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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Placebo Comparator | Individuals who take placebo after total mesorectal excision |
|
| Udenafil | Experimental | Individuals who take udenafil after total mesorectal excision |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo drug | Drug | After total mesorectal excision for rectal cancer, patients take placebo drug five time per week for 12 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in International Index of Erectile Function (5-item Version) at 12 and 24 week |
| Baseline, 12weeks, 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in SEP Q2,Q3 and GEQ |
| baseline, 12weeks, and 24 weeks |
| Number of patients with adverse events during 24 weeks of the study |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kyungpook National University Medical Center | Daegu | 702-210 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25482466 | Derived | 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. |
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| ID | Term |
|---|---|
| D012004 | Rectal Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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| ID | Term |
|---|---|
| C419664 | udenafil |
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| Udenafil | Drug | After total mesorectal excision, patients take 50mg udenafil five times per week for 12 weeks. |
|
| Baseline through 24 weeks |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |