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

Prostate Cancer research study

What is the primary objective of this study?

The investigators try to investigate the benefit of early administration (immediately after urethral catheter removal) of sildenafil after nerve-sparing RALP for 3 months. The investigators will compare the potency rates up to 2 years after nerve-sparing RALP in men with on- demand sildenafil 100mg dosing from the early postoperative period (immediately after urethral catheter removal) with from the delayed postoperative period (3 months after RP).

Who is eligible to participate?

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.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Prostate Cancer

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:sildenafil 100mgsildenafil 100mg per oral twice a week

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Earlymen with on- demand sildenafil 100mg dosing from the early postoperative period

Delayedmen with on- demand sildenafil 100mg dosing from the delayed postoperative period

Study Status

Unknown status

Start Date: June 2010

Completed Date: January 2013

Phase: N/A

Type: Interventional

Design:

Primary Outcome: 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)

Secondary Outcome: comparison of the potency rates in men with on- demand sildenafil 100mg dosing from the early postoperative period with from the delayed postoperative period

Study sponsors, principal investigator, and references

Principal Investigator: Sang Eun Lee, Professor

Lead Sponsor: Seoul National University Bundang Hospital

Collaborator: Pfizer

More information:https://clinicaltrials.gov/show/NCT01054001

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