TY - JOUR
T1 - Efficacy and safety of udenafil for the treatment of erectile dysfunction after total mesorectal excision of rectal cancer
T2 - A randomized, double-blind, placebo-controlled trial
AU - Park, Soo Yeun
AU - Choi, Gyu Seog
AU - Park, Jun Seok
AU - Kim, Hye Jin
AU - Park, Ju A.
AU - Choi, Jong Ik
N1 - Publisher Copyright:
© 2015 Elsevier Inc.
PY - 2015/1/1
Y1 - 2015/1/1
N2 - Background Nerve-preserving surgery has been provided for patients with rectal cancer; however, sexual dysfunction remains a common complication of rectal cancer surgery. This study explored the efficacy of udenafil to treat erectile dysfunction in male patients who underwent total mesorectal excision (TME) for rectal cancer.Methods We conducted a randomized, double-blind, placebo-controlled clinical trial involving 80 male patients who had decreased International Index of Erectile Function-5 (IIEF-5) scores after TME for rectal cancer. Patients received placebo (50 mg) or udenafil (50 mg) for 12 weeks. The primary outcome variable was the change in IIEF-5 scores. The secondary outcome variables were Sexual Encounter Profile (SEP) questions 2 (Q2) and 3 (Q3), and the Global Assessment Question (GAQ).Results Baseline IIEF-5 scores, SEP Q2 and Q3 responses, and spontaneous erection rates were consistent in both groups. At the end of treatment, the change in IIEF-5 scores from the baseline was significantly higher in the udenafil group than it was in the placebo group (mean IIEF-5 score, 4.8 ± 4.0 vs 2.0 ± 1.7; P <.05). Responses to SEP Q2, SEP Q3, and GAQ were significantly higher in the udenafil group than they were in the placebo group (SEP Q2, P =.025; SEP Q3, P =.044; GAQ, P <.001). Treatment-related adverse events (n = 4) were all mild in severity.Conclusion Oral udenafil was deemed safe and effective for the treatment of erectile dysfunction in patients who underwent TME for rectal cancer.
AB - Background Nerve-preserving surgery has been provided for patients with rectal cancer; however, sexual dysfunction remains a common complication of rectal cancer surgery. This study explored the efficacy of udenafil to treat erectile dysfunction in male patients who underwent total mesorectal excision (TME) for rectal cancer.Methods We conducted a randomized, double-blind, placebo-controlled clinical trial involving 80 male patients who had decreased International Index of Erectile Function-5 (IIEF-5) scores after TME for rectal cancer. Patients received placebo (50 mg) or udenafil (50 mg) for 12 weeks. The primary outcome variable was the change in IIEF-5 scores. The secondary outcome variables were Sexual Encounter Profile (SEP) questions 2 (Q2) and 3 (Q3), and the Global Assessment Question (GAQ).Results Baseline IIEF-5 scores, SEP Q2 and Q3 responses, and spontaneous erection rates were consistent in both groups. At the end of treatment, the change in IIEF-5 scores from the baseline was significantly higher in the udenafil group than it was in the placebo group (mean IIEF-5 score, 4.8 ± 4.0 vs 2.0 ± 1.7; P <.05). Responses to SEP Q2, SEP Q3, and GAQ were significantly higher in the udenafil group than they were in the placebo group (SEP Q2, P =.025; SEP Q3, P =.044; GAQ, P <.001). Treatment-related adverse events (n = 4) were all mild in severity.Conclusion Oral udenafil was deemed safe and effective for the treatment of erectile dysfunction in patients who underwent TME for rectal cancer.
UR - http://www.scopus.com/inward/record.url?scp=84919458727&partnerID=8YFLogxK
U2 - 10.1016/j.surg.2014.07.007
DO - 10.1016/j.surg.2014.07.007
M3 - Article
C2 - 25482466
AN - SCOPUS:84919458727
SN - 0039-6060
VL - 157
SP - 64
EP - 71
JO - Surgery (United States)
JF - Surgery (United States)
IS - 1
ER -
