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Efficacy of RestoreX Penile Traction Therapy In Preserving Erectile Function Post-Prostatectomy
Sponsor: Charitable Union for the Research and Education of Peyronie's Disease
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.
Key Details
Gender
MALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
200
Start Date
2022-03-12
Completion Date
2030-09-14
Last Updated
2025-02-13
Healthy Volunteers
No
Interventions
RestoreX 1-6 months (randomized phase)
Study participants are recommended utilize the device for 30-60 minutes, 5-7 days a week starting at 1 month post-prostatectomy and continuing until 6 months.
RestoreX 6-9 months (open label phase)
Both the treatment and control arms will be allowed to use the therapy from 6-9 months post-prostatectomy (open label phase). Only straight traction will be used (no counterbending).
Locations (1)
The Male Fertility and Peyronie's Clinic
Orem, Utah, United States