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

Kyungpook National University

Status and phase: Completed; Phase 4

Conditions: Rectal Cancer

Treatments: Drug: Placebo drug; Drug: Udenafil

Study type: Interventional

Funder types: Other

Identifiers

NCT01421940

KNUHCRC002

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: Male

Ages: 20 to 65 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 2 patient groups, including a placebo group

Control

Placebo Comparator group

Description:

Individuals who take placebo after total mesorectal excision

Treatment:

Drug: Placebo drug

Udenafil

Experimental group

Description:

Individuals who take udenafil after total mesorectal excision

Treatment:

Drug: Udenafil