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he idea of the experiment is to calculate the volume of fluid that is required to raise cuff pressure from 20 cmH2O to 120 cmH2O in the American Medical System's AMS 800 Artificial Urinary Sphincter (AUS).
The current AMS 800 is not personalized to the patient's needs. Most men only need 20 cm H2O of urethral compression to remain dry when they are sedentary, yet need 120 cm H2O of urethral compression when they are active. The current device compromises with an in between pressure - as high as it can be without exceeding safety tolerance thresholds. As such many men still leak when they are active. In fact, this compromise is so central to the device that a new term has evolved to describe men's suboptimal level of continence after the AMS 800. We call it "social continence", meaning that they are dry enough to only have to wear 1-2 pads per day for protection.
The market is hungry for a device that can adapt to the patient's level of activity, reducing the pressure most of the day to protect the urethra and then briefly increasing the pressure when he is more active.
The experimental procedure is explained below and care will be taken to make sure the pressure sensor is sterile. The experiment involves minimal risk and will be conducted by the PI who has 10+ years of experience in AUS implantations.
The procedure for implanting the AMS 800 is mentioned in the Operating Manual attached with this protocol. The treatment procedure is linked with the experimental setup designed by the PI and the research student in the following manner:
For all other details including device description and post-operative care, refer to the AMS 800 operating Manual. All devices including the AMS 800 (PMA-P000053) and the Edward LifeSciences Pressure Transducer (501K- K142749) are FDA approved.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AMS 800 Artificial Urinary Sphincter | Experimental | The AMS 800â„¢ Urinary Control System is an implantable, fluid-filled, solid silicone elastomer prosthesis used to treat urinary incontinence due to reduced outlet resistance (intrinsic sphincter deficiency) following prostate surgery. The AMS 800 Urinary Control System simulates normal sphincter function by opening and closing the urethra, under patient control. When the cuff is closed, urine stays in the bladder. When the patient wishes to void, he simply squeezes and releases the pump several times. This causes the fluid in the cuff to move into the pressure-regulating balloon . The cuff opens and urine passes through the urethra. The balloon then automatically re-pressurizes the cuff through the pump, within several minutes, the cuff again closes the urethra. The control pump, which in implanted in the scrotum, is also designed to allow the clinician or patient to deactivate and activate the system without additional surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AMS 800 | Device | AMS 800 Artificial Urinary Sphincter |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pressure-Volume Measurements on the AMS 800TM Cuff | Measure volume and corresponding pressure in AMS 800TM occlusion Cuff | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sean Elliot, MD | University of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Minnesota Medical Center | Minneapolis | Minnesota | 55455 | United States |
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| ID | Term |
|---|---|
| D014550 | Urinary Incontinence, Stress |
| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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Volume and Pressure Profiles in the AMS 800 cuff. The cuff is filled with deionized water and the amount of fluid in it decides the pressure it will apply while wrapped around the urethra. The pressure-volume profiles will be taken from 6 patients consented by the PI and these will be used for the secondary end point.
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| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |