Overview of Artificial Urinary Sphincters and Adjustable Dual-Balloon Continence Therapy in Men
According to the American Urological Association, people with persistent or intense urinary incontinence, or the inability to control urine flow, may find relief through surgery. This option is usually considered when the issue significantly interrupts daily life, despite trying other non-surgical methods. One of the leading causes of this serious uncontrollable urine leakage in men is post-prostatectomy incontinence that occurs after prostate surgery. This type of incontinence ranges in prevalence from 4% to 69%, depending on how you define it.
Primary cause of incontinence following prostate surgery is injury to the external urethral sphincter, which is a muscle controlling the release of urine. Symptoms often improve after the surgery if combined with pelvic floor exercises and some changes in lifestyle, showing most improvements over the course of 1 to 2 years. However, a study suggests that 8.4% of men still experience severe incontinence 18 months after surgery.
The usual surgical procedure for urinary incontinence after prostate surgery is the Artificial Urinary Sphincter (AUS). However, there are other available options like urethral sling or dual-balloon adjustable continence therapy. If the urinary issues are severe, these surgical treatments could be considered after 6 months from the prostate surgery, while for moderate cases, it’s generally advised to wait for 1 year before this type of intervention.
Artificial Urinary Sphincter (AUS) has been used since 1972 as an effective treatment of urinary incontinence, particularly stress-induced kind. This device is an actuated system comprised of three main components: a clamping cuff, a control pump, and a pressure-regulating balloon. These are linked together in a closed system that prevents kinking.
The AUS helps in controlling urination by compressing around the urethra. It passes urine by tightening the urethra through a fluid-filled silicone cuff. This allows urine to be passed through a manually operated pump implanted in the scrotum that moves fluid from the clamping cuff into the pressure-regulating balloon. After passing urine, the cuff refills within approximately 3 to 5 minutes to regain the clamp and restore urine control. While the AUS is used around the world for severe cases of urinary incontinence, its use among women in the US is uncommon but is more frequent in Europe. Typically, the device lasts for approximately 10 years.
The AUS devices can be used with MRI. However, this might affect the image quality around the device. Currently, they’re available from a singular manufacturer in the US, Boston Scientific Corp, who provides the devices with an antibiotic coating that helps protect against certain bacterial infections.
Another surgical option is Dual-Balloon Adjustable Continence Therapy (DBACT), a system that uses two silicon balloons which are implanted on each side of the urethra, near the bladder. They help to control the urine flow by increasing passive urethral pressure. The balloons have a titanium port, connected through a silicon tube in the scrotum, which provides office-friendly volume adjustments to the balloons when needed.
The DBACT insertion is deemed as minimally invasive and can be quickly reversed; the devices can be removed in a clinic with basic surgical tools under local anesthesia. The DBACT is also compatible with MRI scanning and currently, they’re provided by a single manufacturer in the US, UroMedica, Inc. Elsewhere, like in Europe and South America, DBACT is used for both men and women, however in the US, it is not approved for use in women.
Anatomy and Physiology of Artificial Urinary Sphincters and Adjustable Dual-Balloon Continence Therapy in Men
In the male body, urine control is maintained by five different muscles in the bladder and prostate. These muscles include two smooth muscle sphincters, the internal sphincter and the prostatic sphincter, and three striated muscle sphincters: prostatic, urethral, and periurethral. Among them, the periurethral striated sphincter is chiefly involved in controlling the release of urine manually, meaning you decide when to go.
In a process called prostatectomy, where the prostate is removed, a man may end up developing urinary incontinence, a condition of losing bladder control. This can happen due to potential damage to the external urethral sphincter caused during surgery. Also, in-depth surgical dissection and injury to the bundle of nerves and vessels could increase the risk of urinary incontinence after surgery.
The prostatectomy process removes some parts that help control urine, and this can affect the functioning of the periurethral striated sphincter, a muscle mainly responsible for maintaining no-leakage after surgery. The modification in the structure and the disruption in the nerves due to the operation all play a role in urinary issues after prostate surgery.
Also, certain patient-specific factors could influence urinary incontinence after prostate surgery. These include age, diabetes, existing bladder abnormalities and previous urinary incontinence conditions. Recently, research is being done to find if body mass index and lifestyle aspects could also contribute to urinary issues after prostate surgery.
Furthermore, radiation therapy can impact bladder control negatively, especially when treating prostate issues. The radiation can lead to chronic inflammation, scar tissue formation, abnormal cell growth, and specific bladder infections – all potentially leading to a sudden urge to urinate, or urge incontinence. However, note that the current interventions involving prostheses are not created specifically for radiation-induced incontinence. Any usage for this purpose is considered “off-label”, meaning it was not its intended or approved use.
Data indicate that those who get pelvic radiation therapy after prostate surgery generally experience lower rates of continence than similar patients who didn’t undergo radiation. Also, the success rate of full continence was significantly lower in all patients using Artificial Urinary Sphincter (AUS), especially in patients undergoing duplicate AUS implantation. Patients who had radiation therapy showed similar rates of AUS device durability as those without radiation, if the final cuff size was at least 3.5 cm.
Why do People Need Artificial Urinary Sphincters and Adjustable Dual-Balloon Continence Therapy in Men
An Artificial Urinary Sphincter (AUS) is an option for individuals suffering from serious and troubling urinary incontinence, often a consequence of prostate surgery, that hasn’t improved with simpler treatments. Choosing the right candidates for an AUS is crucial for its success. The person must be highly willing, able to do regular self-catheterization if needed, and physically, mentally capable of using the pump mechanism. While older age is not a disqualifying factor, people over 80 have a higher risk of infection and complication, but can still consider AUS installation.
A Differential Balloon Adjusted Continence Therapy (DBACT) is used for stress incontinence that lasts at least a year after prostate surgery (radical prostatectomy or transurethral resection) in patients who haven’t adequately improved with simpler therapy. This surgical device helps control bladder function so it’s used for other causes leading to a lack of control like pelvic fractures, spinal cord injuries, reconstructed urine passages, nerve problems in the bladder affecting sphincter function, and unsuccessful continence procedures in the past.
When a Person Should Avoid Artificial Urinary Sphincters and Adjustable Dual-Balloon Continence Therapy in Men
There may be certain reasons that prevent patients from getting AUS (a device to control urine flow) and DBACT (a type of therapy used to treat bladder problems) treatments. These reasons can be, for example, patients who can’t go under anesthesia or aren’t able to handle possible complications from surgery. However, if a patient has previously had a urethral sling (a method used to control urine flow), that doesn’t stop them from getting either treatment.
The AUS requires some user interaction and may not be suitable for people who have cognitive problems or issues with hand movement. Other reasons that might prevent patients from getting the AUS include having urine leakage caused by a blocked lower urinary tract, a bladder that contracts too frequently, or an unstable bladder. The AUS would also not be given to people who are allergic to antibiotics, have active urinary tract infections, recurring problems or increasing strictures (narrowing) in the urethra, issues with emptying the bladder completely, or a small bladder.
If a patient has vesicoureteral reflux (a condition where urine flows backward into the kidneys from the bladder), this should be surgically corrected before getting an AUS to prevent the condition from worsening. Other factors, such as recurring kidney stones and bladder tumors which require regular bladder examinations can increase the risk of erosion in the AUS and thus it may not be advisable. Any narrowing in the bladder neck should be repaired and checked to make sure it’s permanently fixed at least three months before getting an AUS.
DBACT treatment might not be suitable for people with severe urine leakage, people who’ve undergone or are planning to undergo radiation therapy within six months of getting the DBACT, and for those suffering from urine leakage due to nerve-related stress. Additional reasons can include active urinary tract infections, incontinence caused by unstable or overactive bladder muscles, reduced bladder compliance, post-void residual urine volumes over 100 milliliters, significant urge incontinence, or uncorrected bleeding disorders.
Equipment used for Artificial Urinary Sphincters and Adjustable Dual-Balloon Continence Therapy in Men
When a patient needs a procedure to control urinary incontinence called an Artificial Urinary Sphincter (AUS), the medical team uses the following equipment:
- Ties made of a non-absorbable plastic called polypropylene.
- Single-use 10 mL and 30 mL syringes.
- Measuring containers of 500 mL and 1000 mL.
- Suture, or medical thread, that will dissolve over time for closing the wound.
- Antibiotic solution to fight possible infection.
- A specific kit containing the artificial urinary sphincter, assembly tools and tubing passers, which are instruments needed for the procedure.
- Babcock clamps and other types of retractors to hold tissues and organs in place.
- Catheters, rubber tubes used to drain and collect urine from the body.
- Contrast solution, a special liquid which helps to highlight certain areas during imaging procedures.
- Dry skin dressings to protect the wound.
- Electrocautery, a tool that uses electricity to cut tissue or stop bleeding.
- Hegar dilators, devices to expand body openings for the procedure.
- Scissors designed for surgery, including Mayo and Metzembaum types.
- A Penrose drain or vessel loop for fluid drainage.
- Right-angle clamps and rubber-shod hemostats to securely clamp tubing.
- Containers such as sponge bowl and basin.
- Sterile salt water, also known as sterile normal saline.
- Umbilical tape, a surgical tool used to encircle and hold structures during surgery.
If the patient needs a different procedure for incontinence called Dual-Balloon Adjustable Continence Therapy (DBACT), the equipment includes:
- Stitching threads made of absorbable materials.
- A single-use 10 mL syringe.
- A scalpel with either a 15 or 11 blade to make incisions.
- A 50 mL syringe with luer lock.
- A device kit needed for controlling incontinence.
- Adson forceps, a surgical tool used for holding and manipulating tissues.
- Allis clamp, a surgical tool for holding or securing body tissues.
- Antibiotic irrigation to clean out wounds.
- A C-arm fluoroscopy system, an imaging scanner shaped like a “C” to provide real-time x-ray images during the procedure.
- Dry skin dressings for wound protection.
- Metzenbaum scissors, delicate surgical scissors used for cutting soft tissues.
- A rigid cystoscopy set, an instrument used to view the inside of the urinary bladder.
- Forceps with rubber coating.
- A solution of contrast and sterile water to improve visibility during imaging.
- Containers for medical use.
- Sterilized gel to reduce friction during procedures.
- Sterile salt water, also known as sterile normal saline.
- Pure sterile water for medical use.
- A set of instruments specifically designed for urological surgery.
Who is needed to perform Artificial Urinary Sphincters and Adjustable Dual-Balloon Continence Therapy in Men?
During procedures to treat incontinence (difficulty controlling urination), various medical professionals work together.
Firstly, the operation is led by a specific kind of surgeon called a ‘urologic surgeon’. They are experts in treating health problems related to the urinary system.
An ‘anesthesia provider’ also participates in the procedure. Their role is to administer anesthesia, which is a medicine to help you sleep and not feel any pain during the operation.
Another person in the operating room will often be a ‘circulator’ or ‘operating room nurse’. Their job is to make sure everything runs smoothly by passing needed instruments and other supplies to the surgeon and anesthesia provider.
Furthermore, a ‘surgical technologist’, who is another type of nurse. They help in setting up the surgical instruments and equipment.
Lastly, a ‘radiology technician’ may be needed if there is a need to capture images of your body’s structure during the operation. They specialized in using medical imaging machines, like X-rays or ultrasound.
These professionals all work together to ensure your safety and a successful outcome from the operation.
Preparing for Artificial Urinary Sphincters and Adjustable Dual-Balloon Continence Therapy in Men
Before starting the treatment for urinary incontinence (bladder control loss), your doctors would carry out an in-depth examination. This might include taking a detailed medical history, physical check-up, observing urination habits, or carrying out more specific tests if required. They may use techniques like urodynamics or video-urodynamics, which are sophisticated tests to understand how your bladder and urethra are performing. If needed, you would also do a urine test (urine culture) before the procedure. If this test shows you have a bacterial infection, you would need antibiotic treatment to clear it up before the procedure.
For some people, the doctors might opt for an advanced treatment that involves an Artificial Urinary Sphincter (AUS) or something called Dual-Balloon Adjustable Continence Therapy (DBACT). These help control urine flow using a device. If these are being considered, the doctor would also use a small camera (cystoscopy) to look at your urinary tract and identify any abnormalities. You will also be given antibiotics as a preventive measure to ward off infections before the procedure.
All the equipment used during the procedure is carefully cleaned and stored in a sterile saline solution to ensure it is germ-free. Special attention is given to surgical gloves to avoid any unwanted particles from creating issues.
An AUS is usually inserted through the perineum (the area between the genitals and rectum) and is typically placed in the bulbar urethra, a part of your lower urinary tract. The location can vary according to the patient’s anatomy and men are the usual candidates for this procedure. In women, another method involving robotic-assisted surgery could be used to place the AUS at the bladder neck that leads to fewer complications.
Prior to surgery, patients are put in a position called dorsal lithotomy which offers suitable access and comfort during procedure. Certain preparation steps are required such as removal of hair in the operational area, followed by cleaning with a special solution. A urinary catheter is also placed for draining urine and identifying the urethra. The area is then prepped for surgery and draped to keep it sterile.
Similar preparation steps are taken for the Dual-Balloon Adjustable Continence therapy. The operational area is prepped and draped in a sterile manner. However, any instructions for using betadine (an antiseptic) for skin preparation should be ignored as it isn’t the recommended standard for these kinds of surgeries.
How is Artificial Urinary Sphincters and Adjustable Dual-Balloon Continence Therapy in Men performed
An artificial urinary sphincter is a device that helps control urination. Here’s a simplified explanation of how your doctor might put one in place.
First, they make a small cut in the area between your anus and genitals. By making a combination of careful cuts and peeling back some layers, the doctor will expose the urethra (the tube that carries urine out of the body). They’ll use small, compact tools to keep the area open so they can work easily.
After the urethra is visible, the surgeon will slip something called a Penrose drain or a vessel loop around it to secure it. They’ll then make sure there is enough space to place the artificial urinary sphincter cuff. This cuff is a silicone tube that closes off the urethra to avoid any leakage.
They will then decide which size cuff to use by measuring your urethra’s circumference. The cuff will be put in its place with the inflatable side near the urethra. After putting the device in place, they will lock it securely to ensure it stays in place.
Next, they’ll put in a reservoir known as the pressure-regulating balloon. This goes just above your pubic bone on the same side as the pump. This will be filled up to the desired pressure level. Depending on your situation, this could be different for each person.
Afterward, a small pump will be put into your scrotum (males) or labia (females). This will be in an area that’s easy for you to reach and feel. After the pump is in place, they’ll connect it to the other parts of your device using a small metal device. They’ll make this connection comfortable for you by adjusting the tubing and the implantation depth. Lastly, they will check and confirm the device is working properly once everything is connected.
Once everything is done, they’ll clean the area and close everything up using stitches that your body can naturally absorb. They’ll also add a sterile dressing to the cuts to keep them clean while they heal.
There’s also a device called a Dual-Balloon Adjustable Continence Therapy Device which they place using similar steps. They begin with a procedure known as a cystoscopy, to look inside your urinary tract. They then continue with similar steps as the artificial urinary sphincter placement, but specific to the device. The surgeon will do these procedures with a balance between preciseness and effectiveness to ensure your comfort.
Possible Complications of Artificial Urinary Sphincters and Adjustable Dual-Balloon Continence Therapy in Men
When a person has a procedure to have an artificial urinary sphincter (AUS) inserted, there is a chance that they might experience complications. For example, during the surgery, there might be damage to the urethra, which is the tube that carries urine out of the body. When this happens, surgeons usually need to fix the damage, then delay putting in the AUS to give the urethra a chance to heal. Generally, surgeons are advised to wait for three months after an injury before trying to put in the AUS again.
If someone has had previous surgery or treatment in the pelvic area, this can make it more likely that the bladder might be damaged during the AUS surgery. However, to reduce this risk, a catheter (a tube for draining urine) can be kept in place continuously during the surgery.
In some cases, the surgeon may accidentally enter into the peritoneum (the tissue lining the abdomen) or injure the bowels during surgery. If the bowels are injured, they need to be repaired straight away, and the AUS surgery must be stopped.
Particularly for women, it’s critical to take care during the AUS procedure because of the close proximity of the bladder, vagina, and other surrounding structures. To help with this, some surgeons use special instruments and techniques, including opening the bladder for a better view during surgery.
After the surgery, a patient might experience problems like a loss of fluid from the device, the thinning of urethral tissue, infection, and the need for more surgery. Some patients may not see an improvement in their symptoms, and they might even continue to experience symptoms such as frequent urination or urgent need to urinate, especially at night. If these types of complications happen, they may see blood in the urine, find it painful to urinate or find it difficult to pass urine at all.
If a patient can’t pass urine in the first 24 hours after surgery, a catheter can be used to help. If the problem lasts for more than 48 hours, a different type of catheter may be inserted above the pubic bone to help drain the bladder.
After surgery, infection rates range from 2% to 3%. Those who had radiation treatment in the pelvic area in the past are at a higher risk. The kinds of bacteria most often found in these cases are Staphylococcus aureus and Streptococcus epidermidis. To decrease the risk of infection, antibiotics may be used. But if a sign of infection appears, the device must be removed immediately.
Over a long period, the urethra may become thin due to repeated compression, resulting in leaking. Techniques have been developed to deal with this and have helped reduce the occurrence to less than 10%. Even so, the best approach is often to move the cuff to a healthier part of the urethra.
If the AUS erodes, it must be assumed that it’s infected. A catheter should be inserted, and the AUS should be removed. A rest period of at least three months is recommended before a new device can be put in.
Overall, out of every 100 patients who have an AUS put in, about 20 will need to have the device serviced or replaced in future. If a patient finds that the device isn’t working, they should have a physical examination to help find out why. Imaging tests might also be needed. The most common reasons the device might not work are that the cuff is too big or the device doesn’t have enough pressure.
What Else Should I Know About Artificial Urinary Sphincters and Adjustable Dual-Balloon Continence Therapy in Men?
Urinary continence, or the ability to control your bladder, is often affected by prostate surgery. Sometimes, the normal methods of regaining control don’t work and patients must turn to other solutions. Two such solutions are the AUS (artificial urinary sphincter) and the DBACT (adjustable continence therapy).
The AUS is an active system, meaning it needs you to physically operate a pump to control the device. It’s proven effective in the long term, with half of patients achieving complete control five years after having it fitted. Another 40% need to use only one padding or less each day five years after. Users also reported high satisfaction rates. According to the manufacturer, over 94,000 of these devices have been implanted.
The DBACT is regarded as a passive system and requires a less invasive procedure to install. Success rates vary, with between 30% to 67% of patients achieving complete control, and an additional 22% to 38% experiencing at least 50% improvement in leakage. Some patients experienced complications, including malfunctioning balloons, but these were usually resolved by balloon replacement.
Choosing between the AUS and DBACT often depends on the individual’s situation. Those with limited manual strength, who desire a less invasive procedure, or who find it difficult to operate an AUS, might prefer a DBACT. But those who want a solution with more long-term data or a more natural functionality might lean towards an AUS. Patients’ experiences and preferences, as well as the surgeon’s expertise, should all factor into the shared decision-making process.
Patients should manage their expectations about surgery. While perfect control is a goal, it might be more realistic to focus on improved control or “social continence”, needing no more than one incontinence pad per day, which often improves postoperative satisfaction rates.
The AUS device available in the United States could use some improvements, especially regarding easier operation, varied cuff sizes, and simpler surgical procedures. Some adjustments have been considered, like adding an implanted stress reservoir in certain patients, which has shown to improve AUS devices’ functionality. However, more research is needed before it’s used widely.
Some new devices coming from overseas are designed with these improvements in mind, including the Rigicon AUS from Europe, which is easier to operate and adjusts to changes in pressure. Others like the Victo and Zephyr AUSs from Austria and Switzerland, respectively, offer other enhancements and are available in many countries, but still not in the U.S.
