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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2013-10-31

Brief Summary

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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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Detailed Description

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Conditions

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Rectal Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Control

Individuals who take placebo after total mesorectal excision

Group Type PLACEBO_COMPARATOR

Placebo drug

Intervention Type DRUG

After total mesorectal excision for rectal cancer, patients take placebo drug five time per week for 12 weeks.

Udenafil

Individuals who take udenafil after total mesorectal excision

Group Type EXPERIMENTAL

Udenafil

Intervention Type DRUG

After total mesorectal excision, patients take 50mg udenafil five times per week for 12 weeks.

Interventions

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Placebo drug

After total mesorectal excision for rectal cancer, patients take placebo drug five time per week for 12 weeks.

Intervention Type DRUG

Udenafil

After total mesorectal excision, patients take 50mg udenafil five times per week for 12 weeks.

Intervention Type DRUG

Eligibility Criteria

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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)

Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No