Inflatable Penile Prosthesis for Erectile Dysfunction

(UNITED Trial)

Not yet recruiting at 7 trial locations

Overseen By Zeynep Tin Konukcu

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Rigicon, Inc.

Must not be taking: Immunosuppressants, Chemotherapy

Disqualifiers: Penile neuropathy, Fibrotic disease, Uncontrolled diabetes, others

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

Compensation: Varies

Number of Visits: 22

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the safety and effectiveness of the Rigicon Infla10® Inflatable Penile Prosthesis (IPP) for men with erectile dysfunction. Researchers will track the progress of men with this device implanted over three years to evaluate its performance. Men diagnosed with erectile dysfunction who are willing to try this specific prosthesis may qualify for the trial. As an unphased trial, this study provides an opportunity to contribute to understanding the benefits of this prosthesis for future patients.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are on immunosuppressive drugs or chemotherapy, you cannot participate in the trial.

What prior data suggests that this inflatable penile prosthesis is safe for erectile dysfunction?

Research has shown that the Rigicon Infla10® Inflatable Penile Prosthesis (IPP) is generally safe for treating erectile dysfunction. In studies involving 319 patients, only 2.5% of the devices experienced mechanical problems, and just 0.7% had parts that moved out of place. Notably, no infections occurred in patients using this device.

The device also demonstrates high durability. After 12 months, 95.6% of the devices remained functional, with a slight decrease to 94.7% at 24 months and 93.7% at 36 months. These results suggest that the Rigicon Infla10® IPP is well-tolerated and maintains a strong safety record over time. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Rigicon Infla10® Inflatable Penile Prosthesis (IPP) is unique because it offers an advanced dynamic solution for erectile dysfunction, unlike traditional fixed or semi-rigid implants. Most penile implants are either non-inflatable or require manual manipulation, but the Infla10® introduces a more natural and controlled experience with its three-piece inflatable design, allowing for more comfortable and discreet use. Researchers are excited about this treatment because it promises improved patient satisfaction by mimicking a natural erection more closely and offering ease of use.

What evidence suggests that this inflatable penile prosthesis is effective for erectile dysfunction?

Research has shown that the Rigicon Infla10® Inflatable Penile Prosthesis (IPP), which trial participants will receive, effectively treats erectile dysfunction. One study found that 97.6% of the devices functioned well after three years, indicating long-lasting implants. Additionally, 92.4% of patients reported satisfaction with the device. Early results showed no infections and few cases requiring adjustments, suggesting durability and safety. These findings indicate that the Rigicon Infla10® IPP is a reliable option for those seeking treatment for erectile dysfunction. ^{2 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for men with erectile dysfunction who are considering the Rigicon Infla10® Inflatable Penile Prosthesis (IPP) as a treatment option. Specific eligibility criteria have not been provided, but typically participants must meet certain health standards and agree to follow-up assessments.

Inclusion Criteria

Willing to complete all protocol required for follow-up visits and tests

I have been diagnosed with erectile dysfunction.

I am a man aged 22 or older.

Exclusion Criteria

I have been diagnosed with a fibrotic condition like priapism, Peyronie's disease, or Chordee.

Expected life expectancy < two years

Psychogenic erectile dysfunction

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Implantation

Participants are implanted with the Rigicon Infla10® Inflatable Penile Prosthesis

1 day

1 visit (in-person)

Post-implantation Follow-up

Participants are monitored for safety and effectiveness of the implant

12 months

Visits at Months 3, 6, and 12 (in-person)

Long-term Follow-up

Participants continue to be monitored for safety and effectiveness

24 months

Visits at Months 18, 24, and 36 (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Rigicon Infla10® Inflatable Penile Prosthesis (IPP)

Trial Overview

The study is testing the safety and effectiveness of the Rigicon Infla10® IPP over a period of up to three years following implantation in patients with erectile dysfunction.

How Is the Trial Designed?

Group I: Patients implanted with Infla10® Pulse™ Dynamic Inflatable Penile Prosthesis Experimental Treatment 1 Intervention

Male subjects 22 years of age and older who are implanted with an Rigicon Infla 10® Three-Piece Inflatable Penile Prosthesis for erectile dysfunction.

Who Is Running the Clinical Trial?

Rigicon, Inc.

Lead Sponsor

Trials

1

Recruited

180+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07273773?term=NA

Evaluation of the Rigicon Infla10® Inflatable Penile ...

This study is to assess the safety and effectiveness of the Rigicon IPP in treating ED. Clinical literature and preclinical testing, including ...

2.

rigicon.com

rigicon.com/clinical-evidence/

Clinical Evidence | Peer-Reviewed Research in Prosthetic ...

This retrospective study evaluated 250 Rigicon Infla10® penile implantations in Türkiye. With a 97.6% device survival rate over 3 years and 92.4% patient ...

3.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/39660417

Patient satisfaction study for the new Rigicon Infla10 ...

This study aims to report the first patient satisfaction, efficacy, and safety from revision data for the newly available Rigicon Infla10 IPP.

4.

rigicon.com

rigicon.com/clinical-evidence/initial-safety-outcomes-for-rigicon-infla10-inflatable-penile-prosthesis/

Initial Safety Outcomes for Infla10® | BJU Int

Early results show Infla10® is durable with no infections and low revision rates, supporting its viability as a penile prosthesis.

5.

ctv.veeva.com

ctv.veeva.com/study/evaluation-of-the-rigicon-infla10-r-inflatable-penile-prosthesis-ipp-for-erectile-dysfunction

Evaluation of the Rigicon Infla10® Inflatable Penile Prosthesis ...

This study evaluates the long-term safety and effectiveness of the Rigicon Infla10® Inflatable Penile Prosthesis in patients with erectile ...

6.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/36633050/

Initial safety outcomes for the Rigicon Infla10® inflatable ...

Kaplan-Meier analysis showed the rates of cumulative survival of the device at 12, 24, 36 months were 95.6%, 94.7% and 93.7%, respectively. Conclusions: The ...

7.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07273773?aggFilters=funderType%3Aindustry%2Cstatus%3Anot%2CstudyType%3Aint&start=2025-01-01_

Evaluation of the Rigicon Infla10® Inflatable Penile ...

This study is to assess the safety and effectiveness of the Rigicon IPP in treating ED. Clinical literature and preclinical testing, including ...

8.

urotoday.com

urotoday.com/recent-abstracts/men-s-health/peyronie-s-disease/142244-initial-safety-outcomes-for-rigicon-infla10-inflatable-penile-prosthesis.html

Initial Safety Outcomes for Rigicon Infla10® Inflatable ...

Complications include mechanical failure (2.5%) and component migration (0.7%). There were no infections observed in this series. One patient ( ...