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

Tracking Information

First Received Date ^ICMJE

March 11, 2008

Last Updated Date

March 11, 2008

Start Date ^ICMJE

August 2005

Primary Completion Date

February 2006 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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.

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Erectile Dysfunction

Intervention ^ICMJE

Device: AMS IPP 2005

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

January 2008

Primary Completion Date

February 2006 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Male

Ages

21 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00636506

Other Study ID Numbers ^ICMJE

AMS052

Has Data Monitoring Committee

Not Provided

Responsible Party

Danette Bonogofsky, Clinical Research Specialist, American Medical Systems, Inc

Study Sponsor ^ICMJE

American Medical Systems

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

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

Information Provided By

American Medical Systems

Verification Date

March 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top