Does on-demand vardenafil improve erectile function recovery after radical prostatectomy?
Sexual and Reproductive Medicine, Urology Service, Memorial Sloan-Kettering Cancer Center, New York, NY 10021, USA. Nature Clinical Practice Urology
(Impact Factor: 4.07).
01/2009; 6(1):14-5. DOI: 10.1038/ncpuro1271
The randomized, placebo-controlled trial reported by Montorsi and colleagues attempted to determine if nightly vardenafil was more effective than on-demand drug in restoring erectile function after radical prostatectomy. No significant difference in outcomes was found between the study groups at 11 or 13 months after surgery. The study, however, had enough methodological flaws to prevent any definitive conclusions from being drawn. The authors' conclusion that the data support a shift towards on-demand phosphodiesterase 5 inhibitor use after radical prostatectomy is not supported by the data.
Available from: onlinelibrary.wiley.com
- "Very recently, the Bayer-sponsored REINVENT study raised questions about the utility of penile rehabilitation (Montorsi et al, 2008). This study has been critiqued in detail elsewhere (Mulhall, 2009). The study was very complicated in its design: specifically, within 14 days of bilateral nerve-sparing RP, patients were randomized in a 1:1:1 ratio to receive either 9 months of treatment with 10 mg nightly vardenafil (which could be decreased to 5 mg if required) plus ondemand placebo for sexual relations; 9 months of treatment with flexible-dose on-demand vardenafil for sexual relations (starting at 10 mg with the option to titrate to 5 mg or 20 mg), plus nightly placebo; or 9 months of treatment with nightly placebo plus ondemand placebo for sexual relations. "
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ABSTRACT: Since the introduction of the nerve-sparing radical prostatectomy (RP), potency preservation rates of between 20% and 90% have been reported. It is irrefutable that the nerve-sparing status of an RP is predictive of recovery of erectile function. Bilateral nerve sparing is associated with superior spontaneous and oral therapy-assisted recovery of erectile function compared to unilateral nerve sparing, which in turn is more likely to lead to functional erections than non-nerve-sparing surgery. Neural regeneration is the mechanism by which erectile function improves over time following RP. Although the degree of neural trauma that occurs intraoperatively is a determinant of long-term recovery of neural function, biological factors involved in neural regeneration are likely important determinants of the completeness of neural recovery. Furthermore, these biological factors are likely a major reason for the interindividual variation in recovery of erectile function after this operation. Recently, the development of rat models of cavernous nerve injury has facilitated the study of neuroprotective and neuroregenerative agents. This paper reviews the current knowledge on pharmacological neuromodulation as it pertains to the radical pelvic surgery patient. The animal evidence is highly supportive of such agents' having a positive impact on erectile function recovery after RP. Human trial data are awaited.
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ABSTRACT: Erectile dysfunction (ED) is common after radical prostatectomy (RP). ED has a negative impact on health-related quality of life. Penile rehabilitation is defined as the use of any drug or device at or after RP to maximize erectile function recovery. The purpose of penile rehabilitation is the prevention of corpus cavernosal smooth muscle structural alterations not only to maximize the chances of a man having recovery of functional erections but also returning him to his preoperative erectile function level. Appreciating the value of penile rehabilitation requires understanding five concepts: the pathophysiology of ED after RP, cavernosal oxygenation, venous leak, and both the animal and human data supporting this strategy. This paper gives an overview of these factors and attempts to give a common-sense, practical guide to a rehabilitation program.
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