Efficacy of RestoreX Penile Traction Therapy In Preserving Erectile Function Post-Prostatectomy
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
Evaluate the efficacy of the RestoreX penile traction device in preserving erectile function in men undergoing robotic-assisted prostatectomy. This study will evaluate men undergoing prostatectomy with bilateral nerve preservation and preserved baseline erectile function (moderate ED or better). The primary outcome will be changes in the IIEF-EFD scores between groups at 6 months. Secondary outcomes include differences in questionnaire outcomes at 3, 6, and 9 months.
Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:
• Undergoing bilateral nerve-sparing prostatectomy
• \>18 years old
• Have a regular sexual partner for at least 6 months prior to study enrollment
Locations
United States
Utah
The Male Fertility and Peyronie's Clinic
RECRUITING
Orem
Contact Information
Primary
Landon Trost, MD
landontrost@gmail.com
801-655-0015
Backup
Benjamin Green, BA
bengreen927@gmail.com
801-655-0015
Time Frame
Start Date: 2022-03-12
Estimated Completion Date: 2030-09-14
Participants
Target number of participants: 200
Treatments
Experimental: Treatment Arm
Men will begin utilizing PTT 30-60 minutes daily for 5-7 days weekly beginning 1 month post-prostatectomy until 6 months. After 6 months, they will have the option to continue to use the therapy for 3 additional months or discontinue at their discretion.
Active_comparator: Control
Men will not utilize PTT for the first 6 months post-prostatectomy. Beginning at 6 months, they may utilize PTT if they desire (open label) until 9 months post-prostatectomy.
Related Therapeutic Areas
Sponsors
Leads: Charitable Union for the Research and Education of Peyronie's Disease