Erectile DysfunctionPhase 2NCT00636506
Evaluation of the 2005 AMS (American Medical System) IPP (Inflatable Penile Prosthesis)
A Phase 2 study testing AMS 700 IPP with MS Pump in people with Erectile Dysfunction, run by American Medical Systems at 7 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 21 years and older, men only
- Conditions the study is for
- Erectile Dysfunction
- What is being tested?
- AMS 700 IPP with MS Pump
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 7 sitesUnited States
- Study dates
- Aug 2005to Jan 2008
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
- 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:
- 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.
- The subject does not have the manual dexterity or mental ability to operate the pump.
- 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.
- The subject has been diagnosed with severe fibrosis due to priapism.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
University of Michigan School of Medicine
Ann Arbor, Michigan, 48109
New York Center for Human Sexuality
Brooklyn, New York, 11219
Institute for Urologic Excellence
Indio, California, 92201
Medical Research Associates of Nashville
Nashville, Tennessee, 37203
Advanced Research Institute
New Port Richey, Florida, 34652
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
Regional Urology, LLC
Shreveport, Louisiana, 71106
About this study
Official title: A Multi-Center Study to Assess the AMS IPP 2005 Inflatable Penile Prosthesis Cylinders, Pump and Reservoir.
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.
Read the 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.
- Conditions
- Erectile Dysfunction
- Being tested
- AMS 700 IPP with MS Pump
- Keywords
- Erectile dysfunction, Impotence
- Medical subject headings
- Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AMS 700 IPP with MS PumpDevice
Also called AMS IPP 2005
AMS 700 Series Inflatable Penile Prosthesis with MS Pump
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: AMS 700 IPP with MS Pump |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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
Measured: 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"
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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".
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: For duration of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2008 (estimated)
- Study startAug 2005
- Primary completionFeb 2006
- Study completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Erectile DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- American Medical Systems
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- L. Dean Knoll, MD, Principal investigator, Medical Research Associates of NasvilleGerard D Henry, MD, Principal investigator, Regional Urology LLCDaniel Culkin, MD, Principal investigator, University of Oklahoma Health Science CenterDana A Ohl, MD, Principal investigator, University of MichiganJuan Otheguy, MD, Principal investigator, Advanced Research InstituteRidwan Shabsigh, MD, Principal investigator, New York Center for Human SexualitySteven K Wilson, MD, Principal investigator, Institute for Urologic Excellence
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00636506
- Sponsor's protocol ID
- AMS052
- Status last verified
- May 2019
- First submitted
- 11 Mar 2008
- Last updated
- 22 Jul 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 19473458
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center Study to Assess the AMS IPP 2005 Inflatable Penile Prosthesis Cylinders, Pump and Reservoir.
- ClinicalTrials.gov ID
- NCT00636506
- Acronym / sponsor ID
- AMS052
- Conditions
- Erectile Dysfunction
- Keywords
- Erectile dysfunction, Impotence
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- American Medical SystemsIndustry (pharma, biotech, devices)
- Study start
- Aug 2005
- Primary completion
- Feb 2006 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 14 Mar 2008 (estimated)
- Results
- Posted 22 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AMS 700 IPP 2005 Implant Group | Experimental | Device: AMS 700 IPP with MS PumpMale subjects 21 years of age and older who are implanted with an AMS 700 IPP with MS (Momentary Squeeze) pump for erectile dysfunction. |
Who may qualify
- Ages
- 21 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AMS 700 IPP with MS PumpAlso: AMS IPP 2005AMS 700 Series Inflatable Penile Prosthesis with MS Pump | Device | AMS 700 IPP 2005 Implant Group |
Primary outcome
Ease of Locating the Inflation Pump Bulb
Time frame: 4-8 weeks
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
Ease of Pumping Device to Full Erection
Time frame: 4-8 weeks post-op
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.
Quality of Erection (Suitability for Intercourse)
Time frame: 4-8 weeks, 3 months, 6 months
Physicians were asked: "After inflation, did the erection appear suitable for sexual intercourse?" Response options were: Yes, No, Not Assessed
Subjective Force Required to Inflate Device
Time frame: 3 months, 6 months
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"
Ability to Inflate Device Using One Hand
Time frame: 3 months, 6 months
Subjects were asked if they were able to inflate the device using one hand. Response options were: Yes, No
Ease of Training Patient to Inflate Device Compared to the AMS Tactile Pump
Time frame: 4-8 weeks follow-up
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
Ease of Training Patient to Inflate Device Compared to the Standard AMS 700 Pump
Time frame: 4-8 week activation visit
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
Time to Complete Inflation
Time frame: 4-8 week activation visit
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
Ease of Locating the Deflation Block
Time frame: 4-8 week activation visit
Physicians were asked: "Could the deflation button be easily located?" Response options were: Yes, No, and Not Tested
Subjective Force Required to Initiate Deflation
Time frame: 3 months, 6 months
Subjects were asked: "The force required to initiate deflation was..." The response options were: "Too Much" and "Reasonable amount".
Ability to Deflate Cylinders by Pressing the Deflation Button for Only a Few Seconds
Time frame: 3 months, 6 months
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.
Time to Complete Deflation
Time frame: 3 months, 6 months
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
Ability to Deflate Device With One Hand
Time frame: 3 months, 6 months
"Could the subject easily deflate the AMS IPP 2005 with one hand?" The response options were: Yes; No; and Not Tested.
Level of Flaccidity Achieved
Time frame: 4-8 weeks
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.
Ease of Training Patient to Deflate Device
Time frame: 4-8 weeks
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
Patient Satisfaction With Deflation Mechanism
Time frame: 3 Months, 6 Months
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
Ease of Dilation With the Reduced Angle of the Input Tubing
Time frame: Time of implant (surgery)
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
Ease of Cylinder Placement With the Enhanced Profile of the Proximal Tip
Time frame: For duration of surgery
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
Comparison With Other Devices for Ease of Placement
Time frame: For duration of surgery
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
Rating of the Rigidity of the Cylinders
Time frame: 4-8 weeks follow-up
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
Ease of Insertion of New Flare Design Reservoir
Time frame: For duration of surgery
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
Ability of New Flare Design to Remain in Place
Time frame: For duration of surgery
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
Ease Attaching the New Snap Design Rear Tip Extender (RTE) to the Proximal Tip of the Cylinder
Time frame: For duration of surgery
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.
Comparison Rating of the New Rear Tip Extender Design to Previous Design
Time frame: For duration of surgery
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 Evaluation of the Pre-threaded Suture Needle for Ease of Removing Sheath
Time frame: For duration of surgery
Physicians were asked, "Was it easy to remove the blue suture sheath and white needle holder?" Answer options were: Yes; No, please explain
Physician Evaluation of the Pre-threaded Suture Needle for Ease of Loading Furlow Tool
Time frame: For duration of surgery
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 Evaluation of OR Device Preparation Time
Time frame: For duration of surgery
Physicians were asked if the design of the pre-threaded needle facilitated faster loading of the Furlow tool. Answer options were: Yes; No
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 19473458Knoll 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
L. Dean Knoll, MD principal investigator
Medical Research Associates of Nasville
Gerard D Henry, MD principal investigator
Regional Urology LLC
Daniel Culkin, MD principal investigator
University of Oklahoma Health Science Center
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AMS 700 IPP with MS Pump in people with Erectile Dysfunction, run by American Medical Systems at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ease of Locating the Inflation Pump Bulb (time frame: 4-8 weeks). The study lists 27 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00636506, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2019.