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
  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 3

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:


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 April 17, 2014