These results show that sildenafil is a well tolerated and effective oral therapy for male erectile dysfunction with no established organic cause and may represent a new class of peripherally acting drug for the treatment of this condition.
The efficacy and safety of oral sildenafil, a potent inhibitor of phosphodiesterase type 5, were evaluated in men with diabetes mellitus and erectile dysfunction (ED). Twenty-one men (aged 42-65 years) were enrolled in a double-blind, placebo-controlled, three-way crossover study conducted in two parts. In part I, the effect of a single dose (25 mg or 50 mg) of sildenafil or placebo on penile rigidity was assessed by penile plethysmography during visual sexual stimulation. In part II, daily diary records of erectile activity and a global efficacy question were used to evaluate once-daily dosing with 25 mg or 50 mg of sildenafil or placebo for 10 days. After a single 50 mg dose of sildenafil, the adjusted geometric mean duration (min) of penile rigidity >60% at the base of the penis during visual sexual stimulation was significantly increased (10.1 min) compared with placebo (2.8 min; p = 0.0053). In part II, sildenafil significantly increased the number of erections considered sufficiently hard for vaginal penetration compared with placebo (p = 0.0005). Improved erections were reported by 50% and 52% of patients treated with 25 mg and 50 mg of sildenafil, respectively, compared with 10% of those receiving placebo (p values < 0.05). Adverse events were mostly mild or moderate in nature and included muscular pains, headache, and dyspepsia. Sildenafil is a well-tolerated and potentially efficacious oral treatment for ED in men with diabetes mellitus.
Introduction Viagra® (sildenafil citrate) has a rapid onset of action for the treatment of erectile dysfunction (ED). However, its duration of action has not been thoroughly investigated. Practical knowledge of the time window available for sexual intercourse would be valuable for couples planning sexual activity. Aim We investigated the duration of action of sildenafil in men with ED. Methods This was a double-blind, randomized, placebo-controlled, four-way crossover study of 16 men, mean age of 55 years (range, 36–68 years) with ED of no known organic cause. Participants received oral sildenafil (100 mg) or placebo 1, 8, or 12 hours before visual sexual stimulation (VSS). Measurements included the duration of erections of ≥ 60% rigidity, assessed by penile plethysmography (RigiScan®), and the proportion of sildenafil responders, defined as patients with erections of ≥ 60% rigidity for ≥ 4 minutes and ≥ 50% improvement over erections achieved in their placebo arm. Self-assessed duration of grade 3 (hard enough for penetration) or grade 4 (fully hard) erections was also recorded. Results At 1, 8, and 12 hours after dosing with sildenafil, the mean duration of erections with ≥ 60% rigidity was 26, 11, and 8 minutes, respectively, compared with only 3 minutes after placebo dosing (P < 0.05). However, the mean duration of self-assessed erections was 33, 23, and 16 minutes, respectively, compared with 7 minutes after placebo dosing (P < 0.05), and was greater than that assessed by RigiScan. Of the 69% sildenafil responders at 1 hour, 82% responded at 8 hours and 45% responded at 12 hours after sildenafil administration. Conclusion Sildenafil improved objective and self-assessed erectile function in men with ED, and the duration of action of sildenafil was longer than that previously reported. These data suggest that sildenafil may be effective in a significant proportion of men with ED up to 12 hours after being taken.
Tests have been performed on animal models shortly post-mortem and on a healthy human subject in order to obtain estimates of the forces which act on suprapubic urinary catheters and similar devices and to develop an abdominal wall simulator. Such data and test methods are required for the systematic design of suprapubic devices because of the dual need to maintain the functionality of devices and to avoid excessive pressure on soft body tissue which could lead to ischaemia and in turn necrosis. In the post-mortem animal models, electrical excitation was applied to the abdominal wall in order to stimulate muscle activity. Two types of transducers were used: a soft membrane transducer (SMT) for pressure measurement and novel instrumented 'tongs' to determine indentation stiffness characteristics in the suprapubic track or artificial pathway created for a device. The SMT has been extensively used in the urethras and bladders of human subjects while the tongs were built specifically for these tests. Only the well-established SMT was used with the human subject; a peak pressure of 22 kPa was obtained. In the animal models the pressure profile given by the SMT had a peak whose position corresponded well with the estimated location of the rectus muscle measured on the fixed tissue section. The peak value was 5.5 kPa, comparable with values likely to cause necrosis if maintained for more than 1 day. Remarkably consistent indentation stiffness values were obtained with the instrumented tongs; all values were close to 0.45 N/mm (33 kPa/mm).
Reports of malignant tumors in enterocystoplasties have recently been accumulating. To date no case of benign tumors has been recorded. We present a case of villous adenoma in a sigmoid colocystoplasty. The possible etiological factors and pathogenesis are discussed, and recommendations are made about followup.
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