Effect of Nightly Versus Prn Sildenafil on Early Return of Erectile Function Following Laparoscopic Radical Prostatectomy - Full Text View

Sponsored by:	Johns Hopkins University
Information provided by:	Johns Hopkins University
ClinicalTrials.gov Identifier:	NCT00511498

Purpose

The ability of sildenafil to aid in the return of erections after nerve-sparing radical prostatectomy has been established. Patients who had either one or both neurovascular bundles spared demonstrated dramatically better responses to "as needed" sildenafil than those that did not, and a positive erectile response to sildenafil was only seen in patients in whom at least one NVB was spared. This study has been designed to determine if sildenafil taken nightly works better than sildenafil on as "as needed" basis for the return of erectile function. The investigators hypothesis is that sildenafil taken nightly promotes a more rapid return of erectile function after nerve-sparing laparoscopic radical prostatectomy.

Condition	Intervention
Prostate Cancer	Drug: Sildenafil

MedlinePlus related topics: Cancer Prostate Cancer

Drug Information available for: Sildenafil citrate Sildenafil

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Double Blind (Subject, Investigator), Placebo Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	Effect of Nightly Versus Prn Sildenafil on Early Return of Erectile Function Following Nerve-Sparing Laparoscopic Radical Prostatectomy

Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:

IIEF score [ Time Frame: 13 months ] [ Designated as safety issue: No ]

Enrollment:	100
Study Start Date:	March 2006
Study Completion Date:	October 2008
Primary Completion Date:	September 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Arm: Placebo Comparator Placebo nightly	Drug: Sildenafil 50 mg daily at bedtime
Drug: Active Comparator Sildenafil 50mg nightly	Drug: Sildenafil 50 mg daily at bedtime

Eligibility

Ages Eligible for Study:	18 Years to 64 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male sex
Age < 65
IIEF erectile function domain score > 26 (out of 30 points possible for this subscale)
Steady sexual partner
Untreated prostate cancer TNM stage < cT2bNxMx (cT1a, cT1b, cT1c, cT2a) and Gleason grade < 8.
Willingness to participate in a clinical trial as manifested by informed consent
Actually undergo nerve-sparing LRP surgery

Exclusion Criteria:

Not fulfilling all of the criteria for entry above
Any prior prostate cancer treatment (radiation, hormonal deprivation, chemotherapy)
Contraindication to sildenafil (e.g. nitrates, hypersensitivity)
Existing PDE5 inhibitor requirement for functional erection (e.g. for intercourse) preoperatively
Obstructive sleep apnea

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00511498

Locations

United States, Maryland
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, United States, 21224

Sponsors and Collaborators

Johns Hopkins University

Investigators

Principal Investigator:

Christian P Pavlovich, MD

Johns Hopkins University

More Information

Responsible Party:	Johns Hopkins University ( Christian Pavlovich, M.D. )
Study ID Numbers:	NA_00001428
Study First Received:	August 3, 2007
Last Updated:	November 28, 2008
ClinicalTrials.gov Identifier:	NCT00511498
Health Authority:	United States: Institutional Review Board

Keywords provided by Johns Hopkins University:

Laparoscopic Radical Prostatectomy
Nightly sildenafil

Study placed in the following topic categories:

Prostatic Diseases
Genital Neoplasms, Male
Sildenafil

Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms

Additional relevant MeSH terms:

Vasodilator Agents
Neoplasms
Phosphodiesterase Inhibitors
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action

Therapeutic Uses
Enzyme Inhibitors
Cardiovascular Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009