Phase 2
Completed N=76
Evaluation of the 2005 AMS (American Medical System) IPP (Inflatable Penile Prosthesis)
Source: ClinicalTrials.gov NCT00636506 ↗Enrolled (actual)
76
Serious AEs
8.7%
Results posted
Jul 2019
Primary outcomePrimary: Ease of Locating the Inflation Pump Bulb — 63 Participants who easily located pumpbulb
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Ease of Locating the Inflation Pump Bulb |
63 | — |
| PRIMARY Ease of Pumping Device to Full Erection |
28; 19; 3; 16; 0 | — |
| PRIMARY Quality of Erection (Suitability for Intercourse) |
66; 60; 59 | — |
| PRIMARY Subjective Force Required to Inflate Device |
50; 48; 11; 9; 0; 1 | — |
| PRIMARY Ability to Inflate Device Using One Hand |
31; 33; 30; 23; 0; 2 | — |
| PRIMARY Ease of Training Patient to Inflate Device Compared to the AMS Tactile Pump |
36; 11; 5; 13; 1 | — |
| PRIMARY Ease of Training Patient to Inflate Device Compared to the Standard AMS 700 Pump |
39; 18; 4; 4; 1 | — |
| PRIMARY Time to Complete Inflation |
17; 23; 12; 4; 2; 8 | — |
| PRIMARY Ease of Locating the Deflation Block |
65; 1; 0 | — |
| PRIMARY Subjective Force Required to Initiate Deflation |
54; 51; 6; 6; 1; 1 | — |
| PRIMARY Ability to Deflate Cylinders by Pressing the Deflation Button for Only a Few Seconds |
18.0; 16.9; 45.9; 61.0; 26.2; 20.3 | — |
| PRIMARY Time to Complete Deflation |
18.3; 20.7; 13.3; 17.2; 20.0; 27.6 | — |
| PRIMARY Ability to Deflate Device With One Hand |
50.8; 56.9; 49.2; 39.7; 0.0; 3.4 | — |
| PRIMARY Level of Flaccidity Achieved |
53.0; 34.8; 12.1; 0.0; 0.0 | — |
| PRIMARY Ease of Training Patient to Deflate Device |
54.5; 59.1; 16.7; 27.3; 7.6; 6.1 | — |
| PRIMARY Patient Satisfaction With Deflation Mechanism |
42.6; 56.9; 24.6; 20.7; 16.4; 17.2 | — |
| PRIMARY Ease of Dilation With the Reduced Angle of the Input Tubing |
56.5; 43.5 | — |
| PRIMARY Ease of Cylinder Placement With the Enhanced Profile of the Proximal Tip |
56.5; 27.5; 15.9; 0.0; 0.0 | — |
| PRIMARY Comparison With Other Devices for Ease of Placement |
27.5; 37.7; 33.3; 1.4; 0.0 | — |
| PRIMARY Rating of the Rigidity of the Cylinders |
40.9; 43.9; 15.2; 0.0; 0.0 | — |
| PRIMARY Ease of Insertion of New Flare Design Reservoir |
1.4; 13.0; 84.1; 1.4; 0.0 | — |
| PRIMARY Ability of New Flare Design to Remain in Place |
100; 0 | — |
| PRIMARY Ease Attaching the New Snap Design Rear Tip Extender (RTE) to the Proximal Tip of the Cylinder |
50.0; 16.7; 28.8; 1.5; 3.0 | — |
| PRIMARY Comparison Rating of the New Rear Tip Extender Design to Previous Design |
40.9; 25.8; 31.8; 1.5; 0.0 | — |
| PRIMARY Physician Evaluation of the Pre-threaded Suture Needle for Ease of Removing Sheath |
88.4; 11.6 | — |
| PRIMARY Physician Evaluation of the Pre-threaded Suture Needle for Ease of Loading Furlow Tool |
1.4; 37.7; 46.4; 14.5; 0.0 | — |
| PRIMARY Physician Evaluation of OR Device Preparation Time |
53.6; 46.4 | — |
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.
Data sourced from ClinicalTrials.gov (NCT00636506). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.