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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov processed this record on October 21, 2014