Artificial Bladder Sphincter: Information & Specialists

What is an artificial sphincter?

An artificial sphincter is an artificial bladder sphincter that is implanted in patients with severe stress incontinence. This form of urinary incontinence often develops after a prostatectomy or other procedures involving the urethra and leads to uncontrolled urine leakage.

The hydraulic implant replaces the damaged sphincter function and enables patients to regain controlled urinary flow. Modern systems such as the AMS 800 or ZSI 375 consist of a cuff, a reservoir, and a pump, all connected by tubing.

This surgical treatment for urinary incontinence is considered the gold standard in urology for severe stress incontinence—in both men and women—when conservative measures such as pelvic floor exercises or medication prove ineffective.

Causes and Diagnosis of Urinary Incontinence

Urinary incontinence can have many causes. It is often due to damage to the sphincter muscle or the urethra—for example, following prostate surgery or due to age-related changes in the pelvic floor muscles.

In men, stress incontinence often occurs after a radical prostatectomy, while in women, childbirth, pelvic surgery, or hormonal changes during menopause play a role. Being overweight and chronic coughing also increase abdominal pressure and can lead to urine leakage.

Diagnosis involves several steps:

• Medical history (review of past medical history, surgeries, medications, pregnancies)
• Urinalysis and residual urine measurement
• Urodynamic testing to assess bladder and sphincter function
• Cystoscopy (examination of the bladder and urethra)
• Voiding diary to record the frequency and volume of urination

Only after a precise diagnosis can a decision be made as to whether conservative treatment—such as pelvic floor exercises—is sufficient or whether surgical treatment, such as the implantation of an artificial sphincter, is necessary.

Illustration of various forms of urinary incontinence © bilderzwerg | AdobeStock

Treatment Options for Stress Incontinence

Treatment for stress incontinence depends on the severity of the symptoms and the individual causes. For mild forms, conservative treatment is the first line of approach, while severe cases often require surgery.

1. Conservative treatment options:

• Pelvic floor exercises: Regular exercises strengthen the muscles around the bladder, urethra, and pelvic floor.
• Biofeedback and electrostimulation: These support the exercises to improve control over urine flow.
• Medication: Active ingredients such as duloxetine can increase sphincter tone in some patients.
• Lifestyle changes: Weight loss for those who are overweight and avoiding physical activities that increase pressure on the abdomen.

2. Surgical treatments:
If conservative measures are ineffective, various surgical procedures may be considered:

• Sling procedures, which stabilize the urethra.
• Artificial sphincter: The most effective solution for severe stress incontinence, particularly after prostate surgery.
• Injections of fillers into the bladder neck (rarely used).

The artificial sphincter is currently considered the gold standard when other treatment options fail. It can be used in both men and women and, in most cases, enables nearly complete continence.

How the artificial urinary sphincter works

The artificial urinary sphincter (AUS) is a hydraulic device that replaces the natural sphincter of the urethra. The goal is to restore control over urine flow and enable long-term continence.

The system consists of three components:

1. Cuff: It is placed around the urethra, where it exerts gentle pressure on the urethra.

2. Pump: It is usually located in the scrotum (in men) or in the lower abdomen (in women) and is manually operated by the patient.

3. Reservoir: This is filled with sterile saline solution and is located in the abdominal cavity or pelvic floor.

When urinating, the pump is briefly activated. This forces the fluid from the cuff into the reservoir, opening the urethra—allowing the patient to empty the bladder. After a few minutes, the saline solution automatically flows back into the cuff, which closes the urethra again. The patient regains continence.

The best-known system is the AMS 800, developed by Elliott & Meyer; there are also modern variants such as the ZSI 375 from Zephyr Surgical Implants or the ARTUS device. Studies by Linder, Ziegelmann, Gozzi, and Stief show high success rates ranging from 75% to 90%. These systems are initially deactivated after implantation to ensure proper healing and are activated by the urologist after about six weeks.

When used for the correct indications and with proper follow-up care, the artificial sphincter is considered the gold standard of surgical therapy for stress urinary incontinence—both following prostatectomy and for urinary incontinence in women.

Implantation of the Artificial Sphincter

The artificial sphincter is implanted during a surgical procedure performed under general anesthesia by experienced urologists. The procedure typically takes one to two hours and is successfully performed in both men and women.

Implantation in men:

• Through a small incision in the perineum or scrotum, the cuff is placed around the urethra.
• The reservoir is placed in the lower abdomen or behind the pubic bone.
• The pump is easily palpable in the scrotum and can be operated by the patient themselves once the incision has healed.

Implantation in women:

• In most cases, an incision in the lower abdomen is made to gain access to the urethra.
• The system is assembled similarly to that used in men: the cuff, pump, and reservoir are connected via thin tubes.

After surgery, the artificial sphincter remains deactivated for about six weeks to allow the surgical wounds to heal completely. The urologist then activates the system, and the patient regains continence. Studies (including those by Meyer, Elliott, Linder, Rivera, Gozzi, Ziegelmann, and Stief) have shown that 75–90% of patients achieve stable continence after implantation.

Postoperative outcomes and success rates:

• The patient regains continence, often requiring no more than one pad per day.
• Functional outcomes show very good long-term results, even after secondary implantations.
• Systems such as the ZSI 375, the ARTUS Device, or the proven AMS 800 achieve similarly high success rates.

The hydraulic implant is filled with sterile saline solution and allows for controlled pressure regulation on the urethra. Thanks to the combination of precise technique, surgical experience, and regular follow-up care, this therapy is a safe and effective option for patients with severe stress urinary incontinence or stress urinary incontinence following prostatectomy.

Complications and Follow-Up Care After Artificial Sphincter Implantation

As with any surgery, there are certain risks and complications associated with the artificial sphincter; however, these can be largely minimized by experienced urologists and careful follow-up care.

Possible complications:

• Infection: In 2–10% of cases, a wound infection may occur at the implantation site. In this case, the implant must be removed or replaced.
• Tissue damage: Due to continuous pressure on the urethra, the surrounding tissue may atrophy over time—this affects about 8–9% of patients.
• Mechanical wear: Like any device, the hydraulic mechanism also ages. Studies by Linder, Gozzi, and Meyer show that replacement becomes necessary over time in 10–20% of patients.
• Erosion or leakage of the cuff: In rare cases, the cuff around the urethra may loosen or fluid may leak, impairing function.

Follow-up care:
After implantation of the artificial sphincter, the system remains deactivated for about six weeks to promote healing. Afterward, the doctor activates it, and the patient regains continence. In many cases, postoperative continence is achieved and remains stable for many years.

Regular urological checkups ensure the implant is functioning properly and help detect complications early. During these checkups, the treatment team assesses:

• the pressure in the cuff,
• the position of the components (pump, reservoir, cuff),
• and the patient’s ability to operate the system correctly.

The average success rate following implantation of an artificial sphincter ranges between 75% and 90%. Many patients report a significant improvement in their quality of life following implantation. Studies by Ziegelmann, Rivera, Elliott, and Stief also confirm that very good results (“functional outcomes”) continue to be achieved even after a secondary replacement of the system.

FAQ: Frequently Asked Questions About the Artificial Sphincter

What is an artificial sphincter, and when is it used?
An artificial urinary sphincter (e.g., AMS 800 or ZSI 375) is an artificial bladder sphincter used to treat urinary incontinence. The artificial sphincter is implanted in patients with severe stress incontinence, particularly in men following a prostatectomy. The procedure is considered the gold standard of surgical treatment for persistent urinary leakage.

How does the artificial sphincter work?
The system consists of three components—a cuff around the urethra, a hydraulic balloon reservoir in the lower abdomen, and a pump in the scrotum (or in the labia in women).
The cuff is filled with sterile saline solution, which exerts gentle pressure on the urethra to retain urine. To empty the bladder, the pump is activated, causing the fluid to flow from the cuff into the reservoir. It then refills automatically, and the patient is continent.

What models of artificial sphincters are available?
Several systems are used in modern urology:

• the tried-and-true AMS 800 (American Medical Systems),
• the ZSI 375 from Zephyr Surgical Implants,
• as well as newer developments such as The ARTUS Device.
  All systems follow the same principle but differ in operation, pressure regulation, and adaptability.

What is the success rate of artificial sphincter implantation?
According to international multicenter studies (including those by Meyer, Linder, Rivera, Ziegelmann, Elliott, Gozzi, and Stief), the success rate is 75–90%. In most cases, stable postoperative continence is achieved. Many patients report a largely symptom-free life after implantation, even years after the procedure.

Can women also receive an artificial sphincter?
Yes, an artificial bladder sphincter can also be implanted in women with urinary incontinence—for example, following pelvic surgery. In these cases, the artificial system is implanted through an incision in the lower abdomen. Women also benefit from improved continence and a significantly enhanced quality of life.