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Early Start of Oral Sildenafil 100mg for Erectile Dysfunction After Robotic Assisted Laparoscopic Radical Prostatectomy

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Prostate Cancer

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Trial Information

Early Start of Oral Sildenafil 100mg for Erectile Dysfunction After Robotic Assisted Laparoscopic Radical Prostatectomy

Various studies using animal models of CN neuroparaxia and clinical trials have demonstrated
somewhat beneficial effect of PDE-5 inhibitors on smooth muscle cells of the corpus
cavernosum. PDE-5 inhibitors including sildenafil have demonstrated the effectiveness in the
management of postprostatectomy ED. In the animal experiments, PDE-5 inhibitors lowered the
severity of the fibrosis in the corpus cavernosum of rats with CN cutting. In the clinical
trials, on-demand dosing or routine dosing of PDE-5 inhibitors improved the potency rates in
men received NSRP, and improvements of the potency rate did not appear to be statistically
different among two dosing regimens.

But, there are few studies on the potency rate according to the start time of the
administration of PDE-5 inhibitors (eg. early vs. delayed post-operative dosing). At
present, it is not conclusive that whether nerve-sparing RALP provides more higher potency
rate than conventional surgery in men with prostate cancers. But, with more precise
dissection of CN, the robotic surgery appears to have more chances to maintain the potency
in men received RP.

Inclusion Criteria:

- Patients with agree to participate with the study

- Korean male subjects aged 50 years or older with clinically localized prostate cancer

- Preoperative potent men (IIEF-5 score 17 or more than 17)

- Patients in a stable, heterosexual relationship with a single partner for at least
the past six months

- Suitable for nerve sparing indication

Exclusion Criteria:

- Genital anatomical deformities that would significantly impair erection

- Other sexual disorders (e.g. hypoactive sexual desire) that are considered to be the
primary diagnosis when there is a coexisting diagnosis of erectile dysfunction.

- Known raised prolactin level (>3 times the upper limit of the normal range) or low
free testosterone level (confirmed to be >20% below the lower limit of the normal
range on blood collected between 09:00 and 11:00 hours).

- Major psychiatric disorder (including major depression or schizophrenia) that is not
well controlled on treatment.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

patterns of recovery of erectile functions after nerve sparing RALP in men with on- demand sildenafil 100mg dosing from the early postoperative period (using IIEF-5)

Outcome Time Frame:

1 year

Safety Issue:


Principal Investigator

Sang Eun Lee, Professor

Investigator Role:

Study Chair

Investigator Affiliation:

Seoul National University Bundang Hospital


Korea: Institutional Review Board

Study ID:




Start Date:

June 2010

Completion Date:

January 2013

Related Keywords:

  • Prostate Cancer
  • prostate cancer
  • prostatectomy
  • erectile dysfunction
  • Prostatic Neoplasms
  • Erectile Dysfunction