All information collected during this clinical study is kept strictly confidential in accordance with IRB guidelines and federal regulations (HIPAA). Your personal identifying information will not be shared without your explicit consent. Study data is de-identified and used only for research purposes.
About the Clinical Study
UNITED is a U.S. FDA-supervised clinical study evaluating an investigational penile prosthesis. The study is collecting information on the safety and performance/effectiveness of the Rigicon Infla10® Pulse™ Dynamic Inflatable Penile Prosthesis in men with erectile dysfunction.
About the Clinical Study
UNITED is a U.S. FDA-supervised clinical study evaluating an investigational penile prosthesis. The study is collecting information on the safety and performance/effectiveness of the Rigicon Infla10® Pulse™ Dynamic Inflatable Penile Prosthesis in men with erectile dysfunction.
What Is Being Studied?
The study device is investigational, meaning it is being studied and is not FDA-approved for commercial use in the United States.
Who May Be a Fit?
You may be considered if you:
- Are a man with ED considering penile prosthesis surgery
- Are willing to attend follow-up visits for up to 36 months
Screening is required, and not everyone qualifies.
What Does Participation Involve?
Throughout the study, various assessments will be conducted to ensure your safety and evaluate device performance. Participation is voluntary and includes follow-up visits for up to 36 months after implantation, with scheduled visits (timing may vary by site/protocol). Typical visits include: discharge, ~10–14 days, ~45 days, 3, 6, 12, 18, 24, and 36 months.
Benefits
There are no guaranteed direct benefits from participating. Some participants may experience improvement, but it cannot be promised.
Risks
Risks exist and will be discussed during informed consent.
Costs and Insurance
There may be costs. The study team will explain what is covered and what is not.
You will be responsible for the costs of your usual medical care, including doctor visits, hospital charges, and procedures/tests that would normally occur as part of your treatment for erectile dysfunction. Participation does not mean these costs will be paid by the sponsor or the study site. Please speak with the study team about what may be billed to you or your insurance.
Medicare / Insurance (Category B)
UNITED is conducted under FDA IDE No. G250274 and is classified by CMS as a Category B IDE study (FDA letter dated November 7, 2025). For eligible Medicare beneficiaries, some routine care services may be billed to and covered by Medicare and/or your insurance according to plan rules. Coverage, prior authorization requirements, and out-of-pocket costs (such as copays and deductibles) vary by plan. Your study site will review potential costs with you before you decide whether to participate.
Routine care costs may be billed to you and/or your insurer (including Medicare) as they would outside a study. Coverage and out-of-pocket responsibilities vary—your study site will review this with you before you decide.
Reimbursement
You may receive reimbursement (e.g., travel/parking) as described in the informed consent form.
Am I Eligible?
Eligibility for this clinical study is determined by specific medical criteria. Your healthcare provider will review these criteria with you during the screening process. Participation is voluntary and eligibility is determined by the study team. Not all individuals will qualify.
General Eligibility Considerations
- Diagnosis of erectile dysfunction
- May be a candidate for penile prosthesis implantation (per investigator judgment)
- Ability to attend all scheduled follow-up visits
- Willingness to complete study questionnaires
- No medical conditions that would contraindicate surgery
Important Note
Final eligibility is determined by the study team through a comprehensive medical evaluation. Completing the online ED self-check does not guarantee study eligibility or enrollment.
Your Privacy is Protected
Your privacy and confidentiality are our top priorities throughout the clinical study process.
Important Privacy Notice
Do not submit personal health information through this website outside designated study forms. For medical questions or concerns, please contact the study team directly.
Have Questions?
If you have questions about the clinical study, eligibility criteria, or what participation involves, please contact us or speak with your urologist.
Contacting a site does not imply eligibility or enrollment.
Medical Emergencies
Important Note: Do not send medical emergencies via this site; call 911.
Study Registration
ClinicalTrials.gov ID: NCT07273773