Clinical trial NCT00636506: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Erectile Dysfunction
Keywords: Erectile dysfunction
Impotence
Lead sponsor: American Medical Systems
Sponsor class: INDUSTRY
First posted: 2008-03-14
Enrollment: 76
Sex: MALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Ease of Locating the Inflation Pump Bulb
timeFrame: 4-8 weeks
measure: Ease of Pumping Device to Full Erection
timeFrame: 4-8 weeks post-op
measure: Quality of Erection (Suitability for Intercourse)
timeFrame: 4-8 weeks, 3 months, 6 months
measure: Subjective Force Required to Inflate Device
timeFrame: 3 months, 6 months
measure: Ability to Inflate Device Using One Hand
timeFrame: 3 months, 6 months
measure: Ease of Training Patient to Inflate Device Compared to the AMS Tactile Pump
timeFrame: 4-8 weeks follow-up
measure: Ease of Training Patient to Inflate Device Compared to the Standard AMS 700 Pump
timeFrame: 4-8 week activation visit
measure: Time to Complete Inflation
timeFrame: 4-8 week activation visit
measure: Ease of Locating the Deflation Block
timeFrame: 4-8 week activation visit
measure: Subjective Force Required to Initiate Deflation
timeFrame: 3 months, 6 months
measure: Ability to Deflate Cylinders by Pressing the Deflation Button for Only a Few Seconds
timeFrame: 3 months, 6 months
measure: Time to Complete Deflation
timeFrame: 3 months, 6 months
measure: Ability to Deflate Device With One Hand
timeFrame: 3 months, 6 months
measure: Level of Flaccidity Achieved
timeFrame: 4-8 weeks
measure: Ease of Training Patient to Deflate Device
timeFrame: 4-8 weeks
measure: Patient Satisfaction With Deflation Mechanism
timeFrame: 3 Months, 6 Months
measure: Ease of Dilation With the Reduced Angle of the Input Tubing
timeFrame: Time of implant (surgery)
measure: Ease of Cylinder Placement With the Enhanced Profile of the Proximal Tip
timeFrame: For duration of surgery
measure: Comparison With Other Devices for Ease of Placement
timeFrame: For duration of surgery
measure: Rating of the Rigidity of the Cylinders
timeFrame: 4-8 weeks follow-up
measure: Ease of Insertion of New Flare Design Reservoir
timeFrame: For duration of surgery
measure: Ability of New Flare Design to Remain in Place
timeFrame: For duration of surgery
measure: Ease Attaching the New Snap Design Rear Tip Extender (RTE) to the Proximal Tip of the Cylinder
timeFrame: For duration of surgery
measure: Comparison Rating of the New Rear Tip Extender Design to Previous Design
timeFrame: For duration of surgery
measure: Physician Evaluation of the Pre-threaded Suture Needle for Ease of Removing Sheath
timeFrame: For duration of surgery
measure: Physician Evaluation of the Pre-threaded Suture Needle for Ease of Loading Furlow Tool
timeFrame: For duration of surgery
measure: Physician Evaluation of OR Device Preparation Time
timeFrame: For duration of surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Indio
country: United States
facility: Institute for Urologic Excellence
state: California
city: New Port Richey
country: United States
facility: Advanced Research Institute
state: Florida
city: Shreveport
country: United States
facility: Regional Urology, LLC
state: Louisiana
city: Ann Arbor
country: United States
facility: University of Michigan School of Medicine
state: Michigan
city: Brooklyn
country: United States
facility: New York Center for Human Sexuality
state: New York
city: Oklahoma City
country: United States
facility: University of Oklahoma Health Sciences Center
state: Oklahoma
city: Nashville
country: United States
facility: Medical Research Associates of Nashville
state: Tennessee
Study officials:
affiliation: Medical Research Associates of Nasville
name: L. Dean Knoll, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Regional Urology LLC
name: Gerard D Henry, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Oklahoma Health Science Center
name: Daniel Culkin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Michigan
name: Dana A Ohl, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Advanced Research Institute
name: Juan Otheguy, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: New York Center for Human Sexuality
name: Ridwan Shabsigh, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Institute for Urologic Excellence
name: Steven K Wilson, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.