Evaluating the Effect of the VCD on Erectile Function and Penile Length Post RRP

This study has been completed.

First Received: September 13, 2005 Last Updated: May 30, 2007 History of Changes

Sponsor:	University of Minnesota - Clinical and Translational Science Institute
Collaborators:	Endocare, Inc. Manoj, Monga, M.D.
Information provided by:	University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:	NCT00177125

Purpose

The purpose of this study is to perform a randomized prospective study to evaluate whether the vacuum erection device facilitates an earlier return of erectile function post radical prostatectomy. A secondary measure will be to evaluate if the vacuum erection device can help prevent penile shortening.

Condition	Intervention	Phase
Prostatic Neoplasms Prostatectomy	Device: ErectAid	Phase III

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study
Official Title:	Evaluating the Effect of the Vacuum Constriction Device on Erectile Function and Penile Length Post Radical Retropubic Prostatectomy

Resource links provided by NLM:

MedlinePlus related topics: Cancer Prostate Cancer

U.S. FDA Resources

Further study details as provided by University of Minnesota - Clinical and Translational Science Institute:

Estimated Enrollment:	220
Study Start Date:	January 2004

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients undergoing a radical prostatectomy for prostate cancer who are able to attain a partial or full erection preoperatively and are sexually active.

Exclusion Criteria:

Patients on anticoagulation therapy and those with bleeding diatheses
Insufficient manual dexterity of patient or spouse
IIEF(International Index of Erectile Function) at baseline < 11, indicating severe erectile dysfunction

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00177125

Locations

United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455
VAMC Minneapolis
Minneapolis, Minnesota, United States, 55417

Sponsors and Collaborators

University of Minnesota - Clinical and Translational Science Institute

Endocare, Inc.

Manoj, Monga, M.D.

Investigators

Principal Investigator:

Manoj Monga, MD

University of Minnesota and VAMC Minneapolis

More Information

No publications provided

Study ID Numbers:	0406M61241, 3358B
Study First Received:	September 13, 2005
Last Updated:	May 30, 2007
ClinicalTrials.gov Identifier:	NCT00177125 History of Changes
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Prostatic Diseases
Genital Neoplasms, Male

Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms

ClinicalTrials.gov processed this record on February 08, 2010