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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Erectile Dysfunction

Intervention / Treatment
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* Device: AMS 700 IPP with MS Pump


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AMS 700 IPP 2005 Implant Group<br>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<br>* AMS 700 Series Inflatable Penile Prosthesis with MS Pump<br>* Other names: AMS IPP 2005;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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. | 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 | 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 | 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 | 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 | 4-8 weeks follow-up | 
| 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 | 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 | 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 | 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. | 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. | 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 | 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. | 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. | 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 | 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 | 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 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 | For duration of surgery | 
| Comparison With Other Devices for Ease of Placement | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Erectile dysfunction, Impotence