Effect of tolterodine extended release with or without tamsulosin on measures of urgency and patient reported outcomes in men with lower urinary tract symptoms.

PURPOSE: We evaluated the efficacy of tolterodine extended release and/or tamsulosin on micturition related urgency episodes, urgency severity and patient reported outcomes in men who met entry criteria for prostatic enlargement and overactive bladder trials. MATERIALS AND METHODS: Men 40 years old or older with an International Prostate Symptom Score of 12 or greater, frequency (8 or more voids per 24 hours) and urgency (3 or more episodes per 24 hours) with or without urgency urinary incontinence were randomized to placebo, 4 mg tolterodine extended release, 0.4 mg tamsulosin or tolterodine extended release plus tamsulosin for 12 weeks. Subjects completed 5-day diaries; the Patient Perception of Bladder Condition and Urgency Perception Scale at baseline, and weeks 1, 6 and 12; Overactive Bladder Questionnaire at baseline, and weeks 6 and 12; Perception of Treatment Satisfaction question at weeks 1, 6 and 12; and Willingness to Continue question at week 12. Subjects rated the urgency associated with each micturition on a 5-point scale and micturition related urgency episodes were those rated 3 or greater. Urgency severity was measured using frequency-urgency sum, defined as the sum of urgency ratings for all micturitions. RESULTS: Compared with placebo, tolterodine extended release plus tamsulosin significantly reduced daytime and nocturnal micturition related urgency episodes as well as frequency-urgency sum at weeks 1, 6 and 12. It also improved Patient Perception of Bladder Condition scores at weeks 1, 6 and 12; improved Urgency Perception Scale and Overactive Bladder Questionnaire, Symptom Bother and Health Related Quality of Life scores at weeks 6 and 12; and increased the percentage of subjects who reported treatment satisfaction at weeks 6 and 12, and willingness to continue at week 12. CONCLUSIONS: Treatment with tolterodine extended release plus tamsulosin significantly improved urgency variables and patient reported outcomes in men meeting entry criteria for overactive bladder and prostatic enlargement trials.

Barriers to accessing urethroplasty.

Urethroplasty is an effective treatment for men with anterior urethral strictures, but is utilized less frequently than ineffective treatments such as internal urethrotomy. We sought to identify provider-level barriers to urethroplasty. An anonymous online survey was emailed to all Mid-Atlantic American Urological Association members. Six scenarios in which urethroplasty was the most appropriate treatment were presented. Primary outcome was recommendation for urethroplasty in ≥ three clinical scenarios. Other factors measured include practice zip code, urethroplasty training, and proximity to a urethroplasty surgeon. Multivariate logistic regression identified factors associated with increased likelihood of urethroplasty recommendation. Of 670 members emailed, 109 (16%) completed the survey. Final analysis included 88 respondents. Mean years in practice was 17.2. Most respondents received formal training in urethroplasty: 43 (49%) in residency, 5 (6%) in fellowship, and 10 (11%) in both; 48 respondents (55%) had a urethroplasty surgeon in their practice, whereas 18 (20%) had a urethroplasty surgeon within 45 minutes of his or her primary practice location. The only covariate that was associated with an increased likelihood of recommending urethroplasty in ≥ three scenarios was formal urethroplasty training. Most members (68%) reported no barriers to referring patients for urethroplasty; the most common barriers cited were long distance to urethroplasty surgeon (n 5 13, 15%) and concern about complications (n 5 8, 9%). Urethroplasty continues to be underutilized in men with anterior urethral strictures, potentially due to lack of knowledge dissemination and access to a urethroplasty surgeon. Appropriate urethroplasty utilization may increase with greater exposure to urethroplasty in training.

Pharmacokinetics, pharmacodynamics, and efficacy of phosphodiesterase type 5 inhibitors.

Clinical evidence in men with erectile dysfunction (ED) shows that the phosphodiesterase type 5 (PDE5) inhibitors sildenafil citrate, tadalafil, and vardenafil hydrochloride have favorable safety and efficacy profiles. However, as mild vasodilators, the PDE5 inhibitors are also associated with hemodynamic effects that may be clinically significant, especially when treating men with ED who have comorbid cardiovascular disease. Hemodynamic studies have shown that therapeutic dosages of the PDE5 inhibitors produce only mild and transient changes in mean systolic and diastolic blood pressure and heart rate in healthy men as well as those with ischemic heart disease or chronic stable angina. Overall, PDE5 inhibitors are safe and effective in most patient populations, including men with ischemic cardiovascular disease or those receiving anti-hypertensive agents, and men with diabetes or those who have undergone nerve-sparing retropubic radical prostatectomy. With the entry of three novel PDE5 inhibitors into the therapeutic armamentarium for ED, differentiating properties of the new agents may confer clinical benefits that physicians as well as patients and their partners should consider when selecting a PDE5 inhibitor.

A current review of medical therapy for benign prostatic hyperplasia.

Benign prostatic hyperplasia (BPH) is one of the most common diseases of aging men. It is estimated that by age 60 years, greater than 50% of men will have histologically documented evidence of the disease. Therapy for this disease has evolved considerably from its inception. Recent data from long-term population-based studies have shed new light on the treatment of this common problem in aging men. The authors review the current state of diagnosis of BPH and medical therapy for this condition in the primary care setting.

Human papillomavirus testing in men.

Despite the morbidity associated with anogenital condylomas and the mortality associated with anal, penile, and cervical carcinoma as a direct consequence of human papillomavirus (HPV), the US Centers for Disease Control and Prevention currently does not recommend routine screening for HPV in immuno competent men. However, findings of emerging research focusing on the high-risk populations of men who have sex with men and men who test positive for human immunodeficiency virus, in whom HPV infection is pervasive and persistent, suggest that these populations may benefit from screening. Therefore, HPV screening, including anal cytology, should be considered for these men in settings where appropriate follow-up, including high-resolution anoscopy, is available.

Safety and efficacy of once-daily trospium chloride extended-release in male patients with overactive bladder.

OBJECTIVES: This study used pooled data from 2 large, phase III, double-blind, randomized, placebo-controlled studies for a subgroup analysis of the safety and efficacy of trospium chloride extended-release (XR) in men with overactive bladder (OAB). METHODS: A subgroup analysis was performed on data from the 176 male patients (trospium XR, 94; placebo, 82) who participated in 1 of the 2 studies. Patients received either trospium XR 60 mg or placebo once daily for 12 weeks. RESULTS: The mean age was 66.2 years for trospium XR and 63.1 years for placebo. A history of benign prostatic hyperplasia was recorded for 29 trospium XR recipients (30.9%) and 23 placebo recipients (28.0%). A total of 19 patients (20.2%) receiving trospium XR and 15 (18.3%) receiving placebo experienced ≥1 treatment-emergent adverse event considered at least possibly related to the study medication. Two trospium XR patients (2.1%) developed urinary retention; both were aged ≥75 years, and 1 had a history of prostate enlargement. Treatment with trospium XR compared with placebo resulted in significantly greater decreases from baseline in the mean number of daily toilet voids (-2.5 vs -1.5; P < .05) and urgency urinary incontinence episodes (-2.3 vs -1.4; P < .05) in men at week 12 (the coprimary efficacy variables). CONCLUSIONS: Trospium XR is safe and effective in men with OAB. The risk of urinary retention is low and may be further decreased by careful patient selection.

Overactive bladder: treatment options in primary care medicine.

Overactive bladder is a highly prevalent condition, affecting approximately 33 million adults in the United States. Despite the considerable impact this condition has on patients' quality of life, overactive bladder remains underrecognized and undertreated as a result of patient embarrassment and reluctance to seek medical help, as well as a lack of proactive questioning by physicians. The present article encourages physicians to initiate a dialogue with patients regarding urinary control and, specifically, overactive bladder. Treatment options for overactive bladder recommended in the current article include both nonpharmacologic and pharmacologic therapies. Properties of antimuscarinic agents, including three new drug therapies, are reviewed and provided for physicians to optimize therapy options, particularly among elderly patients.

Onset of efficacy of tolterodine extended release in patients with overactive bladder.

OBJECTIVE: To assess the onset of efficacy of tolterodine extended release (ER) in patients with overactive bladder (OAB). RESEARCH DESIGN AND METHODS: A post hoc analysis was conducted using 3-day bladder diary data from a 12-week, multicenter, prospective, open-label study of tolterodine ER (4 mg qd) in patients (aged > or = 18 years) with urinary frequency (> or = 8 micturitions/24 h) and urgency (strong and sudden desire to urinate) with or without urgency urinary incontinence (UUI). MAIN OUTCOME MEASURES: Changes in micturition frequency, urgency, and UUI episodes/24 h were evaluated for treatment Days 5, 6, and 7. The percentages of patients who achieved normal micturition frequency (< 8/day) and 50%, 70%, 90%, and 100% reductions in urgency and UUI episodes (i.e., responders) were determined at Days 5, 6, and 7. Week 12 data are presented as a referent for the magnitude of treatment efficacy during Week 1. RESULTS: This analysis included 698 patients. On Day 5, there were significant reductions in all three diary variables (all p < 0.0001), and improvements continued on Days 6 and 7. More than half of the patients reported > or = 50% reductions in urgency or UUI episodes on Day 5. Responder rates for all three symptoms increased through Week 12. CONCLUSIONS: Patients with OAB experienced significant reductions in OAB symptoms as early as Day 5 of treatment with tolterodine ER. These data extend the findings of a previous analysis, in which all 3 days of the bladder diary were pooled, that demonstrated improvements in micturition frequency, urgency episodes, and UUI episodes in patients with OAB after 1 week of treatment with tolterodine ER. Limitations are that efficacy was not assessed before Day 5, this was a post hoc analysis, and the study was not placebo-controlled.