A Randomised, Placebo-Controlled Study to Assess the Efficacy of Twice-Daily Vardenafil in the Treatment of Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia

There is strong evidence from multiple epidemological studies that lower urinary tract symptoms (LUTS) and erectile dysfunction (ED) are correlated, independent of age or comorbidities as diabetes or hypertension. Although a direct causal relationship is not established yet, four pathophysio logical mechanisms can explain the relationship. These include alteration in nitric oxide bioavailability, a1-adrenergic receptor hyperactivity, pelvic atherosclerosis and sex hormones. This association has different clinical implications on the management of both disorders. Men seeking care for one condition should always be screened for complaints of the other condition. Sexual function should be assessed and discussed with the patient when choosing the appropriate management strategy for LUTS, as well as when evaluating the patient's response to treatment. Multiple large clinical trials have shown an improvement in LUTS after phosphodiesterase-5 (PDE5)-inhibitor treatment. PDE5 inhibitors show promise as a future treatment for LUTS, either in conjunction with existing therapies or as a primary treatment. There may be a potential therapeutic role for testosterone in LUTS treatment in cases of testosterone deficiency that needs to be investigated. Much further investigation is required, but it is evident that the association between LUTS and ED is fundamental for future therapies and possible preventative strategies.

show abstract

“…86 No history of ED was required for inclusion in the study. Vardenafil treatment resulted in a decrease in IPSS of 2.3 greater than placebo.…”

Section: Luts and Ed: Effects On Clinical Managementmentioning

confidence: 99%

Association of lower urinary tract symptoms and erectile dysfunction: pathophysiological aspects and implications for clinical management

2011

View full text Add to dashboard Cite

show abstract

“…3,19 In a multicentre randomized double-blinded study, Dmochowski and colleagues 20 found that tadalafil did not affect urodynamic parameters, but did improve both obstructive and irritative IPSS domains. Given the relatively strong evidence that PDE5i improves LUTS, it is not entirely surprising that nightly sildenafil in our study negatively affected early urinary functional recovery after RP.…”

Section: Discussionmentioning

confidence: 99%

“…While the major effect of PDE5i is on potency, one of the pleiotropic effects of PDE5i is their ability to improve urinary symptoms in men with lower urinary tract symptoms (LUTS). 3 Therefore in addition to affecting post-RP potency rates, the use of PDE5i may affect recovery of urinary continence and/or urinary quality of life after RP. 4 While several randomized controlled trials (RCT) suggest that nightly use of PDE5i is no more beneficial than on-demand use in terms of improving long-term erectile function after nerve-sparing RP, 5,6 many urologists nevertheless still prescribe chronic PDE5i immediately after RP.…”

Section: Introductionmentioning

confidence: 99%

Nightly sildenafil use after radical prostatectomy has adverse effects on urinary convalescence: Results from a randomized trial of nightly vs on-demand dosing regimens

Hyndman

Bivalacqua

Mettee

et al. 2015

CUAJ

View full text Add to dashboard Cite

Introduction: This is a report on potency results from a randomized trial of nightly versus on-demand sildenafil after nerve-sparing radical prostatectomy (RP). A secondary objective was to analyze the effects of these sildenafil administration schemes on urinary health-related quality of life after RP. Methods: In total, 100 potent men were equally randomized to nightly and on-demand sildenafil 50 mg after minimally-invasive RP for 1 year. Health-related quality of life questionnaires were administered at various postoperative intervals. Urinary function was assessed using appropriate expanded prostate cancer index composite (EPIC) subscales. Analyses of covariance and linear mixed-effects modeling were used to compare the effects of treatment over time on urinary recovery, controlling for age, nervesparing score, and time from surgery. Results: The nightly (n = 50) and on-demand (n = 50) sildenafil groups were well-matched at baseline. Nightly sildenafil patients had worse EPIC urinary bother and urinary irritative/obstructive subscale scores at 3 and 6 months after RP, even after controlling for multiple variables. On mixed-model analyses, the differences between groups for these EPIC subscales (4.9 and 2.5, respectively) were greater than documented thresholds for clinical significance. Increasing nerve-sparing score was associated with improvements in EPIC urinary summary, bother, incontinence, and function scores; time from surgery was associated with improvements in all EPIC urinary health-related quality of life subscales. Conclusions: In this specific population and drug dose, we found that on-demand short-acting phosphodiesterase-5 inhibitor (PDE5i) dosing may be more effective after RP to maximize early urinary and erectile health-related quality of life. In preoperatively potent men, nightly sildenafil 50 mg impaired urinary health-related quality of life more than on-demand use in the early months after nerve-sparing RP, independent of effects on urinary continence.

show abstract

“…Stief et al 79 examined vardenafil (LEVITRA) for the treatment of LUTS in a multi-center, randomized, double-blind, placebo-controlled trial. A group of 222 men with LUTS (IPSSX12) were randomized to either vardenafil (10 mg twice daily) or placebo, and studied over an 8-week period.…”

Section: Pde5 Inhibitors For Luts S Mouli and Kt Mcvarymentioning

confidence: 99%

PDE5 inhibitors for LUTS

Mouli

McVary

2009

Prostate Cancer Prostatic Dis

View full text Add to dashboard Cite

To review the current literature regarding the relationship between lower urinary tract symptoms (LUTS) and erectile dysfunction (ED), and the role of phosphodiesterase-5 (PDE5) inhibitors for the treatment of LUTS. Review of recently published (1990)(1991)(1992)(1993)(1994)(1995)(1996)(1997)(1998)(1999)(2000)(2001)(2002)(2003)(2004)(2005)(2006)(2007)(2008)(2009) Keywords: erectile dysfunction; benign prostatic hyperplasia; lower urinary tract symptoms; LUTS; ED IntroductionLower urinary tract symptoms (LUTS) and erectile dysfunction (ED) are highly prevalent in aging males, with a substantial impact on quality of life (QOL). Multiple studies have shown a strong association between these two entities, independent of other risk factors. This relationship may be explained by four interrelated theories: the nitric oxide/cyclic guanosine monophosphate pathway (NO/cGMP), the Rho-kinase pathway, autonomic hyperactivity (AH), and pelvic atherosclerosis. Clinical trials have shown that phosphodiesterase-5 (PDE5)-inhibitor treatment results in significant improvement in LUTS. The exact mechanism of action is not well understood. The results of these studies indicate that PDE5-inhibitor treatment has a role in treating LUTS in the setting of ED. Furthermore, PDE5-inhibitor therapy may expand to treat not only men with ED and/or LUTS, but also LUTS in women.

show abstract

A Randomised, Placebo-Controlled Study to Assess the Efficacy of Twice-Daily Vardenafil in the Treatment of Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia

Cited by 260 publications

References 27 publications

Association of lower urinary tract symptoms and erectile dysfunction: pathophysiological aspects and implications for clinical management

Association of lower urinary tract symptoms and erectile dysfunction: pathophysiological aspects and implications for clinical management

Nightly sildenafil use after radical prostatectomy has adverse effects on urinary convalescence: Results from a randomized trial of nightly vs on-demand dosing regimens

PDE5 inhibitors for LUTS

Contact Info

Product

Resources

About