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

NCT00636506 | Completed Phase 2 Results

• 1 other identifier: AMS052
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 7

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.

Conditions

Erectile Dysfunction

Keywords

Erectile dysfunction; Impotence

Outcome Measures

Primary Outcomes (27)

• 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

Study Arms (1)

AMS 700 IPP 2005 Implant Group

EXPERIMENTAL

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

Interventions

AMS 700 IPP with MS Pump DEVICE

AMS 700 Series Inflatable Penile Prosthesis with MS Pump

Also known as: AMS IPP 2005

AMS 700 IPP 2005 Implant Group

Eligibility Criteria

• Age: 21 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• American Medical Systems: lead

Study Sites (7)

Institute for Urologic Excellence

Indio, California, 92201, United States

Location

Advanced Research Institute

New Port Richey, Florida, 34652, United States

Location

Regional Urology, LLC

Shreveport, Louisiana, 71106, United States

Location

University of Michigan School of Medicine

Ann Arbor, Michigan, 48109, United States

Location

New York Center for Human Sexuality

Brooklyn, New York, 11219, United States

Location

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

Location

Medical Research Associates of Nashville

Nashville, Tennessee, 37203, United States

Location

Related 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.1743-6109.2009.01251.x. Epub 2009 Mar 30.

  PMID: 19473458 RESULT

MeSH Terms

Conditions

Erectile Dysfunction

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Men's Health Clinical Affairs
• Organization: American Medical Systems

Karen.Seybold@ammd.com

952-930-6328

Study Officials

• L. Dean Knoll, MD

  Medical Research Associates of Nasville

  PRINCIPAL INVESTIGATOR

• Gerard D Henry, MD

  Regional Urology LLC

  PRINCIPAL INVESTIGATOR

• Daniel Culkin, MD

  University of Oklahoma Health Science Center

  PRINCIPAL INVESTIGATOR

• Dana A Ohl, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

• Juan Otheguy, MD

  Advanced Research Institute

  PRINCIPAL INVESTIGATOR

• Ridwan Shabsigh, MD

  New York Center for Human Sexuality

  PRINCIPAL INVESTIGATOR

• Steven K Wilson, MD

  Institute for Urologic Excellence

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2008
• First Posted: March 14, 2008
• Study Start: August 1, 2005
• Primary Completion: February 1, 2006
• Study Completion: January 1, 2008
• Last Updated: July 22, 2019
• Results First Posted: July 22, 2019

Record last verified: 2019-05

Locations

US (7)