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

August 18, 2011 updated by: Sang Eun Lee, Seoul National University Bundang Hospital
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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

124

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Gyeonggido
      • Seongnam, Gyeonggido, Korea, Republic of, 463-707
        • Recruiting
        • Seoul National University Bundang Hospital
        • Contact:
        • Contact:
          • Seong Jin Jeong, Professor
          • Phone Number: 82-31-787-7349
          • Email: urojsj@empal.com
        • Principal Investigator:
          • Sang Eun Lee, Professor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Early
men with on- demand sildenafil 100mg dosing from the early postoperative period
Drug: sildenafil 100mg
sildenafil 100mg per oral twice a week
Other Names:
  • Viagra 100mg
Active Comparator: Delayed
men with on- demand sildenafil 100mg dosing from the delayed postoperative period
Drug: sildenafil 100mg
sildenafil 100mg per oral twice a week
Other Names:
  • Viagra 100mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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)
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
comparison of the potency rates in men with on- demand sildenafil 100mg dosing from the early postoperative period with from the delayed postoperative period
Time Frame: 2 year
2 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Bundang Hospital

Collaborators

Pfizer

Investigators

  • Study Chair: Sang Eun Lee, Professor, Seoul National University Bundang Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (Anticipated)

December 1, 2012

Study Completion (Anticipated)

January 1, 2013

Study Registration Dates

First Submitted

January 21, 2010

First Submitted That Met QC Criteria

January 21, 2010

First Posted (Estimate)

January 22, 2010

Study Record Updates

Last Update Posted (Estimate)

August 22, 2011

Last Update Submitted That Met QC Criteria

August 18, 2011

Last Verified

August 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WS486539

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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