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

• Sponsor: American Medical Systems (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00636506
• Collaborator: (none)
• Enrollment: 76
• Locations: 7
• Arm: 1
• Duration (Months): 29
• Patients Per Site: 10.9
• Patients Per Site Per Month: 0.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Erectile Dysfunction	Device: AMS 700 IPP with MS Pump	Phase 2

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 76 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Multi-Center Study to Assess the AMS IPP 2005 Inflatable Penile Prosthesis Cylinders, Pump and Reservoir.
• Study Start Date: Aug 1, 2005
• Actual Primary Completion Date: Feb 1, 2006
• Actual Study Completion Date: Jan 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: AMS 700 IPP 2005 Implant Group Male subjects 21 years of age and older who are implanted with an AMS 700 IPP with MS (Momentary Squeeze) pump for erectile dysfunction.	Device: AMS 700 IPP with MS Pump; AMS 700 Series Inflatable Penile Prosthesis with MS Pump; Other Names: AMS IPP 2005

Outcome Measures

Primary Outcome Measures

1. 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

2. 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.

3. 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

4. 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"

5. 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

6. 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

7. 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

8. 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

9. 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

10. 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".

11. 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.

12. 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

13. 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.

14. 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.

15. 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

16. 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

17. 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

18. 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

19. 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

20. 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

21. 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

22. 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

23. 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.

24. 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

25. 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

26. 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

27. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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.

12. 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:

1. known allergy to or sensitivity to rifampin, minocycline, or to tetracyclines.

1. 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.

1. The subject does not have the manual dexterity or mental ability to operate the pump.

2. 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.

3. The subject has been diagnosed with severe fibrosis due to priapism.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Institute for Urologic Excellence	Indio	California	United States	92201
2	Advanced Research Institute	New Port Richey	Florida	United States	34652
3	Regional Urology, LLC	Shreveport	Louisiana	United States	71106
4	University of Michigan School of Medicine	Ann Arbor	Michigan	United States	48109
5	New York Center for Human Sexuality	Brooklyn	New York	United States	11219
6	University of Oklahoma Health Sciences Center	Oklahoma City	Oklahoma	United States	73104
7	Medical Research Associates of Nashville	Nashville	Tennessee	United States	37203

Sponsors and Collaborators

• American Medical Systems

Investigators

• Principal Investigator: L. Dean Knoll, MD, Medical Research Associates of Nasville
• Principal Investigator: Gerard D Henry, MD, Regional Urology LLC
• Principal Investigator: Daniel Culkin, MD, University of Oklahoma Health Science Center
• Principal Investigator: Dana A Ohl, MD, University of Michigan
• Principal Investigator: Juan Otheguy, MD, Advanced Research Institute
• Principal Investigator: Ridwan Shabsigh, MD, New York Center for Human Sexuality
• Principal Investigator: Steven K Wilson, MD, Institute for Urologic Excellence

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: American Medical Systems
• ClinicalTrials.gov Identifier: NCT00636506
• Other Study ID Numbers: AMS052
• First Posted: Mar 14, 2008
• Last Update Posted: Jul 22, 2019
• Last Verified: May 1, 2019

• Keywords provided by American Medical Systems: Erectile dysfunction; Impotence
• Additional relevant MeSH terms: Erectile Dysfunction

Study Results

Participant Flow

Pre-assignment Detail	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
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

Baseline Characteristics

Arm/Group Title	AMS 700 IPP 2005 Implant Group
Arm/Group Description	Male subjects 21 years of age and older who choose to undergo an IPP implantation for erectile dysfunction.
Overall Participants	76
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	47 61.8%
>=65 years	29 38.2%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	60.1 (9.5)
Sex: Female, Male (Count of Participants)
Female	0 0%
Male	76 100%
Region of Enrollment (participants) [Number]
United States	76 100%

Outcome Measures

1. Primary Outcome

Title	Ease of Locating the Inflation Pump Bulb
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

Outcome Measure Data

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
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.
Measure Participants	66
Number [Participants who easily located pumpbulb]	63 82.9%

2. Primary Outcome

Title	Ease of Pumping Device to Full Erection
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

Outcome Measure Data

Analysis Population Description

Subjects who attended the 4-8 week activation visit

Arm/Group Title	AMS 700 IPP 2005 Implant Group
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
Measure Participants	66
Much Easier	28 36.8%
Somewhat Easier	19 25%
Same	3 3.9%
Somewhat Harder	16 21.1%
Harder	0 0%

3. Primary Outcome

Title	Quality of Erection (Suitability for Intercourse)
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

Outcome Measure Data

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
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.
Measure Participants	66	61	60
Number [participants who answered yes]	66 86.8%	60 NaN	59 NaN

4. Primary Outcome

Title	Subjective Force Required to Inflate Device
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

Outcome Measure Data

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
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.
Measure Participants	61	58
Reasonable	50 65.8%	48 NaN
Too much	11 14.5%	9 NaN
Missing	0 0%	1 NaN

5. Primary Outcome

Title	Ability to Inflate Device Using One Hand
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

Outcome Measure Data

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
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.
Measure Participants	61	58
Yes	31 40.8%	33 NaN
No	30 39.5%	23 NaN
Missing	0 0%	2 NaN

6. Primary Outcome

Title	Ease of Training Patient to Inflate Device Compared to the AMS Tactile Pump
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

Outcome Measure Data

Analysis Population Description

All subjects who attended the 4-8 week activation visit

Arm/Group Title	AMS 700 IPP 2005 Implant Group
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.
Measure Participants	66
Much easier	36 47.4%
Somewhat easier	11 14.5%
Same	5 6.6%
Somewhat harder	13 17.1%
Much harder	1 1.3%

7. Primary Outcome

Title	Ease of Training Patient to Inflate Device Compared to the Standard AMS 700 Pump
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

Outcome Measure Data

Analysis Population Description

All subjects who attended the 4-8 week activation visit

Arm/Group Title	AMS 700 IPP 2005 Implant Group
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.
Measure Participants	66
Much easier	39 51.3%
Somewhat easier	18 23.7%
Same	4 5.3%
Somewhat harder	4 5.3%
Much harder	1 1.3%

8. Primary Outcome

Title	Time to Complete Inflation
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

Outcome Measure Data

Analysis Population Description

All subjects who attended the 4-8 activation visit

Arm/Group Title	AMS 700 IPP 2005 Implant Group
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.
Measure Participants	66
0-30 seconds	17 22.4%
30-60 seconds	23 30.3%
60-90 seconds	12 15.8%
90-120 seconds	4 5.3%
2-3 minutes	2 2.6%
Over 3 minutes	8 10.5%

9. Primary Outcome

Title	Ease of Locating the Deflation Block
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

Outcome Measure Data

Analysis Population Description

All subjects who attended the 4-8 week activation visit

Arm/Group Title	AMS 700 IPP 2005 Implant Group
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.
Measure Participants	66
Yes	65 85.5%
No	1 1.3%
Not tested	0 0%

10. Primary Outcome

Title	Subjective Force Required to Initiate Deflation
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

Outcome Measure Data

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
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
Measure Participants	61	58
Reasonable	54 71.1%	51 NaN
Too Much	6 7.9%	6 NaN
No response	1 1.3%	1 NaN

11. Primary Outcome

Title	Ability to Deflate Cylinders by Pressing the Deflation Button for Only a Few Seconds
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

Outcome Measure Data

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
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.
Measure Participants	61	59
1-2 seconds	18.0 23.7%	16.9 NaN
3-4 seconds	45.9 60.4%	61.0 NaN
5-6 seconds	26.2 34.5%	20.3 NaN
7-8 seconds	9.8 12.9%	1.7 NaN
9-10 seconds	0 0%	0 NaN
More than 10 seconds	0 0%	0 NaN

12. Primary Outcome

Title	Time to Complete Deflation
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

Outcome Measure Data

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
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.
Measure Participants	61	58
5-6 seconds	18.3 24.1%	20.7 NaN
7-8 seconds	13.3 17.5%	17.2 NaN
9-10 seconds	20.0 26.3%	27.6 NaN
10-15 seconds	21.7 28.6%	10.3 NaN
15-20 seconds	16.7 22%	12.0 NaN
20-25 seconds	3.3 4.3%	6.9 NaN
25-30 seconds	6.7 8.8%	1.7 NaN
30-35 seconds	0.0 0%	0.0 NaN
35-40 seconds	0.0 0%	3.4 NaN
40-45 seconds	0.0 0%	0.0 NaN
45-50 seconds	0.0 0%	0.0 NaN
More than 50 seconds	0.0 0%	0.0 NaN

13. Primary Outcome

Title	Ability to Deflate Device With One Hand
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

Outcome Measure Data

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
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.
Measure Participants	61	58
Yes	50.8	56.9
No	49.2	39.7
Missing	0.0	3.4

14. Primary Outcome

Title	Level of Flaccidity Achieved
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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	AMS 700 IPP 2005 Implant Group
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.
Measure Participants	66
Excellent	53.0 69.7%
Very Good	34.8 45.8%
Good	12.1 15.9%
Fair	0.0 0%
Poor	0.0 0%

15. Primary Outcome

Title	Ease of Training Patient to Deflate Device
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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	AMS Tactile Pump	Standard AMS 700 Pump
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.
Measure Participants	66	66
Much Easier	54.5 71.7%	59.1 NaN
Somewhat Easier	16.7 22%	27.3 NaN
Same	7.6 10%	6.1 NaN
Somewhat harder	19.7 25.9%	6.1 NaN
Much harder	1.5 2%	1.5 NaN

16. Primary Outcome

Title	Patient Satisfaction With Deflation Mechanism
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

Outcome Measure Data

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
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.
Measure Participants	61	58
Very satisified	42.6 56.1%	56.9 NaN
Moderately satisfied	24.6 32.4%	20.7 NaN
Somewhat satisified	16.4 21.6%	17.2 NaN
Somewhat dissatisfied	13.1 17.2%	3.4 NaN
Moderately dissatisfied	3.3 4.3%	0.0 NaN
Very dissatisified	0.0 0%	1.7 NaN

17. Primary Outcome

Title	Ease of Dilation With the Reduced Angle of the Input Tubing
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)

Outcome Measure Data

Analysis Population Description

Physician assessment of each subject at time of implant

Arm/Group Title	AMS 700 IPP 2005 Implant Group
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.
Measure Participants	69
Yes	56.5 74.3%
No/No Effect	43.5 57.2%

18. Primary Outcome

Title	Ease of Cylinder Placement With the Enhanced Profile of the Proximal Tip
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

Outcome Measure Data

Analysis Population Description

Physician assessment of each subject at time of implant

Arm/Group Title	AMS 700 IPP 2005 Implant Group
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.
Measure Participants	69
Very easy	56.5 74.3%
Moderately easy	27.5 36.2%
Neither easy nor difficult	15.9 20.9%
Moderately difficult	0.0 0%
Very difficult	0.0 0%

19. Primary Outcome

Title	Comparison With Other Devices for Ease of Placement
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

Outcome Measure Data

Analysis Population Description

Physician assessment of each subject at time of implant

Arm/Group Title	AMS 700 IPP 2005 Implant Group
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.
Measure Participants	69
Much easier	27.5 36.2%
Slightly easier	37.7 49.6%
Same	33.3 43.8%
Somewhat more difficult	1.4 1.8%
More difficult	0.0 0%

20. Primary Outcome

Title	Rating of the Rigidity of the Cylinders
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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	AMS 700 IPP 2005 Implant Group
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.
Measure Participants	66
Excellent	40.9 53.8%
Very good	43.9 57.8%
Good	15.2 20%
Fair	0.0 0%
Poor	0.0 0%

21. Primary Outcome

Title	Ease of Insertion of New Flare Design Reservoir
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	AMS 700 IPP 2005 Implant Group
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.
Measure Participants	69
Much easier	1.4 1.8%
Somewhat easier	13.0 17.1%
Same	84.1 110.7%
Somewhat harder	1.4 1.8%
Much harder	0.0 0%

22. Primary Outcome

Title	Ability of New Flare Design to Remain in Place
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

Outcome Measure Data

Analysis Population Description

Physician assessment of each patient at time of implant

Arm/Group Title	AMS 700 IPP 2005 Implant Group
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.
Measure Participants	69
% Yes	100 131.6%
% No	0 0%

23. Primary Outcome

Title	Ease Attaching the New Snap Design Rear Tip Extender (RTE) to the Proximal Tip of the Cylinder
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

Outcome Measure Data

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
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.
Measure Participants	66
% 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
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

Outcome Measure Data

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
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.
Measure Participants	66
% 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
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

Outcome Measure Data

Analysis Population Description

Physician assessment of each patient at time of implant

Arm/Group Title	AMS 700 IPP 2005 Implant Group
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.
Measure Participants	69
% Yes	88.4
% No	11.6

26. Primary Outcome

Title	Physician Evaluation of the Pre-threaded Suture Needle for Ease of Loading Furlow Tool
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

Outcome Measure Data

Analysis Population Description

Physician assessment of each patient at time of implant

Arm/Group Title	AMS 700 IPP 2005 Implant Group
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.
Measure Participants	69
% 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
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

Outcome Measure Data

Analysis Population Description

Physician assessment of each patient at time of implant

Arm/Group Title	AMS 700 IPP 2005 Implant Group
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.
Measure Participants	69
% Assessed as Faster	53.6
% Assessed as Not as Fast	46.4

Adverse Events

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
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 (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	AMS 700 IPP 2005 Implant Group
	Affected / at Risk (%)	# Events
Total	6/69 (8.7%)
Infections and infestations
Device Infection	1/69 (1.4%)	1
Infection	1/69 (1.4%)	1
Reproductive system and breast disorders
Urogenital Edema and Pain	1/69 (1.4%)	1
Device extrusion/erosion	1/69 (1.4%)	1
Cylinder Erosion	1/69 (1.4%)	1
Urethral Erosion	1/69 (1.4%)	1
Other (Not Including Serious) Adverse Events
	AMS 700 IPP 2005 Implant Group
	Affected / at Risk (%)	# Events
Total	25/69 (36.2%)
General disorders
Pain/soreness with inflation/cycling of device	6/69 (8.7%)	6
Other	1/69 (1.4%)	1
Not Device Related, Not Serious	10/69 (14.5%)	10
Reproductive system and breast disorders
Device Aneurysm	1/69 (1.4%)	1
Mechanical Malfunction	2/69 (2.9%)	2
Pain/Discomfort with Ejaculation	1/69 (1.4%)	1
Pain/Discomfort with Erections	1/69 (1.4%)	1
Penile Sensation Change	1/69 (1.4%)	1
Surgical and medical procedures
Device Auto-Inflation	7/69 (10.1%)	7
Seroma	1/69 (1.4%)	1

Limitations/Caveats

[Not Specified]

More Information

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.