ContiReflex<sup>®</sup> Enhanced Artificial Urinary Sphincter

ContiReflex®

Enhanced Artificial Urinary Sphincter

ContiReflex<sup>®</sup> Enhanced Artificial Urinary Sphincter

ContiReflex®

Enhanced Artificial Urinary Sphincter
  • ContiReflex® Enhanced Artificial Urinary Sphincter is used to treat urinary incontinence due to intrinsic sphincter deficiency in cases such as incontinence following prostate surgery.1

  • ContiReflex® Enhanced Artificial Urinary Sphincter’s smart “Reflex Balloon” senses changes in intraabdominal pressure (IAP) and, in response, modifies the pressure on the urethra in response to this change in IAP.

  • The Reflex Balloon has two bladders which allows the occlusive urethral pressure to be altered in response to the patient’s sudden Valsalva maneuver and, as a result, better protects the patient from stress incontinence. In effect, this means that cuff occlusion pressure is no longer limited by the pressure regulating balloon’s (PRB’s) labeled maximum pressure.

  • In addition, this two-bladder construction means the resting pressure of the balloon can be lower than competitive devices because protection from leakage is no longer reliant on the PRB’s labeled pressure. It is believed lower resting pressure of the PRB will prolong urethral viability decreasing the necessity for revision operations.

Smart Reflex Balloon

Smart Reflex Balloon

Smart Reflex Balloon senses IAP; changes and modifies occlusive cuff pressure in real-time. Cuff pressure is no longer limited by PRB’s labeled pressure capacity.
New Cuff Sizes

New Cuff Sizes

New and diverse occlusive cuff sizes for a surgeon-made fit to the patient’s urethral anatomy.

HydroShield™ Coating

HydroShield™ Coating

ContiReflex® incorporates a hydrophilic coating on all external surfaces of every component including the pressure regulating balloon.

This allows the possibility of dipping the components in an aqueous solution in which antibiotics and/or anesthetic drugs have been added. Published studies on other devices show the drugs should elute into the patient’s tissue spaces upon implantation.

EasyClick™ Connector

EasyClick™ Connector

EasyClick™ Connectors do not require an additional assembly tool.

EasyClick™ Y-Connector

EasyClick™ Y-Connector

EasyClick™ Y-Connector enables double-cuff placement.

Control Pump

Control Pump

The ContiReflex® pump resembles competitive devices but differs because it is very easy to activate and deactivate. 

While competitive pumps are difficult to turn on and turn off, this pump can easily be activated without the necessity of a large amount of fluid left in the pump. Ease of operation makes it possible to teach the patient to deactivate the pump when sleeping which protects his urethra from constant occlusion 24 hours, 7 days a week

Combined Use with IPP

Combined Use with IPP

Can be used in combination with the Infla10® Inflatable Penile Prosthesis models.2

Tubing Passer

Tubing Passer

Passer is already included in the Conti® Accessory Kit. No need for a separate purchase.



FAQ

In this section, you will find quick answers to some of the most frequently asked questions. Keep in mind that each person and his condition are unique, and you should always consult an experienced physician to get the right answers for you.
Read more about urinary incontinence

What is urinary incontinence?

Urinary incontinence (UI), sometimes referred to as “lack of bladder control,” is the involuntary loss of urine. Patients suffering from UI cannot control urine release from the bladder. Urinary incontinence is estimated to affect 1 out of 10 males, with increasing prevalence associated with aging. 


What are the common causes of chronic stress urinary incontinence in men?

Eliminating overactive bladder muscles, weakened pelvic floor muscles, enlarged prostate, a disability or mobility, chronic illness, being overweight, and smoking.

This leaves only prostate cancer treatment and nerve damage.


What is Stress Urinary Incontinence (SUI)?

Stress urinary incontinence is the unexpected leakage of urine when an outside pressure occurs with activities such as heavy lifting, coughing, sneezing, laughing, or exercise.

This outside pressure causes the already weakened bladder to leak urine.

The bladder is held in place by the muscles and connective tissue in the pelvis. When these muscles are weak, the outside pressure can push the bladder downward, causing the urethra to open and the urine to leak out.

A weak or damaged sphincter may also cause stress urinary incontinence.


Is stress urinary incontinence a normal part of aging?

It is true that, stress urinary incontinence (SUI) is a normal part of aging for females, but it takes an event like trauma or surgery to give a man stress urinary incontinence.


How will my doctor diagnose urinary incontinence?

For diagnosis, your doctor will perform a physical examination and take your detailed medical history.

Depending on your medical history and physical examination findings, your doctor may require further testing. 


Is stress urinary incontinence a side effect of surgical prostate treatment?

One of the most common side effects of radical prostatectomy is stress urinary incontinence.

It is expected for post-radical prostatectomy SUI to be resolved within one year following surgery. In some cases, patients may continue to experience SUI without any improvement over time. If you are having issues with bladder control and it is an issue six months after your procedure, you should see a specialized physician to seek medical advice and, if necessary, discuss your treatment options.


What are some of the treatment options for stress urinary incontinence (SUI)?

Remember that most stress urinary incontinence cases are treatable. Depending on the severity and the type of urinary incontinence, your doctor will decide on the best treatment option. 

Commonly there are two treatment options:

1) Conservative treatment (e.g., medicines, special exercises)

2) Surgical treatment (e.g., Enhanced Artificial Urinary Sphincter)


What is an artificial urinary sphincter?

Enhanced Artificial Urinary Sphincter (AUS) is a medical device to treat stress urinary incontinence. Enhanced Artificial Urinary Sphincter is a surgical treatment option when non-surgical or behavioral treatment options fail.

Enhanced Artificial Urinary Sphincter placement is regarded as the “gold standard” in the surgical treatment of SUI.

A specialized physician (i.e., a urologist) will surgically place the artificial urinary sphincter in the body. Enhanced Artificial Urinary Sphincter will mimic the role of a healthy urinary sphincter (the two muscles controlling the exit of urine from the bladder through the urethra). The Artificial Urinary Sphincter will close the urethra preventing urine leakage. The patient will squeeze a pump in his scrotum to release the cuff over the urethra and void. The cuff will return to its closed state. The Enhanced ContiReflex® smart “Reflex Balloon” senses IAP; changes and modifies occlusive cuff pressure in real time. Cuff pressure is responsive to IAP changes and is no longer limited by the PRB’s labeled pressure capacity.


What are the benefits of ContiReflex® Enhanced Artificial Urinary Sphincter?

ContiReflex® Pump is easily manipulated, deactivated, and activated.

ContiReflex® Smart PRB adapts occlusive cuff pressure in a real-time manner.

ContiReflex® has a safe implantation via a single-incision penoscrotal approach.

ContiReflex® Enhanced Artificial Urinary Sphincter has more comprehensive occlusive cuff size options. This will enable your surgeon to choose the occlusive cuff that fits best with your urethral anatomy.

In some cases, double-cuff placement might be preferred. EasyClick™ Y-Connector will enable a double-cuff configuration of the device.

ContiReflex® Enhanced Artificial Urinary Sphincter incorporates a hydrophilic coating on all device surfaces. This hydrophilic coating will allow your surgeon to choose the aqueous solution she will dip into the device before implantation.


What should I expect for recovery after AUS implantation?

It is expected that a full recovery from artificial urinary sphincter implantation could take up to 6 weeks. Please keep in mind that every patient will have a different timeline for recovery. Your physician will manage your post-op care. You need to follow your physician’s suggestions for a speedy recovery. Your implanted Artificial Urinary Sphincter will be activated by your physician in your follow-up appointment, which is generally scheduled for four to six weeks after implantation.


Will others be able to notice that I have an Artificial Urinary Sphincter?

All components of the artificial urinary sphincter are concealed in your body and can not be noticed from the outside. Others will not know that you have an artificial urinary sphincter implanted unless you choose to disclose it.


Can Artificial Urinary Sphincter be used with Inflatable Penile Prosthesis simultaneously?

Aside from stress urinary incontinence, erectile dysfunction is another common side effect of radical prostatectomy surgery. If you are experiencing SUI and erectile dysfunction, consult a specialized physician. An artificial Urinary Sphincter can be used simultaneously with Inflatable Penile Prosthesis (e.g., Infla10 Three-Piece Inflatable Penile Prosthesis).



FAQ’s Disclaimer

The content is not intended to be a substitute for, nor does it replace professional medical advice, diagnosis, or treatment. If you have any concerns or questions about your health, you should always consult with a physician or other health-care professional.

Caution

Federal law (USA) restricts this device to sale by or on the order of a physician.

References

1 Rigicon® ContiReflex® Enhanced Artificial Urinary Sphincter Instructions for Use.

2 Boysen, William, et al. “Combined Placement of Artificial Urinary Sphincter and Inflatable Penile Prosthesis Does Not Increase Risk of Perioperative Complications or Impact Long-term Device Survival.” Urology vol. 124 (2019): 264-270.


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