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

This study has been completed.
Sponsor:
Information provided by:
American Medical Systems
ClinicalTrials.gov Identifier:
NCT00636506
First received: March 11, 2008
Last updated: NA
Last verified: March 2008
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Erectile Dysfunction
Device: AMS IPP 2005
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multi-Center Study to Assess the AMS IPP 2005 Inflatable Penile Prosthesis Cylinders, Pump and Reservoir.

Resource links provided by NLM:


Further study details as provided by American Medical Systems:

Primary Outcome Measures:
  • Device function questionnaires, ease of use questionnaires, and adverse event reporting will be obtained at product activation, 3 month and 6 month follow-up visits. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 70
Study Start Date: August 2005
Study Completion Date: January 2008
Primary Completion Date: February 2006 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00636506

Locations
United States, California
Institute for Urologic Excellence
Indio, California, United States, 92201
United States, Florida
Advanced Research Institute
New Port Richey, Florida, United States, 34652
United States, Louisiana
Regional Urology, LLC
Shreveport, Louisiana, United States, 71106
United States, Michigan
University of Michigan School of Medicine
Ann Arbor, Michigan, United States, 48109
United States, New York
New York Center for Human Sexuality
Brooklyn, New York, United States, 11219
United States, Oklahoma
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
United States, Tennessee
Medical Research Associates of Nashville
Nashville, Tennessee, United States, 37203
Sponsors and Collaborators
American Medical Systems
Investigators
Principal Investigator: L. Dean Knoll, MD Medical Research Associates of Nasville
Principal Investigator: Gerard D Henry, MD Regional Urology LLC
Principal Investigator: Daniel Culkin, MD University of Oklahoma Health Science Center
Principal Investigator: Dana A Ohl, MD University of Michigan
Principal Investigator: Juan Otheguy, MD Advanced Research Institute
Principal Investigator: Ridwan Shabsigh, MD New York Center for Human Sexuality
Principal Investigator: Steven K Wilson, MD Institute for Urologic Excellence
Principal Investigator: John Delk II, MD Institute for Urologic Excellence
  More Information

No publications provided

Responsible Party: Danette Bonogofsky, Clinical Research Specialist, American Medical Systems, Inc
ClinicalTrials.gov Identifier: NCT00636506     History of Changes
Other Study ID Numbers: AMS052
Study First Received: March 11, 2008
Last Updated: March 11, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by American Medical Systems:
Erectile dysfunction
Impotence

Additional relevant MeSH terms:
Erectile Dysfunction
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Sexual and Gender Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 24, 2014