Evaluation of the 2005 AMS (American Medical System) IPP (Inflatable Penile Prosthesis)

A Multi-Center Study to Assess the AMS IPP 2005 Inflatable Penile Prosthesis Cylinders, Pump and Reservoir.

The purpose of this study is to evaluate modifications to the AMS 700 Series pump, cylinders, reservoir and rear tip extender design, their impact on ease of use for the patient, and ease of implantation for the physician.

Erectile dysfunction, the inability to attain or sustain a penile erection sufficient to permit satisfactory sexual intercourse, affects an estimated ten to 30 million men in the United States. Erectile dysfunction can be caused by many organic abnormalities, including diabetes mellitus, hypertension, vascular disease, neurogenic disorders, and other chronic diseases. Erectile dysfunction can be effectively treated with a variety of methods, including the implantation of an inflatable penile prosthesis. A multi-center trial is to be conducted to assess the AMS IPP 2002 Inflatable Penile Prosthesis including handling during IPP implantation procedures and short-term follow-up experience of subjects. The study will collect pre-operative information comparing the pump operation using scrotal models of the current pump with the study pump, and baseline erectile function history. Surgical data will be collected to assess device design and procedure enhancements. Patient and physician assessment of study device function, ease of use, ease of training/learning, and adverse events will be gathered post-operatively.

1. Inclusion Criteria

   To be eligible to participate in this study, male subjects must meet the following requirements:

   1. The subject has been diagnosed with erectile dysfunction and has made an informed decision to be implanted with the AMS IPP 2005 Inflatable Penile Prosthesis Cylinder, Pump, and Reservoir.
   2. The subject has not had a previous penile prosthesis.
   3. The subject is willing and able to give written valid Informed Consent.
   4. The subject's reading level is judged adequate for reading and understanding the Informed Consent, patient questionnaires, and other study material
   5. The subject is ≥ 21 years of age.
   6. The subject has no known sensitivity to rifampin, minocycline or other tetracyclines as indicated in the device labeling.
   7. The subject does not have systemic lupus erythematosus
   8. The subject has the manual dexterity or mental ability to operate the pump.
   9. The subject does not have active urogenital infection or active skin infection in region of surgery as indicated in the device labeling.
   10. The subject is willing and able to return for follow-up evaluations and questionnaire completion according to the study protocol.
   11. The subject is an acceptable risk for anesthesia and surgery.

2. Exclusion Criteria

   Subjects will not be eligible for entry into this study if they meet any of the following criteria:

   1. The subject's reading level is judged inadequate for reading and understanding the Informed Consent, patient questionnaires, and other study materials.
   2. The subject is not willing or able to give written valid Informed Consent
   3. The subject meets any of the following contraindications for InhibiZone™ use:

   i. known allergy to or sensitivity to rifampin, minocycline, or to tetracyclines.

   ii. diagnosed with systemic lupus erythematosus. d) The subject has a current Urinary Tract Infection (UTI), urogenital infection, or active skin infection in the region of surgery.

   e) The subject does not have the manual dexterity or mental ability to operate the pump.

   f) The subject has a compromised immune system. g) The subject refuses to, or is unable to, comply with the requirements of the protocol or return for follow-up visits.

   h) The subject has been diagnosed with severe fibrosis due to priapism.