RestoreX Therapy for Erectile Dysfunction Post-Prostatectomy

Overseen By Landon Trost, MD

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

Trial Summary

What is the purpose of this trial?

This trial is testing the RestoreX device, which gently stretches the penis, to see if it can help men keep their erectile function after prostate surgery. The study focuses on men who already have good erectile function before surgery. The device works by improving blood flow and maintaining penile length. RestoreX is a new device with data showing improvements in penile length and erectile function with regular use in men with certain conditions.

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 data supports the effectiveness of the treatment RestoreX for erectile dysfunction after prostate surgery?

Research shows that the RestoreX device, originally used for Peyronie's disease, has been effective in improving penile length and erectile function in men after prostate surgery, according to a randomized controlled trial. ^{1 2 3 4 5}

Is RestoreX therapy safe for humans?

The RestoreX device has been used in studies for conditions like Peyronie's disease and post-prostatectomy erectile dysfunction, with no significant safety concerns reported in these trials. ^{1 2 3 4 5}

How is RestoreX treatment different from other treatments for erectile dysfunction after prostate surgery?

RestoreX is a unique treatment because it is a penile traction device that helps improve penile length and erectile function by using gentle stretching, unlike other treatments that might involve medications or surgery. It is used daily for 30 to 90 minutes, offering a non-invasive option for men recovering from prostate surgery. ^{1 2 3 4 6}

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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]

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]

References

1. United States 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. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Efficacy of RestoreX after prostatectomy: open-label phase of a randomized controlled trial. [2023]

3. Netherlands 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. [2021]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Efficacy of Combined Collagenase Clostridium histolyticum and RestoreX Penile Traction Therapy in Men with Peyronie's Disease. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

Outcomes of a Novel Penile Traction Device in Men with Peyronie's Disease: A Randomized, Single-Blind, Controlled Trial. [2019]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Penile Rehabilitation Therapy Following Radical Prostatectomy: A Meta-Analysis. [2022]