Skip to main content
OpenTrials
Completed

NCT Number: NCT00636506

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Erectile Dysfunction Genital Diseases Genital Diseases, Male Male Urogenital Diseases Mental Disorders Sexual Dysfunction, Physiological Sexual Dysfunctions, Psychological Urogenital Diseases

Age range

21 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Institute for Urologic Excellence, Indio, California, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • Inclusion Criteria

To be eligible to participate in this study, male subjects must meet the following requirements:

  • 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.
  • The subject has not had a previous penile prosthesis.
  • The subject is willing and able to give written valid Informed Consent.
  • The subject's reading level is judged adequate for reading and understanding the Informed Consent, patient questionnaires, and other study material
  • The subject is ≥ 21 years of age.
  • The subject has no known sensitivity to rifampin, minocycline or other tetracyclines as indicated in the device labeling.
  • The subject does not have systemic lupus erythematosus
  • The subject has the manual dexterity or mental ability to operate the pump.
  • The subject does not have active urogenital infection or active skin infection in region of surgery as indicated in the device labeling.
  • The subject is willing and able to return for follow-up evaluations and questionnaire completion according to the study protocol.
  • The subject is an acceptable risk for anesthesia and surgery.
  • Exclusion Criteria

Subjects will not be eligible for entry into this study if they meet any of the following criteria:

  • The subject's reading level is judged inadequate for reading and understanding the Informed Consent, patient questionnaires, and other study materials.
  • The subject is not willing or able to give written valid Informed Consent
  • 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.

Treatment and study plan

AMS 700 IPP with MS Pump

Device

AMS 700 Series Inflatable Penile Prosthesis with MS Pump

Other names: AMS IPP 2005

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

American Medical Systems

Industry

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2006
Study completion
2008
First posted
Mar 14, 2008
Registry last updated
Jul 22, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.