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Radical prostatectomy - discharge Physical Medicine Erectile Dysfunction as Warning Sign 4–6-wk-old BALB/c and C57BL/6 mice were purchased from Harlan. C57BL/6-NOS2–/– mice (strain B6;129P2-Nos2tm1Lau) and control mice (strain B6;129PF2/J-100903) were purchased from the Jackson Laboratory. BALB/c-Rag-2–/– (17), clone 4 mice transgenic for the H-2Kd–restricted TCR recognizing the influenza virus, HA peptide (HAp512–520) TCR-transgenic (6.5) mice recognizing the HAp110–120 presented by I-Ed, and OT-II TCR-transgenic mice recognizing OVAp329–337 presented by I-Ab were all bred in the Johns Hopkins University animal facility. BALB/c–pIL-2/GFP mice were a gift of C.T. Weaver (University of Alabama, Tuscaloosa, AL) (25). All mouse experiments were in accordance with protocols approved by the Animal Care and Use Committee of the Johns Hopkins University School of Medicine. 0.5 x 106 tumor cells were injected s.c. in the inguinal area. Tumor measurements were performed with a caliper by measuring the largest diameter and its perpendicular length. The tumor size index is the average of the product of these diameters measured independently by two operators. Gr-1 depletion was performed by i.p. injection of 100 µg of anti–Gr-1 depleting antibody (clone RB6.8C5-18) per mouse on days 0, 3, and 6. CD8 depletion used 200 µg of the anti-CD8 depleting antibody (clone 2.43) on days 0, 2, 4, and 6. All of the experiments were performed at least twice with five mice per group unless otherwise indicated in the figures. Results Two hundred fifty-two patients (94%) completed the study (131/136 in the sildenafil group, 121/132 in the placebo group). By intention-to-treat analysis, at 12 weeks, 74 (56%) of 131 patients in the sildenafil group reported improved erections compared with 13 (10%) of 127 patients in the placebo group (P<.001). The proportion of men with at least 1 successful attempt at sexual intercourse was 61% (71/117) for the sildenafil group vs 22% (25/114) for the placebo group (P<.001). Adverse events related to treatment were reported for 22 (16%) of 136 patients taking sildenafil and 1 (1%) of 132 patients receiving placebo. The most common adverse events were headache (11% sildenafil, 2% placebo), dyspepsia (9% sildenafil, 0% placebo), and respiratory tract disorder (6% sildenafil, 2% placebo), predominantly sinus congestion or drainage. The incidence of cardiovascular adverse events was comparable for both groups (3% sildenafil, 5% placebo).
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