Rigi10™ Malleable Penile Prosthesis
Also Known As
Pressure-Regulating Balloon, PRB
Definition
A pressure regulating balloon is a component of an artificial urinary sphincter (AUS) system, a medical device used to treat urinary incontinence. The AUS system typically consists of three main parts: an inflatable cuff that is placed around the urethra (the tube that carries urine from the bladder out of the body), a pump that is manually operated by the patient, and the pressure regulating balloon itself.¹
The pressure regulating balloon is implanted in the lower abdomen, typically under the tissues.¹ It serves as a reservoir for the fluid that inflates and deflates the urethral cuff.¹ When the cuff is inflated, it compresses the urethra, preventing urine leakage. When the patient wishes to urinate, they squeeze the pump, which moves fluid from the cuff to the pressure regulating balloon. This deflates the cuff, allowing the urethra to open and urine to pass. The balloon is designed to maintain a specific pressure within the system, ensuring that the cuff exerts enough pressure on the urethra to maintain continence without damaging the urethral tissue. After urination, the cuff automatically re-inflates as fluid returns from the balloon to the cuff, usually within one to two minutes.¹
Clinical Context
A pressure regulating balloon (PRB), as a key component of an Artificial Urinary Sphincter (AUS) system, is clinically utilized in the management of moderate to severe stress urinary incontinence (SUI), particularly in male patients following prostate surgery (e.g., radical prostatectomy) or in cases of intrinsic sphincter deficiency due to other causes.¹² The AUS, including the PRB, is often considered the gold standard treatment when conservative therapies have failed.⁴
Relevant Medical Conditions: The primary condition addressed is stress urinary incontinence, where involuntary urine leakage occurs during activities that increase abdominal pressure, such as coughing, sneezing, or lifting. It is also used in cases of SUI resulting from neurological disorders or congenital abnormalities affecting sphincter function.²
Patient Selection Criteria: Patients considered for AUS implantation typically have persistent, bothersome SUI that has not responded to less invasive treatments. Key selection criteria include:
- Demonstrated intrinsic sphincter deficiency.¹
- Adequate manual dexterity and cognitive function to operate the pump mechanism.²
- Absence of active urinary tract infection or significant bladder dysfunction (e.g., detrusor overactivity, poor bladder compliance) that might compromise outcomes or require separate management.²
- Patients with certain urethral risk factors (e.g., prior pelvic radiation, previous urethroplasty, or prior AUS erosion) may be candidates for a low-pressure PRB (e.g., 51-60 cm H₂O) to minimize complications like urethral erosion.¹
Surgical Procedure: The implantation of an AUS system, including the PRB, is a surgical procedure. The urethral cuff is placed around the bulbar urethra or bladder neck. The PRB is typically implanted in the prevesical space (space of Retzius) or a high submuscular location in the abdominal wall.²⁵ The pump is placed in a subcutaneous pocket in the scrotum (for males) or labia (for females) for easy patient access.² The components are connected via tubing. The device is usually left deactivated for several weeks post-surgery to allow for healing before activation and use by the patient.²
Expected Outcomes: AUS implantation generally has high success rates in restoring urinary continence and significantly improving patient quality of life.² Success is often defined by the number of pads used per day, with many patients achieving social continence (0-1 pad per day).¹ However, outcomes can vary, and some patients may require revision surgery due to mechanical failure, infection, urethral atrophy, or erosion over time.¹³ The choice of PRB pressure (e.g., 51-60 cm H₂O, 61-70 cm H₂O, or 71-80 cm H₂O) can be tailored based on individual patient factors and risk of complications, with lower pressure balloons considered for higher-risk urethras.¹⁴ When AUS failure occurs, revision procedures, which may involve changing the PRB or other components, can often restore device function.⁴