About this trial
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 criteria
Qualifiers
Undergoing bilateral nerve-sparing prostatectomy
>18 years old
Have a regular sexual partner for at least 6 months prior to study enrollment
Disqualifiers
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
Trial design
Treatments tested in this trial
- RestoreX 1-6 months (randomized phase)
- RestoreX 6-9 months (open label phase)