CompletedPhase 2

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

United States76 participantsStarted 2005-08

Plain-language 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.

Who can participate

Age range

21 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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.

Exclusion criteria

. The subject's reading level is judged inadequate for reading and understanding the Informed Consent, patient questionnaires, and other study materials.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Ease of Locating the Inflation Pump Bulb

Timeframe: 4-8 weeks

Ease of Pumping Device to Full Erection

Timeframe: 4-8 weeks post-op

Quality of Erection (Suitability for Intercourse)

Timeframe: 4-8 weeks, 3 months, 6 months

Subjective Force Required to Inflate Device

Timeframe: 3 months, 6 months

Ability to Inflate Device Using One Hand

Timeframe: 3 months, 6 months

Ease of Training Patient to Inflate Device Compared to the AMS Tactile Pump

Timeframe: 4-8 weeks follow-up

Ease of Training Patient to Inflate Device Compared to the Standard AMS 700 Pump

Timeframe: 4-8 week activation visit

Trial details

NCT IDNCT00636506

SponsorAmerican Medical Systems

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2006-02

Results submitted2011-06-24

View on ClinicalTrials.gov More Erectile Dysfunction trials

Who can participate

Age range

21 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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.

Exclusion criteria

. The subject's reading level is judged inadequate for reading and understanding the Informed Consent, patient questionnaires, and other study materials.

What they're measuring

Ease of Locating the Inflation Pump Bulb

Timeframe: 4-8 weeks

Ease of Pumping Device to Full Erection

Timeframe: 4-8 weeks post-op

Quality of Erection (Suitability for Intercourse)

Timeframe: 4-8 weeks, 3 months, 6 months

Subjective Force Required to Inflate Device

Timeframe: 3 months, 6 months

Ability to Inflate Device Using One Hand

Timeframe: 3 months, 6 months

Ease of Training Patient to Inflate Device Compared to the AMS Tactile Pump

Timeframe: 4-8 weeks follow-up

Ease of Training Patient to Inflate Device Compared to the Standard AMS 700 Pump

Timeframe: 4-8 week activation visit