Evaluation of a new inflatable penile prosthesis for erectile dysfunction

Evaluation of the Rigicon Infla10® Three-Piece Inflatable Penile Prosthesis for the Treatment of Patients With Erectile Dysfunction

This study is testing a new inflatable penile implant to see if it safely helps men with erectile dysfunction feel better over the long term.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 182 (estimated)
• Ages: 22 Years and up
• Sex: Male
• Sponsor: Rigicon, Inc. (Industry-sponsored)
• Locations: 7 sites (Auchenflower and 6 other locations)
• Trial ID: NCT05574868 on ClinicalTrials.gov

What this trial studies

This study assesses the long-term safety and effectiveness of the Rigicon Infla 10® Three-Piece Inflatable Penile Prosthesis in men diagnosed with erectile dysfunction. Participants will be followed for up to three years post-implantation, with evaluations occurring at multiple intervals to monitor outcomes. The study aims to provide insights into the prosthesis's performance and its impact on patients' quality of life. The research involves a structured follow-up protocol to ensure comprehensive data collection and patient care.

Who should consider this trial

Good fit: Ideal candidates for this study are men aged 21 and older who have been diagnosed with erectile dysfunction and are willing to undergo implantation of the prosthesis.

Not a fit: Patients with contraindications to general anesthesia, previous penile prosthesis, or certain medical conditions such as uncontrolled diabetes or active infections may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could offer a reliable surgical option for men suffering from erectile dysfunction, significantly improving their sexual health and quality of life.

How similar studies have performed: Previous studies on inflatable penile prostheses have shown positive outcomes, indicating that this approach is well-established and has a history of success.

Eligibility criteria

Inclusion Criteria:

1. Male ≥22 years of age.
2. Diagnosed with erectile dysfunction (impotence).
3. Agree to receive Infla10® three-piece IPP as an ED treatment.
4. Willing to complete all protocol required follow-up visits and tests.

Exclusion Criteria:

1. 1\. Contraindication to general anesthesia.
2. Known allergy or sensitivity to product materials as indicated in the device labeling.
3. Previous penile prosthesis or prior enlargement surgeries
4. Diagnosed penile sensory neuropathy.
5. Diagnosed with fibrotic disease, such as priapism, Peyronie's disease or Chordee.
6. Compromised immune system, such as systemic lupus erythematosus, discoid lupus, or scleroderma
7. Patients who are receiving immunosuppressive drugs or have a history of kidney transplantation
8. Uncontrolled diabetes (Fasting Blood Sugar FBS) \>300 or HbA1c ≥9.0 on morning of surgery)
9. Bleeding disorder or coagulopathy that may in the judgment of the investigator preclude safe procedure.
10. Active urogenital infection or active skin infection in region of surgery or systemic infection at the time of assessment.
11. Clinically significant comorbidities or presence of unstable conditions (e.g. cardiovascular, lung, renal \[serum creatinine \> 2.0 mg/dl\], hepatic, bleeding disorders, or metabolic impairment) that may confound the results of the study or in the judgment of the physician investigator preclude safe procedure.
12. Any cognitive disorder that interferes with or precludes direct and accurate communication with the study investigator regarding the study or affects the ability to complete the study questionnaires.
13. Lacking manual dexterity or mental abilities necessary to operate the device.
14. Expected life expectancy \< two years.
15. Unwilling or unable to sign the Informed Consent.
16. Unwilling or unable to comply with the follow-up study requirements.
17. Currently participating in an investigational drug or another investigational device exemption (IDE) study.
18. Incarcerated subjects
19. Psychogenic erectile dysfunction

Where this trial is running

Auchenflower and 6 other locations

• Wesley Hospital — Auchenflower, Australia (Recruiting)
• Canberra Laparoscopic, Robotic & Laser Urology Centre — Garran, Australia (Recruiting)
• Katelaris Urology — Hornsby, Australia (Recruiting)
• St George Urology — Hurstville, Australia (Recruiting)
• Advanced Urology Melbourne — Malvern, Australia (Recruiting)
• Shire Urology — Miranda, Australia (Recruiting)
• Urology South at Holmesglen Private Hospital — Moorabbin, Australia (Recruiting)

Study contacts

• Principal investigator: Chris Love, Dr. — Urology South at Holmesglen Private Hospital
• Study coordinator: Zeynep Tin Konukcu

Conditions Erectile Dysfunction; Infla10; Rigicon; Dynamic; Inflatable Penile Prosthesis; Penile Prosthesis