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.
Undergoing bilateral nerve-sparing prostatectomy
>18 years old
Have a regular sexual partner for at least 6 months prior to study enrollment
Requiring adjuvant radiation therapy or androgen deprivation / androgen blockade post-operatively (by the time of enrollment)
Baseline severe erectile dysfunction as measured by the IIEF-EFD
Urethral complications from prostatectomy at the time of baseline visit including contrast extravasation, anastomotic dehiscence of vesicourethral anastomosis, need for re-doing of vesicourethral anastomosis intra-operatively
Parallel
RestoreX 1-6 months (randomized phase)
DeviceStudy 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)
DeviceBoth 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).
Erectile Function Post-Prostatectomy
Compare erectile function between treatment and control cohorts, as assessed by the International Index of Erectile Function, Erectile Function Domain (IIEF-EFD) at 6-months post-prostatectomy. IIEF-EFD scores 1-30, with higher scores representing better function.
Non-erectile function domains of the International Index of Erectile Function
Compare the non-erectile function domains of the International Index of Erectile Function between cohorts. This represents 4 additional scales, with min/max being 0-10, 0-10, 0-15, and 0-10; higher scores indicated better function.
International Index of Erectile Function from baseline to 6 months
Compare International Index of Erectile Function subdomains within cohorts from baseline to 6 months. Scale 1-30, with higher scores representing better outcomes.
Adverse events at 3 months
Evaluate number of participants reporting adverse events at 3 months.
Adverse events at 6 months
Evaluate number of participants reporting adverse events at 6 months
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