Actively Recruiting
Efficacy of RestoreX Penile Traction Therapy In Preserving Erectile Function Post-Prostatectomy
Led by Charitable Union for the Research and Education of Peyronie's Disease · Updated on 2025-02-13
200
Participants Needed
1
Research Sites
444 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Efficacy of RestoreX Penile Traction Therapy In Preserving Erectile Function Post-Prostatectomy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Undergoing bilateral nerve-sparing prostatectomy
- Male aged 18 years or older
- Have had a regular sexual partner for at least 6 months before enrolling
You will not qualify if you...
- Requiring adjuvant radiation therapy or androgen deprivation/blockade after surgery at enrollment
- Having severe erectile dysfunction at baseline as measured by IIEF-EFD
- Experiencing urethral complications from prostatectomy at baseline, including contrast leakage, anastomotic problems, or need for surgical revision
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The Male Fertility and Peyronie's Clinic
Orem, Utah, United States, 84057
Actively Recruiting
Research Team
L
Landon Trost, MD
CONTACT
B
Benjamin Green, BA
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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