RestoreX Therapy for Erectile Dysfunction Post-Prostatectomy

Overseen By Benjamin D. Green, Economics/MA

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Charitable Union for the Research and Education of Peyronie's Disease

Must not be taking: Androgen blockers

Disqualifiers: Severe ED, Urethral complications, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 5 months

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test whether the RestoreX device, a penile traction device, can help maintain erectile function in men who have undergone robotic-assisted prostate surgery. The study compares men who use the device regularly starting one month after surgery with those who do not use it initially but may start after six months. Ideal candidates are men undergoing prostate surgery with nerve-sparing techniques who have moderate or better erectile function. As an unphased trial, this study offers participants the chance to contribute to important research that could improve post-surgery outcomes for future patients.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators for more details.

What prior data suggests that the RestoreX penile traction device is safe for preserving erectile function post-prostatectomy?

Research has shown that the RestoreX penile traction device is generally well-received. One study found that using RestoreX increased penile length and improved erectile function without major side effects. Another study discovered that daily use of RestoreX for 30 to 90 minutes was safe and led to noticeable improvements in sexual function. These findings suggest that RestoreX is a safe option for men recovering from prostate surgery who wish to maintain their erectile function. ^{1 2 3 4 5}

Why are researchers excited about this trial?

RestoreX is unique because it uses a mechanical approach to address erectile dysfunction post-prostatectomy. Unlike standard treatments that often involve medications like PDE5 inhibitors (e.g., Viagra), RestoreX employs penile traction therapy (PTT) to stimulate natural blood flow and tissue growth. This technique offers a non-invasive alternative that could appeal to those seeking options beyond pharmaceuticals. Researchers are excited about the potential for RestoreX to provide a more natural and drug-free method to improve erectile function, especially for men recovering from prostate surgery.

What evidence suggests that the RestoreX device is effective for erectile dysfunction post-prostatectomy?

Research shows that the RestoreX device can improve erectile function after prostate surgery. In this trial, participants in the treatment arm will start using the RestoreX device one month after surgery. Studies have shown that this timing leads to better erectile function and maintains these improvements even after stopping use. Additionally, 94% of users regained lost penile length, with an average increase of 1.6 cm. The device has also benefited men with other conditions, such as Peyronie's disease and diabetes, further supporting its effectiveness. Overall, evidence suggests that RestoreX can be a helpful tool for men recovering from prostate surgery. ^{2 3 4 6 7}

Are You a Good Fit for This Trial?

Men over 18 with preserved erectile function facing prostatectomy can join this trial. They must be undergoing nerve-sparing surgery, not need post-op radiation or hormone therapy, and have had a stable sexual partner for the past 6 months. Men with severe ED or urethral complications from surgery are excluded.

Inclusion Criteria

I am over 18 years old.

I am having surgery to remove my prostate while preserving nerve function.

I have been in a sexual relationship with the same partner for at least 6 months.

Exclusion Criteria

I need hormone therapy or radiation after surgery.

Baseline severe erectile dysfunction as measured by the IIEF-EFD

I have complications from prostate surgery affecting my urethra.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants in the treatment arm utilize the RestoreX PTT device for 5 months, starting 1 month post-prostatectomy

5 months

Monthly visits (in-person or virtual)

Open-label extension

Participants may continue using the RestoreX PTT device for an additional 3 months

3 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

9 months

Quarterly visits (in-person or virtual)

What Are the Treatments Tested in This Trial?

Interventions

• RestoreX

Trial Overview The RestoreX penile traction device's effectiveness in maintaining erectile function after robotic-assisted prostatectomy is being tested. Participants will use the device for up to 9 months, with their erectile function scored at intervals to measure any changes.

How Is the Trial Designed?

Group I: Treatment Arm Experimental Treatment 2 Interventions

Men will begin utilizing PTT 30-60 minutes daily for 5-7 days weekly beginning 1 month post-prostatectomy until 6 months. After 6 months, they will have the option to continue to use the therapy for 3 additional months or discontinue at their discretion.

Group II: Control Active Control 1 Intervention

Men will not utilize PTT for the first 6 months post-prostatectomy. Beginning at 6 months, they may utilize PTT if they desire (open label) until 9 months post-prostatectomy.

RestoreX is already approved in United States, Canada, European Union for the following indications:

Approved in United States as RestoreX for:

• Peyronie's disease
• Erectile dysfunction

Approved in Canada as RestoreX for:

• Peyronie's disease
• Erectile dysfunction

Approved in European Union as RestoreX for:

• Peyronie's disease
• Erectile dysfunction

Who Is Running the Clinical Trial?

Charitable Union for the Research and Education of Peyronie's Disease

Lead Sponsor

Trials

6

Recruited

920+

Published Research Related to This Trial

In a study of 82 men post-prostatectomy, the use of the RestoreX penile traction therapy device significantly improved penile length by an average of 1.6 cm compared to only 0.3 cm in the control group after 6 months (p < 0.01).

Participants using penile traction therapy also reported better erectile function and sexual satisfaction, with 87% expressing willingness to repeat the therapy and 93% recommending it to others, indicating both efficacy and high patient satisfaction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of a Novel Penile Traction Device in Improving Penile Length and Erectile Function Post Prostatectomy: Results from a Single-Center Randomized, Controlled Trial. Toussi, A., Ziegelmann, M., Yang, D., et al.[2021]

In a randomized controlled trial involving 110 men with Peyronie's disease, RestoreX traction therapy led to significant improvements in penile length (1.7-2.0 cm) and curvature (18-20%) after 6 months, with 95% of participants experiencing length gains.

The therapy was found to be safe, with no significant adverse events reported, and was preferred by 100% of participants over other traction devices, making it a promising low-cost option for managing Peyronie's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes of RestoreX Penile Traction Therapy in Men With Peyronie's Disease: Results From Open Label and Follow-up Phases. Joseph, J., Ziegelmann, MJ., Alom, M., et al.[2021]

In a randomized controlled trial involving 82 men post-prostatectomy, Restorex penile traction therapy (RxPTT) significantly improved penile length by an average of 1.7 cm and erectile function compared to no treatment after 5 months, with benefits maintained even after therapy was discontinued.

Men who started RxPTT early showed better outcomes in both penile length and erectile function than those who began treatment later, indicating that early intervention may be crucial for optimal results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of RestoreX after prostatectomy: open-label phase of a randomized controlled trial. Zganjar, A., Toussi, A., Ziegelmann, M., et al.[2023]

Penile rehabilitation using treatments like PDE5 inhibitors, vacuum erection devices, and intracorporeal injections significantly improves erectile function in patients after radical prostatectomy, with a combined odds ratio of 2.800 based on 16 studies involving randomized controlled trials and case-control studies.

However, while these treatments enhance erectile function during therapy, they do not lead to improved spontaneous erectile function after stopping PDE5 inhibitors, indicating that ongoing treatment is necessary for maintaining benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Penile Rehabilitation Therapy Following Radical Prostatectomy: A Meta-Analysis. Liu, C., Lopez, DS., Chen, M., et al.[2022]

The RestoreX penile traction therapy device, used for just 30 to 90 minutes a day, was found to be safe and effective, leading to significant improvements in penile curvature (average reduction of -11.7 degrees) and length (average increase of 1.5 cm) in men with Peyronie's disease over a 3-month period.

In addition to physical improvements, the device also enhanced erectile function, with a notable increase in scores on the International Index of Erectile Function, and was preferred by all men who had previously used other traction devices, highlighting its user-friendly design and efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes of a Novel Penile Traction Device in Men with Peyronie's Disease: A Randomized, Single-Blind, Controlled Trial. Ziegelmann, M., Savage, J., Toussi, A., et al.[2019]

The RestoreX penile traction therapy device, when used in combination with collagenase Clostridium histolyticum (CCH), significantly improves curvature and penile length in men with Peyronie's disease compared to CCH alone or CCH with other traction devices, with group 3 (RestoreX) showing a 71% enhancement in curvature outcomes.

In a study of 287 men, those using RestoreX were 6.9 times more likely to achieve significant curvature improvements and 10.7 times more likely to see length gains, while experiencing similar rates of adverse events as the other treatment groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of Combined Collagenase Clostridium histolyticum and RestoreX Penile Traction Therapy in Men with Peyronie's Disease. Alom, M., Sharma, KL., Toussi, A., et al.[2020]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37088866/

Efficacy of RestoreX after prostatectomy: open-label phase ... Use of RxPTT beginning 1 month post-prostatectomy results in improved penile length and erectile function, with benefits maintained after discontinuing therapy.

2. bjui-journals.onlinelibrary.wiley.com bjui-journals.onlinelibrary.wiley.com/doi/10.1111/bju.16033

Efficacy of RestoreX after prostatectomy: open‐label phase of ... Use of RxPTT beginning 1 month post-prostatectomy results in improved penile length and erectile function, with benefits maintained after discontinuing therapy.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05244486

Efficacy of RestoreX Penile Traction Therapy In Preserving ... PTT with Restorex has been shown to improve erectile function in several clinical scenarios, including in men with Peyronie's disease, men with diabetes ...

4. restorex.com restorex.com/clinical-results/

Clinical Results Key Findings include: · 94% of men regained lost length, with an average of 1.6cm or 11% · 77% of men experienced a reduction in curvature that average 17 degrees ...

5. auajournals.org auajournals.org/doi/abs/10.1097/JU.0000000000001792?utm_source=chatgpt.com

Efficacy of a Novel Penile Traction Device in Improving ... RestoreX is a novel penile traction therapy device, with randomized, controlled data demonstrating improvements in penile length and ...

6. academic.oup.com academic.oup.com/jsm/article/17/12/2462/6973517

Outcomes of RestoreX Penile Traction Therapy in Men with ... PTT with RestoreX results in significant improvements in length, curve, and subjective and objective measures of sexual function without significant AEs.

7. auajournals.org auajournals.org/doi/10.1097/JU.0000000000000245

Outcomes of a Novel Penile Traction Device in Men with ... Penile traction therapy with the RestoreX device for 30 to 90 minutes per day was safe, and resulted in significant and clinically meaningful improvements in ...