Clinical trial · Interventional
The Efficacy of Penile Rehabilitation Using Udenafil After Total Mesorectal Excision of Rectal Cancer
NCT01421940CI-TRIAL-00017100completedPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Placebo drug | Drug | — | UNRESOLVED |
| Udenafil | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- PLACEBO_COMPARATOR
- label
- Control
- description
- Individuals who take placebo after total mesorectal excision
- interventionNames
- Drug: Placebo drug
- type
- EXPERIMENTAL
- label
- Udenafil
- description
- Individuals who take udenafil after total mesorectal excision
- interventionNames
- Drug: Udenafil
Primary outcomes (1)
- measure
- Change from baseline in International Index of Erectile Function (5-item Version) at 12 and 24 week
- timeFrame
- Baseline, 12weeks, 24 weeks
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 20 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Age : 20-65 * Rectal cancer within 15cm from anal verge * Patients with more than 5 points decreased IIEF-5 after operation * Patients with sexual activity Exclusion Criteria: * Preoperative IIEF-5 : ≤14 * Recent MI, CVA, nitrate medication * Severe cardiovascular disease, psychiatric disease * Severe hepatic dysfunction (GOT, GPT ≥100IU/L) * Renal dysfunction (Cr ≥2mg/dl)
References
Publications (1)
- DERIVEDPark 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. PMID 25482466