Status:
RECRUITING
Efficacy of RestoreX Penile Traction Therapy In Preserving Erectile Function Post-Prostatectomy
Lead Sponsor:
Charitable Union for the Research and Education of Peyronie's Disease
Conditions:
Erectile Dysfunction Following Radical Prostatectomy
Eligibility:
MALE
18+ years
Phase:
NA
Brief 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 wit...
Detailed Description
Background and Preliminary Data The treatment of prostate cancer results in several known sexual dysfunctions/risks, including erectile dysfunction, orgasmic dysfunction, ejaculatory dysfunction, pen...
Eligibility Criteria
Inclusion
- Undergoing bilateral nerve-sparing prostatectomy
- \>18 years old
- Have a regular sexual partner for at least 6 months prior to study enrollment
Exclusion
- 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
Key Trial Info
Start Date :
March 12 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 14 2030
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT05244486
Start Date
March 12 2022
End Date
September 14 2030
Last Update
February 13 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
The Male Fertility and Peyronie's Clinic
Orem, Utah, United States, 84057