Efficacy of RestoreX after prostatectomy: open-label phase of a randomized controlled trial.
Andrew Zganjar, Amir Toussi, Matthew Ziegelmann...
https://pubmed.ncbi.nlm.nih.gov/37088866Actively Recruiting
Phase Not Applicable
Age: 18Years +
MALE
ID05244486
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
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the effectiveness of the RestoreX penile traction device in preserving erectile function in men undergoing robotic-assisted prostatectomy with bilateral nerve preservation and moderate or better baseline erectile function. The study addresses the challenge of erectile dysfunction following prostate cancer surgery, a problem without effective preventative treatments, by comparing erectile function outcomes at 6 months between groups using the device or not. It builds on previous smaller trials that suggested potential benefits of RestoreX in erectile function and penile length preservation. Participants will be randomly assigned to either use the RestoreX device starting one month after surgery for 30-60 minutes daily, 5-7 days per week, continuing until 6 months, or to a control group that does not use the device during this period. After 6 months, all participants may choose to use the device openly for an additional 3 months. Only the straight traction feature of the device will be used during the study. Throughout the study, men will undergo assessments of erectile function and other related measures using questionnaires at 3, 6, and 9 months post-surgery. Researchers will monitor changes in erectile function scores as the primary outcome at 6 months, along with secondary outcomes including additional questionnaire domains and adverse events over 9 months. The study duration is planned for 3 years to allow for enrollment and follow-up, with safety and effectiveness carefully tracked during and after treatment phases.
CONDITIONS
Brief Title
Efficacy of RestoreX Penile Traction Therapy In Preserving Erectile Function Post-Prostatectomy
Who Can Participate
Age: 18Years +
MALE
Eligibility Criteria
You may qualify if you...
- Undergoing bilateral nerve-sparing prostatectomy
- Male aged over 18 years
- Have a regular sexual partner for at least 6 months prior to study enrollment
You will not qualify if you...
- Require radiation therapy or androgen deprivation/blockade after surgery at enrollment
- Have severe erectile dysfunction before surgery as measured by IIEF-EFD
- Have urethral complications from prostatectomy such as contrast leakage, anastomotic problems, or need for re-doing anastomosis at baseline
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 5 months
Participants use the RestoreX penile traction therapy device starting 1 month post-prostatectomy for 30-60 minutes daily, 5-7 days a week, continuing until 6 months post-prostatectomy.
Regular assessments during 5 months of treatment
Treatment
Duration - 3 months
After the initial 6 months, all participants may choose to continue using the RestoreX device for an additional 3 months in an open label phase.
Optional treatment with device from 6 to 9 months post-prostatectomy
Trial Site Locations
Total: 1 location
1
The Male Fertility and Peyronie's Clinic
Orem, Utah, United States, 84057
Actively Recruiting
Loading map...
Research Team
L
Landon Trost, MD
B
Benjamin Green, BA
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here