Penile Traction Device for Erectile Dysfunction

Recruiting at 1 trial location

Overseen By Michelle Lucas, MS

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: University of Pittsburgh

Must not be taking: Androgen deprivation

Disqualifiers: Ischemic priapism, Penile prosthesis, others

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

Compensation: Varies

Number of Visits: 1

48 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether using a penile traction device before receiving a penile implant can increase the implant's length. The device, known as RestoreX, has been used to aid penile lengthening in men with diabetes or after prostate surgery, without affecting sexual or overall health. The trial includes two groups: one uses the device for three months before surgery, while the other proceeds directly to implant surgery. Men with erectile dysfunction who plan to receive a penile implant and have not used similar devices or undergone certain surgeries may be suitable candidates for this trial. As an unphased trial, this study allows participants to contribute to innovative research that could improve outcomes for future patients.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this penile traction device is safe for use?

Research has shown that the RestoreX device is generally safe for users. Studies have found it can improve penis length and shape without causing significant side effects. Men who used it for 30 to 90 minutes a day reported no major issues and experienced noticeable improvements. To date, no negative effects on sexual or overall health have been identified with this device. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using the RestoreX penile traction device for erectile dysfunction because it offers a non-surgical option to potentially enhance the outcomes of standard penile prosthesis implants. Unlike the standard approach, which involves directly implanting a prosthesis, the RestoreX device is used for three months before surgery to possibly improve penile length and function. This traction method might lead to better satisfaction and function post-implant, offering a proactive way to address penile shortening, a common concern among patients opting for implants.

What evidence suggests that the penile traction device is effective for erectile dysfunction?

Research has shown that the RestoreX device, which participants in this trial may use, can help increase penis length. In one study, 95% of men who used the device for six months experienced an average length increase of 2.0-2.2 cm. Another study found that 94% of men regained lost length, with an average increase of 1.6 cm. The device also aids erectile function, particularly for men with conditions like Peyronie's disease and diabetes. Overall, studies consistently demonstrate that RestoreX can improve both penis length and curvature. ^{1 3 6 7 8}

Who Is on the Research Team?

J. Peter Rubin, MD

Principal Investigator

University of Pittsburgh

Are You a Good Fit for This Trial?

This trial is for men with erectile dysfunction who are candidates for penile prosthesis implantation. It's designed to see if using a traction device before surgery can increase the length of the implant.

Inclusion Criteria

Are willing and able to comply with study procedures and visit schedules

I have been diagnosed with erectile dysfunction.

Can provide informed consent

Exclusion Criteria

Prior implantation of a penile prosthesis

I have received hormone therapy for cancer.

I currently have a genital infection.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative Penile Traction Therapy

Participants in the intervention arm use the RestoreX penile traction device for 30 minutes, 3 times daily for 3 months prior to penile prosthesis implantation

3-4 months

Regular device use diary entries

Penile Prosthesis Implantation

Participants undergo placement of a three-piece inflatable penile prosthesis

Surgical appointment

1 visit (in-person)

Follow-up

Participants are monitored for satisfaction with penile length and adverse events postoperatively

3-8 months

Multiple visits (in-person and virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Penile Traction Device

Trial Overview The study tests whether pre-surgical use of RestoreX, a penile traction therapy device, can lead to longer implants in penile prosthesis surgery. Participants will use RestoreX prior to their scheduled procedure.

How Is the Trial Designed?

Group I: RestoreX and Penile Prosthesis Implantation Experimental Treatment 2 Interventions

Patients with erectile dysfunction presenting for placement of a three-piece inflatable prosthesis who are randomized to the intervention arm will be provided with a RestoreX penile traction device, which they will utilize for three months prior to implantation of a standard-of-care inflatable penile prosthesis. They will complete standardized assessments of sexual function and satisfaction before and after placement, as well as a device use diary.

Group II: Penile Prosthesis Implantation Active Control 1 Intervention

Patients with erectile dysfunction presenting for placement of a three-piece inflatable prosthesis who are randomized to the no intervention arm will proceed directly to implantation of a standard-of-care inflatable penile prosthesis at the next available surgical appointment. They will not use the RestoreX penile traction device. They will complete standardized assessments of sexual function and satisfaction before and after placement.

Who Is Running the Clinical Trial?

University of Pittsburgh

Lead Sponsor

Trials

1,820

Recruited

16,360,000+

Pathright Medical

Collaborator

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/33223425/

Outcomes of RestoreX Penile Traction Therapy in Men ... 95% of men treated for 6 months experienced length gains (mean 2.0-2.2 cm), and 61% had curve improvements (16.8-21.4° [32.8-35.8%]). RestoreX was preferred 3-4 ...

2. 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 ...

3. auajournals.org auajournals.org/doi/10.1097/JU.0000000000001792

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 erectile ...

4. 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 ...

5. restorex.com restorex.com/clinical-results/restorex-for-pd-6-month-data/

RestoreX® for PD, 6 Month Data This includes the 94% of men that had length improvement and the 77% of men that experience an improvement in curvature.

6. 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 ...

7. academic.oup.com academic.oup.com/jsm/article-pdf/17/Supplement_1/S44/49025438/jsm_17_1_supplement_1_s44.pdf

149 6-Month Outcomes of RestoreX Penile Traction ... All men then entered an open label phase for an additional 3 months. The primary outcome was safety, and sec- ondary outcomes included penile length, curvature, ...

8. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/30916626/

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 ...