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

Erectile Dysfunction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00636506
• Other study ID #: AMS052
• Status: Completed
• Phase: Phase 2
• Start date: August 2005
• Est. completion date: January 2008

Study information

• Verified date: May 2019
• Source: American Medical Systems
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: January 2008
• Est. primary completion date: February 2006
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Erectile Dysfunction

Intervention

Device:
• AMS 700 IPP with MS Pump
AMS 700 Series Inflatable Penile Prosthesis with MS Pump

Locations

Country	Name	City	State
United States	University of Michigan School of Medicine	Ann Arbor	Michigan
United States	New York Center for Human Sexuality	Brooklyn	New York
United States	Institute for Urologic Excellence	Indio	California
United States	Medical Research Associates of Nashville	Nashville	Tennessee
United States	Advanced Research Institute	New Port Richey	Florida
United States	University of Oklahoma Health Sciences Center	Oklahoma City	Oklahoma
United States	Regional Urology, LLC	Shreveport	Louisiana

Sponsors (1)

Lead Sponsor	Collaborator
American Medical Systems

Country where clinical trial is conducted

United States, 

References & Publications (1)

Knoll LD, Henry G, Culkin D, Ohl DA, Otheguy J, Shabsigh R, Wilson SK, Delk Ii J. Physician and patient satisfaction with the new AMS 700 momentary squeeze inflatable penile prosthesis. J Sex Med. 2009 Jun;6(6):1773-1778. doi: 10.1111/j.1743-6109.2009.012 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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)
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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