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

May 16, 2019 updated by: American Medical Systems

A Multi-Center Study to Assess the AMS IPP 2005 Inflatable Penile Prosthesis Cylinders, Pump and Reservoir.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

76

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

  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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
4-8 weeks
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.
4-8 weeks post-op
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
4-8 weeks, 3 months, 6 months
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"
3 months, 6 months
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
3 months, 6 months
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
4-8 weeks follow-up
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
4-8 week activation visit
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
4-8 week activation visit
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
4-8 week activation visit
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".
3 months, 6 months
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.
3 months, 6 months
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
3 months, 6 months
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.
3 months, 6 months
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.
4-8 weeks
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
4-8 weeks
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
3 Months, 6 Months
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
Time of implant (surgery)
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
For duration of surgery
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
For duration of surgery
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
4-8 weeks follow-up
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
For duration of surgery
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
For duration of surgery
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.
For duration of surgery
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
For duration of surgery
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
For duration of surgery
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
For duration of surgery
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
For duration of surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2005

Primary Completion (Actual)

February 1, 2006

Study Completion (Actual)

January 1, 2008

Study Registration Dates

First Submitted

March 11, 2008

First Submitted That Met QC Criteria

March 11, 2008

First Posted (Estimate)

March 14, 2008

Study Record Updates

Last Update Posted (Actual)

July 22, 2019

Last Update Submitted That Met QC Criteria

May 16, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AMS052

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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