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

NCT ID: NCT00177125

Last Updated: 2012-02-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-01-31

Study Completion Date

2004-01-31

Brief Summary

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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

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Conditions

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Prostatic Neoplasms Prostatectomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Interventions

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ErectAid

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Endocare, Inc.

INDUSTRY

Sponsor Role collaborator

Manoj, Monga, M.D.

INDIV

Sponsor Role collaborator

University of Minnesota

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Manoj Monga, MD

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota and VAMC Minneapolis

Locations

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VAMC Minneapolis

Minneapolis, Minnesota, United States

Site Status

University of Minnesota

Minneapolis, Minnesota, United States

Site Status

Countries

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United States

Other Identifiers

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3358B

Identifier Type: -

Identifier Source: secondary_id

0406M61241

Identifier Type: -

Identifier Source: org_study_id

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