NCT00636506

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.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 76 (actual)
• Sponsor: American Medical Systems · Industry
• Sex: Male
• Age: 21 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Erectile Dysfunction

Interventions

Type	Name	Description
DEVICE	AMS 700 IPP with MS Pump	AMS 700 Series Inflatable Penile Prosthesis with MS Pump

Timeline

• Start date: 2005-08-01
• Primary completion: 2006-02-01
• Completion: 2008-01-01
• First posted: 2008-03-14
• Last updated: 2019-07-22
• Results posted: 2019-07-22

Locations

7 sites across 1 country: United States