OBJECTIVE
To evaluate the clinical outcome and clinical efficacy of vardenafil in the treatment of benign prostatic hyperplasia (BPH) and to assess the side effects and oral effects in comparison with the use of oral drugs for erectile dysfunction (ED) with or without a comorbidity.
MATERIALS AND METHODS
In a randomized, placebo-controlled study (Buss-5), 70 pre-treatment, peer-based ED patients received a single dose of vardenafil 5 mg once daily, followed by a 15-week NSAID-free window of active treatment for 10 days. The treatment group was followed 1 month later and dosing continued until of the end of the study with additional NSAID-free windows during this period, after which the treatment was stopped. An nondrug-based test was carried out on 15 healthy healthy male volunteers to observe oral pain at baseline, and oral comfort tests at baseline, 2 weeks and 2 months were undertaken to assess risk of any form of erectile dysfunction, discontinuation, and bilateral voiding difficulties. Reporting was continued on 7 days post-study and oral assessment for affected men was carried on for 3 months with DAPT therapy for a 2-week dosing window (mono- or tran-epidididymitis-induced) to monitor compliance with the study intervention.
RESULTS
We found that a combination of Vardenafil 5 mg with EDA and sildenafil was administered, as demonstrated in a series of pilot studies (Buss-5). No recording of any side effects demonstrated any deviations from expected values, but some were noted. Paper annotations of vardenafil 5 mg with EDA and sildenafil were replicated with the addition of sildenafil, and a nichlorodenafil 10mg dose was added.
CONCLUSION
This preliminary multicentre, non-follow-up study would be a valuable gain for the future, as standardization of this compound might greatly improve the tolerated oral bioavailability and potency of the molecule. It remains to be clarified whether a transdermal formulation is the likely next step to construct a standardized efferent model that is safe and effective for the treatment of BPH.