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

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.

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Key information

Conditions

Prostatic Neoplasms Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatectomy Prostatic Diseases Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

University of Minnesota, Minneapolis, Minnesota, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ErectAid

Device

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start: 2004
Primary completion: 2004
Study completion: 2004
First posted: Sep 15, 2005
Registry last updated: Feb 6, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed