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

This study has been completed.

Sponsor:

Collaborators:

Endocare, Inc.

Manoj, Monga, M.D.

Information provided by (Responsible Party):

University of Minnesota - Clinical and Translational Science Institute

ClinicalTrials.gov Identifier:

NCT00177125

First received: September 13, 2005

Last updated: February 3, 2012

Last verified: February 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

September 13, 2005

Last Updated Date

February 3, 2012

Start Date ^ICMJE

January 2004

Primary Completion Date

January 2004 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00177125 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Current Other Outcome Measures ^ICMJE

Original Other Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Evaluating the Effect of the Vacuum Constriction Device on Erectile Function and Penile Length Post Radical Retropubic Prostatectomy

Brief Summary

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.

Detailed Description

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention

Condition ^ICMJE

Prostatic Neoplasms
Prostatectomy

Intervention ^ICMJE

Device: ErectAid

Study Arm (s)

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

220

Completion Date

January 2004

Primary Completion Date

January 2004 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Male

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00177125

Other Study ID Numbers ^ICMJE

0406M61241, 3358B

Has Data Monitoring Committee

Responsible Party

University of Minnesota - Clinical and Translational Science Institute

Study Sponsor ^ICMJE

University of Minnesota - Clinical and Translational Science Institute

Collaborators ^ICMJE

Endocare, Inc.
Manoj, Monga, M.D.

Investigators ^ICMJE

Principal Investigator:

Manoj Monga, MD

University of Minnesota and VAMC Minneapolis

Information Provided By

University of Minnesota - Clinical and Translational Science Institute

Verification Date

February 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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