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

Primary Purpose

Erectile Dysfunction

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

AMS 700 IPP with MS Pump

About this trial

This is an interventional treatment trial for Erectile Dysfunction focused on measuring Erectile dysfunction, Impotence

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.
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.

Sites / Locations

Institute for Urologic Excellence
Advanced Research Institute
Regional Urology, LLC
University of Michigan School of Medicine
New York Center for Human Sexuality
University of Oklahoma Health Sciences Center
Medical Research Associates of Nashville

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

AMS 700 IPP 2005 Implant Group

Arm Description

Male subjects 21 years of age and older who are implanted with an AMS 700 IPP with MS (Momentary Squeeze) pump for erectile dysfunction.

Outcomes

Primary Outcome Measures

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

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.

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

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"

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

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

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 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

Ease of Locating the Deflation Block

Physicians were asked: "Could the deflation button be easily located?" Response options were: Yes, No, and Not Tested

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".

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 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

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.

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.

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

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

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

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

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

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

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

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

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.

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

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

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

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

Secondary Outcome Measures

Full Information

NCT ID

NCT00636506

First Posted

March 11, 2008

Last Updated

May 16, 2019

Sponsor

American Medical Systems

1. Study Identification

Unique Protocol Identification Number

NCT00636506

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2019

Overall Recruitment Status

Completed

Study Start Date

August 2005 (undefined)

Primary Completion Date

February 2006 (Actual)

Study Completion Date

January 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

American Medical Systems

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Erectile Dysfunction

Keywords

Erectile dysfunction, Impotence

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

76 (Actual)

8. Arms, Groups, and Interventions

Arm Title

AMS 700 IPP 2005 Implant Group

Arm Type

Experimental

Arm Description

Male subjects 21 years of age and older who are implanted with an AMS 700 IPP with MS (Momentary Squeeze) pump for erectile dysfunction.

Intervention Type

Device

Intervention Name(s)

AMS 700 IPP with MS Pump

Other Intervention Name(s)

AMS IPP 2005

Intervention Description

AMS 700 Series Inflatable Penile Prosthesis with MS Pump

Primary Outcome Measure Information:

Title

Ease of Locating the Inflation Pump Bulb

Description

Time Frame

4-8 weeks

Title

Ease of Pumping Device to Full Erection

Description

Time Frame

4-8 weeks post-op

Title

Quality of Erection (Suitability for Intercourse)

Description

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

Title

Subjective Force Required to Inflate Device

Description

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

Title

Ability to Inflate Device Using One Hand

Description

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

Title

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

Description

Time Frame

4-8 weeks follow-up

Title

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

Description

Time Frame

4-8 week activation visit

Title

Time to Complete Inflation

Description

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

Title

Ease of Locating the Deflation Block

Description

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

Title

Subjective Force Required to Initiate Deflation

Description

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

Title

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

Description

Time Frame

3 months, 6 months

Title

Time to Complete Deflation

Description

Time Frame

3 months, 6 months

Title

Ability to Deflate Device With One Hand

Description

"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

Title

Level of Flaccidity Achieved

Description

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

Title

Ease of Training Patient to Deflate Device

Description

Time Frame

4-8 weeks

Title

Patient Satisfaction With Deflation Mechanism

Description

Time Frame

3 Months, 6 Months

Title

Ease of Dilation With the Reduced Angle of the Input Tubing

Description

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)

Title

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

Description

Time Frame

For duration of surgery

Title

Comparison With Other Devices for Ease of Placement

Description

Time Frame

For duration of surgery

Title

Rating of the Rigidity of the Cylinders

Description

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

Time Frame

4-8 weeks follow-up

Title

Ease of Insertion of New Flare Design Reservoir

Description

Time Frame

For duration of surgery

Title

Ability of New Flare Design to Remain in Place

Description

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

Time Frame

For duration of surgery

Title

Ease Attaching the New Snap Design Rear Tip Extender (RTE) to the Proximal Tip of the Cylinder

Description

Time Frame

For duration of surgery

Title

Comparison Rating of the New Rear Tip Extender Design to Previous Design

Description

Time Frame

For duration of surgery

Title

Physician Evaluation of the Pre-threaded Suture Needle for Ease of Removing Sheath

Description

Physicians were asked, "Was it easy to remove the blue suture sheath and white needle holder?" Answer options were: Yes; No, please explain

Time Frame

For duration of surgery

Title

Physician Evaluation of the Pre-threaded Suture Needle for Ease of Loading Furlow Tool

Description

Physicians were asked to assess the overall design compared to the current non-threaded design. Answer options: Significantly better; Better; Same; Worse; Significantly worse

Time Frame

For duration of surgery

Title

Physician Evaluation of OR Device Preparation Time

Description

Physicians were asked if the design of the pre-threaded needle facilitated faster loading of the Furlow tool. Answer options were: Yes; No

Time Frame

For duration of surgery

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

21 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials: