This study checks how safe and effective the Rigicon Infla10® Inflatable Penile Prosthesis (IPP) is for men who have erectile dysfunction (ED). ED means having trouble getting or keeping an erection. It usually happens more often as men get older and can be caused by health problems like diabetes or heart disease. The study will watch patients with this special device for up to 3 years after they get it implanted.
Key Points:
- The study lasts for up to 3 years.
- Participants need to be male, at least 22 years old, and willing to receive the Infla10® IPP and attend follow-up visits.
- Participants cannot have certain health conditions like uncontrolled diabetes or allergies to the device materials.
Participants will receive a three-piece IPP, which is a device that can be inflated to help achieve an erection. This study will help doctors understand if this device is a good choice for men with ED. Remember, if you have other health issues or can't follow the study steps, you might not be able to join.
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