Stress Urinary IncontinenceAUSNCT03122392
Pressure-Volume Measurements on the AMS 800TM Cuff
A study testing AMS 800 in people with Stress Urinary Incontinence, run by University of Minnesota at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 100 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Stress Urinary Incontinence
- What is being tested?
- AMS 800
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jun 2017to 1 Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 100 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men between 18 and 100 years of age who are to undergo AUS placement for treatment of stress urinary incontinence.
Who cannot join
- Under the age of 18 years old English non-speaking Unable to consent for themselves If a trans-corporal technique to AUS implantation is planned as this may affect the pressure measurements (<10% of the AUSs we implant are transcorporal).
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota Medical Center
Minneapolis, Minnesota, 55455
About this study
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).
Read the detailed description
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:
- Follow surgical preparation steps mentioned on pages 14-15 of the AMS 800 Operating Manual. Once the cuff sizer is used to determine the cuff length (usually 4.0cm or 4.5cm), move on to next step. For graphical representation, follow steps 1 to 9b on pages 18- 20 of the AMS 800 Operating Manual.
- The AMS 800 cuff is filled with deionized water such that pressure is 20cmH2O. Follow steps on pages 13-14 of the AMS 800 Operating Manual for filling the cuff.
- The AMS 800 cuff around the urethra has a kink-free tubing which goes into a female connector
- The female connector connects to the male connector of the IV tubing
- The IV tubing is connected to a T-Connector
- One end of the T-Connector goes to the TruWave Pressure Transducer
- Other end goes to a syringe
- The system is pumped with deionized water and is therefore sterile.
- Water is pumped into the cuff with the syringe and as the volume in the cuff increases, corresponding cuff pressure changes. This is done until we have a volume for a pressure reading of 120cmH2O on the pressure transducer.
- Once the reading is obtained, the PI will flush out the excess water from the cuff, and fill it with an optimal volume as required by the treatment procedure which he has performed for over 10 years.
- The treatment procedure will continue to follow the steps hereafter as has been designed for AUS placement.
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.
- Conditions
- Stress Urinary Incontinence
- Being tested
- AMS 800
- Medical subject headings
- Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AMS 800Device
AMS 800 Artificial Urinary Sphincter
| Study group | Role | What they receive |
|---|---|---|
| AMS 800 Artificial Urinary Sphincter | Experimental | The AMS 800™ 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. Receives: Device: AMS 800 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pressure-Volume Measurements on the AMS 800TM Cuff
Measure volume and corresponding pressure in AMS 800TM occlusion Cuff
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2017
- Study start28 Jun 2017
- Primary completion7 Feb 2018
- Study completion1 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress Urinary IncontinenceStudies 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 N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sean Elliot, MD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03122392
- Sponsor's protocol ID
- 1703M09441
- Acronym
- AUS
- Status last verified
- Jun 2019
- First submitted
- 17 Apr 2017
- Last updated
- 2 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pressure-Volume Measurements on the AMS 800TM Cuff
- ClinicalTrials.gov ID
- NCT03122392
- Acronym / sponsor ID
- AUS / 1703M09441
- Conditions
- Stress Urinary Incontinence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 28 Jun 2017 (actual)
- Primary completion
- 7 Feb 2018 (actual)
- Study completion
- 1 Mar 2018 (actual)
- First posted
- 20 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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:
- Follow surgical preparation steps mentioned on pages 14-15 of the AMS 800 Operating Manual. Once the cuff sizer is used to determine the cuff length (usually 4.0cm or 4.5cm), move on to next step. For graphical representation, follow steps 1 to 9b on pages 18- 20 of the AMS 800 Operating Manual.
- The AMS 800 cuff is filled with deionized water such that pressure is 20cmH2O. Follow steps on pages 13-14 of the AMS 800 Operating Manual for filling the cuff.
- The AMS 800 cuff around the urethra has a kink-free tubing which goes into a female connector
- The female connector connects to the male connector of the IV tubing
- The IV tubing is connected to a T-Connector
- One end of the T-Connector goes to the TruWave Pressure Transducer
- Other end goes to a syringe
- The system is pumped with deionized water and is therefore sterile.
- Water is pumped into the cuff with the syringe and as the volume in the cuff increases, corresponding cuff pressure changes. This is done until we have a volume for a pressure reading of 120cmH2O on the pressure transducer.
- Once the reading is obtained, the PI will flush out the excess water from the cuff, and fill it with an optimal volume as required by the treatment procedure which he has performed for over 10 years.
- The treatment procedure will continue to follow the steps hereafter as has been designed for AUS placement.
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| AMS 800 Artificial Urinary Sphincter | Experimental | Device: AMS 800The AMS 800™ 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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Men between 18 and 100 years of age who are to undergo AUS placement for treatment of stress urinary incontinence.
Key exclusion criteria (1 listed)
- Under the age of 18 years old English non-speaking Unable to consent for themselves If a trans-corporal technique to AUS implantation is planned as this may affect the pressure measurements (<10% of the AUSs we implant are transcorporal).
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 800AMS 800 Artificial Urinary Sphincter | Device | AMS 800 Artificial Urinary Sphincter |
Primary outcome
Pressure-Volume Measurements on the AMS 800TM Cuff
Time frame: 6 months
Measure volume and corresponding pressure in AMS 800TM occlusion Cuff
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2019.
- Individual participant dataSharing planned: No
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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.
Sean Elliot, MD principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AMS 800 in people with Stress Urinary Incontinence, run by University of Minnesota at 1 site 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?
The sponsor lists 1 inclusion and 1 exclusion criteria. 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 2 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 1 site 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Pressure-Volume Measurements on the AMS 800TM Cuff (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Jul 2019.