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Trial record 93 of 494 for:    penis

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00636506
Recruitment Status : Completed
First Posted : March 14, 2008
Results First Posted : July 22, 2019
Last Update Posted : July 22, 2019
Sponsor:
Information provided by (Responsible Party):
American Medical Systems

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Erectile Dysfunction
Intervention Device: AMS 700 IPP with MS Pump
Enrollment 76
Recruitment Details  
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.
Arm/Group Title AMS 700 IPP 2005 Implant Group
Hide Arm/Group Description Male subjects 21 years of age and older who are implanted with an AMS 700 IPP with MS pump for erectile dysfunction.
Period Title: Overall Study
Started 76
Completed 60
Not Completed 16
Reason Not Completed
Lost to Follow-up             8
Explanted             1
Withdrawal by Subject             6
Procedure aborted             1
Arm/Group Title AMS 700 IPP 2005 Implant Group
Hide Arm/Group Description Male subjects 21 years of age and older who choose to undergo an IPP implantation for erectile dysfunction.
Overall Number of Baseline Participants 76
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 76 participants
<=18 years
0
   0.0%
Between 18 and 65 years
47
  61.8%
>=65 years
29
  38.2%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 76 participants
60.1  (9.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 76 participants
Female
0
   0.0%
Male
76
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 76 participants
76
1.Primary Outcome
Title Ease of Locating the Inflation Pump Bulb
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects who were implanted and attended the device activation visit at 4-8 weeks post-op
Arm/Group Title AMS 700 IPP 2005 Implant Group at 4-8 Weeks
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 66
Measure Type: Number
Unit of Measure: Participants who easily located pumpbulb
63
2.Primary Outcome
Title Ease of Pumping Device to Full Erection
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects who attended the 4-8 week activation visit
Arm/Group Title AMS 700 IPP 2005 Implant Group
Hide Arm/Group Description:

Male subjects 21 years of age and older who are implanted with an AMS 700 IPP with MS pump for erectile dysfunction.

AMS 700 IPP with MS Pump: AMS 700 Series Inflatable Penile Prosthesis with MS Pump

Overall Number of Participants Analyzed 66
Measure Type: Number
Unit of Measure: Participants
Much Easier 28
Somewhat Easier 19
Same 3
Somewhat Harder 16
Harder 0
3.Primary Outcome
Title Quality of Erection (Suitability for Intercourse)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects who attended the 4-8 week activation visit.
Arm/Group Title AMS 700 IPP 2005 Implant Group at 4-8 Weeks Follow-up AMS 700 IPP 2005 Implant Group at 3 Months Follow-up AMS 700 IPP 2005 Implant Group at 6 Months Follow-up
Hide Arm/Group Description:
Male subjects 21 years of age and older who are implanted with an AMS 700 IPP with MS pump for erectile dysfunction at 4-8 weeks 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.
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.
Overall Number of Participants Analyzed 66 61 60
Measure Type: Number
Unit of Measure: participants who answered yes
66 60 59
4.Primary Outcome
Title Subjective Force Required to Inflate Device
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects who attended the 3 month and/or 6 month follow-up visit
Arm/Group Title AMS 700 IPP 2005 Implant Group at 3 Months Follow-up AMS 700 IPP 2005 Implant Group at 6 Months Follow-up
Hide Arm/Group Description:
Male subjects 21 years of age and older who are implanted with an AMS 700 IPP with MS pump for erectile dysfunction.
Male subjects 21 years of age and older who are implanted with an AMS 700 IPP with MS pump for erectile dysfunction.
Overall Number of Participants Analyzed 61 58
Measure Type: Number
Unit of Measure: Participants
Reasonable 50 48
Too much 11 9
Missing 0 1
5.Primary Outcome
Title Ability to Inflate Device Using One Hand
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects who attended the follow-up visits
Arm/Group Title AMS 700 IPP 2005 Implant Group at 3 Months AMS 700 IPP 2005 Implant Group at 6 Months
Hide Arm/Group Description:
Male subjects 21 years of age and older who are implanted with an AMS 700 IPP with MS pump for erectile dysfunction and who attended the 3 month follow-up visit.
Male subjects 21 years of age and older who are implanted with an AMS 700 IPP with MS pump for erectile dysfunction and who attended the 6 month follow-up visit.
Overall Number of Participants Analyzed 61 58
Measure Type: Number
Unit of Measure: Participants
Yes 31 33
No 30 23
Missing 0 2
6.Primary Outcome
Title Ease of Training Patient to Inflate Device Compared to the AMS Tactile Pump
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects who attended the 4-8 week activation visit
Arm/Group Title AMS 700 IPP 2005 Implant Group
Hide Arm/Group Description:
Male subjects 21 years of age and older who are implanted with an AMS 700 IPP with MS pump for erectile dysfunction.
Overall Number of Participants Analyzed 66
Measure Type: Number
Unit of Measure: Participants
Much easier 36
Somewhat easier 11
Same 5
Somewhat harder 13
Much harder 1
7.Primary Outcome
Title Ease of Training Patient to Inflate Device Compared to the Standard AMS 700 Pump
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects who attended the 4-8 week activation visit
Arm/Group Title AMS 700 IPP 2005 Implant Group
Hide Arm/Group Description:
Male subjects 21 years of age and older who are implanted with an AMS 700 IPP with MS pump for erectile dysfunction.
Overall Number of Participants Analyzed 66
Measure Type: Number
Unit of Measure: Participants
Much easier 39
Somewhat easier 18
Same 4
Somewhat harder 4
Much harder 1
8.Primary Outcome
Title Time to Complete Inflation
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects who attended the 4-8 activation visit
Arm/Group Title AMS 700 IPP 2005 Implant Group
Hide Arm/Group Description:
Male subjects 21 years of age and older who are implanted with an AMS 700 IPP with MS pump for erectile dysfunction.
Overall Number of Participants Analyzed 66
Measure Type: Number
Unit of Measure: Participants
0-30 seconds 17
30-60 seconds 23
60-90 seconds 12
90-120 seconds 4
2-3 minutes 2
Over 3 minutes 8
9.Primary Outcome
Title Ease of Locating the Deflation Block
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects who attended the 4-8 week activation visit
Arm/Group Title AMS 700 IPP 2005 Implant Group
Hide Arm/Group Description:
Male subjects 21 years of age and older who are implanted with an AMS 700 IPP with MS pump for erectile dysfunction.
Overall Number of Participants Analyzed 66
Measure Type: Number
Unit of Measure: Participants
Yes 65
No 1
Not tested 0
10.Primary Outcome
Title Subjective Force Required to Initiate Deflation
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects who attended the follow-up visit
Arm/Group Title AMS 700 IPP 2005 Implant Group at 3 Months Follow-up AMS 700 IPP 2005 Implant Group at 6 Months Follow-up
Hide Arm/Group Description:
Subjects implanted with the AMS 700 IPP 2005 who attended the 3 month follow-up visit
Subjects implanted with the AMS 700 IPP 2005 who attended the 6 month follow-up visit
Overall Number of Participants Analyzed 61 58
Measure Type: Number
Unit of Measure: Participants
Reasonable 54 51
Too Much 6 6
No response 1 1
11.Primary Outcome
Title Ability to Deflate Cylinders by Pressing the Deflation Button for Only a Few Seconds
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Physician assessment of all subjects who attended the 3 month and/or 6 month follow-up visit.
Arm/Group Title 3 Months - AMS 700 IPP 2005 Implant Group 6 Months - AMS 700 IPP 2005 Implant Group
Hide Arm/Group Description:
Male subjects 21 years of age and older who are implanted with an AMS 700 IPP with MS pump for erectile dysfunction and who attended the 3 month follow-up visit.
Male subjects 21 years of age and older who are implanted with an AMS 700 IPP with MS pump for erectile dysfunction and who attended the 6 month follow-up visit.
Overall Number of Participants Analyzed 61 59
Measure Type: Number
Unit of Measure: Percentage of Participants
1-2 seconds 18.0 16.9
3-4 seconds 45.9 61.0
5-6 seconds 26.2 20.3
7-8 seconds 9.8 1.7
9-10 seconds 0 0
More than 10 seconds 0 0
12.Primary Outcome
Title Time to Complete Deflation
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Physician assessment of all subjects who attended the 3 month and/or 6 month follow-up visit.
Arm/Group Title 3 Months - AMS 700 IPP 2005 Implant Group 6 Months - AMS 700 IPP 2005 Implant Group
Hide Arm/Group Description:
Male subjects 21 years of age and older who are implanted with an AMS 700 IPP with MS pump for erectile dysfunction attending the 3 month visit.
Male subjects 21 years of age and older who are implanted with an AMS 700 IPP with MS pump for erectile dysfunction attending the 6 month visit.
Overall Number of Participants Analyzed 61 58
Measure Type: Number
Unit of Measure: Percentage of participants
5-6 seconds 18.3 20.7
7-8 seconds 13.3 17.2
9-10 seconds 20.0 27.6
10-15 seconds 21.7 10.3
15-20 seconds 16.7 12.0
20-25 seconds 3.3 6.9
25-30 seconds 6.7 1.7
30-35 seconds 0.0 0.0
35-40 seconds 0.0 3.4
40-45 seconds 0.0 0.0
45-50 seconds 0.0 0.0
More than 50 seconds 0.0 0.0
13.Primary Outcome
Title Ability to Deflate Device With One Hand
Hide Description "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
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects who attended the 3 month and/or 6 month follow-up visit.
Arm/Group Title 3 Months - AMS 700 IPP 2005 Implant Group 6 Months - AMS 700 IPP 2005 Implant Group
Hide Arm/Group Description:
Male subjects 21 years of age and older who are implanted with an AMS 700 IPP with MS pump for erectile dysfunction and who attended the 3 month follow-up visit.
Male subjects 21 years of age and older who are implanted with an AMS 700 IPP with MS pump for erectile dysfunction and who attended the 6 month follow-up visit.
Overall Number of Participants Analyzed 61 58
Measure Type: Number
Unit of Measure: % who selected response option
Yes 50.8 56.9
No 49.2 39.7
Missing 0.0 3.4
14.Primary Outcome
Title Level of Flaccidity Achieved
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects who attended the 4-8 week follow-up visit
Arm/Group Title AMS 700 IPP 2005 Implant Group
Hide Arm/Group Description:
Male subjects 21 years of age and older who are implanted with an AMS 700 IPP with MS pump for erectile dysfunction.
Overall Number of Participants Analyzed 66
Measure Type: Number
Unit of Measure: Percentage of participants
Excellent 53.0
Very Good 34.8
Good 12.1
Fair 0.0
Poor 0.0
15.Primary Outcome
Title Ease of Training Patient to Deflate Device
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects who attended the 4-8 follow-up visit.
Arm/Group Title AMS Tactile Pump Standard AMS 700 Pump
Hide Arm/Group Description:
Male subjects 21 years of age and older who are implanted with an AMS 700 IPP with MS pump for erectile dysfunction.
Male subjects 21 years of age and older who are implanted with an AMS 700 IPP with MS pump for erectile dysfunction.
Overall Number of Participants Analyzed 66 66
Measure Type: Number
Unit of Measure: Percentage of participants
Much Easier 54.5 59.1
Somewhat Easier 16.7 27.3
Same 7.6 6.1
Somewhat harder 19.7 6.1
Much harder 1.5 1.5
16.Primary Outcome
Title Patient Satisfaction With Deflation Mechanism
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects who attended the 3 month and/or 6 month follow-up visit.
Arm/Group Title 3 Months - AMS 700 IPP 2005 Implant Group 6 Months - AMS 700 IPP 2005 Implant Group
Hide Arm/Group Description:
Male subjects 21 years of age and older who are implanted with an AMS 700 IPP with MS pump for erectile dysfunction and who attended the 3 month follow-up visit.
Male subjects 21 years of age and older who are implanted with an AMS 700 IPP with MS pump for erectile dysfunction and who attended the 6 month follow-up visit.
Overall Number of Participants Analyzed 61 58
Measure Type: Number
Unit of Measure: Percentage of participants
Very satisified 42.6 56.9
Moderately satisfied 24.6 20.7
Somewhat satisified 16.4 17.2
Somewhat dissatisfied 13.1 3.4
Moderately dissatisfied 3.3 0.0
Very dissatisified 0.0 1.7
17.Primary Outcome
Title Ease of Dilation With the Reduced Angle of the Input Tubing
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
Physician assessment of each subject at time of implant
Arm/Group Title AMS 700 IPP 2005 Implant Group
Hide Arm/Group Description:
Male subjects 21 years of age and older who are implanted with an AMS 700 IPP with MS pump for erectile dysfunction.
Overall Number of Participants Analyzed 69
Measure Type: Number
Unit of Measure: Percentage of participants
Yes 56.5
No/No Effect 43.5
18.Primary Outcome
Title Ease of Cylinder Placement With the Enhanced Profile of the Proximal Tip
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Physician assessment of each subject at time of implant
Arm/Group Title AMS 700 IPP 2005 Implant Group
Hide Arm/Group Description:
Male subjects 21 years of age and older who are implanted with an AMS 700 IPP with MS pump for erectile dysfunction.
Overall Number of Participants Analyzed 69
Measure Type: Number
Unit of Measure: Percentage of participants
Very easy 56.5
Moderately easy 27.5
Neither easy nor difficult 15.9
Moderately difficult 0.0
Very difficult 0.0
19.Primary Outcome
Title Comparison With Other Devices for Ease of Placement
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Physician assessment of each subject at time of implant
Arm/Group Title AMS 700 IPP 2005 Implant Group
Hide Arm/Group Description:
Male subjects 21 years of age and older who are implanted with an AMS 700 IPP with MS pump for erectile dysfunction.
Overall Number of Participants Analyzed 69
Measure Type: Number
Unit of Measure: Percentage of participants
Much easier 27.5
Slightly easier 37.7
Same 33.3
Somewhat more difficult 1.4
More difficult 0.0
20.Primary Outcome
Title Rating of the Rigidity of the Cylinders
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects who attended the 4-8 week follow-up visit
Arm/Group Title AMS 700 IPP 2005 Implant Group
Hide Arm/Group Description:
Male subjects 21 years of age and older who are implanted with an AMS 700 IPP with MS pump for erectile dysfunction.
Overall Number of Participants Analyzed 66
Measure Type: Number
Unit of Measure: Percentage of participants
Excellent 40.9
Very good 43.9
Good 15.2
Fair 0.0
Poor 0.0
21.Primary Outcome
Title Ease of Insertion of New Flare Design Reservoir
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title AMS 700 IPP 2005 Implant Group
Hide Arm/Group Description:
Male subjects 21 years of age and older who are implanted with an AMS 700 IPP with MS pump for erectile dysfunction.
Overall Number of Participants Analyzed 69
Measure Type: Number
Unit of Measure: Percentage of participants
Much easier 1.4
Somewhat easier 13.0
Same 84.1
Somewhat harder 1.4
Much harder 0.0
22.Primary Outcome
Title Ability of New Flare Design to Remain in Place
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Physician assessment of each patient at time of implant
Arm/Group Title AMS 700 IPP 2005 Implant Group
Hide Arm/Group Description:
Male subjects 21 years of age and older who are implanted with an AMS 700 IPP with MS pump for erectile dysfunction.
Overall Number of Participants Analyzed 69
Measure Type: Number
Unit of Measure: Percentage of participants
% Yes 100
% No 0
23.Primary Outcome
Title Ease Attaching the New Snap Design Rear Tip Extender (RTE) to the Proximal Tip of the Cylinder
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Physician assessment of each patient at time of implant for whom they used the RTEs (rear tip extenders)
Arm/Group Title AMS 700 IPP 2005 Implant Group
Hide Arm/Group Description:
Male subjects 21 years of age and older who are implanted with an AMS 700 IPP with MS pump for erectile dysfunction.
Overall Number of Participants Analyzed 66
Measure Type: Number
Unit of Measure: percentage of physician responses
% Very satisfied 50.0
% Moderately satisfied 16.7
% Neutral 28.8
% Moderately dissatisfied 1.5
% Very dissatisfied 3.0
24.Primary Outcome
Title Comparison Rating of the New Rear Tip Extender Design to Previous Design
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Physician assessment of each patient for whom they used RTEs at time of implant
Arm/Group Title AMS 700 IPP 2005 Implant Group With RTEs
Hide Arm/Group Description:
Male subjects 21 years of age and older who are implanted with an AMS 700 IPP with MS pump for erectile dysfunction for whom physicians used RTEs.
Overall Number of Participants Analyzed 66
Measure Type: Number
Unit of Measure: percentage of physician responses
% Much better 40.9
% Somewhat better 25.8
% Same 31.8
% Somewhat worse 1.5
% Much worse 0.0
25.Primary Outcome
Title Physician Evaluation of the Pre-threaded Suture Needle for Ease of Removing Sheath
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Physician assessment of each patient at time of implant
Arm/Group Title AMS 700 IPP 2005 Implant Group
Hide Arm/Group Description:
Male subjects 21 years of age and older who are implanted with an AMS 700 IPP with MS pump for erectile dysfunction.
Overall Number of Participants Analyzed 69
Measure Type: Number
Unit of Measure: percentage of physician responses
% Yes 88.4
% No 11.6
26.Primary Outcome
Title Physician Evaluation of the Pre-threaded Suture Needle for Ease of Loading Furlow Tool
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Physician assessment of each patient at time of implant
Arm/Group Title AMS 700 IPP 2005 Implant Group
Hide Arm/Group Description:
Male subjects 21 years of age and older who are implanted with an AMS 700 IPP with MS pump for erectile dysfunction.
Overall Number of Participants Analyzed 69
Measure Type: Number
Unit of Measure: percentage of physician responses
% Significantly Better 1.4
% Better 37.7
% Same 46.4
% Worse 14.5
Significantly worse 0.0
27.Primary Outcome
Title Physician Evaluation of OR Device Preparation Time
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Physician assessment of each patient at time of implant
Arm/Group Title AMS 700 IPP 2005 Implant Group
Hide Arm/Group Description:
Male subjects 21 years of age and older who are implanted with an AMS 700 IPP with MS pump for erectile dysfunction.
Overall Number of Participants Analyzed 69
Measure Type: Number
Unit of Measure: percentage of physician responses
% Assessed as Faster 53.6
% Assessed as Not as Fast 46.4
Time Frame [Not Specified]
Adverse Event Reporting Description Adverse events are assessed at the time of implant and at each follow-up visit.
 
Arm/Group Title AMS 700 IPP 2005 Implant Group
Hide Arm/Group Description Male subjects 21 years of age and older who choose to undergo an IPP implantation for erectile dysfunction.
All-Cause Mortality
AMS 700 IPP 2005 Implant Group
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
AMS 700 IPP 2005 Implant Group
Affected / at Risk (%) # Events
Total   6/69 (8.70%)    
Infections and infestations   
Device Infection   1/69 (1.45%)  1
Infection  [1]  1/69 (1.45%)  1
Reproductive system and breast disorders   
Urogenital Edema and Pain   1/69 (1.45%)  1
Device extrusion/erosion   1/69 (1.45%)  1
Cylinder Erosion   1/69 (1.45%)  1
Urethral Erosion  [2]  1/69 (1.45%)  1
Indicates events were collected by systematic assessment
[1]
Not related to study device.
[2]
Not related to study device. Due to infected AUS (Artificial Urinary Sphincter)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
AMS 700 IPP 2005 Implant Group
Affected / at Risk (%) # Events
Total   25/69 (36.23%)    
General disorders   
Pain/soreness with inflation/cycling of device   6/69 (8.70%)  6
Other  [1]  1/69 (1.45%)  1
Not Device Related, Not Serious   10/69 (14.49%)  10
Reproductive system and breast disorders   
Device Aneurysm   1/69 (1.45%)  1
Mechanical Malfunction   2/69 (2.90%)  2
Pain/Discomfort with Ejaculation   1/69 (1.45%)  1
Pain/Discomfort with Erections   1/69 (1.45%)  1
Penile Sensation Change   1/69 (1.45%)  1
Surgical and medical procedures   
Device Auto-Inflation   7/69 (10.14%)  7
Seroma   1/69 (1.45%)  1
Indicates events were collected by systematic assessment
[1]
Treated with retraining on pump
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Men's Health Clinical Affairs
Organization: American Medical Systems
Phone: 952-930-6328
EMail: Karen.Seybold@ammd.com
Layout table for additonal information
Responsible Party: American Medical Systems
ClinicalTrials.gov Identifier: NCT00636506     History of Changes
Other Study ID Numbers: AMS052
First Submitted: March 11, 2008
First Posted: March 14, 2008
Results First Submitted: June 24, 2011
Results First Posted: July 22, 2019
Last Update Posted: July 22, 2019