Efficacy of RestoreX Penile Traction Therapy In Preserving Erectile Function Post-Prostatectomy
Charitable Union for the Research and Education of Peyronie's Disease
200 participants
Mar 12, 2022
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria3
- Undergoing bilateral nerve-sparing prostatectomy
- >18 years old
- Have a regular sexual partner for at least 6 months prior to study enrollment
Exclusion Criteria3
- 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
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
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.
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)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05244486