Efficacy of RestoreX Penile Traction Therapy In Preserving Erectile Function Post-Prostatectomy

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18+
SponsorCharitable Union for the Research and Education of Peyronie's Disease

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)

Treatment groups

200 Participants
are divided into 2 treatment groups