Evaluation of the Rigicon Infla10® Inflatable Penile Prosthesis (IPP) A Prospective, Multicenter, Single-Arm Performance-Goal Study
Rigicon, Inc.
Summary
This study evaluates the long-term safety and effectiveness of the Rigicon Infla10® Inflatable Penile Prosthesis in patients with erectile dysfunction. The study follows patients implanted with the Rigicon Infla10® Pulse™ Dynamic Inflatable Penile Prosthesis for up to 3 years after implantation.
Description
Erectile dysfunction (ED) is a common male sexual dysfunction associated with a reduced quality of life for patients and their partners. Incidence of ED increases with age and is associated with depression, obesity, diabetes mellitus, hypertension, cardiovascular disease and benign prostatic hyperplasia. ED is diagnosed with symptoms of (1) inability to attain or sustain a penile erection during sexual activity and (2) a reduction of penile rigidity in \>75% of sexual encounters during six months period. ED is estimated to affect approximately 52% of men in age of 40 to 70 years. It is project…
Eligibility
- Age range
- 22+ years
- Sex
- Male
- Healthy volunteers
- No
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 for follow-up visits and tests. Exclusion Criteria: 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. Patients who are receiving immunosuppressive drugs or have a history of kidney transplantation. 6. P…
Interventions
- DeviceRigicon Infla10® Inflatable Penile Prosthesis (IPP)
Medical Device: Infla10® Pulse™ Dynamic Inflatable Penile Prosthesis • Other Names: Inflatable Penile Prosthesis (IPP) Treatment: Erectile dysfunction
Locations (7)
- Perito UrologyCoral Gables, Florida
- Atlanta Cosmetic UrologyAtlanta, Georgia
- UroPartnersChicago, Illinois
- Kramer UrologyHyannis, Massachusetts
- Washington Heights UrologyNew York, New York
- Urology Partners of North TexasArlington, Texas