Evaluation of the 2005 AMS (American Medical System) IPP (Inflatable Penile Prosthesis)
Condition: Erectile Dysfunction
MeSH terms: Erectile Dysfunction
Intervention: AMS 700 IPP with MS Pump
Intervention description: AMS 700 Series Inflatable Penile Prosthesis with MS Pump
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 76.0
Sex: Male
Minimum age: 21 Years
Healthy volunteers: No
Keywords: Erectile dysfunction; Impotence

Summary:

      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.
    

Eligibility criteria:

        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.