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Purpose Medical treatment for men with lower urinary tract symptoms and prostatic enlargement secondary to benign prostatic hyperplasia is 5α-reductase inhibitor monotherapy or coadministration with an α-blocker. We assessed the effects of tadalafil 5 mg coadministered with finasteride 5 mg during 26 weeks on lower urinary tract symptoms and sexual symptoms. Materials and Methods In an international, randomized, double-blind, parallel study of men 45 years old or older who were 5α-reductase inhibitor naïve and had an I-PSS (International Prostate Symptom Score) of 13 or greater and prostate volume 30 ml or greater, 350 were treated with placebo/finasteride and 345 received tadalafil/finasteride for 26 weeks. Changes in lower urinary tract symptoms secondary to benign prostatic hyperplasia were assessed with the I-PSS, erectile dysfunction improvements were assessed with the IIEF-EF (International Index of Erectile Function-Erectile Function) in sexually active men and safety was assessed by evaluating adverse events. Results Least squares mean changes from baseline in I-PSS after 4, 12 and 26 weeks of tadalafil/finasteride coadministration were -4.0, -5.2 and -5.5, respectively. Corresponding values for placebo/finasteride coadministration were -2.3, -3.8 and -4.5 (p ≤0.022 at all visits favoring tadalafil/finasteride coadministration). I-PSS subscores (storage and voiding) and quality of life index were also numerically improved with tadalafil/finasteride coadministration. Least squares mean changes from baseline in IIEF-EF with tadalafil/finasteride coadministration were 3.7 after 4 weeks, and 4.7 after 12 and 26 weeks. Corresponding values for placebo/finasteride coadministration were -1.1, 0.6 and -0.0 (p

Phosphodiesterase type 5 inhibitors are widely used to treat erectile dysfunction. Preliminary data have suggested phosphodiesterase type 5 inhibitor efficacy in men with lower urinary tract symptoms associated with clinical benign prostatic hyperplasia.After a 4-week placebo run-in period 1,058 men with benign prostatic hyperplasia lower urinary tract symptoms were randomly allocated to receive 12-week, once daily treatment with placebo or tadalafil (2.5, 5, 10 or 20 mg).The International Prostate Symptom Score least squares mean change from baseline to end point was significantly improved for 2.5 (-3.9, p = 0.015), 5 (-4.9, p0.001), 10 (-5.2, p0.001) and 20 mg (-5.2, p0.001) tadalafil compared to placebo (-2.3). International Prostate Symptom Score improvements at 4, 8 and 12 weeks were significant for all tadalafil doses and they demonstrated a dose-response relationship. Tadalafil (2.5 mg) significantly improved the International Prostate Symptom Score obstructive subscore and the International Index of Erectile Function-Erectile Function domain, the latter in sexually active men with a history of erectile dysfunction. Statistically significant improvements were noted for 5, 10 and 20 mg tadalafil compared to placebo, as assessed by the International Prostate Symptom Score irritative and obstructive subscores, International Prostate Symptom Score Quality of Life, Benign Prostatic Hyperplasia Impact Index (nonsignificant for 10 mg), Global Assessment Question and International Index of Erectile Function-Erectile Function domain. No statistically significant effect of treatment compared to placebo was noted for peak flow at any tadalafil dose. Treatment emergent adverse events were infrequent in all tadalafil groups.Once daily tadalafil demonstrated clinically meaningful and statistically significant efficacy and it was well tolerated in men with benign prostatic hyperplasia lower urinary tract symptoms. Of the doses studied 5 mg tadalafil appeared to provide a positive risk-benefit profile.

We estimated the incidence and remission of lower urinary tract symptoms during the 12 years following the first pregnancy and delivery.In a cohort study 242 primiparae were questioned about lower urinary tract symptoms 3 months, 5 years and 12 years after the first delivery.From 3 months to 5 years after first delivery the incidence of stress urinary incontinence, urge urinary incontinence, urgency, diurnal frequency and nocturia was 56 of 213 cases (26.3%), 33 of 219 (15.1%), 33 of 206 (16.0%), 49 of 219 (22.4%) and 6 of 225 (2.7%), respectively. Remission of stress urinary incontinence, urge urinary incontinence, urgency, diurnal frequency and nocturia during the same period occurred in 1 of 11 cases (9.1%), 2 of 5 (40%), 2 of 5 (40%), 4 of 7 (57.1%) and 1 of 1 (100%), respectively. From 5 to 12 years after the first delivery the incidence of stress urinary incontinence, urge urinary incontinence, urgency, diurnal frequency and nocturia was 40 of 158 cases (25.3%), 25 of 188 (13.3%), 24 of 175 (13.7%), 40 of 174 (23.0%) and 13 of 220 (5.9%), respectively. Remission of stress urinary incontinence, urge urinary incontinence, urgency, diurnal frequency and nocturia during the same period occurred in 14 of 66 cases (21.2%), 13 of 36 (36.1%), 22 of 36 (61.1%), 14 of 52 (26.9%) and 4 of 6 (66.7%), respectively. Of 62 women with pure stress urinary incontinence during the first pregnancy and puerperium 20 (32.2%) had pure stress urinary incontinence, 3 (4.8%) had pure urge urinary incontinence and 15 (24.2%) had mixed urinary incontinence 12 years later. Of 13 women with pure urge urinary incontinence during the first pregnancy and puerperium 3 (23.1%) had pure urge urinary incontinence, 2 (15.4%) had pure stress urinary incontinence and 3 (23.1%) had mixed urinary incontinence 12 years later. The overall prevalence of lower urinary tract symptoms 12 years after the first delivery increased significantly.The incidence and remission of lower urinary tract symptoms after the first pregnancy and delivery fluctuate and the types of urinary incontinence may interchange, while the overall prevalence of lower urinary tract symptoms increases in the long term.