OBJECTIVE
To evaluate the effect of the early use of the vacuum erection device (VED) on erectile dysfunction (ED) and penile shortening after radical retropubic prostatectomy (RP), as these are important concerns for men choosing among treatment alternatives for localized prostate cancer.
PATIENTS AND METHODS
Twenty‐eight men undergoing RP were randomized to early intervention (1 month after RP, group 1) or a control group (6 months after RP, group 2) using a traditional VED protocol. An International Index of Erectile Function (IIEF) score of >11 (no, mild or mild to moderate ED) was required as a baseline criterion for inclusion in the study. Only patients in whom unilateral or bilateral nerves were spared were subsequently randomized. Patients in group 1 followed a daily rehabilitation protocol consisting of 10 min/day using the VED with no constriction ring, for 5 months. Patients were evaluated with the IIEF‐5 questionnaire and measurements of penile flaccid length, stretched length, prepubic fat pad, and midshaft circumference before and at 1, 3, 6, 9 and 12 months after RP; the mean (range) last follow‐up visit was 9.5 (6–12) months after RP.
RESULTS
The mean (sd) baseline IIEF scores were similar in groups 1 and 2, at 21.1 (4.6) and 22.3 (3.3), respectively (P = 0.54). The IIEF scores were significantly higher in group 1 than group 2 at 3 months, at 11.5 (9.4) vs 1.8 (1.4) (P = 0.008) and at 6 months, at 12.4 (8.7) vs 3.0 (1.9) (P = 0.012) after RP. There were no significant changes in penile flaccid length, prepubic fat pad, or mid‐shaft circumference in either group. Stretched penile length was significantly decreased at both 3 and 6 months, by ≈ 2 cm (P = 0.013) in group 2. By contrast, stretched penile length was preserved in group 1 at all sample times. At the last follow‐up, the proportion of men with a mean loss of penile length of ≥ 2 cm was significantly lower in group 1 than group 2 (two/17, 12%, vs five/11, P = 0.044).
CONCLUSIONS
Initiating the use of a VED protocol at 1 month after RP improves early sexual function and helps to preserve penile length.
with eventual full recovery of function [6], but with longer periods of warm ischaemia there is significant immediate functional loss with either incomplete or no delayed recovery of renal function [5]. In humans, 30 min is the maximum tolerable period of warm ischaemia before permanent damage ensues.Hypothermia is the technique most commonly used to protect the kidneys from ischaemic damage. Lowering renal temperature reduces energy-dependent metabolic activity of the cortical cells, leading to decreased oxygen consumption and reduced ATP breakdown. A negative effect of hypothermia is inactivation of the sodiumpotassium pump at the cellular level, which ultimately allows salt and water to enter the cell. These effects are completely reversible at temperatures of > 4 ° C. For practical purposes, a uniform temperature of 20-25 ° C is adequate to maintain renal function even after 3 h of arterial occlusion.
Renal responses to ANP and renal NEP activity were preserved in 24-hour BUO. NEP inhibition to attenuate ANP degradation augmented responses to ANP in increasing GFR, natriuresis and diuresis. These findings provide the theoretical potential for facilitating the recovery of GFR after BUO release by inhibiting ANP degradation by pharmacological means.
Aim
To determine short‐term efficacy and safety of Paxerol®, novel immediate:sustained (50%:50%) release tablets containing 325 mg acetaminophen and 150 mg ibuprofen per tablet.
Methods
One of three dose levels, corresponding to the amounts in 1, 2, and 3 tablets, of Paxerol and placebo were administered for 14 consecutive days to patients with severe nocturia (defined in this study as an average nocturnal voids [NV] ≥2.5) associated with overactive bladder (OAB). Changes in NV, as well as Nocturia Quality of Life (NQOL), duration of first uninterrupted sleep (DFUS), and total hours of nightly sleep (THNS) associated with treatment were assessed. Short‐term safety/tolerability was assessed throughout the study and for at least 30 days post‐treatment.
Results
Paxerol at all three doses reduced NV to a greater degree than placebo (average NV −1.1, −1.4, −1.3 voids for low, mid, and high doses, respectively, vs −0.3 void for placebo). NQOL and THNS were similar between baseline and treatment values in all four groups. There were also no between‐group differences. Paxerol at high dose tended to (although not statistical significantly) increase DFUS to a greater degree than placebo (1.2 vs 0.4 h, P = 0.057). There were no treatment related adverse events in any of the four groups.
Conclusions
This study demonstrates short‐term efficacy and short‐term safety of Paxerol in patients with severe nocturia associated with OAB. The results warrant further investigation of the long‐term efficacy and safety of Paxerol in larger patient populations.
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