Using RestoreX device to help maintain erectile function after prostate surgery
Efficacy of RestoreX Penile Traction Therapy In Preserving Erectile Function Post-Prostatectomy
This study is testing whether the RestoreX device can help men keep their erectile function after prostate surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Charitable Union for the Research and Education of Peyronie's Disease Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Orem, Utah) |
| Trial ID | NCT05244486 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of the RestoreX penile traction device in preserving erectile function in men who are undergoing robotic-assisted prostatectomy with bilateral nerve preservation. Participants will be men with moderate erectile dysfunction or better, and the primary outcome will be measured through changes in the IIEF-EFD scores at 6 months. Secondary outcomes will include various questionnaire results at 3, 6, and 9 months to assess overall sexual function and satisfaction.
Who should consider this trial
Good fit: Ideal candidates are men over 18 years old undergoing bilateral nerve-sparing prostatectomy with preserved baseline erectile function.
Not a fit: Patients with severe erectile dysfunction at baseline or those requiring additional treatments like radiation therapy post-surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve erectile function preservation in men post-prostatectomy.
How similar studies have performed: Previous studies have shown promising results with similar penile traction therapy approaches, indicating potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
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 intra-operatively
Where this trial is running
Orem, Utah
- The Male Fertility and Peyronie's Clinic — Orem, Utah, United States (Recruiting)
Study contacts
- Study coordinator: Landon Trost, MD
- Email: landontrost@gmail.com
- Phone: 801-655-0015
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.