Efficacy of RestoreX Penile Traction Therapy In Preserving Erectile Function Post-Prostatectomy
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.
Description
Background and Preliminary Data The treatment of prostate cancer results in several known sexual dysfunctions/risks, including erectile dysfunction, orgasmic dysfunction, ejaculatory dysfunction, penile curvature (Peyronie's disease), and reduced penile length. Although all forms of prostate cancer treatment are associated with many of these changes, prostatectomy currently has the most data available on sexual function outcomes. Among the dysfunctions, erectile dysfunction has remained a very challenging adverse effect without effective preventative therapies. Specifically, prior randomized…
Eligibility
- Age range
- 18+ years
- Sex
- Male
- Healthy volunteers
- No
Inclusion Criteria: * Undergoing bilateral nerve-sparing prostatectomy * \>18 years old * Have a regular sexual partner for at least 6 months prior to study enrollment Exclusion Criteria: * 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 intr…
Interventions
- DeviceRestoreX 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.
- DeviceRestoreX 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).
Location
- The Male Fertility and Peyronie's ClinicOrem, Utah