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

University of Minnesota (UMN)

Status and phase: Completed; Phase 3

Conditions: Prostatectomy; Prostatic Neoplasms

Treatments: Device: ErectAid

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00177125

3358B

0406M61241

Details and patient eligibility

About

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.

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)