Evaluation of the 2005 AMS (American Medical System) IPP (Inflatable Penile Prosthesis)
- Conditions
- Erectile Dysfunction
- Interventions
- Device: AMS 700 IPP with MS Pump
- Registration Number
- NCT00636506
- Lead Sponsor
- American Medical Systems
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 76
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description AMS 700 IPP 2005 Implant Group AMS 700 IPP with MS Pump Male subjects 21 years of age and older who are implanted with an AMS 700 IPP with MS (Momentary Squeeze) pump for erectile dysfunction.
- Primary Outcome Measures
Name Time Method Rating of the Rigidity of the Cylinders 4-8 weeks follow-up Physicians were asked: "How would you rate the rigidity of the AMS IPP 2005 cylinders at full inflation?" Response options were: Excellent; Very good; Good; Fair; Poor
Subjective Force Required to Inflate Device 3 months, 6 months At the 3 and 6 month visit, subjects were asked to assess the force required to initiate inflation of the device. Response options were "Reasonable" and "Too Much"
Ease of Training Patient to Inflate Device Compared to the AMS Tactile Pump 4-8 weeks follow-up Physicians were asked: "Please rate the ease of training the subject to use the new AMS IPP 2005 pump in comparison to the AMS tactile pump." Response options were: Much easier, Somewhat easier, Same, Somewhat harder, Much harder
Ease of Training Patient to Inflate Device Compared to the Standard AMS 700 Pump 4-8 week activation visit Physicians were asked: "Please rate the ease of training the subject to use the new AMS IPP 2005 pump in comparison to the standard AMS 700 pump." Response options were: Much easier, Somewhat easier, Same, Somewhat harder, Much harder
Ability to Deflate Device With One Hand 3 months, 6 months "Could the subject easily deflate the AMS IPP 2005 with one hand?" The response options were: Yes; No; and Not Tested.
Ability to Inflate Device Using One Hand 3 months, 6 months Subjects were asked if they were able to inflate the device using one hand. Response options were: Yes, No
Physician Evaluation of the Pre-threaded Suture Needle for Ease of Loading Furlow Tool For duration of surgery Physicians were asked to assess the overall design compared to the current non-threaded design. Answer options: Significantly better; Better; Same; Worse; Significantly worse
Physician Evaluation of OR Device Preparation Time For duration of surgery Physicians were asked if the design of the pre-threaded needle facilitated faster loading of the Furlow tool. Answer options were: Yes; No
Ease of Locating the Inflation Pump Bulb 4-8 weeks Physicians were asked to observe patients manipulating the device and to answer the question: "Could the subject easily locate the inflation pump bulb?" The response options were: Yes, No, and Not Tested
Time to Complete Inflation 4-8 week activation visit Physicians were asked: "How much time was required for the subject to inflate?" Response options were: 0-30 seconds, 30-60 seconds, 60-90 seconds, 90-120 seconds, 2-3 minutes, Over 3 minutes
Ease of Locating the Deflation Block 4-8 week activation visit Physicians were asked: "Could the deflation button be easily located?" Response options were: Yes, No, and Not Tested
Ability to Deflate Cylinders by Pressing the Deflation Button for Only a Few Seconds 3 months, 6 months Physicians were asked to assess: "How long did you have to hold the deflation button for the deflation to set in motion?" The response options were: 1-2 seconds; 3-4 seconds; 5-6 seconds; 7-8 seconds; 9-10 seconds; More than 10 seconds, specify seconds.
Ease of Training Patient to Deflate Device 4-8 weeks Physicians were asked to assess: "Please rate the ease of training the subject to use the new AMS IPP 2005 pump in comparison to the AMS Tactile Pump." The response options were: Much easier; Somewhat easier; Same; Somewhat harder; Much harder
Patient Satisfaction With Deflation Mechanism 3 Months, 6 Months Subjects were asked to assess: "Satisfaction with softness of penis when prosthesis is flaccid." Response options were: Very satisfied; Moderately satisfied; Somewhat satisfied; Somewhat dissatisfied; Moderately dissatisfied; Very dissatisfied
Comparison With Other Devices for Ease of Placement For duration of surgery Physicians were asked: "Compared to other cylinders you have used, how would you rate the ease of proximal insertion of the AMS IPP 2005 cylinders?" Response options were: Much easier; Slightly easier; Same; Somewhat more difficult; More difficult
Ease of Insertion of New Flare Design Reservoir For duration of surgery Physicians were asked: "As compared to the current 700 reservoir, how would you rate the ease of insertion of the AMS IPP 2005 reservoir?" Response options were: Much easier; Somewhat easier; Same; Somewhat harder; Much harder
Time to Complete Deflation 3 months, 6 months Physicians were asked to assess: "How much time did it take for the device to deflate?" The response options were: 5-6 seconds; 7-8 seconds; 9-10 seconds; 10-15 seconds; 15-20 seconds; 20-25 seconds; 25-30 seconds; 35-40 seconds; 40-45 seconds; 45-50 seconds; More than 50 seconds, specify # of seconds
Level of Flaccidity Achieved 4-8 weeks Physicians were asked "How would you rate the flaccidity of the AMS IPP 2005 cylinders at full deflation?" Response options were: Excellent; Very good; Good; Fair; Poor.
Ease of Dilation With the Reduced Angle of the Input Tubing Time of implant (surgery) Physicians were asked: "As compared to other devices, did the angle of the input tubing make it easier to insert?" Response options were: Yes; No/No effect
Ease of Cylinder Placement With the Enhanced Profile of the Proximal Tip For duration of surgery Physicians were asked: "How would you rate the overall ease of proximal insertion of the AMS IPP 2005 cylinders?" Response options were: Very easy; Moderately easy; Neither easy nor difficult; Moderately difficult; Very difficult
Ease of Pumping Device to Full Erection 4-8 weeks post-op Physicians were asked, "Compared to current AMS 700 pumps, please rate the ease of the inflation relating to the downward orientation of the AMS IPP 2005 pump bulb". Response options were on a 5-point Likert scale - Much easier; Somewhat easier; Same; Somewhat harder; Much harder.
Quality of Erection (Suitability for Intercourse) 4-8 weeks, 3 months, 6 months Physicians were asked: "After inflation, did the erection appear suitable for sexual intercourse?" Response options were: Yes, No, Not Assessed
Subjective Force Required to Initiate Deflation 3 months, 6 months Subjects were asked: "The force required to initiate deflation was..." The response options were: "Too Much" and "Reasonable amount".
Ability of New Flare Design to Remain in Place For duration of surgery Physicians were asked: "As comparable to the previous AMS 700 reservoir, does the new flare design of the AMS IPP 2005 reservoir retain its position as implanted?" Response options were: Yes; No
Ease Attaching the New Snap Design Rear Tip Extender (RTE) to the Proximal Tip of the Cylinder For duration of surgery Physicians were asked to assess their satisfaction level with the new snap design rear tip extender. Answer options were: Very satisfied; Moderate satisfied; Neutral; Moderately dissatisfied; Very dissatisfied.
Comparison Rating of the New Rear Tip Extender Design to Previous Design For duration of surgery Physicians were asked, "Compared to AMS 700 RTE and other stackable RTE configurations, how would you rate the AMS IPP 2005 RTE configuration?" Answer options were: No RTEs implanted; Much better; Somewhat better; Same; Somewhat worse; Much worse
Physician Evaluation of the Pre-threaded Suture Needle for Ease of Removing Sheath For duration of surgery Physicians were asked, "Was it easy to remove the blue suture sheath and white needle holder?" Answer options were: Yes; No, please explain
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (7)
Institute for Urologic Excellence
🇺🇸Indio, California, United States
University of Michigan School of Medicine
🇺🇸Ann Arbor, Michigan, United States
Advanced Research Institute
🇺🇸New Port Richey, Florida, United States
Regional Urology, LLC
🇺🇸Shreveport, Louisiana, United States
New York Center for Human Sexuality
🇺🇸Brooklyn, New York, United States
University of Oklahoma Health Sciences Center
🇺🇸Oklahoma City, Oklahoma, United States
Medical Research Associates of Nashville
🇺🇸Nashville, Tennessee, United States