiopsy plus the additional biopsies targeted to the ASAP lesion, the detection rate was lower for patients with a larger prostate than those with a smaller prostate.

Aged↗
PubMed2005

Penetration and maintenance of erection with vardenafil: a time-from-dosing analysis.

OBJECTIVE: To assess success rates in ability to penetrate (Sexual Encounter Profile question 2 [SEP2]) and maintain erections to completion of intercourse (SEP3) from time of dosing to start of sexual activity in a retrospective analysis of two pivotal trials. METHODS: In two randomized, double-blind studies, men with ED for > 6 months received vardenafil 5 mg, 10 mg, or 20 mg or placebo for 12-26 weeks. Patients were instructed to start sexual activity 1 hour after dosing. In this retrospective pooled analysis, patient diary questions through week 12 were analyzed, providing attempt data was recorded 0-12 hours post-dose. Mean per-patient SEP2 and SEP3 success rates (intent-to-treat population) were calculated by time between dosing and start of sexual activity, from 0-12 hours through week 12. Least-square means and nominal p-values for differences versus placebo were derived by analysis of covariance with terms for baseline, study and treatment. RESULTS: Most attempts at sexual intercourse occurred 30-90 minutes after dosing: 88%-93% of attempts occurred within 120 minutes. SEP2 success rates in patients choosing to attempt sexual activity in each interval from < or = 15 minutes through the 4-8-hour interval were higher with vardenafil compared with placebo, while SEP3 success rates were greater with vardenafil for patients choosing to initiate sexual activity from < or = 15 min through the 8-12-hour interval. The most commonly reported treatment-emergent adverse events in patients receiving vardenafil included headache (11%-22%), flushing (6%-13%), rhinitis (5%-13%), and dyspepsia (2%-7%). CONCLUSION: In this retrospective analysis of two pivotal trials, vardenafil improved success rates compared with placebo in ED patients who attempted intercourse from as early as 15 minutes or less and through 4-8 hours after dosing in ability to penetrate (SEP2) and from as early as 15 minutes or less and through 8-12 hours after dosing in maintenance of erection (SEP3).

Coitus↗
PubMed2005

Detection and diagnosis of prostate cancer: what's new.

OBJECTIVE: Prior the widespread use of PSA screening in asymptomatic men, prostate cancer was historically detected by a simple digital rectal examination. Although the gold standard for prostate cancer still remains prostate biopsy, current researches in the area of detection and diagnosis of prostate carcinoma are focusing on identification of better sampling protocols, biologic markers and imaging strategies in order to detect disease at an earlier stage. We reviewed all the recent literature on the detection of clinically meaningful prostate cancer. METHODS: A systematic review of the literature using Medline up to 2005 was performed. Electronic searches were limited to the English language using the keywords prostate cancer, diagnosis, transrectal ultrasound, prostate biopsy. Unpublished information known by the authors and that were considered of interest to the readers were also included. RESULTS: The prostate biopsy technique has extremely changed from the original Hodge's sextant biopsy protocol. Several authors have already reported high rates of false negative biopsy using sextant protocols. The optimal protocol should, nowadays, include six standard sextant biopsies with additional biopsies weighted more laterally (anterior horn) and medially to the apex. Repeat biopsies should also be based on an extended scheme and should include the transition zone especially in patient with at initial negative biopsy. To increase accuracy of prostatic biopsy and reduce unnecessary prostate biopsy, TRUS, power Doppler imaging (PDI), colour Doppler TRUS (CDUS), and 3-dimensional Doppler (3DD) can be successfully adopted, but their routine use is still controversial. Several types of local anaesthesia are now available and can be safely performed to reduce the pain of multi-sites biopsy protocol. CONCLUSION: Extended biopsy schemes should be performed not only at first biopsy but especially at repeated biopsy for premalignancy lesions. The widespread use of local anesthesia makes the procedure more comfortable.

Biopsy↗