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

Rating of the Rigidity of the Cylinders

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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 Inflate Device Using One Hand

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

Ability to Deflate Device With One Hand

时间窗: 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.

Level of Flaccidity Achieved

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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)

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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