What is a Bladder Pacemaker?
A bladder pacemaker is a small device, about the size of a stopwatch, that is used to treat urinary problems by controlling electrical activity in the urinary tract.
Pacemaker process is achieved through targeted electrical stimulation of pudendal nerve, which serves two primary functions:
- Restore urine storage (continence).
- Improve urine evacuation (voiding).
In terms of functionality, the device interacts with the detrusor muscle and the sphincter muscles. Specifically, it utilizes detrusor stimulation for emptying, and sphincteric stimulation to achieve control.
Surgically inserted near the third sacral nerve by the tailbone, the pacemaker is linked to nearby nerves via an insulated wire. This setup enables the device to send and receive signals, thereby facilitating bladder control.
In simple terms, bladder pacemaker, aims to improve life quality for individuals with urinary incontinence and related disorders.
In fact, if you want to see some statistics , Melbourne Bladder Clinic reported the following clinical success rates with Pacemaker Bladder:
- 45% of patients remained totally dry.
- 34% of patients reduced the number of wetting episodes by at least 50%.
- 70% of patients eliminated heavy leaking episodes.
- Overall clinical success rate of 79% for urge incontinence
Medical Conditions Addressed
Bladder pacemakers treat a variety of urinary disorders. Here’s how they relate to specific medical conditions:
Overactive Bladder (OAB) and Urinary Incontinence:
Overactive Bladder (OAB) is characterized by urinary urgency, frequency, and incontinence. In cases where patients are not responsive to conservative therapies or certain medications, bladder pacemakers come into play.
Denervated Bladder:
A bladder pacemaker helps achieve complete intermittent emptying of a denervated bladder, which is crucial for maintaining the integrity of the urinary tract.
Urinary Retention:
The bladder pacemaker also tackles urinary retention issues. It uses what’s called state-dependent stimulation to manage the bladder more effectively. This method promotes continence, or control, during the storage phase while ensuring efficient emptying during the voiding or releasing phase.
Complex Patients with Multiple Comorbidities:
In some complex cases where patients have multiple comorbidities, bladder pacemakers like InterStim are used for bladder function restoration.
Failed or Intolerable Other Treatments:
Bladder pacemakers are considered for patients who have failed or could not tolerate other treatments such as lifestyle changes, pelvic floor exercises, or medication.
The Procedure Explained
- Pre-Surgical Assessment: Before the surgical procedure, a medical professional performs a thorough evaluation to determine the urinary disorders’ severity and to ensure the patient is a good candidate for bladder pacemaker implantation.
- Implantation: The surgeon implants the bladder pacemaker near the third sacral nerve, close to the tailbone. This spot is ideal for modulating the electrical activity tied to bladder control.
- Electrical Connection: The surgeon meticulously connects an insulated wire from the bladder pacemaker to the nearby sacral nerves, facilitating the transmission of electrical signals between the device and the nerves.
- Detrusor and Sphincteric Stimulation: The device interacts with the detrusor and sphincter muscles, utilizing detrusor stimulation for emptying and sphincteric to achieve control. This approach involves varying the electrical parameters during the bladder’s filling and emptying phases, improving both bladder continence and voiding efficiency.
- Post-Surgical Monitoring and Adjustment: Following the surgery, the programming of the bladder pacemaker is finely adjusted to emit the required electrical pulses that manage the communication between the brain and sacral nerves.
- Follow-Up: Medical staff usually monitor patients post-procedure to ensure the device functions correctly and to make any necessary adjustments to the pacemaker’s programming to optimize its effectiveness.
Post-Surgery: Recovery and Side Effects
Post-Surgery Recovery
Recovery Time:
The recovery period following bladder pacemaker surgery mainly focuses on healing the pocket made for the device’s battery. While usually brief, this time frame varies among individuals.
Initial Assessment:
After surgery, patients are generally evaluated to gauge the procedure’s immediate success and the device’s initial effectiveness in treating urinary issues.
Follow-Up:
Patients may require follow-up visits to confirm adequate healing and to fine-tune the bladder pacemaker’s settings for optimal function.
Side Effects in Bladder Pacemaker:
- Pain and Discomfort: Patients might experience pain at the implant site, which can cause discomfort initially.
- Skin Irritation and Infection: Skin irritation or infection around the implant site is another side effect some individuals might encounter post-surgery.
- Wire Movement: Movement or migration of the wire connecting the bladder pacemaker to the sacral nerves could occur, potentially requiring adjustment or repositioning.
- Device Issues: Issues with the device, such as malfunction or incorrect programming, might arise, necessitating further medical intervention or adjustments.
- Changes in Bowel or Urinary Function: Some patients might experience changes in bowel or urinary function, which could result from the electrical stimulation from the bladder pacemaker.
- Unpleasant Feelings of Stimulation: The electrical stimulation rendered by the bladder pacemaker might cause an unpleasant sensation in some individuals.
The side effects and the recovery process post-bladder pacemaker surgery are crucial aspects that individuals should be prepared for improved urinary control.
Patients should maintain an open line of communication with their healthcare providers to promptly address any concerns or complications that may arise during the recovery phase.
Financial Aspects
Costs of Neuromodulation Therapies:
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- In a specific study, the costs associated with sacral nerve stimulation, one of the techniques used in bladder pacemaker therapy, were outlined. The study reported that the expenses were $4,867 for percutaneous tibial nerve stimulation and $24,342 for sacral nerve stimulation.1.
Medicare Coverage:
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- Medicare might cover some of the costs associated with pacemaker implantation when it’s deemed medically necessary and is prescribed by a Medicare-approved healthcare provider. However, the extent of coverage might vary. It could depend on the specifics of Medicare Part A and Part B plans2.
Cost Comparisons:
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- Though not a direct comparison, the cost of heart pacemakers can vary widely, ranging from $19,000 to $96,000. These figures depend on several factors, such as the type of pacemaker, location, and duration of hospital stay. While not identical, these numbers can offer a ballpark estimate of the financial burden tied to implantable medical devices like bladder pacemakers, whose costs may differ.3
Patients Reviews
For medical reviews, Medtronic devices have received patient testimonials highlighting the benefits of their bladder pacemakers:
- Sara H. (Dealing with OAB): Sara expressed her enthusiasm for running and mentioned that post-InterStim implantation, she can spend as much time as she desires at the gym.
- Shamay B. (Living with non-obstructive urinary retention): Shamay shared that the treatment has allowed her family to enjoy outdoor activities like hiking and brought a sense of normalcy back to their lives.
- Tammy S. (Dealing with OAB): Tammy conveyed that her ability to continue her teaching career was in jeopardy before the treatment. Still, now she feels capable of carrying on.
- Tina (Living with OAB): Tina recounted her journey of trying numerous treatments without success, but post-InterStim system implantation, she achieved a dry state.
Alternatives and Other Devices
- Next-Generation Electronic Devices and Biological Pacemakers: Advances in technology are leading to next-generation electronic devices and biological pacemakers designed to address current limitations and serve as alternatives to traditional implantable devices. These innovations are tailored to specific clinical needs, potentially providing hardware-free or leadless solutions to manage urinary disorders5.
- Bladder Botox :Involves injecting Botox into the bladder muscles by a urologist. This procedure helps relax the muscles, giving individuals more time to reach the bathroom when the urge to urinate arises, making it a suitable treatment for OAB. This treatment isn’t permanent; the effects gradually diminish over time, typically within 4 to 12 months, necessitating re-treatment if needed.
Conclusion
The bladder pacemaker represents a significant advancement in treating urinary disorders, showing promising clinical success rates and offering an alternative for those who have not responded to conventional treatments. Its ability to regulate both urine storage and evacuation addresses a range of conditions, including Overactive Bladder and Urinary Retention.
However, the technology is not without drawbacks, such as post-surgical complications and financial burden. With ongoing technological innovations, including next-gen devices and alternatives like Bladder Botox, the future of urinary disorder treatment seems to be on a promising trajectory. Despite its current limitations, the bladder pacemaker serves as a vital option that can significantly improve patients’ quality of life.
References :
[1] E. A. Tanagho and R. A. Schmidt, “Bladder pacemaker: scientific basis and clinical future,” Urology Dec. 1982, doi: 10.1016/0090-4295(82)90312-0.
[2] M. Martinson, S. MacDiarmid, and E. Black, “Cost of neuromodulation therapies for overactive bladder: percutaneous tibial nerve stimulation versus sacral nerve stimulation,” J Urol, Jan. 2013, doi: 10.1016/j.juro.2012.08.085.
[3] L. W. Jones, U. Jonas, E. A. Tanagho, and J. P. Heine, “Urodynamic evaluation of a chronically implanted bladder pacemaker,” Invest Urol, , Mar. 1976.
[4] J. A. Hokanson, C. L. Langdale, A. Sridhar, P. Milliken, and W. M. Grill, “State-dependent bioelectronic interface to control bladder function,” 2021, doi: 10.1038/s41598-020-79493-7.