The Efficacy of Penile Rehabilitation Using Udenafil After Total Mesorectal Excision of Rectal Cancer

NCT01421940 ↗

Phase 4 Completed 80 enrolled Kyungpook National University Hospital

RandomizedParallel-groupDouble-blindSupportive care

Summary

Sexual dysfunctions are well-recognized complications after rectal cancer surgery. Damage to the pelvic plexus and pelvic splanchnic nerves results in ejaculatory dysfunction. The purpose of this study is to evaluate the efficacy of Udenafil(Zydena®, Dong-A Pharmaceutical co., Ltd, Seoul, Korea) in penile rehabilitation for patients who undertake total mesorectal excision.

Timeline

Start: 2009-10
Primary completion: 2011-12
Completion: 2013-10

Outcome

Met primary endpoint

paper change in IIEF-5 scores from the baseline was significantly higher in the udenafil group than it was in the placebo group PMID 25482466 ↗

paper mean IIEF-5 score, 4.8 ± 4.0 vs 2.0 ± 1.7; P < .05 PMID 25482466 ↗

Publications

Park SY, Choi GS, Park JS, Kim HJ, Park JA, Choi JI. Efficacy and safety of udenafil for the treatment of erectile dysfunction after total mesorectal excision of rectal cancer: a randomized, double-blind, placebo-controlled trial. Surgery. 2015 Jan;157(1):64-71. doi: 10.1016/j.surg.2014.07.007.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Udenafil	Small molecule	50 mg	Oral