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

American Medical Systems76 enrolled

Overview

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.

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

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Erectile Dysfunction

Interventions

AMS 700 IPP with MS PumpDEVICE

AMS 700 Series Inflatable Penile Prosthesis with MS Pump

Eligibility

Sex: MALEMin age: 21 Years

Medical Language ↔ Plain English

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.

Locations (7)

Institute for Urologic Excellence

Indio, California, United States

Advanced Research Institute

New Port Richey, Florida, United States

Regional Urology, LLC

Shreveport, Louisiana, United States

University of Michigan School of Medicine

Ann Arbor, Michigan, United States

Outcomes

Primary Outcomes

Ease of Locating the Inflation Pump Bulb

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

Ease of Pumping Device to Full Erection

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

Quality of Erection (Suitability for Intercourse)

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

Subjective Force Required to Inflate Device

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

Ability to Inflate Device Using One Hand

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

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

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

Data from ClinicalTrials.gov

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New York Center for Human Sexuality

Brooklyn, New York, United States

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

Medical Research Associates of Nashville

Nashville, Tennessee, United States

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

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

Time to Complete Inflation

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

Ease of Locating the Deflation Block

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

Subjective Force Required to Initiate Deflation

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

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

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

Time to Complete Deflation

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

Ability to Deflate Device With One Hand

"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

Level of Flaccidity Achieved

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

Ease of Training Patient to Deflate Device

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

Patient Satisfaction With Deflation Mechanism

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

Ease of Dilation With the Reduced Angle of the Input Tubing

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)

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

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