NCT01660152

Vacuum Erection Device in Improving Recovery of Erectile Function in Patients With Prostate Cancer Undergoing Surgery

Analysis of Technique Comparison With a Vacuum Erection Device as Part of an Erectile Rehabilitation Program Following Robotic Radical Prostatectomy: A Randomized Comparison of Methodology

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Ohio State University Comprehensive Cancer Center · Academic / Other
• Sex: Male
• Age: 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine which technique in using a vacuum erection device (VED) is best. Erectile dysfunction (ED) after robotic prostate cancer surgery is a concern for both the surgeon and the patient. Recent studies have shown that beginning to use the vacuum pump on a daily basis starting with in 2-8 weeks may help prevent the start of penile shrinkage. This is a potential issue that can occur because of decreased blood flow after prostate cancer surgery. This study will allow researchers to determine and compare vacuum therapy techniques and erectile function outcomes of patients who have prostate cancer surgery

Detailed description

PRIMARY OBJECTIVES: I. Determine sexual function and penile morphometric outcomes for the post-robotic-assisted laparoscopic prostatectomy (RALP) patients undergoing daily vacuum therapy using one of two randomized methods and whether these outcomes differ. SECONDARY OBJECTIVES: I. Compare compliance rates between the two randomized groups using the compliance questionnaire and a diary collected from patients at each follow up visit. II. Compare overall patient satisfaction with the recovery procedure between the two randomized groups utilizing the SHIM (Sexual Health Inventory for Men) questionnaire. OUTLINE: Patients are randomized to 1 of 2 treatment groups. GROUP A: Patients receive vacuum therapy daily over 10 minutes while holding erection for 2 minutes after undergoing RALP. Patients complete erection process 5 times. GROUP B: Patients receive vacuum therapy daily over 10 minutes while holding erection for 5 minutes after undergoing RALP. Patients complete erection process 2 times. After completion of study treatment, patients are followed up at 3, 6, and 12 months.

Conditions

• Male Erectile Disorder
• Prostate Cancer
• Sexual Dysfunction

Interventions

Type	Name	Description
OTHER	Sexual Health Inventory for Men (SHIM) questionnaire administration	Questionnaire will be completed prior to surgery and at 3, 6, 12 months and the compliance questionnaire at 3, 6, 12 months.
PROCEDURE	management of therapy complications	Receive VED
PROCEDURE	Daily vacuum therapy	Patients randomized to Group A or Group B following removal of catheter at first post op visit following surger. Daily vacuum therapy for approximately 10 minutes. Depending on which group randomized to erection held for 2 minutes or 5 mintues.

Timeline

• Start date: 2011-09-01
• Primary completion: 2013-07-17
• Completion: 2013-07-17
• First posted: 2012-08-08
• Last updated: 2017-04-13

Locations

1 site across 1 country: United States