Inflatable Penile Prosthesis for Erectile Dysfunction

Recruiting at 7 trial locations

Overseen By Paul Perito, MD

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Rigicon, Inc.

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

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

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 8

Duration: Procedure day

177 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial evaluates the safety and effectiveness of the Rigicon Infla 10® Three-Piece Inflatable Penile Prosthesis for treating erectile dysfunction. The study tracks patients with this device implanted to assess its performance over three years. Men aged 21 or older with erectile dysfunction who agree to receive this implant and attend all follow-up visits are suitable candidates for this study. Researchers will closely monitor participants to ensure the device functions properly and improves their condition. As an unphased trial, this study allows patients to contribute to valuable research on a potentially life-improving treatment.

Will I have to stop taking my current medications?

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

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

Research has shown that the Rigicon Infla 10® Three-Piece Inflatable Penile Prosthesis is generally safe. Studies on this device report few mechanical issues. Importantly, early analyses found no cases of infection, suggesting patients tolerate the device well. Overall, the safety of this prosthesis aligns with other products already available. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Rigicon Infla 10® Three-Piece Inflatable Penile Prosthesis is unique because it offers an innovative approach to treating erectile dysfunction. Unlike traditional penile implants, which may be semi-rigid or require more invasive procedures, this inflatable device allows for more natural control over erections, providing flexibility and comfort. Researchers are excited about this treatment because it potentially improves both the quality of life and the satisfaction of those who use it, offering a customizable and discreet solution that aligns closely with natural function.

What evidence suggests that the Rigicon Infla 10® Three-Piece Inflatable Penile Prosthesis is effective for erectile dysfunction?

Research has shown that the Rigicon Infla 10® Three-Piece Inflatable Penile Prosthesis, which trial participants will receive, effectively treats erectile dysfunction. One study found that 91.4% of patients were satisfied with the prosthesis six months post-surgery and would recommend it. Another report indicated that the device remained functional for three years in 97.6% of cases, with 92.4% of patients satisfied. These findings suggest that the Rigicon Infla 10® is a reliable and popular option for those with erectile dysfunction. ^{3 6 7 8 9}

Who Is on the Research Team?

Onder Kayigil, MD

Principal Investigator

SBU Diskapi Yildirim Beyazit Training and Research Hospital

Muhammet Abdurrahim Imamoglu, MD

Principal Investigator

SBU Diskapi Yildirim Beyazit Training and Research Hospital

Metin Ishak Ozturk, MD

Principal Investigator

SBU Haydarpasa Numune Training and Research Hospital

Orhan Koca, MD

Principal Investigator

Kavacik Medistate Hospital

Duygu Kirkik, PhD

Principal Investigator

Rigicon, Inc.

Musab Ali Kutluhan, MD

Principal Investigator

SBU Diskapi Yildirim Beyazit Training and Research Hospital

Steven K. Wilson, MD

Principal Investigator

Department of Urology, Institute for Urologic Excellence

Paul Perito, MD

Principal Investigator

Perito Urology - Penile Implant Clinic

Are You a Good Fit for This Trial?

Men over 21 with erectile dysfunction can join this trial if they agree to use the Rigicon Infla10® prosthesis as treatment, can follow up on visits and tests, and have no allergies to device materials. Exclusions include those with anesthesia risks, previous penile surgeries, infections at surgery site or systemic infections, limited manual dexterity or mental capacity for device operation, life expectancy under two years, uncontrolled diabetes or significant other health issues.

Inclusion Criteria

I am a man aged 21 or older.

I have been diagnosed with erectile dysfunction.

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

Exclusion Criteria

I have a bleeding disorder that may make procedures unsafe for me.

Expected life expectancy < two years

I have been diagnosed with a fibrotic condition affecting my reproductive organs.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are implanted with the Rigicon Infla 10® Three-Piece Inflatable Penile Prosthesis

Procedure day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after implantation

36 months

7 visits (in-person) at 14 days, 1 month, 6 months, 12 months, 18 months, 24 months, and 36 months post-procedure

What Are the Treatments Tested in This Trial?

Interventions

• Rigicon Infla 10® Three-Piece Inflatable Penile Prosthesis

Trial Overview The study is testing the safety and effectiveness of the Rigicon Infla10® Three-Piece Inflatable Penile Prosthesis in men with erectile dysfunction over a period of up to three years post-implantation. Participants will be monitored regularly following institutional standards for managing ED and any related conditions.

How Is the Trial Designed?

Group I: Experimental: Rigicon Infla 10® Three-Piece Inflatable Penile Prosthesis Group Experimental Treatment 1 Intervention

Male subjects 21 years of age and older who are implanted with an Rigicon Infla 10® Three-Piece Inflatable Penile Prosthesis for erectile dysfunction.

Rigicon Infla 10® Three-Piece Inflatable Penile Prosthesis is already approved in European Union, United States for the following indications:

Approved in European Union as Infla10 for:

• Erectile dysfunction

Approved in United States as Infla10 for:

• Erectile dysfunction

Who Is Running the Clinical Trial?

Rigicon, Inc.

Lead Sponsor

Trials

1

Recruited

180+

Published Research Related to This Trial

A novel technique using a Foley catheter balloon for dilating the retropubic space during inflatable penile prosthesis reservoir placement resulted in a 0% rate of reservoir herniation and a 7% infection rate among 15 patients, which is lower than average reported rates for these complications.

This method is considered safe, cost-effective, and less traumatic, suggesting it could improve outcomes in patients undergoing this procedure compared to traditional techniques.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Retropubic Dilation With a Foley Catheter Balloon: A Novel Technique for Penile Prosthesis Reservoir Placement. Szell, NM., McIntosh, GV., DiMatteo, AD., et al.[2017]

In a study of 319 patients who received the Rigicon Infla10 inflatable penile prosthesis over an average follow-up of 21.2 months, only 4.4% required removal or revision, indicating strong early durability of the device.

No infections were reported among the patients, and the device showed cumulative survival rates of 95.6% at 12 months and 93.7% at 36 months, suggesting it performs comparably to other contemporary penile prostheses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Initial safety outcomes for the Rigicon Infla10® inflatable penile prosthesis. Wilson, SK., Wen, L., Rossello, M., et al.[2023]

In a safety study of 605 first-time patients implanted with the Rigicon10® malleable penile prosthesis, only 0.99% required revision or explantation, indicating a high safety profile over a mean follow-up of 21.6 months.

The three-year implant survival rate was 99.2%, demonstrating that the Rigicon10® prosthesis has a comparable safety record to other devices, with the majority of reoperations due to patient dissatisfaction rather than device failure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety outcomes of the first Rigi10™ malleable penile prostheses implanted worldwide. Wilson, SK., Wen, L., Carrion, R., et al.[2023]

In a study of 442 patients with Mentor Alpha I inflatable penile prostheses over 12 years, 4.98% experienced device malfunctions, with a higher failure rate in scrotal devices (5.6%) compared to infrapubic devices (3.9%).

The most common malfunction in scrotal devices was tubing fractures at the pump strain reliefs, while infrapubic devices typically failed at the cylinders or reservoir, highlighting different failure sites that could inform future design improvements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inflatable penile prosthesis: site-specific malfunction analysis. Garber, BB.[2007]

A laparoscopic capsulotomy procedure was successfully performed on four patients to treat autoinflation of inflatable penile prostheses, with an average operative time of 45 minutes and no reported complications.

All patients achieved complete deflation of their prostheses at follow-up, indicating that this outpatient surgical method is both effective and safe for addressing this common malfunction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Laparascopic capsulotomy to treat autoinflation of inflatable penile prostheses. Abbosh, PH., Thom, MR., Bullock, A.[2013]

In a study of 395 patients treated for chronic erectile impotence over 11 years, the original inflatable prosthesis had a high complication and revision rate of 61%, while newer models showed a much lower revision rate of only 13% over 4 years.

Despite the complications associated with the original prosthesis, 97% of patients reported satisfaction with their treatment, highlighting the effectiveness of salvage procedures and improvements in product reliability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Eleven years of experience with the inflatable penile prosthesis. Wilson, SK., Wahman, GE., Lange, JL.[2019]

In a study of 50 men with organic impotence, the Mentor Alpha 1 inflatable penile prosthesis demonstrated a high satisfaction rate, with 98% of patients and 96% of their partners expressing satisfaction with the device.

The device showed good reliability with only a 4% complication rate, including one infection and one aneurysm, and 98% of patients indicated they would choose the procedure again, highlighting its effectiveness and safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mentor Alpha 1 inflatable penile prosthesis: patient satisfaction and device reliability. Garber, BB.[2019]

In a study of 535 patients who received the Rigicon Infla10 inflatable penile prosthesis over a mean follow-up of 24.2 months, only 3.5% required reoperation, indicating a high level of reliability for this device.

The survival rates from needing corrective surgery were impressive, with 96.4% at 1 year, 95.0% at 2 years, and 94.0% at 3 years, suggesting that the Rigicon Infla10 performs comparably to more established devices in the market.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Survival From Revision Surgery for New Rigicon Infla10 Three-piece Inflatable Penile Prosthesis Is Comparable to Preceding Devices. Wilson, SK., Haxhimolla, H., Kua, B., et al.[2023]

The three-piece inflatable penile prosthesis has been used for over 35 years and is associated with the highest patient satisfaction rates among treatments for erectile dysfunction (ED).

This device also boasts the lowest mechanical revision rates compared to other medically implanted devices, indicating its reliability and effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Updates in inflatable penile prostheses. Henry, GD., Wilson, SK.[2007]

Citations

1. 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.

2. urologyresearchandpractice.org urologyresearchandpractice.org/Content/files/sayilar/219/URP_20240122_nlm_new_indd(1).pdf

Interim Results of Rigicon Penile Prosthesis Implantation in ... The findings suggest that Rigicon Infla10® offers a promising alternative for patients with. ED and provides effective solutions where ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0090429523006416

Survival From Revision Surgery for New Rigicon Infla10 ... Rigicon Infla10 prostheses with three different cylinder types were used to treat ED in this study. Frequency of usage of the different models was 64.6% Infla10 ...

4. academic.oup.com academic.oup.com/jsm/article-abstract/22/2/344/7920010

Patient satisfaction study for the new Rigicon Infla10 inflatable ... Overall, 53 patients (91.4%) were satisfied at 6 months postoperatively and would recommend the procedure. Diminished satisfaction was due to perceived penile ...

5. rigicon.com rigicon.com/clinical-evidence/

Clinical Evidence | Peer-Reviewed Research in Prosthetic ... With a 97.6% device survival rate over 3 years and 92.4% patient satisfaction, the results highlight the device's reliability and acceptance. Urology Research ...

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

Initial safety outcomes for the Rigicon Infla10® inflatable ... The vast majority of the early Rigicon Infla10 IPPs implanted prior to January 2022 were included in this retrospective analysis of volunteered PIFs.

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

Initial Safety Outcomes for Infla10® | BJU Int The Rigicon Infla10® demonstrated low rates of mechanical complications and no infections in this early analysis. Its safety profile is consistent with ...

8. rigicon.com rigicon.com/inflatable-penile-prosthesis/

Infla10® Pulse™ Series - Inflatable Penile Prosthesis Rigicon offers the Infla10 Pulse three-piece dynamic inflatable penile prostheses, designed for men suffering from chronic, organic erectile dysfunction (ED)

9. nature.com nature.com/articles/s41443-023-00761-x

Safety outcomes of the first Rigi10™ malleable penile ... In this multi-center across 15 countries, we aim to evaluate the first reported safety outcomes of the new Rigi10® device.