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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AMS 700 IPP with MS Pump | Device | AMS 700 Series Inflatable Penile Prosthesis with MS Pump |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria
To be eligible to participate in this study, male subjects must meet the following requirements:
Exclusion Criteria
Subjects will not be eligible for entry into this study if they meet any of the following criteria:
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.
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute for Urologic Excellence | Indio | California | 92201 | United States | ||
| Advanced Research Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19473458 | Result | 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. |
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76 subjects enrolled; 6 withdrew consent prior to the procedure, and 1 had the procedure aborted. 69 subjects were implanted with the study device; of these, 60 completed the study, 8 were lost to follow-up, and 1 had their device explanted.
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| ID | Title | Description |
|---|---|---|
| FG000 | AMS 700 IPP 2005 Implant Group | Male subjects 21 years of age and older who are implanted with an AMS 700 IPP with MS pump for erectile dysfunction. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | AMS 700 IPP 2005 Implant Group | Male subjects 21 years of age and older who choose to undergo an IPP implantation for erectile dysfunction. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | All subjects who were implanted and attended the device activation visit at 4-8 weeks post-op | Posted | Number | Participants who easily located pumpbulb | 4-8 weeks |
|
|
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Adverse events are assessed at the time of implant and at each follow-up visit.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | AMS 700 IPP 2005 Implant Group | Male subjects 21 years of age and older who choose to undergo an IPP implantation for erectile dysfunction. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urogenital Edema and Pain | Reproductive system and breast disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Device Auto-Inflation | Surgical and medical procedures | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Men's Health Clinical Affairs | American Medical Systems | 952-930-6328 | Karen.Seybold@ammd.com |
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| ID | Term |
|---|---|
| D007172 | Erectile Dysfunction |
| ID | Term |
|---|---|
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D012735 | Sexual Dysfunction, Physiological |
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| 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 |
| New Port Richey |
| Florida |
| 34652 |
| United States |
| Regional Urology, LLC | Shreveport | Louisiana | 71106 | United States |
| University of Michigan School of Medicine | Ann Arbor | Michigan | 48109 | United States |
| New York Center for Human Sexuality | Brooklyn | New York | 11219 | United States |
| University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | 73104 | United States |
| Medical Research Associates of Nashville | Nashville | Tennessee | 37203 | United States |
| Procedure aborted |
|
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Counts |
|---|
| Participants |
|
|
| 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. | Subjects who attended the 4-8 week activation visit | Posted | Number | Participants | 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 | Subjects who attended the 4-8 week activation visit. | Posted | Number | participants who answered yes | 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" | Subjects who attended the 3 month and/or 6 month follow-up visit | Posted | Number | Participants | 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 | All subjects who attended the follow-up visits | Posted | Number | Participants | 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 | All subjects who attended the 4-8 week activation visit | Posted | Number | Participants | 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 | All subjects who attended the 4-8 week activation visit | Posted | Number | Participants | 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 | All subjects who attended the 4-8 activation visit | Posted | Number | Participants | 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 | All subjects who attended the 4-8 week activation visit | Posted | Number | Participants | 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". | All subjects who attended the follow-up visit | Posted | Number | Participants | 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. | Physician assessment of all subjects who attended the 3 month and/or 6 month follow-up visit. | Posted | Number | Percentage of Participants | 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 | Physician assessment of all subjects who attended the 3 month and/or 6 month follow-up visit. | Posted | Number | Percentage of participants | 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. | All subjects who attended the 3 month and/or 6 month follow-up visit. | Posted | Number | % who selected response option | 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. | All subjects who attended the 4-8 week follow-up visit | Posted | Number | Percentage of participants | 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 | All subjects who attended the 4-8 follow-up visit. | Posted | Number | Percentage of participants | 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 | All subjects who attended the 3 month and/or 6 month follow-up visit. | Posted | Number | Percentage of participants | 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 | Physician assessment of each subject at time of implant | Posted | Number | Percentage of participants | 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 | Physician assessment of each subject at time of implant | Posted | Number | Percentage of participants | 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 | Physician assessment of each subject at time of implant | Posted | Number | Percentage of participants | 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 | All subjects who attended the 4-8 week follow-up visit | Posted | Number | Percentage of participants | 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 | Posted | Number | Percentage of participants | 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 | Physician assessment of each patient at time of implant | Posted | Number | Percentage of participants | 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. | Physician assessment of each patient at time of implant for whom they used the RTEs (rear tip extenders) | Posted | Number | percentage of physician responses | 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 | Physician assessment of each patient for whom they used RTEs at time of implant | Posted | Number | percentage of physician responses | 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 | Physician assessment of each patient at time of implant | Posted | Number | percentage of physician responses | 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 | Physician assessment of each patient at time of implant | Posted | Number | percentage of physician responses | 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 | Physician assessment of each patient at time of implant | Posted | Number | percentage of physician responses | For duration of surgery |
|
|
|
| 6 |
| 69 |
| 25 |
| 69 |
| Device extrusion/erosion | Reproductive system and breast disorders | Systematic Assessment |
|
| Device Infection | Infections and infestations | Systematic Assessment |
|
| Cylinder Erosion | Reproductive system and breast disorders | Systematic Assessment |
|
| Infection | Infections and infestations | Systematic Assessment | Not related to study device. |
|
| Urethral Erosion | Reproductive system and breast disorders | Systematic Assessment | Not related to study device. Due to infected AUS (Artificial Urinary Sphincter) |
|
| Device Aneurysm | Reproductive system and breast disorders | Systematic Assessment |
|
| Mechanical Malfunction | Reproductive system and breast disorders | Systematic Assessment |
|
| Pain/Discomfort with Ejaculation | Reproductive system and breast disorders | Systematic Assessment |
|
| Pain/Discomfort with Erections | Reproductive system and breast disorders | Systematic Assessment |
|
| Penile Sensation Change | Reproductive system and breast disorders | Systematic Assessment |
|
| Seroma | Surgical and medical procedures | Systematic Assessment |
|
| Pain/soreness with inflation/cycling of device | General disorders | Systematic Assessment |
|
| Other | General disorders | Systematic Assessment | Treated with retraining on pump |
|
| Not Device Related, Not Serious | General disorders | Systematic Assessment |
|
Not provided
Not provided
| D052801 | Male Urogenital Diseases |
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |
| Title | Measurements |
|---|---|
|
| Somewhat Harder |
|
| Harder |
|
| Missing |
|
| Missing |
|
| Title | Measurements |
|---|---|
|
| Somewhat harder |
|
| Much harder |
|
| Title | Measurements |
|---|---|
|
| Somewhat harder |
|
| Much harder |
|
| Title | Measurements |
|---|---|
|
| 90-120 seconds |
|
| 2-3 minutes |
|
| Over 3 minutes |
|
|
| No response |
|
| 5-6 seconds |
|
| 7-8 seconds |
|
| 9-10 seconds |
|
| More than 10 seconds |
|
| 9-10 seconds |
|
| 10-15 seconds |
|
| 15-20 seconds |
|
| 20-25 seconds |
|
| 25-30 seconds |
|
| 30-35 seconds |
|
| 35-40 seconds |
|
| 40-45 seconds |
|
| 45-50 seconds |
|
| More than 50 seconds |
|
| Missing |
|
| Title |
|---|
| Measurements |
|---|
|
| Fair |
|
| Poor |
|
| Same |
|
| Somewhat harder |
|
| Much harder |
|
| Somewhat satisified |
|
| Somewhat dissatisfied |
|
| Moderately dissatisfied |
|
| Very dissatisified |
|
| Title | Measurements |
|---|---|
|
| Moderately difficult |
|
| Very difficult |
|
| Title | Measurements |
|---|---|
|
| Somewhat more difficult |
|
| More difficult |
|
| Title | Measurements |
|---|
|
| Fair |
|
| Poor |
|
| Title |
|---|
| Measurements |
|---|
|
| Somewhat harder |
|
| Much harder |
|
| Title | Measurements |
|---|---|
|
| % Moderately dissatisfied |
|
| % Very dissatisfied |
|
| Title | Measurements |
|---|---|
|
| % Somewhat worse |
|
| % Much worse |
|
| Title | Measurements |
|---|---|
|
| % Worse |
|
| Significantly worse |
|