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

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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

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 76 participants
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 : August 2005
Actual Primary Completion Date : February 2006
Actual Study Completion Date : January 2008

Resource links provided by the National Library of Medicine


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 Name: AMS IPP 2005




Primary Outcome Measures :
  1. Ease of Locating the Inflation Pump Bulb [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00636506


Locations
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United States, California
Institute for Urologic Excellence
Indio, California, United States, 92201
United States, Florida
Advanced Research Institute
New Port Richey, Florida, United States, 34652
United States, Louisiana
Regional Urology, LLC
Shreveport, Louisiana, United States, 71106
United States, Michigan
University of Michigan School of Medicine
Ann Arbor, Michigan, United States, 48109
United States, New York
New York Center for Human Sexuality
Brooklyn, New York, United States, 11219
United States, Oklahoma
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
United States, Tennessee
Medical Research Associates of Nashville
Nashville, Tennessee, United States, 37203
Sponsors and Collaborators
American Medical Systems
Investigators
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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

Publications of Results:
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Responsible Party: American Medical Systems
ClinicalTrials.gov Identifier: NCT00636506     History of Changes
Other Study ID Numbers: AMS052
First Posted: March 14, 2008    Key Record Dates
Results First Posted: July 22, 2019
Last Update Posted: July 22, 2019
Last Verified: May 2019
Keywords provided by American Medical Systems:
Erectile dysfunction
Impotence
Additional relevant MeSH terms:
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Erectile Dysfunction
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Mental Disorders