Clinical Trials Logo

Clinical Trial 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.


Clinical Trial Description

Background and Preliminary Data The treatment of prostate cancer results in several known sexual dysfunctions/risks, including erectile dysfunction, orgasmic dysfunction, ejaculatory dysfunction, penile curvature (Peyronie's disease), and reduced penile length. Although all forms of prostate cancer treatment are associated with many of these changes, prostatectomy currently has the most data available on sexual function outcomes. Among the dysfunctions, erectile dysfunction has remained a very challenging adverse effect without effective preventative therapies. Specifically, prior randomized controlled trials evaluating the efficacy of PDE5 inhibitors (vardenafil and tadalafil) have failed to demonstrate improved erectile function preservation post-operatively. Recently, out team conducted a single-center randomized, controlled trial evaluating the efficacy of a novel penile traction therapy (PTT) device, RestoreX at preventing penile length loss post-prostatectomy. In addition to meeting the primary outcome of achieving improved penile length compared to controls, the study unexpectedly demonstrated improvements in erectile function in the treatment group compared to controls. Results were also consistent with two other prior randomized, controlled trials, one of which demonstrated improved erectile function in men with Peyronie's Disease and the other in men with diabetes mellitus (unpublished). As these findings represent the first known therapy which resulted in preserved erectile function post-prostatectomy, we sought to perform a larger, multi-center study in an attempt to confirm or refute findings. Investigational Device RestoreX is a PTT device developed by PathRight Medical using technology licensed from the Mayo Clinic. The device is classified as class I (orthotic) and does not require clinical trials to prove safety or efficacy. Mayo Clinic has previously performed 3 randomized controlled trials which have confirmed the safety of the device as well as efficacy in improving erectile function and penile length in various cohorts of men. The device has two functional aspects. The first is the ability to provide direct traction on the penis. The second is the ability to provide counter-bending forces, to treat conditions such as Peyronie's disease (bent penis). In the current study, only the direct traction aspects of the device will be utilized. Study Rationale PTT with Restorex has been shown to improve erectile function in several clinical scenarios, including in men with Peyronie's disease, men with diabetes mellitus (unpublished), and post-prostatectomy. As no therapy has ever been shown to improve erectile function or prevent loss of erectile function post-prostatectomy, we felt that there was significant clinical value in performing a large, multi-center, randomized, controlled trial to affirm or refute the efficacy of Restorex PTT in preserving erectile function post-prostatectomy. Potential Benefits There are several anticipated benefits to using PTT following prostatectomy. As loss of penile length results in several issues including loss of sexual function, cosmetic concerns, and difficulty in maintaining hygiene (incontinence resulting in yeast infections), the ability to maintain or restore length post-prostatectomy may mitigate these issues. Our team has previously demonstrated that Restorex PTT significantly improved penile length post-prostatectomy. Although this is an anticipated beneficial effect of therapy, we will not be specifically evaluating this outcome in the current study. In addition to improved penile length, our prior investigations have demonstrated preserved erectile function in men who received PTT with Restorex post-prostatectomy compared to controls. And among all patients in the three prior randomized, controlled trials evaluating Restorex, no significant or long-term adverse events were reported, highlighting the safety of the therapy. Anticipated Duration of the Clinical Investigation The overall study will be scheduled for 3 years, to permit adequate time for enrollment and follow-up. The intervention phase will include 5 months of randomized treatment (for the treatment arm), and 3 months of open label treatment (for all arms). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05244486
Study type Interventional
Source Charitable Union for the Research and Education of Peyronie's Disease
Contact Landon Trost, MD
Phone 801-655-0015
Email landontrost@gmail.com
Status Recruiting
Phase N/A
Start date March 12, 2022
Completion date September 14, 2025

See also
  Status Clinical Trial Phase
Completed NCT05735223 - A Prospective Study to Evaluate the Impact of Maximal Urethral Length Preservation Technique During Robotic Laparoscopic Prostatectomy on the Stretched Flaccid Penile Length and Continence N/A
Recruiting NCT05868668 - Efficacy of Low-intensity Shockwave vs Radial Wave for Treatment of Erectile Dysfunction and Pelvic Pain N/A
Completed NCT03241758 - Vascular Changes Of Patients Undergoing Laparoscopic Radical Prostatectomy N/A
Recruiting NCT05558007 - Safety and Efficacy Evaluation of BZ371A Topically Applied on Prostatectomized Patients Phase 2
Completed NCT05332340 - Safety, Tolerability and Pharmacokinetics (PK) Evaluation of BZ371A, Topically Administered Phase 1
Completed NCT04491773 - Study of Retinal and Choriocapillary Vascular Changes in Patients Undergoing Tadalafil 20mg for More Than 6 Months
Recruiting NCT05650866 - Safety and Tolerability of a Novel Implantable Device for the Treatment of Erectile Dysfunction N/A
Recruiting NCT03905057 - Early Shockwave Therapy for Post-RP ED N/A
Not yet recruiting NCT06126874 - Additional Effects of Aerobic and Resistance Exercises to Pelvic Floor Muscle Training After Radical Prostatectomy N/A
Completed NCT05772598 - Validating the 'Sexual Minorities and Prostate Cancer Scale' to Gold Standard Questionnaires
Not yet recruiting NCT06458855 - Nerve Grafting Technique to Restore Erectile Function Post Radical Prostatectomy N/A
Completed NCT00335634 - Sexual Dysfunction and Adaptation in Couples Affected by Prostate Cancer Surgery N/A
Recruiting NCT03862599 - Low Intensity Shock-wave Therapy (Li-ESWT) in Penile Rehabilitation After Radical Prostatectomy N/A
Active, not recruiting NCT04434352 - Low Intensity Shockwave Therapy for Erectile Dysfunction N/A
Completed NCT04164355 - Study of Retinal and Choriocapillary Vascular Changes in Patients Undergoing Tadalafil 20mg
Not yet recruiting NCT05960149 - Use of Indocyanine Green in Robotic Prostate Surgeries Phase 4
Terminated NCT01996852 - Improving Erectile Function and Quality of Life After Prostate Cancer Treatment N/A
Recruiting NCT06076850 - Low-Intensity Extracorporeal Shockwave Therapy for Penile Rehabilitation in Post-Radical Prostatectomy Patients N/A
Terminated NCT01770340 - Nerve Grafting With an Allograft During Radical Prostatectomy - Extended Follow-up in a Prospective Randomized Trial Phase 4
Not yet recruiting NCT05578157 - MENDiP: Measurements of Overnight Penile Temperature to Evaluate Nocturnal Erection Detection in Patients With Absence of Erectile Functioning After Robot-assisted Radical Prostatectomy