Back to resultsEvaluating the Effect of the VCD on Erectile Function and Penile Length Post RRP
Primary Purpose
Prostatic Neoplasms, Prostatectomy
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
ErectAid
Sponsored by
About this trial
This is an interventional prevention trial for Prostatic Neoplasms
Eligibility 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
Sites / Locations
- VAMC Minneapolis
- University of Minnesota
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00177125
First Posted
September 13, 2005
Last Updated
February 3, 2012
Sponsor
University of Minnesota
Collaborators
Endocare, Inc., Manoj, Monga, M.D.
1. Study Identification
Unique Protocol Identification Number
NCT00177125
Brief Title
Evaluating the Effect of the VCD on Erectile Function and Penile Length Post RRP
Official Title
Evaluating the Effect of the Vacuum Constriction Device on Erectile Function and Penile Length Post Radical Retropubic Prostatectomy
Study Type
Interventional
2. Study Status
Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
January 2004 (undefined)
Primary Completion Date
January 2004 (Actual)
Study Completion Date
January 2004 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota
Collaborators
Endocare, Inc., Manoj, Monga, M.D.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostatic Neoplasms, Prostatectomy
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
220 (false)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
ErectAid
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Manoj Monga, MD
Organizational Affiliation
University of Minnesota and VAMC Minneapolis
Official's Role
Principal Investigator
Facility Information:
Facility Name
VAMC Minneapolis
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55417
Country
United States
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Evaluating the Effect of the VCD on Erectile Function and Penile Length Post RRP
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