Evaluate Improvement of Erectile Dysfunction After Placement of the AMS IPP 2005 Inflatable Penile Prosthesis



Status:Completed
Conditions:Erectile Dysfunction
Therapuetic Areas:Nephrology / Urology
Healthy:No
Age Range:21 - Any
Updated:10/14/2017
Start Date:August 2005
End Date:January 2008

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

The purpose of this study is to assess the American Medical System's IPP 2005 inflatable
penile prosthesis implant in subjects receiving the implant for erectile dysfunction for ease
of patient operability and use, as well as ease of surgery 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.

Inclusion Criteria:

- 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.

- The subject has not had a previous penile prosthesis, is willing and able to comply to
study protocol.

- No known sensitivity to rifampin, minocycline or other tetracyclines. Does not have
systemic lupus erythematosus.

Exclusion Criteria:

- Inadequate reading level for for reading and understanding the Informed Consent,
patient questionnaires, and other study materials.

- Has Urinary Tract Infection (UTI), urogenital infection, or active skin infection in
the region of surgery. Has a compromised immune system. Diagnosed with severe fibrosis
due to priapism

- Does not have the manual dexterity or mental ability to operate the pump.
We found this trial at
7
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1500 Church Street
Nashville, Tennessee 37203
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1150 West Medical Center Drive
Ann Arbor, Michigan 48109
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Brooklyn, New York 11219
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81719 Doctor Carreon Boulevard
Indio, California 92201
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Indio, CA
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New Port Richey, Florida
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New Port Richey, FL
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940 NE 13th St
Oklahoma City, Oklahoma 73190
(405) 271-6458
University of Oklahoma Health Sciences Center The OU Health Sciences Center is composed of seven...
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Shreveport, Louisiana 71106
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Shreveport, LA
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