Trial Outcomes & Findings for Evaluation of the 2005 AMS (American Medical System) IPP (Inflatable Penile Prosthesis) (NCT NCT00636506)

NCT ID: NCT00636506

Last Updated: 2019-07-22

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 76 participants
• Primary outcome timeframe: 4-8 weeks
• Results posted on: 2019-07-22

Participant Flow

76 subjects enrolled; 6 withdrew consent prior to the procedure, and 1 had the procedure aborted. 69 subjects were implanted with the study device; of these, 60 completed the study, 8 were lost to follow-up, and 1 had their device explanted.

Participant milestones

Measure	AMS 700 IPP 2005 Implant Group Male subjects 21 years of age and older who are implanted with an AMS 700 IPP with MS pump for erectile dysfunction.
Overall Study STARTED	76
Overall Study COMPLETED	60
Overall Study NOT COMPLETED	16

Reasons for withdrawal

Measure	AMS 700 IPP 2005 Implant Group Male subjects 21 years of age and older who are implanted with an AMS 700 IPP with MS pump for erectile dysfunction.
Overall Study Lost to Follow-up	8
Overall Study Explanted	1
Overall Study Withdrawal by Subject	6
Overall Study Procedure aborted	1

Baseline Characteristics

Evaluation of the 2005 AMS (American Medical System) IPP (Inflatable Penile Prosthesis)

Baseline characteristics by cohort

Measure	AMS 700 IPP 2005 Implant Group n=76 Participants Male subjects 21 years of age and older who choose to undergo an IPP implantation for erectile dysfunction.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	47 Participants n=5 Participants
Age, Categorical >=65 years	29 Participants n=5 Participants
Age, Continuous	60.1 years STANDARD_DEVIATION 9.5 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	76 Participants n=5 Participants
Region of Enrollment United States	76 participants n=5 Participants

PRIMARY outcome

Timeframe: 4-8 weeks

Population: All subjects who were implanted and attended the device activation visit at 4-8 weeks post-op

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

Outcome measures

Measure	AMS 700 IPP 2005 Implant Group at 4-8 Weeks n=66 Participants Male subjects 21 years of age and older who choose to undergo an IPP implantation for erectile dysfunction and who attended the 4-8 week follow-up visit.	AMS 700 IPP 2005 Implant Group at 3 Months Follow-up Male subjects 21 years of age and older who are implanted with an AMS 700 IPP with MS pump for erectile dysfunction at 3 months follow-up.	AMS 700 IPP 2005 Implant Group at 6 Months Follow-up Male subjects 21 years of age and older who are implanted with an AMS 700 IPP with MS pump for erectile dysfunction at 6 months follow-up.
Ease of Locating the Inflation Pump Bulb	63 Participants who easily located pumpbulb	—	—

PRIMARY outcome

Timeframe: 4-8 weeks post-op

Population: Subjects who attended the 4-8 week activation visit

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.

Outcome measures

Measure	AMS 700 IPP 2005 Implant Group at 4-8 Weeks n=66 Participants Male subjects 21 years of age and older who choose to undergo an IPP implantation for erectile dysfunction and who attended the 4-8 week follow-up visit.	AMS 700 IPP 2005 Implant Group at 3 Months Follow-up Male subjects 21 years of age and older who are implanted with an AMS 700 IPP with MS pump for erectile dysfunction at 3 months follow-up.	AMS 700 IPP 2005 Implant Group at 6 Months Follow-up Male subjects 21 years of age and older who are implanted with an AMS 700 IPP with MS pump for erectile dysfunction at 6 months follow-up.
Ease of Pumping Device to Full Erection Much Easier	28 Participants	—	—
Ease of Pumping Device to Full Erection Somewhat Harder	16 Participants	—	—
Ease of Pumping Device to Full Erection Harder	0 Participants	—	—
Ease of Pumping Device to Full Erection Somewhat Easier	19 Participants	—	—
Ease of Pumping Device to Full Erection Same	3 Participants	—	—

PRIMARY outcome

Timeframe: 4-8 weeks, 3 months, 6 months

Population: Subjects who attended the 4-8 week activation visit.

Physicians were asked: "After inflation, did the erection appear suitable for sexual intercourse?" Response options were: Yes, No, Not Assessed

Outcome measures

Measure	AMS 700 IPP 2005 Implant Group at 4-8 Weeks n=66 Participants Male subjects 21 years of age and older who choose to undergo an IPP implantation for erectile dysfunction and who attended the 4-8 week follow-up visit.	AMS 700 IPP 2005 Implant Group at 3 Months Follow-up n=61 Participants Male subjects 21 years of age and older who are implanted with an AMS 700 IPP with MS pump for erectile dysfunction at 3 months follow-up.	AMS 700 IPP 2005 Implant Group at 6 Months Follow-up n=60 Participants Male subjects 21 years of age and older who are implanted with an AMS 700 IPP with MS pump for erectile dysfunction at 6 months follow-up.
Quality of Erection (Suitability for Intercourse)	66 participants who answered yes	60 participants who answered yes	59 participants who answered yes

PRIMARY outcome

Timeframe: 3 months, 6 months

Population: Subjects who attended the 3 month and/or 6 month follow-up visit

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"

Outcome measures

Measure	AMS 700 IPP 2005 Implant Group at 4-8 Weeks n=61 Participants Male subjects 21 years of age and older who choose to undergo an IPP implantation for erectile dysfunction and who attended the 4-8 week follow-up visit.	AMS 700 IPP 2005 Implant Group at 3 Months Follow-up n=58 Participants Male subjects 21 years of age and older who are implanted with an AMS 700 IPP with MS pump for erectile dysfunction at 3 months follow-up.	AMS 700 IPP 2005 Implant Group at 6 Months Follow-up Male subjects 21 years of age and older who are implanted with an AMS 700 IPP with MS pump for erectile dysfunction at 6 months follow-up.
Subjective Force Required to Inflate Device Reasonable	50 Participants	48 Participants	—
Subjective Force Required to Inflate Device Too much	11 Participants	9 Participants	—
Subjective Force Required to Inflate Device Missing	0 Participants	1 Participants	—

PRIMARY outcome

Timeframe: 3 months, 6 months

Population: All subjects who attended the follow-up visits

Subjects were asked if they were able to inflate the device using one hand. Response options were: Yes, No

Outcome measures

Measure	AMS 700 IPP 2005 Implant Group at 4-8 Weeks n=61 Participants Male subjects 21 years of age and older who choose to undergo an IPP implantation for erectile dysfunction and who attended the 4-8 week follow-up visit.	AMS 700 IPP 2005 Implant Group at 3 Months Follow-up n=58 Participants Male subjects 21 years of age and older who are implanted with an AMS 700 IPP with MS pump for erectile dysfunction at 3 months follow-up.	AMS 700 IPP 2005 Implant Group at 6 Months Follow-up Male subjects 21 years of age and older who are implanted with an AMS 700 IPP with MS pump for erectile dysfunction at 6 months follow-up.
Ability to Inflate Device Using One Hand Yes	31 Participants	33 Participants	—
Ability to Inflate Device Using One Hand No	30 Participants	23 Participants	—
Ability to Inflate Device Using One Hand Missing	0 Participants	2 Participants	—

PRIMARY outcome

Timeframe: 4-8 weeks follow-up

Population: All subjects who attended the 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 AMS tactile pump." Response options were: Much easier, Somewhat easier, Same, Somewhat harder, Much harder

Outcome measures

Measure	AMS 700 IPP 2005 Implant Group at 4-8 Weeks n=66 Participants Male subjects 21 years of age and older who choose to undergo an IPP implantation for erectile dysfunction and who attended the 4-8 week follow-up visit.	AMS 700 IPP 2005 Implant Group at 3 Months Follow-up Male subjects 21 years of age and older who are implanted with an AMS 700 IPP with MS pump for erectile dysfunction at 3 months follow-up.	AMS 700 IPP 2005 Implant Group at 6 Months Follow-up Male subjects 21 years of age and older who are implanted with an AMS 700 IPP with MS pump for erectile dysfunction at 6 months follow-up.
Ease of Training Patient to Inflate Device Compared to the AMS Tactile Pump Somewhat easier	11 Participants	—	—
Ease of Training Patient to Inflate Device Compared to the AMS Tactile Pump Same	5 Participants	—	—
Ease of Training Patient to Inflate Device Compared to the AMS Tactile Pump Much easier	36 Participants	—	—
Ease of Training Patient to Inflate Device Compared to the AMS Tactile Pump Somewhat harder	13 Participants	—	—
Ease of Training Patient to Inflate Device Compared to the AMS Tactile Pump Much harder	1 Participants	—	—

PRIMARY outcome

Timeframe: 4-8 week activation visit

Population: All subjects who attended the 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

Outcome measures

Measure	AMS 700 IPP 2005 Implant Group at 4-8 Weeks n=66 Participants Male subjects 21 years of age and older who choose to undergo an IPP implantation for erectile dysfunction and who attended the 4-8 week follow-up visit.	AMS 700 IPP 2005 Implant Group at 3 Months Follow-up Male subjects 21 years of age and older who are implanted with an AMS 700 IPP with MS pump for erectile dysfunction at 3 months follow-up.	AMS 700 IPP 2005 Implant Group at 6 Months Follow-up Male subjects 21 years of age and older who are implanted with an AMS 700 IPP with MS pump for erectile dysfunction at 6 months follow-up.
Ease of Training Patient to Inflate Device Compared to the Standard AMS 700 Pump Much easier	39 Participants	—	—
Ease of Training Patient to Inflate Device Compared to the Standard AMS 700 Pump Somewhat easier	18 Participants	—	—
Ease of Training Patient to Inflate Device Compared to the Standard AMS 700 Pump Same	4 Participants	—	—
Ease of Training Patient to Inflate Device Compared to the Standard AMS 700 Pump Somewhat harder	4 Participants	—	—
Ease of Training Patient to Inflate Device Compared to the Standard AMS 700 Pump Much harder	1 Participants	—	—

PRIMARY outcome

Timeframe: 4-8 week activation visit

Population: All subjects who attended the 4-8 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

Outcome measures

Measure	AMS 700 IPP 2005 Implant Group at 4-8 Weeks n=66 Participants Male subjects 21 years of age and older who choose to undergo an IPP implantation for erectile dysfunction and who attended the 4-8 week follow-up visit.	AMS 700 IPP 2005 Implant Group at 3 Months Follow-up Male subjects 21 years of age and older who are implanted with an AMS 700 IPP with MS pump for erectile dysfunction at 3 months follow-up.	AMS 700 IPP 2005 Implant Group at 6 Months Follow-up Male subjects 21 years of age and older who are implanted with an AMS 700 IPP with MS pump for erectile dysfunction at 6 months follow-up.
Time to Complete Inflation 30-60 seconds	23 Participants	—	—
Time to Complete Inflation 60-90 seconds	12 Participants	—	—
Time to Complete Inflation 90-120 seconds	4 Participants	—	—
Time to Complete Inflation 0-30 seconds	17 Participants	—	—
Time to Complete Inflation 2-3 minutes	2 Participants	—	—
Time to Complete Inflation Over 3 minutes	8 Participants	—	—

PRIMARY outcome

Timeframe: 4-8 week activation visit

Population: All subjects who attended the 4-8 week activation visit

Physicians were asked: "Could the deflation button be easily located?" Response options were: Yes, No, and Not Tested

Outcome measures

Measure	AMS 700 IPP 2005 Implant Group at 4-8 Weeks n=66 Participants Male subjects 21 years of age and older who choose to undergo an IPP implantation for erectile dysfunction and who attended the 4-8 week follow-up visit.	AMS 700 IPP 2005 Implant Group at 3 Months Follow-up Male subjects 21 years of age and older who are implanted with an AMS 700 IPP with MS pump for erectile dysfunction at 3 months follow-up.	AMS 700 IPP 2005 Implant Group at 6 Months Follow-up Male subjects 21 years of age and older who are implanted with an AMS 700 IPP with MS pump for erectile dysfunction at 6 months follow-up.
Ease of Locating the Deflation Block Yes	65 Participants	—	—
Ease of Locating the Deflation Block No	1 Participants	—	—
Ease of Locating the Deflation Block Not tested	0 Participants	—	—

PRIMARY outcome

Timeframe: 3 months, 6 months

Population: All subjects who attended the follow-up visit

Subjects were asked: "The force required to initiate deflation was..." The response options were: "Too Much" and "Reasonable amount".

Outcome measures

Measure	AMS 700 IPP 2005 Implant Group at 4-8 Weeks n=61 Participants Male subjects 21 years of age and older who choose to undergo an IPP implantation for erectile dysfunction and who attended the 4-8 week follow-up visit.	AMS 700 IPP 2005 Implant Group at 3 Months Follow-up n=58 Participants Male subjects 21 years of age and older who are implanted with an AMS 700 IPP with MS pump for erectile dysfunction at 3 months follow-up.	AMS 700 IPP 2005 Implant Group at 6 Months Follow-up Male subjects 21 years of age and older who are implanted with an AMS 700 IPP with MS pump for erectile dysfunction at 6 months follow-up.
Subjective Force Required to Initiate Deflation No response	1 Participants	1 Participants	—
Subjective Force Required to Initiate Deflation Reasonable	54 Participants	51 Participants	—
Subjective Force Required to Initiate Deflation Too Much	6 Participants	6 Participants	—

PRIMARY outcome

Timeframe: 3 months, 6 months

Population: Physician assessment of all subjects who attended the 3 month and/or 6 month follow-up visit.

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.

Outcome measures

Measure	AMS 700 IPP 2005 Implant Group at 4-8 Weeks n=61 Participants Male subjects 21 years of age and older who choose to undergo an IPP implantation for erectile dysfunction and who attended the 4-8 week follow-up visit.	AMS 700 IPP 2005 Implant Group at 3 Months Follow-up n=59 Participants Male subjects 21 years of age and older who are implanted with an AMS 700 IPP with MS pump for erectile dysfunction at 3 months follow-up.	AMS 700 IPP 2005 Implant Group at 6 Months Follow-up Male subjects 21 years of age and older who are implanted with an AMS 700 IPP with MS pump for erectile dysfunction at 6 months follow-up.
Ability to Deflate Cylinders by Pressing the Deflation Button for Only a Few Seconds 7-8 seconds	9.8 Percentage of Participants	1.7 Percentage of Participants	—
Ability to Deflate Cylinders by Pressing the Deflation Button for Only a Few Seconds 1-2 seconds	18.0 Percentage of Participants	16.9 Percentage of Participants	—
Ability to Deflate Cylinders by Pressing the Deflation Button for Only a Few Seconds 3-4 seconds	45.9 Percentage of Participants	61.0 Percentage of Participants	—
Ability to Deflate Cylinders by Pressing the Deflation Button for Only a Few Seconds 5-6 seconds	26.2 Percentage of Participants	20.3 Percentage of Participants	—
Ability to Deflate Cylinders by Pressing the Deflation Button for Only a Few Seconds 9-10 seconds	0 Percentage of Participants	0 Percentage of Participants	—
Ability to Deflate Cylinders by Pressing the Deflation Button for Only a Few Seconds More than 10 seconds	0 Percentage of Participants	0 Percentage of Participants	—

PRIMARY outcome

Timeframe: 3 months, 6 months

Population: Physician assessment of all subjects who attended the 3 month and/or 6 month follow-up visit.

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

Outcome measures

Measure	AMS 700 IPP 2005 Implant Group at 4-8 Weeks n=61 Participants Male subjects 21 years of age and older who choose to undergo an IPP implantation for erectile dysfunction and who attended the 4-8 week follow-up visit.	AMS 700 IPP 2005 Implant Group at 3 Months Follow-up n=58 Participants Male subjects 21 years of age and older who are implanted with an AMS 700 IPP with MS pump for erectile dysfunction at 3 months follow-up.	AMS 700 IPP 2005 Implant Group at 6 Months Follow-up Male subjects 21 years of age and older who are implanted with an AMS 700 IPP with MS pump for erectile dysfunction at 6 months follow-up.
Time to Complete Deflation 9-10 seconds	20.0 Percentage of participants	27.6 Percentage of participants	—
Time to Complete Deflation 10-15 seconds	21.7 Percentage of participants	10.3 Percentage of participants	—
Time to Complete Deflation 20-25 seconds	3.3 Percentage of participants	6.9 Percentage of participants	—
Time to Complete Deflation 25-30 seconds	6.7 Percentage of participants	1.7 Percentage of participants	—
Time to Complete Deflation 30-35 seconds	0.0 Percentage of participants	0.0 Percentage of participants	—
Time to Complete Deflation 35-40 seconds	0.0 Percentage of participants	3.4 Percentage of participants	—
Time to Complete Deflation 40-45 seconds	0.0 Percentage of participants	0.0 Percentage of participants	—
Time to Complete Deflation 45-50 seconds	0.0 Percentage of participants	0.0 Percentage of participants	—
Time to Complete Deflation 5-6 seconds	18.3 Percentage of participants	20.7 Percentage of participants	—
Time to Complete Deflation 7-8 seconds	13.3 Percentage of participants	17.2 Percentage of participants	—
Time to Complete Deflation 15-20 seconds	16.7 Percentage of participants	12.0 Percentage of participants	—
Time to Complete Deflation More than 50 seconds	0.0 Percentage of participants	0.0 Percentage of participants	—

PRIMARY outcome

Timeframe: 3 months, 6 months

Population: All subjects who attended the 3 month and/or 6 month follow-up visit.

"Could the subject easily deflate the AMS IPP 2005 with one hand?" The response options were: Yes; No; and Not Tested.

Outcome measures

Measure	AMS 700 IPP 2005 Implant Group at 4-8 Weeks n=61 Participants Male subjects 21 years of age and older who choose to undergo an IPP implantation for erectile dysfunction and who attended the 4-8 week follow-up visit.	AMS 700 IPP 2005 Implant Group at 3 Months Follow-up n=58 Participants Male subjects 21 years of age and older who are implanted with an AMS 700 IPP with MS pump for erectile dysfunction at 3 months follow-up.	AMS 700 IPP 2005 Implant Group at 6 Months Follow-up Male subjects 21 years of age and older who are implanted with an AMS 700 IPP with MS pump for erectile dysfunction at 6 months follow-up.
Ability to Deflate Device With One Hand Yes	50.8 % who selected response option	56.9 % who selected response option	—
Ability to Deflate Device With One Hand No	49.2 % who selected response option	39.7 % who selected response option	—
Ability to Deflate Device With One Hand Missing	0.0 % who selected response option	3.4 % who selected response option	—

PRIMARY outcome

Timeframe: 4-8 weeks

Population: All subjects who attended the 4-8 week follow-up visit

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.

Outcome measures

Measure	AMS 700 IPP 2005 Implant Group at 4-8 Weeks n=66 Participants Male subjects 21 years of age and older who choose to undergo an IPP implantation for erectile dysfunction and who attended the 4-8 week follow-up visit.	AMS 700 IPP 2005 Implant Group at 3 Months Follow-up Male subjects 21 years of age and older who are implanted with an AMS 700 IPP with MS pump for erectile dysfunction at 3 months follow-up.	AMS 700 IPP 2005 Implant Group at 6 Months Follow-up Male subjects 21 years of age and older who are implanted with an AMS 700 IPP with MS pump for erectile dysfunction at 6 months follow-up.
Level of Flaccidity Achieved Fair	0.0 Percentage of participants	—	—
Level of Flaccidity Achieved Excellent	53.0 Percentage of participants	—	—
Level of Flaccidity Achieved Very Good	34.8 Percentage of participants	—	—
Level of Flaccidity Achieved Good	12.1 Percentage of participants	—	—
Level of Flaccidity Achieved Poor	0.0 Percentage of participants	—	—

PRIMARY outcome

Timeframe: 4-8 weeks

Population: All subjects who attended the 4-8 follow-up visit.

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

Outcome measures

Measure	AMS 700 IPP 2005 Implant Group at 4-8 Weeks n=66 Participants Male subjects 21 years of age and older who choose to undergo an IPP implantation for erectile dysfunction and who attended the 4-8 week follow-up visit.	AMS 700 IPP 2005 Implant Group at 3 Months Follow-up n=66 Participants Male subjects 21 years of age and older who are implanted with an AMS 700 IPP with MS pump for erectile dysfunction at 3 months follow-up.	AMS 700 IPP 2005 Implant Group at 6 Months Follow-up Male subjects 21 years of age and older who are implanted with an AMS 700 IPP with MS pump for erectile dysfunction at 6 months follow-up.
Ease of Training Patient to Deflate Device Much Easier	54.5 Percentage of participants	59.1 Percentage of participants	—
Ease of Training Patient to Deflate Device Somewhat Easier	16.7 Percentage of participants	27.3 Percentage of participants	—
Ease of Training Patient to Deflate Device Same	7.6 Percentage of participants	6.1 Percentage of participants	—
Ease of Training Patient to Deflate Device Somewhat harder	19.7 Percentage of participants	6.1 Percentage of participants	—
Ease of Training Patient to Deflate Device Much harder	1.5 Percentage of participants	1.5 Percentage of participants	—

PRIMARY outcome

Timeframe: 3 Months, 6 Months

Population: All subjects who attended the 3 month and/or 6 month follow-up visit.

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

Outcome measures

Measure	AMS 700 IPP 2005 Implant Group at 4-8 Weeks n=61 Participants Male subjects 21 years of age and older who choose to undergo an IPP implantation for erectile dysfunction and who attended the 4-8 week follow-up visit.	AMS 700 IPP 2005 Implant Group at 3 Months Follow-up n=58 Participants Male subjects 21 years of age and older who are implanted with an AMS 700 IPP with MS pump for erectile dysfunction at 3 months follow-up.	AMS 700 IPP 2005 Implant Group at 6 Months Follow-up Male subjects 21 years of age and older who are implanted with an AMS 700 IPP with MS pump for erectile dysfunction at 6 months follow-up.
Patient Satisfaction With Deflation Mechanism Very satisified	42.6 Percentage of participants	56.9 Percentage of participants	—
Patient Satisfaction With Deflation Mechanism Moderately satisfied	24.6 Percentage of participants	20.7 Percentage of participants	—
Patient Satisfaction With Deflation Mechanism Moderately dissatisfied	3.3 Percentage of participants	0.0 Percentage of participants	—
Patient Satisfaction With Deflation Mechanism Very dissatisified	0.0 Percentage of participants	1.7 Percentage of participants	—
Patient Satisfaction With Deflation Mechanism Somewhat satisified	16.4 Percentage of participants	17.2 Percentage of participants	—
Patient Satisfaction With Deflation Mechanism Somewhat dissatisfied	13.1 Percentage of participants	3.4 Percentage of participants	—

PRIMARY outcome

Timeframe: Time of implant (surgery)

Population: Physician assessment of each subject at time of implant

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

Outcome measures

Measure	AMS 700 IPP 2005 Implant Group at 4-8 Weeks n=69 Participants Male subjects 21 years of age and older who choose to undergo an IPP implantation for erectile dysfunction and who attended the 4-8 week follow-up visit.	AMS 700 IPP 2005 Implant Group at 3 Months Follow-up Male subjects 21 years of age and older who are implanted with an AMS 700 IPP with MS pump for erectile dysfunction at 3 months follow-up.	AMS 700 IPP 2005 Implant Group at 6 Months Follow-up Male subjects 21 years of age and older who are implanted with an AMS 700 IPP with MS pump for erectile dysfunction at 6 months follow-up.
Ease of Dilation With the Reduced Angle of the Input Tubing Yes	56.5 Percentage of participants	—	—
Ease of Dilation With the Reduced Angle of the Input Tubing No/No Effect	43.5 Percentage of participants	—	—

PRIMARY outcome

Timeframe: For duration of surgery

Population: Physician assessment of each subject at time of implant

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

Outcome measures

Measure	AMS 700 IPP 2005 Implant Group at 4-8 Weeks n=69 Participants Male subjects 21 years of age and older who choose to undergo an IPP implantation for erectile dysfunction and who attended the 4-8 week follow-up visit.	AMS 700 IPP 2005 Implant Group at 3 Months Follow-up Male subjects 21 years of age and older who are implanted with an AMS 700 IPP with MS pump for erectile dysfunction at 3 months follow-up.	AMS 700 IPP 2005 Implant Group at 6 Months Follow-up Male subjects 21 years of age and older who are implanted with an AMS 700 IPP with MS pump for erectile dysfunction at 6 months follow-up.
Ease of Cylinder Placement With the Enhanced Profile of the Proximal Tip Very easy	56.5 Percentage of participants	—	—
Ease of Cylinder Placement With the Enhanced Profile of the Proximal Tip Moderately easy	27.5 Percentage of participants	—	—
Ease of Cylinder Placement With the Enhanced Profile of the Proximal Tip Neither easy nor difficult	15.9 Percentage of participants	—	—
Ease of Cylinder Placement With the Enhanced Profile of the Proximal Tip Moderately difficult	0.0 Percentage of participants	—	—
Ease of Cylinder Placement With the Enhanced Profile of the Proximal Tip Very difficult	0.0 Percentage of participants	—	—

PRIMARY outcome

Timeframe: For duration of surgery

Population: Physician assessment of each subject at time of implant

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

Outcome measures

Measure	AMS 700 IPP 2005 Implant Group at 4-8 Weeks n=69 Participants Male subjects 21 years of age and older who choose to undergo an IPP implantation for erectile dysfunction and who attended the 4-8 week follow-up visit.	AMS 700 IPP 2005 Implant Group at 3 Months Follow-up Male subjects 21 years of age and older who are implanted with an AMS 700 IPP with MS pump for erectile dysfunction at 3 months follow-up.	AMS 700 IPP 2005 Implant Group at 6 Months Follow-up Male subjects 21 years of age and older who are implanted with an AMS 700 IPP with MS pump for erectile dysfunction at 6 months follow-up.
Comparison With Other Devices for Ease of Placement Much easier	27.5 Percentage of participants	—	—
Comparison With Other Devices for Ease of Placement Slightly easier	37.7 Percentage of participants	—	—
Comparison With Other Devices for Ease of Placement Same	33.3 Percentage of participants	—	—
Comparison With Other Devices for Ease of Placement Somewhat more difficult	1.4 Percentage of participants	—	—
Comparison With Other Devices for Ease of Placement More difficult	0.0 Percentage of participants	—	—

PRIMARY outcome

Timeframe: 4-8 weeks follow-up

Population: All subjects who attended the 4-8 week follow-up visit

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

Outcome measures

Measure	AMS 700 IPP 2005 Implant Group at 4-8 Weeks n=66 Participants Male subjects 21 years of age and older who choose to undergo an IPP implantation for erectile dysfunction and who attended the 4-8 week follow-up visit.	AMS 700 IPP 2005 Implant Group at 3 Months Follow-up Male subjects 21 years of age and older who are implanted with an AMS 700 IPP with MS pump for erectile dysfunction at 3 months follow-up.	AMS 700 IPP 2005 Implant Group at 6 Months Follow-up Male subjects 21 years of age and older who are implanted with an AMS 700 IPP with MS pump for erectile dysfunction at 6 months follow-up.
Rating of the Rigidity of the Cylinders Excellent	40.9 Percentage of participants	—	—
Rating of the Rigidity of the Cylinders Very good	43.9 Percentage of participants	—	—
Rating of the Rigidity of the Cylinders Good	15.2 Percentage of participants	—	—
Rating of the Rigidity of the Cylinders Fair	0.0 Percentage of participants	—	—
Rating of the Rigidity of the Cylinders Poor	0.0 Percentage of participants	—	—

PRIMARY outcome

Timeframe: 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

Outcome measures

Measure	AMS 700 IPP 2005 Implant Group at 4-8 Weeks n=69 Participants Male subjects 21 years of age and older who choose to undergo an IPP implantation for erectile dysfunction and who attended the 4-8 week follow-up visit.	AMS 700 IPP 2005 Implant Group at 3 Months Follow-up Male subjects 21 years of age and older who are implanted with an AMS 700 IPP with MS pump for erectile dysfunction at 3 months follow-up.	AMS 700 IPP 2005 Implant Group at 6 Months Follow-up Male subjects 21 years of age and older who are implanted with an AMS 700 IPP with MS pump for erectile dysfunction at 6 months follow-up.
Ease of Insertion of New Flare Design Reservoir Somewhat harder	1.4 Percentage of participants	—	—
Ease of Insertion of New Flare Design Reservoir Much harder	0.0 Percentage of participants	—	—
Ease of Insertion of New Flare Design Reservoir Much easier	1.4 Percentage of participants	—	—
Ease of Insertion of New Flare Design Reservoir Somewhat easier	13.0 Percentage of participants	—	—
Ease of Insertion of New Flare Design Reservoir Same	84.1 Percentage of participants	—	—

PRIMARY outcome

Timeframe: For duration of surgery

Population: Physician assessment of each patient at time of implant

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

Outcome measures

Measure	AMS 700 IPP 2005 Implant Group at 4-8 Weeks n=69 Participants Male subjects 21 years of age and older who choose to undergo an IPP implantation for erectile dysfunction and who attended the 4-8 week follow-up visit.	AMS 700 IPP 2005 Implant Group at 3 Months Follow-up Male subjects 21 years of age and older who are implanted with an AMS 700 IPP with MS pump for erectile dysfunction at 3 months follow-up.	AMS 700 IPP 2005 Implant Group at 6 Months Follow-up Male subjects 21 years of age and older who are implanted with an AMS 700 IPP with MS pump for erectile dysfunction at 6 months follow-up.
Ability of New Flare Design to Remain in Place % Yes	100 Percentage of participants	—	—
Ability of New Flare Design to Remain in Place % No	0 Percentage of participants	—	—

PRIMARY outcome

Timeframe: For duration of surgery

Population: Physician assessment of each patient at time of implant for whom they used the RTEs (rear tip extenders)

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.

Outcome measures

Measure	AMS 700 IPP 2005 Implant Group at 4-8 Weeks n=66 Participants Male subjects 21 years of age and older who choose to undergo an IPP implantation for erectile dysfunction and who attended the 4-8 week follow-up visit.	AMS 700 IPP 2005 Implant Group at 3 Months Follow-up Male subjects 21 years of age and older who are implanted with an AMS 700 IPP with MS pump for erectile dysfunction at 3 months follow-up.	AMS 700 IPP 2005 Implant Group at 6 Months Follow-up Male subjects 21 years of age and older who are implanted with an AMS 700 IPP with MS pump for erectile dysfunction at 6 months follow-up.
Ease Attaching the New Snap Design Rear Tip Extender (RTE) to the Proximal Tip of the Cylinder % Moderately satisfied	16.7 percentage of physician responses	—	—
Ease Attaching the New Snap Design Rear Tip Extender (RTE) to the Proximal Tip of the Cylinder % Neutral	28.8 percentage of physician responses	—	—
Ease Attaching the New Snap Design Rear Tip Extender (RTE) to the Proximal Tip of the Cylinder % Very satisfied	50.0 percentage of physician responses	—	—
Ease Attaching the New Snap Design Rear Tip Extender (RTE) to the Proximal Tip of the Cylinder % Moderately dissatisfied	1.5 percentage of physician responses	—	—
Ease Attaching the New Snap Design Rear Tip Extender (RTE) to the Proximal Tip of the Cylinder % Very dissatisfied	3.0 percentage of physician responses	—	—

PRIMARY outcome

Timeframe: For duration of surgery

Population: Physician assessment of each patient for whom they used RTEs at time of implant

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

Outcome measures

Measure	AMS 700 IPP 2005 Implant Group at 4-8 Weeks n=66 Participants Male subjects 21 years of age and older who choose to undergo an IPP implantation for erectile dysfunction and who attended the 4-8 week follow-up visit.	AMS 700 IPP 2005 Implant Group at 3 Months Follow-up Male subjects 21 years of age and older who are implanted with an AMS 700 IPP with MS pump for erectile dysfunction at 3 months follow-up.	AMS 700 IPP 2005 Implant Group at 6 Months Follow-up Male subjects 21 years of age and older who are implanted with an AMS 700 IPP with MS pump for erectile dysfunction at 6 months follow-up.
Comparison Rating of the New Rear Tip Extender Design to Previous Design % Somewhat worse	1.5 percentage of physician responses	—	—
Comparison Rating of the New Rear Tip Extender Design to Previous Design % Much worse	0.0 percentage of physician responses	—	—
Comparison Rating of the New Rear Tip Extender Design to Previous Design % Much better	40.9 percentage of physician responses	—	—
Comparison Rating of the New Rear Tip Extender Design to Previous Design % Somewhat better	25.8 percentage of physician responses	—	—
Comparison Rating of the New Rear Tip Extender Design to Previous Design % Same	31.8 percentage of physician responses	—	—

PRIMARY outcome

Timeframe: For duration of surgery

Population: Physician assessment of each patient at time of implant

Physicians were asked, "Was it easy to remove the blue suture sheath and white needle holder?" Answer options were: Yes; No, please explain

Outcome measures

Measure	AMS 700 IPP 2005 Implant Group at 4-8 Weeks n=69 Participants Male subjects 21 years of age and older who choose to undergo an IPP implantation for erectile dysfunction and who attended the 4-8 week follow-up visit.	AMS 700 IPP 2005 Implant Group at 3 Months Follow-up Male subjects 21 years of age and older who are implanted with an AMS 700 IPP with MS pump for erectile dysfunction at 3 months follow-up.	AMS 700 IPP 2005 Implant Group at 6 Months Follow-up Male subjects 21 years of age and older who are implanted with an AMS 700 IPP with MS pump for erectile dysfunction at 6 months follow-up.
Physician Evaluation of the Pre-threaded Suture Needle for Ease of Removing Sheath % Yes	88.4 percentage of physician responses	—	—
Physician Evaluation of the Pre-threaded Suture Needle for Ease of Removing Sheath % No	11.6 percentage of physician responses	—	—

PRIMARY outcome

Timeframe: For duration of surgery

Population: Physician assessment of each patient at time of implant

Physicians were asked to assess the overall design compared to the current non-threaded design. Answer options: Significantly better; Better; Same; Worse; Significantly worse

Outcome measures

Measure	AMS 700 IPP 2005 Implant Group at 4-8 Weeks n=69 Participants Male subjects 21 years of age and older who choose to undergo an IPP implantation for erectile dysfunction and who attended the 4-8 week follow-up visit.	AMS 700 IPP 2005 Implant Group at 3 Months Follow-up Male subjects 21 years of age and older who are implanted with an AMS 700 IPP with MS pump for erectile dysfunction at 3 months follow-up.	AMS 700 IPP 2005 Implant Group at 6 Months Follow-up Male subjects 21 years of age and older who are implanted with an AMS 700 IPP with MS pump for erectile dysfunction at 6 months follow-up.
Physician Evaluation of the Pre-threaded Suture Needle for Ease of Loading Furlow Tool % Significantly Better	1.4 percentage of physician responses	—	—
Physician Evaluation of the Pre-threaded Suture Needle for Ease of Loading Furlow Tool % Better	37.7 percentage of physician responses	—	—
Physician Evaluation of the Pre-threaded Suture Needle for Ease of Loading Furlow Tool % Same	46.4 percentage of physician responses	—	—
Physician Evaluation of the Pre-threaded Suture Needle for Ease of Loading Furlow Tool % Worse	14.5 percentage of physician responses	—	—
Physician Evaluation of the Pre-threaded Suture Needle for Ease of Loading Furlow Tool Significantly worse	0.0 percentage of physician responses	—	—

PRIMARY outcome

Timeframe: For duration of surgery

Population: Physician assessment of each patient at time of implant

Physicians were asked if the design of the pre-threaded needle facilitated faster loading of the Furlow tool. Answer options were: Yes; No

Outcome measures

Measure	AMS 700 IPP 2005 Implant Group at 4-8 Weeks n=69 Participants Male subjects 21 years of age and older who choose to undergo an IPP implantation for erectile dysfunction and who attended the 4-8 week follow-up visit.	AMS 700 IPP 2005 Implant Group at 3 Months Follow-up Male subjects 21 years of age and older who are implanted with an AMS 700 IPP with MS pump for erectile dysfunction at 3 months follow-up.	AMS 700 IPP 2005 Implant Group at 6 Months Follow-up Male subjects 21 years of age and older who are implanted with an AMS 700 IPP with MS pump for erectile dysfunction at 6 months follow-up.
Physician Evaluation of OR Device Preparation Time % Assessed as Faster	53.6 percentage of physician responses	—	—
Physician Evaluation of OR Device Preparation Time % Assessed as Not as Fast	46.4 percentage of physician responses	—	—

Adverse Events

AMS 700 IPP 2005 Implant Group

Serious events: 6 serious events

Other events: 25 other events

Deaths: 0 deaths

Serious adverse events

Measure	AMS 700 IPP 2005 Implant Group n=69 participants at risk Male subjects 21 years of age and older who choose to undergo an IPP implantation for erectile dysfunction.
Reproductive system and breast disorders Urogenital Edema and Pain	1.4% 1/69 • Number of events 1 Adverse events are assessed at the time of implant and at each follow-up visit.
Reproductive system and breast disorders Device extrusion/erosion	1.4% 1/69 • Number of events 1 Adverse events are assessed at the time of implant and at each follow-up visit.
Infections and infestations Device Infection	1.4% 1/69 • Number of events 1 Adverse events are assessed at the time of implant and at each follow-up visit.
Reproductive system and breast disorders Cylinder Erosion	1.4% 1/69 • Number of events 1 Adverse events are assessed at the time of implant and at each follow-up visit.
Infections and infestations Infection	1.4% 1/69 • Number of events 1 Adverse events are assessed at the time of implant and at each follow-up visit.
Reproductive system and breast disorders Urethral Erosion	1.4% 1/69 • Number of events 1 Adverse events are assessed at the time of implant and at each follow-up visit.

Other adverse events

Measure	AMS 700 IPP 2005 Implant Group n=69 participants at risk Male subjects 21 years of age and older who choose to undergo an IPP implantation for erectile dysfunction.
Surgical and medical procedures Device Auto-Inflation	10.1% 7/69 • Number of events 7 Adverse events are assessed at the time of implant and at each follow-up visit.
Reproductive system and breast disorders Device Aneurysm	1.4% 1/69 • Number of events 1 Adverse events are assessed at the time of implant and at each follow-up visit.
Reproductive system and breast disorders Mechanical Malfunction	2.9% 2/69 • Number of events 2 Adverse events are assessed at the time of implant and at each follow-up visit.
Reproductive system and breast disorders Pain/Discomfort with Ejaculation	1.4% 1/69 • Number of events 1 Adverse events are assessed at the time of implant and at each follow-up visit.
Reproductive system and breast disorders Pain/Discomfort with Erections	1.4% 1/69 • Number of events 1 Adverse events are assessed at the time of implant and at each follow-up visit.
Reproductive system and breast disorders Penile Sensation Change	1.4% 1/69 • Number of events 1 Adverse events are assessed at the time of implant and at each follow-up visit.
Surgical and medical procedures Seroma	1.4% 1/69 • Number of events 1 Adverse events are assessed at the time of implant and at each follow-up visit.
General disorders Pain/soreness with inflation/cycling of device	8.7% 6/69 • Number of events 6 Adverse events are assessed at the time of implant and at each follow-up visit.
General disorders Other	1.4% 1/69 • Number of events 1 Adverse events are assessed at the time of implant and at each follow-up visit.
General disorders Not Device Related, Not Serious	14.5% 10/69 • Number of events 10 Adverse events are assessed at the time of implant and at each follow-up visit.

Additional Information

Men's Health Clinical Affairs

American Medical Systems

Phone: 952-930-6328

Email: Karen.Seybold@ammd.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place