Tadalafil once daily was well tolerated and demonstrated clinically meaningful and statistically significant symptomatic improvement for lower urinary tract symptoms/benign prostatic hyperplasia. Tadalafil also improved erectile function in men with lower urinary tract symptoms and erectile dysfunction.
Introduction
Erectile dysfunction (ED) and lower urinary tract symptoms suggestive of benign prostatic hyperplasia (BPH-LUTS) commonly coexist in aging men. Tadalafil, a phosphodiesterase type 5 inhibitor approved for treating ED, is currently being evaluated for treating BPH-LUTS.
Aims
This multinational Phase 3 study assessed effects of tadalafil 2.5 or 5 mg once daily on ED and BPH-LUTS in men with both conditions during 12 weeks of double-blinded therapy.
Methods
Men were ≥45 years old, sexually active, and experiencing ED for ≥3 months and BPH-LUTS for >6 months. Randomization (baseline) followed a 4-week placebo lead-in; changes from baseline were assessed via analysis of covariance and compared to placebo. A gatekeeping procedure controlled for multiple comparisons of co-primary and key secondary measures at end point (last post-baseline observation).
Main Outcome Measures
The co-primary measures were the International Index of Erectile Function-erectile function (IIEF-EF) domain and International Prostate Symptom Score (IPSS) score; key secondary measures were the Sexual Encounter Profile Question 3 (SEP Q3) and BPH Impact Index (BII). Treatment-emergent adverse events, serious adverse events, orthostatic vital signs, clinical laboratory and uroflowmetry parameters, and postvoid residual volume were assessed.
Results
Tadalafil 2.5 mg (N = 198) and 5 mg (N = 208) significantly improved IIEF-EF domain scores (both P < 0.001) vs. placebo (N = 200) at end point. For IPSS, improvements were significant with tadalafil 5 mg (P < 0.001), but not 2.5 mg, for observations from 2 weeks through end point (least-squares mean ± standard error change from baseline at end point, placebo −3.8 ± 0.5, tadalafil 2.5 mg −4.6 ± 0.4, and 5 mg −6.1 ± 0.4). Tadalafil 5 mg significantly improved SEP Q3 and BII (P < 0.001). Overall, tadalafil was well tolerated with no clinically adverse changes in orthostatic vital signs or uroflowmetry parameters.
Conclusions
Tadalafil 5 mg significantly improved both ED and BPH-related outcomes through 12 weeks and was well tolerated.
Trospium was found to have sustained effectiveness beginning at the end of week 1 in decreasing the number of voids, urge incontinent episodes, total daily micturitions and urge severity, and in increasing volume per void. It also improved symptoms of OAB and quality of life.
• Background Families of critical care patients experience high levels of emotional distress. Access to information about patients’ medical conditions and quality relationships with healthcare staff are high-priority needs for these families.• Objectives To assess satisfaction with needs met, signs and symptoms of acute stress disorder, interpersonal perception of healthcare staff, level of optimism, and the relationships among these variables in patients’ family members.• Methods Family representatives of 40 patients were administered a brief version of the Critical Care Family Needs Inventory, the Acute Stress Disorder Scale, the Brief Symptom Inventory, the Impact Message Inventory, and the Life Orientation Test shortly after admission of the patients to the intensive care unit and after discharge.• Results Levels of dissociative symptoms associated with acute stress disorder were elevated in family members just after admission but decreased significantly after discharge. Needs the families thought were least satisfactorily cared for after admission involved lack of information. Interpersonally, attending physicians were viewed as more controlling than bedside nurses at admission; nurses were viewed as more affiliative than physicians both at admission and after discharge. At admission, higher optimism of the family members was strongly related to greater satisfaction with needs met, to perceptions of affiliation from physicians, and to perceptions of not being controlled by physicians.• Conclusions More interpersonal contact with medical staff can help meet the information needs of patients’ families. Nurses may aid in families’ adjustment by fostering a sense of optimism in family members and encouraging them to participate in the patients’ care.
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