Erectile Dysfunction
Conditions
Keywords
Erectile dysfunction, Impotence
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.
Interventions
DEVICEAMS 700 IPP with MS Pump
AMS 700 Series Inflatable Penile Prosthesis with MS Pump
Sponsors
American Medical Systems
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Inclusion Criteria To be eligible to participate in this study, male subjects must meet the following requirements: 1. 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. 2. The subject has not had a previous penile prosthesis. 3. The subject is willing and able to give written valid Informed Consent. 4. The subject's reading level is judged adequate for reading and understanding the Informed Consent, patient questionnaires, and other study material 5. The subject is ≥ 21 years of age. 6. The subject has no known sensitivity to rifampin, minocycline or other tetracyclines as indicated in the device labeling. 7. The subject does not have systemic lupus erythematosus 8. The subject has the manual dexterity or mental ability to operate the pump. 9. The subject does not have active urogenital infection or active skin infection in region of surgery as indicated in the device labeling. 10. The subject is willing and able to return for follow-up evaluations and questionnaire completion according to the study protocol. 11. The subject is an acceptable risk for anesthesia and surgery. 2.
Exclusion criteria
Subjects will not be eligible for entry into this study if they meet any of the following criteria: 1. The subject's reading level is judged inadequate for reading and understanding the Informed Consent, patient questionnaires, and other study materials. 2. The subject is not willing or able to give written valid Informed Consent 3. The subject meets any of the following contraindications for InhibiZone™ use: i. known allergy to or sensitivity to rifampin, minocycline, or to tetracyclines. ii. diagnosed with systemic lupus erythematosus. d) The subject has a current Urinary Tract Infection (UTI), urogenital infection, or active skin infection in the region of surgery. e) The subject does not have the manual dexterity or mental ability to operate the pump. f) The subject has a compromised immune system. g) The subject refuses to, or is unable to, comply with the requirements of the protocol or return for follow-up visits. h) The subject has been diagnosed with severe fibrosis due to priapism.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 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 |
| 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 |
| 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 |
| 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 |
| 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 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. |
| 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 |
| 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. |
| 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 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| AMS 700 IPP 2005 Implant Group Male subjects 21 years of age and older who choose to undergo an IPP implantation for erectile dysfunction. | 76 |
| Total | 76 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Explanted | 1 |
| Overall Study | Lost to Follow-up | 8 |
| Overall Study | Procedure aborted | 1 |
| Overall Study | Withdrawal by Subject | 6 |
Baseline characteristics
| Characteristic | AMS 700 IPP 2005 Implant Group |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 29 Participants |
| Age, Categorical Between 18 and 65 years | 47 Participants |
| Age, Continuous | 60.1 years STANDARD_DEVIATION 9.5 |
| Region of Enrollment United States | 76 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 76 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 25 / 69 |
| serious Total, serious adverse events | 6 / 69 |
Outcome results
Primary
Ability of New Flare Design to Remain in Place
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
Time frame: For duration of surgery
Population: Physician assessment of each patient at time of implant
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| AMS 700 IPP 2005 Implant Group at 4-8 Weeks | Ability of New Flare Design to Remain in Place | % Yes | 100 Percentage of participants |
| AMS 700 IPP 2005 Implant Group at 4-8 Weeks | Ability of New Flare Design to Remain in Place | % No | 0 Percentage of participants |
Primary
Ability to Deflate Cylinders by Pressing the Deflation Button for Only a Few Seconds
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.
Time frame: 3 months, 6 months
Population: Physician assessment of all subjects who attended the 3 month and/or 6 month follow-up visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| AMS 700 IPP 2005 Implant Group at 4-8 Weeks | Ability to Deflate Cylinders by Pressing the Deflation Button for Only a Few Seconds | 1-2 seconds | 18.0 Percentage of Participants |
| AMS 700 IPP 2005 Implant Group at 4-8 Weeks | Ability to Deflate Cylinders by Pressing the Deflation Button for Only a Few Seconds | 3-4 seconds | 45.9 Percentage of Participants |
| AMS 700 IPP 2005 Implant Group at 4-8 Weeks | Ability to Deflate Cylinders by Pressing the Deflation Button for Only a Few Seconds | 5-6 seconds | 26.2 Percentage of Participants |
| AMS 700 IPP 2005 Implant Group at 4-8 Weeks | Ability to Deflate Cylinders by Pressing the Deflation Button for Only a Few Seconds | 7-8 seconds | 9.8 Percentage of Participants |
| AMS 700 IPP 2005 Implant Group at 4-8 Weeks | Ability to Deflate Cylinders by Pressing the Deflation Button for Only a Few Seconds | 9-10 seconds | 0 Percentage of Participants |
| AMS 700 IPP 2005 Implant Group at 4-8 Weeks | Ability to Deflate Cylinders by Pressing the Deflation Button for Only a Few Seconds | More than 10 seconds | 0 Percentage of Participants |
| AMS 700 IPP 2005 Implant Group at 3 Months Follow-up | Ability to Deflate Cylinders by Pressing the Deflation Button for Only a Few Seconds | 9-10 seconds | 0 Percentage of Participants |
| AMS 700 IPP 2005 Implant Group at 3 Months Follow-up | Ability to Deflate Cylinders by Pressing the Deflation Button for Only a Few Seconds | 1-2 seconds | 16.9 Percentage of Participants |
| AMS 700 IPP 2005 Implant Group at 3 Months Follow-up | Ability to Deflate Cylinders by Pressing the Deflation Button for Only a Few Seconds | 7-8 seconds | 1.7 Percentage of Participants |
| AMS 700 IPP 2005 Implant Group at 3 Months Follow-up | Ability to Deflate Cylinders by Pressing the Deflation Button for Only a Few Seconds | 3-4 seconds | 61.0 Percentage of Participants |
| AMS 700 IPP 2005 Implant Group at 3 Months Follow-up | Ability to Deflate Cylinders by Pressing the Deflation Button for Only a Few Seconds | More than 10 seconds | 0 Percentage of Participants |
| AMS 700 IPP 2005 Implant Group at 3 Months Follow-up | Ability to Deflate Cylinders by Pressing the Deflation Button for Only a Few Seconds | 5-6 seconds | 20.3 Percentage of Participants |
Primary
Ability to Deflate Device With One Hand
Could the subject easily deflate the AMS IPP 2005 with one hand? The response options were: Yes; No; and Not Tested.
Time frame: 3 months, 6 months
Population: All subjects who attended the 3 month and/or 6 month follow-up visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| AMS 700 IPP 2005 Implant Group at 4-8 Weeks | Ability to Deflate Device With One Hand | Yes | 50.8 % who selected response option |
| AMS 700 IPP 2005 Implant Group at 4-8 Weeks | Ability to Deflate Device With One Hand | No | 49.2 % who selected response option |
| AMS 700 IPP 2005 Implant Group at 4-8 Weeks | Ability to Deflate Device With One Hand | Missing | 0.0 % who selected response option |
| AMS 700 IPP 2005 Implant Group at 3 Months Follow-up | Ability to Deflate Device With One Hand | Yes | 56.9 % who selected response option |
| AMS 700 IPP 2005 Implant Group at 3 Months Follow-up | Ability to Deflate Device With One Hand | No | 39.7 % who selected response option |
| AMS 700 IPP 2005 Implant Group at 3 Months Follow-up | Ability to Deflate Device With One Hand | Missing | 3.4 % who selected response option |
Primary
Ability to Inflate Device Using One Hand
Subjects were asked if they were able to inflate the device using one hand. Response options were: Yes, No
Time frame: 3 months, 6 months
Population: All subjects who attended the follow-up visits
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| AMS 700 IPP 2005 Implant Group at 4-8 Weeks | Ability to Inflate Device Using One Hand | Yes | 31 Participants |
| AMS 700 IPP 2005 Implant Group at 4-8 Weeks | Ability to Inflate Device Using One Hand | No | 30 Participants |
| AMS 700 IPP 2005 Implant Group at 4-8 Weeks | Ability to Inflate Device Using One Hand | Missing | 0 Participants |
| AMS 700 IPP 2005 Implant Group at 3 Months Follow-up | Ability to Inflate Device Using One Hand | Yes | 33 Participants |
| AMS 700 IPP 2005 Implant Group at 3 Months Follow-up | Ability to Inflate Device Using One Hand | No | 23 Participants |
| AMS 700 IPP 2005 Implant Group at 3 Months Follow-up | Ability to Inflate Device Using One Hand | Missing | 2 Participants |
Primary
Comparison Rating of the New Rear Tip Extender Design to Previous Design
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
Time frame: For duration of surgery
Population: Physician assessment of each patient for whom they used RTEs at time of implant
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| AMS 700 IPP 2005 Implant Group at 4-8 Weeks | Comparison Rating of the New Rear Tip Extender Design to Previous Design | % Much better | 40.9 percentage of physician responses |
| AMS 700 IPP 2005 Implant Group at 4-8 Weeks | Comparison Rating of the New Rear Tip Extender Design to Previous Design | % Somewhat better | 25.8 percentage of physician responses |
| AMS 700 IPP 2005 Implant Group at 4-8 Weeks | Comparison Rating of the New Rear Tip Extender Design to Previous Design | % Same | 31.8 percentage of physician responses |
| AMS 700 IPP 2005 Implant Group at 4-8 Weeks | Comparison Rating of the New Rear Tip Extender Design to Previous Design | % Somewhat worse | 1.5 percentage of physician responses |
| AMS 700 IPP 2005 Implant Group at 4-8 Weeks | Comparison Rating of the New Rear Tip Extender Design to Previous Design | % Much worse | 0.0 percentage of physician responses |
Primary
Comparison With Other Devices for Ease of Placement
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
Time frame: For duration of surgery
Population: Physician assessment of each subject at time of implant
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| AMS 700 IPP 2005 Implant Group at 4-8 Weeks | Comparison With Other Devices for Ease of Placement | Much easier | 27.5 Percentage of participants |
| AMS 700 IPP 2005 Implant Group at 4-8 Weeks | Comparison With Other Devices for Ease of Placement | Slightly easier | 37.7 Percentage of participants |
| AMS 700 IPP 2005 Implant Group at 4-8 Weeks | Comparison With Other Devices for Ease of Placement | Same | 33.3 Percentage of participants |
| AMS 700 IPP 2005 Implant Group at 4-8 Weeks | Comparison With Other Devices for Ease of Placement | Somewhat more difficult | 1.4 Percentage of participants |
| AMS 700 IPP 2005 Implant Group at 4-8 Weeks | Comparison With Other Devices for Ease of Placement | More difficult | 0.0 Percentage of participants |
Primary
Ease Attaching the New Snap Design Rear Tip Extender (RTE) to the Proximal Tip of the Cylinder
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.
Time frame: For duration of surgery
Population: Physician assessment of each patient at time of implant for whom they used the RTEs (rear tip extenders)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| AMS 700 IPP 2005 Implant Group at 4-8 Weeks | 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 |
| AMS 700 IPP 2005 Implant Group at 4-8 Weeks | 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 |
| AMS 700 IPP 2005 Implant Group at 4-8 Weeks | Ease Attaching the New Snap Design Rear Tip Extender (RTE) to the Proximal Tip of the Cylinder | % Neutral | 28.8 percentage of physician responses |
| AMS 700 IPP 2005 Implant Group at 4-8 Weeks | 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 |
| AMS 700 IPP 2005 Implant Group at 4-8 Weeks | 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
Ease of Cylinder Placement With the Enhanced Profile of the Proximal Tip
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
Time frame: For duration of surgery
Population: Physician assessment of each subject at time of implant
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| AMS 700 IPP 2005 Implant Group at 4-8 Weeks | Ease of Cylinder Placement With the Enhanced Profile of the Proximal Tip | Very easy | 56.5 Percentage of participants |
| AMS 700 IPP 2005 Implant Group at 4-8 Weeks | Ease of Cylinder Placement With the Enhanced Profile of the Proximal Tip | Moderately easy | 27.5 Percentage of participants |
| AMS 700 IPP 2005 Implant Group at 4-8 Weeks | Ease of Cylinder Placement With the Enhanced Profile of the Proximal Tip | Neither easy nor difficult | 15.9 Percentage of participants |
| AMS 700 IPP 2005 Implant Group at 4-8 Weeks | Ease of Cylinder Placement With the Enhanced Profile of the Proximal Tip | Moderately difficult | 0.0 Percentage of participants |
| AMS 700 IPP 2005 Implant Group at 4-8 Weeks | Ease of Cylinder Placement With the Enhanced Profile of the Proximal Tip | Very difficult | 0.0 Percentage of participants |
Primary
Ease of Dilation With the Reduced Angle of the Input Tubing
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
Time frame: Time of implant (surgery)
Population: Physician assessment of each subject at time of implant
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| AMS 700 IPP 2005 Implant Group at 4-8 Weeks | Ease of Dilation With the Reduced Angle of the Input Tubing | Yes | 56.5 Percentage of participants |
| AMS 700 IPP 2005 Implant Group at 4-8 Weeks | Ease of Dilation With the Reduced Angle of the Input Tubing | No/No Effect | 43.5 Percentage of participants |
Primary
Ease of Insertion of New Flare Design Reservoir
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 frame: For duration of surgery
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| AMS 700 IPP 2005 Implant Group at 4-8 Weeks | Ease of Insertion of New Flare Design Reservoir | Much easier | 1.4 Percentage of participants |
| AMS 700 IPP 2005 Implant Group at 4-8 Weeks | Ease of Insertion of New Flare Design Reservoir | Somewhat easier | 13.0 Percentage of participants |
| AMS 700 IPP 2005 Implant Group at 4-8 Weeks | Ease of Insertion of New Flare Design Reservoir | Same | 84.1 Percentage of participants |
| AMS 700 IPP 2005 Implant Group at 4-8 Weeks | Ease of Insertion of New Flare Design Reservoir | Somewhat harder | 1.4 Percentage of participants |
| AMS 700 IPP 2005 Implant Group at 4-8 Weeks | Ease of Insertion of New Flare Design Reservoir | Much harder | 0.0 Percentage of participants |
Primary
Ease of Locating the Deflation Block
Physicians were asked: Could the deflation button be easily located? Response options were: Yes, No, and Not Tested
Time frame: 4-8 week activation visit
Population: All subjects who attended the 4-8 week activation visit
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| AMS 700 IPP 2005 Implant Group at 4-8 Weeks | Ease of Locating the Deflation Block | Yes | 65 Participants |
| AMS 700 IPP 2005 Implant Group at 4-8 Weeks | Ease of Locating the Deflation Block | No | 1 Participants |
| AMS 700 IPP 2005 Implant Group at 4-8 Weeks | Ease of Locating the Deflation Block | Not tested | 0 Participants |
Primary
Ease of Locating the Inflation Pump Bulb
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 frame: 4-8 weeks
Population: All subjects who were implanted and attended the device activation visit at 4-8 weeks post-op
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AMS 700 IPP 2005 Implant Group at 4-8 Weeks | Ease of Locating the Inflation Pump Bulb | 63 Participants who easily located pumpbulb |
Primary
Ease of Pumping Device to Full Erection
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.
Time frame: 4-8 weeks post-op
Population: Subjects who attended the 4-8 week activation visit
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| AMS 700 IPP 2005 Implant Group at 4-8 Weeks | Ease of Pumping Device to Full Erection | Much Easier | 28 Participants |
| AMS 700 IPP 2005 Implant Group at 4-8 Weeks | Ease of Pumping Device to Full Erection | Somewhat Easier | 19 Participants |
| AMS 700 IPP 2005 Implant Group at 4-8 Weeks | Ease of Pumping Device to Full Erection | Same | 3 Participants |
| AMS 700 IPP 2005 Implant Group at 4-8 Weeks | Ease of Pumping Device to Full Erection | Somewhat Harder | 16 Participants |
| AMS 700 IPP 2005 Implant Group at 4-8 Weeks | Ease of Pumping Device to Full Erection | Harder | 0 Participants |
Primary
Ease of Training Patient to Deflate Device
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
Time frame: 4-8 weeks
Population: All subjects who attended the 4-8 follow-up visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| AMS 700 IPP 2005 Implant Group at 4-8 Weeks | Ease of Training Patient to Deflate Device | Somewhat Easier | 16.7 Percentage of participants |
| AMS 700 IPP 2005 Implant Group at 4-8 Weeks | Ease of Training Patient to Deflate Device | Somewhat harder | 19.7 Percentage of participants |
| AMS 700 IPP 2005 Implant Group at 4-8 Weeks | Ease of Training Patient to Deflate Device | Same | 7.6 Percentage of participants |
| AMS 700 IPP 2005 Implant Group at 4-8 Weeks | Ease of Training Patient to Deflate Device | Much harder | 1.5 Percentage of participants |
| AMS 700 IPP 2005 Implant Group at 4-8 Weeks | Ease of Training Patient to Deflate Device | Much Easier | 54.5 Percentage of participants |
| AMS 700 IPP 2005 Implant Group at 3 Months Follow-up | Ease of Training Patient to Deflate Device | Much harder | 1.5 Percentage of participants |
| AMS 700 IPP 2005 Implant Group at 3 Months Follow-up | Ease of Training Patient to Deflate Device | Much Easier | 59.1 Percentage of participants |
| AMS 700 IPP 2005 Implant Group at 3 Months Follow-up | Ease of Training Patient to Deflate Device | Somewhat Easier | 27.3 Percentage of participants |
| AMS 700 IPP 2005 Implant Group at 3 Months Follow-up | Ease of Training Patient to Deflate Device | Same | 6.1 Percentage of participants |
| AMS 700 IPP 2005 Implant Group at 3 Months Follow-up | Ease of Training Patient to Deflate Device | Somewhat harder | 6.1 Percentage of participants |
Primary
Ease of Training Patient to Inflate Device Compared to the AMS Tactile Pump
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
Time frame: 4-8 weeks follow-up
Population: All subjects who attended the 4-8 week activation visit
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| AMS 700 IPP 2005 Implant Group at 4-8 Weeks | Ease of Training Patient to Inflate Device Compared to the AMS Tactile Pump | Much easier | 36 Participants |
| AMS 700 IPP 2005 Implant Group at 4-8 Weeks | Ease of Training Patient to Inflate Device Compared to the AMS Tactile Pump | Somewhat easier | 11 Participants |
| AMS 700 IPP 2005 Implant Group at 4-8 Weeks | Ease of Training Patient to Inflate Device Compared to the AMS Tactile Pump | Same | 5 Participants |
| AMS 700 IPP 2005 Implant Group at 4-8 Weeks | Ease of Training Patient to Inflate Device Compared to the AMS Tactile Pump | Somewhat harder | 13 Participants |
| AMS 700 IPP 2005 Implant Group at 4-8 Weeks | Ease of Training Patient to Inflate Device Compared to the AMS Tactile Pump | Much harder | 1 Participants |
Primary
Ease of Training Patient to Inflate Device Compared to the Standard AMS 700 Pump
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
Time frame: 4-8 week activation visit
Population: All subjects who attended the 4-8 week activation visit
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| AMS 700 IPP 2005 Implant Group at 4-8 Weeks | Ease of Training Patient to Inflate Device Compared to the Standard AMS 700 Pump | Much easier | 39 Participants |
| AMS 700 IPP 2005 Implant Group at 4-8 Weeks | Ease of Training Patient to Inflate Device Compared to the Standard AMS 700 Pump | Same | 4 Participants |
| AMS 700 IPP 2005 Implant Group at 4-8 Weeks | Ease of Training Patient to Inflate Device Compared to the Standard AMS 700 Pump | Somewhat harder | 4 Participants |
| AMS 700 IPP 2005 Implant Group at 4-8 Weeks | Ease of Training Patient to Inflate Device Compared to the Standard AMS 700 Pump | Much harder | 1 Participants |
| AMS 700 IPP 2005 Implant Group at 4-8 Weeks | Ease of Training Patient to Inflate Device Compared to the Standard AMS 700 Pump | Somewhat easier | 18 Participants |
Primary
Level of Flaccidity Achieved
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.
Time frame: 4-8 weeks
Population: All subjects who attended the 4-8 week follow-up visit
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| AMS 700 IPP 2005 Implant Group at 4-8 Weeks | Level of Flaccidity Achieved | Excellent | 53.0 Percentage of participants |
| AMS 700 IPP 2005 Implant Group at 4-8 Weeks | Level of Flaccidity Achieved | Very Good | 34.8 Percentage of participants |
| AMS 700 IPP 2005 Implant Group at 4-8 Weeks | Level of Flaccidity Achieved | Good | 12.1 Percentage of participants |
| AMS 700 IPP 2005 Implant Group at 4-8 Weeks | Level of Flaccidity Achieved | Fair | 0.0 Percentage of participants |
| AMS 700 IPP 2005 Implant Group at 4-8 Weeks | Level of Flaccidity Achieved | Poor | 0.0 Percentage of participants |
Primary
Patient Satisfaction With Deflation Mechanism
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
Time frame: 3 Months, 6 Months
Population: All subjects who attended the 3 month and/or 6 month follow-up visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| AMS 700 IPP 2005 Implant Group at 4-8 Weeks | Patient Satisfaction With Deflation Mechanism | Very satisified | 42.6 Percentage of participants |
| AMS 700 IPP 2005 Implant Group at 4-8 Weeks | Patient Satisfaction With Deflation Mechanism | Moderately satisfied | 24.6 Percentage of participants |
| AMS 700 IPP 2005 Implant Group at 4-8 Weeks | Patient Satisfaction With Deflation Mechanism | Somewhat satisified | 16.4 Percentage of participants |
| AMS 700 IPP 2005 Implant Group at 4-8 Weeks | Patient Satisfaction With Deflation Mechanism | Somewhat dissatisfied | 13.1 Percentage of participants |
| AMS 700 IPP 2005 Implant Group at 4-8 Weeks | Patient Satisfaction With Deflation Mechanism | Moderately dissatisfied | 3.3 Percentage of participants |
| AMS 700 IPP 2005 Implant Group at 4-8 Weeks | Patient Satisfaction With Deflation Mechanism | Very dissatisified | 0.0 Percentage of participants |
| AMS 700 IPP 2005 Implant Group at 3 Months Follow-up | Patient Satisfaction With Deflation Mechanism | Moderately dissatisfied | 0.0 Percentage of participants |
| AMS 700 IPP 2005 Implant Group at 3 Months Follow-up | Patient Satisfaction With Deflation Mechanism | Very satisified | 56.9 Percentage of participants |
| AMS 700 IPP 2005 Implant Group at 3 Months Follow-up | Patient Satisfaction With Deflation Mechanism | Somewhat dissatisfied | 3.4 Percentage of participants |
| AMS 700 IPP 2005 Implant Group at 3 Months Follow-up | Patient Satisfaction With Deflation Mechanism | Moderately satisfied | 20.7 Percentage of participants |
| AMS 700 IPP 2005 Implant Group at 3 Months Follow-up | Patient Satisfaction With Deflation Mechanism | Very dissatisified | 1.7 Percentage of participants |
| AMS 700 IPP 2005 Implant Group at 3 Months Follow-up | Patient Satisfaction With Deflation Mechanism | Somewhat satisified | 17.2 Percentage of participants |
Primary
Physician Evaluation of OR Device Preparation Time
Physicians were asked if the design of the pre-threaded needle facilitated faster loading of the Furlow tool. Answer options were: Yes; No
Time frame: For duration of surgery
Population: Physician assessment of each patient at time of implant
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| AMS 700 IPP 2005 Implant Group at 4-8 Weeks | Physician Evaluation of OR Device Preparation Time | % Assessed as Faster | 53.6 percentage of physician responses |
| AMS 700 IPP 2005 Implant Group at 4-8 Weeks | Physician Evaluation of OR Device Preparation Time | % Assessed as Not as Fast | 46.4 percentage of physician responses |
Primary
Physician Evaluation of the Pre-threaded Suture Needle for Ease of Loading Furlow Tool
Physicians were asked to assess the overall design compared to the current non-threaded design. Answer options: Significantly better; Better; Same; Worse; Significantly worse
Time frame: For duration of surgery
Population: Physician assessment of each patient at time of implant
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| AMS 700 IPP 2005 Implant Group at 4-8 Weeks | Physician Evaluation of the Pre-threaded Suture Needle for Ease of Loading Furlow Tool | % Significantly Better | 1.4 percentage of physician responses |
| AMS 700 IPP 2005 Implant Group at 4-8 Weeks | Physician Evaluation of the Pre-threaded Suture Needle for Ease of Loading Furlow Tool | % Worse | 14.5 percentage of physician responses |
| AMS 700 IPP 2005 Implant Group at 4-8 Weeks | Physician Evaluation of the Pre-threaded Suture Needle for Ease of Loading Furlow Tool | Significantly worse | 0.0 percentage of physician responses |
| AMS 700 IPP 2005 Implant Group at 4-8 Weeks | Physician Evaluation of the Pre-threaded Suture Needle for Ease of Loading Furlow Tool | % Better | 37.7 percentage of physician responses |
| AMS 700 IPP 2005 Implant Group at 4-8 Weeks | Physician Evaluation of the Pre-threaded Suture Needle for Ease of Loading Furlow Tool | % Same | 46.4 percentage of physician responses |
Primary
Physician Evaluation of the Pre-threaded Suture Needle for Ease of Removing Sheath
Physicians were asked, Was it easy to remove the blue suture sheath and white needle holder? Answer options were: Yes; No, please explain
Time frame: For duration of surgery
Population: Physician assessment of each patient at time of implant
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| AMS 700 IPP 2005 Implant Group at 4-8 Weeks | Physician Evaluation of the Pre-threaded Suture Needle for Ease of Removing Sheath | % Yes | 88.4 percentage of physician responses |
| AMS 700 IPP 2005 Implant Group at 4-8 Weeks | Physician Evaluation of the Pre-threaded Suture Needle for Ease of Removing Sheath | % No | 11.6 percentage of physician responses |
Primary
Quality of Erection (Suitability for Intercourse)
Physicians were asked: After inflation, did the erection appear suitable for sexual intercourse? Response options were: Yes, No, Not Assessed
Time frame: 4-8 weeks, 3 months, 6 months
Population: Subjects who attended the 4-8 week activation visit.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AMS 700 IPP 2005 Implant Group at 4-8 Weeks | Quality of Erection (Suitability for Intercourse) | 66 participants who answered yes |
| AMS 700 IPP 2005 Implant Group at 3 Months Follow-up | Quality of Erection (Suitability for Intercourse) | 60 participants who answered yes |
| AMS 700 IPP 2005 Implant Group at 6 Months Follow-up | Quality of Erection (Suitability for Intercourse) | 59 participants who answered yes |
Primary
Rating of the Rigidity of the Cylinders
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
Time frame: 4-8 weeks follow-up
Population: All subjects who attended the 4-8 week follow-up visit
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| AMS 700 IPP 2005 Implant Group at 4-8 Weeks | Rating of the Rigidity of the Cylinders | Excellent | 40.9 Percentage of participants |
| AMS 700 IPP 2005 Implant Group at 4-8 Weeks | Rating of the Rigidity of the Cylinders | Very good | 43.9 Percentage of participants |
| AMS 700 IPP 2005 Implant Group at 4-8 Weeks | Rating of the Rigidity of the Cylinders | Good | 15.2 Percentage of participants |
| AMS 700 IPP 2005 Implant Group at 4-8 Weeks | Rating of the Rigidity of the Cylinders | Fair | 0.0 Percentage of participants |
| AMS 700 IPP 2005 Implant Group at 4-8 Weeks | Rating of the Rigidity of the Cylinders | Poor | 0.0 Percentage of participants |
Primary
Subjective Force Required to Inflate Device
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
Time frame: 3 months, 6 months
Population: Subjects who attended the 3 month and/or 6 month follow-up visit
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| AMS 700 IPP 2005 Implant Group at 4-8 Weeks | Subjective Force Required to Inflate Device | Reasonable | 50 Participants |
| AMS 700 IPP 2005 Implant Group at 4-8 Weeks | Subjective Force Required to Inflate Device | Too much | 11 Participants |
| AMS 700 IPP 2005 Implant Group at 4-8 Weeks | Subjective Force Required to Inflate Device | Missing | 0 Participants |
| AMS 700 IPP 2005 Implant Group at 3 Months Follow-up | Subjective Force Required to Inflate Device | Reasonable | 48 Participants |
| AMS 700 IPP 2005 Implant Group at 3 Months Follow-up | Subjective Force Required to Inflate Device | Too much | 9 Participants |
| AMS 700 IPP 2005 Implant Group at 3 Months Follow-up | Subjective Force Required to Inflate Device | Missing | 1 Participants |
Primary
Subjective Force Required to Initiate Deflation
Subjects were asked: The force required to initiate deflation was... The response options were: Too Much and Reasonable amount.
Time frame: 3 months, 6 months
Population: All subjects who attended the follow-up visit
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| AMS 700 IPP 2005 Implant Group at 4-8 Weeks | Subjective Force Required to Initiate Deflation | Reasonable | 54 Participants |
| AMS 700 IPP 2005 Implant Group at 4-8 Weeks | Subjective Force Required to Initiate Deflation | Too Much | 6 Participants |
| AMS 700 IPP 2005 Implant Group at 4-8 Weeks | Subjective Force Required to Initiate Deflation | No response | 1 Participants |
| AMS 700 IPP 2005 Implant Group at 3 Months Follow-up | Subjective Force Required to Initiate Deflation | Reasonable | 51 Participants |
| AMS 700 IPP 2005 Implant Group at 3 Months Follow-up | Subjective Force Required to Initiate Deflation | Too Much | 6 Participants |
| AMS 700 IPP 2005 Implant Group at 3 Months Follow-up | Subjective Force Required to Initiate Deflation | No response | 1 Participants |
Primary
Time to Complete Deflation
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
Time frame: 3 months, 6 months
Population: Physician assessment of all subjects who attended the 3 month and/or 6 month follow-up visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| AMS 700 IPP 2005 Implant Group at 4-8 Weeks | Time to Complete Deflation | 5-6 seconds | 18.3 Percentage of participants |
| AMS 700 IPP 2005 Implant Group at 4-8 Weeks | Time to Complete Deflation | 7-8 seconds | 13.3 Percentage of participants |
| AMS 700 IPP 2005 Implant Group at 4-8 Weeks | Time to Complete Deflation | 9-10 seconds | 20.0 Percentage of participants |
| AMS 700 IPP 2005 Implant Group at 4-8 Weeks | Time to Complete Deflation | 10-15 seconds | 21.7 Percentage of participants |
| AMS 700 IPP 2005 Implant Group at 4-8 Weeks | Time to Complete Deflation | 15-20 seconds | 16.7 Percentage of participants |
| AMS 700 IPP 2005 Implant Group at 4-8 Weeks | Time to Complete Deflation | 20-25 seconds | 3.3 Percentage of participants |
| AMS 700 IPP 2005 Implant Group at 4-8 Weeks | Time to Complete Deflation | 25-30 seconds | 6.7 Percentage of participants |
| AMS 700 IPP 2005 Implant Group at 4-8 Weeks | Time to Complete Deflation | 30-35 seconds | 0.0 Percentage of participants |
| AMS 700 IPP 2005 Implant Group at 4-8 Weeks | Time to Complete Deflation | 35-40 seconds | 0.0 Percentage of participants |
| AMS 700 IPP 2005 Implant Group at 4-8 Weeks | Time to Complete Deflation | 40-45 seconds | 0.0 Percentage of participants |
| AMS 700 IPP 2005 Implant Group at 4-8 Weeks | Time to Complete Deflation | 45-50 seconds | 0.0 Percentage of participants |
| AMS 700 IPP 2005 Implant Group at 4-8 Weeks | Time to Complete Deflation | More than 50 seconds | 0.0 Percentage of participants |
| AMS 700 IPP 2005 Implant Group at 3 Months Follow-up | Time to Complete Deflation | 45-50 seconds | 0.0 Percentage of participants |
| AMS 700 IPP 2005 Implant Group at 3 Months Follow-up | Time to Complete Deflation | 5-6 seconds | 20.7 Percentage of participants |
| AMS 700 IPP 2005 Implant Group at 3 Months Follow-up | Time to Complete Deflation | 25-30 seconds | 1.7 Percentage of participants |
| AMS 700 IPP 2005 Implant Group at 3 Months Follow-up | Time to Complete Deflation | 7-8 seconds | 17.2 Percentage of participants |
| AMS 700 IPP 2005 Implant Group at 3 Months Follow-up | Time to Complete Deflation | 40-45 seconds | 0.0 Percentage of participants |
| AMS 700 IPP 2005 Implant Group at 3 Months Follow-up | Time to Complete Deflation | 9-10 seconds | 27.6 Percentage of participants |
| AMS 700 IPP 2005 Implant Group at 3 Months Follow-up | Time to Complete Deflation | 30-35 seconds | 0.0 Percentage of participants |
| AMS 700 IPP 2005 Implant Group at 3 Months Follow-up | Time to Complete Deflation | 10-15 seconds | 10.3 Percentage of participants |
| AMS 700 IPP 2005 Implant Group at 3 Months Follow-up | Time to Complete Deflation | More than 50 seconds | 0.0 Percentage of participants |
| AMS 700 IPP 2005 Implant Group at 3 Months Follow-up | Time to Complete Deflation | 15-20 seconds | 12.0 Percentage of participants |
| AMS 700 IPP 2005 Implant Group at 3 Months Follow-up | Time to Complete Deflation | 35-40 seconds | 3.4 Percentage of participants |
| AMS 700 IPP 2005 Implant Group at 3 Months Follow-up | Time to Complete Deflation | 20-25 seconds | 6.9 Percentage of participants |
Primary
Time to Complete Inflation
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
Time frame: 4-8 week activation visit
Population: All subjects who attended the 4-8 activation visit
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| AMS 700 IPP 2005 Implant Group at 4-8 Weeks | Time to Complete Inflation | 2-3 minutes | 2 Participants |
| AMS 700 IPP 2005 Implant Group at 4-8 Weeks | Time to Complete Inflation | Over 3 minutes | 8 Participants |
| AMS 700 IPP 2005 Implant Group at 4-8 Weeks | Time to Complete Inflation | 60-90 seconds | 12 Participants |
| AMS 700 IPP 2005 Implant Group at 4-8 Weeks | Time to Complete Inflation | 90-120 seconds | 4 Participants |
| AMS 700 IPP 2005 Implant Group at 4-8 Weeks | Time to Complete Inflation | 0-30 seconds | 17 Participants |
| AMS 700 IPP 2005 Implant Group at 4-8 Weeks | Time to Complete Inflation | 30-60 seconds | 23 Participants |