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

This study has been completed.

First Received on September 13, 2005. Last Updated on February 3, 2012 History of Changes

Sponsor:	University of Minnesota - Clinical and Translational Science Institute
Collaborators:	Endocare, Inc. Manoj, Monga, M.D.
Information provided by (Responsible Party):	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:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention
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
Study Completion Date:	January 2004
Primary Completion Date:	January 2004 (Final data collection date for primary outcome measure)

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

Responsible Party:	University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:	NCT00177125 History of Changes
Other Study ID Numbers:	0406M61241, 3358B
Study First Received:	September 13, 2005
Last Updated:	February 3, 2012
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Neoplasms
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms

Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on February 09, 2012