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
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.
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.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Changes in sexual function based on the self reported SHIM assessment and penile morphometric outcomes based on penile dimension measurements at rest
Summarized according to assigned treatment group. Linear mixed models will be used to model the changes over time.
3 months post-surgery
Ronney Abaza, MD
Ohio State University
United States: Institutional Review Board
|Ohio State University Medical Center||Columbus, Ohio 43210|