RestoreX Therapy for Erectile Dysfunction Post-Prostatectomy

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

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

Approved in 3 Jurisdictions

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}

Research Team

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.

Trial 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 (Penile Traction Device)

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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

The Male Fertility and Peyronie's Clinic Orem, UT

Who Is Running the Clinical Trial?

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

Lead Sponsor

Trials

6

Patients Recruited

920+

Findings from Research

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]

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]

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]

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]

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]