1.What is a bladder pacemaker? A: Bladder pacemaker is the common name of sacral nerve modulation, the registered trademark of this therapy is Interstim. it is an implantable programmable sacral nerve modulation system used for the treatment of non-obstructive urinary retention, overactive bladder including urge incontinence, urinary frequency and urgency that are ineffective or intolerant to conservative treatment. Sacral nerve electrical stimulation is a new minimally invasive treatment that has been hailed in recent years in the European and American streams as a revolution in traditional treatment methods. It is particularly suitable for patients who suffer from various diseases causing urge incontinence, urinary frequency and urgency syndrome, non-obstructive chronic urinary retention, overactive bladder syndrome, and patients who are refractory to conservative treatment and are about to undergo irreversible surgical treatment such as bladder enlargement or diversion of urinary flow. The cost of domestic treatment is about 170,000. 2.How does a bladder pacemaker control urination? A: By stimulating the sacral nerves, it regulates the neural reflexes of the bladder, sphincter and pelvic floor related to urination, so that the abnormal neural reflexes can reach balance again and control the symptoms of urinary dysfunction. 3. Is it a proven effective treatment? A: In 2001, a multicenter, randomized, prospective study included 23 centers: 9 in Europe and 14 in North America with a total of 581 patients participating in the study. 219 patients received InterStim therapy: urge urinary incontinence (184 patients), non-obstructive urinary retention (177 patients), and severe urinary frequency and urgency (220 patients). The results showed that it is safe and effective. More than 100,000 people worldwide have been treated with bladder pacemakers for related diseases with good results. 4. Is it a licensed and approved treatment? A: 1994 – InterStim treatment was registered in Europe. 1997 – FDA approved for the treatment of urge urinary incontinence. 1999 – U.S. FDA approved for the treatment of urinary frequency and urgency and urinary retention. 2010 – FDA-approved for the treatment of fecal incontinence. More than 100,000 patients have been treated with Interstim and have improved their quality of life. 5. What are the benefits of Interstim treatment? A: The experiential treatment phase provides physicians and patients with the option to try the efficacy of a bladder pacemaker through a minimally invasive puncture. The experiential therapy allows the patient to learn about the efficacy of this therapy in different daily activities prior to implantation. Interstim therapy is reversible. Treatment can be terminated at any time. The clinical effectiveness of Interstim therapy has been proven. In clinical research centers, Interstim therapy has been successful in controlling symptoms in patients with bladder disorders for whom other therapies have not worked. Interstim has resulted in an improved quality of life for patients. In clinical studies and personal consultations, patients have documented a reduction in the number of trips to the bathroom, a reduction or disappearance of urinary leakage time, and a reduction in the number of catheterizations or the elimination of the need for catheterization. The reduction in symptoms allows the patient to resume normal daily activities such as walking, participating in school activities, being able to sleep peacefully throughout the night, and eating out. 6. What are the side effects of the bladder pacemaker (Interstim) procedure? A: As with any treatment, there are some side effects associated with Interstim therapy, including: pain at the implantation site; electrode displacement or local skin infection; brief mild electric shock sensation; changes in bowel function; and changes in menstrual cycle. 7. How does the InterStim Therapy System work? A: The InterStim Therapy System uses a very small device to send weak electrical pulses under your back to stimulate the nerves there. The nerve here is called the sacral nerve and it regulates urinary function by affecting the bladder and surrounding muscles. Electrical stimulation can eliminate or reduce the patient’s symptoms of urinary disturbance. 8. What is the efficacy and safety of the Interstim bladder pacemaker? A: Since the late 1990s, the Interstim bladder pacemaker has enabled tens of thousands of patients to regain normal voiding function and start a new life with long-term stability. The bladder pacemaker effectively controls the symptoms of voiding dysfunction. Patients are able to resume a normal life, such as walking, sleeping through the night, eating out, participating in social activities, etc., and return to work. 9.What is the procedure of surgery? A: Before the surgery your doctor will talk to you about the surgery method and let you understand the procedure. The most appropriate treatment will also be chosen based on your medical history. Patients selected for this procedure will undergo a thorough genitourinary, neurological, and urodynamic examination, and then experimental electrical stimulation of the sacral nerve will be performed if behavioral, interventional, and pharmacological treatments are ultimately confirmed to be ineffective. A very thin electrode guidewire is implanted in the patient’s sacral foramen under X-ray positioning, and a matchbox-sized external regulator transmits weak electrical stimulation pulses through the electrode guidewire to the nerves in the sacral foramen (usually the sacral 3 nerve) to improve the symptoms of urinary dysfunction by stimulating and modulating these voiding reflex nerves. The whole procedure is divided into two stages: the first stage is the experience treatment stage (about one week) is after the above-mentioned surgical operation, under the guidance of an experienced urologist, the patient will keep a detailed record of urination for each day after the operation (each urination time and volume), and adjust the electrode or voltage level of the regulator according to the urination diary and the patient’s complaints, so that the patient can use the regulator correctly and through the week of The patient will be able to use the regulator correctly and to reflect the experience of urination, sleep and life through the week. This will be used to assess whether the treatment improves the patient’s voiding disorder. If the test is effective, the patient will enter the second phase (permanent implantation phase), where the electrode guidewire and the pacemaker will be buried in the skin of the patient’s buttocks, which is generally free of foreign body sensation and free to work and move without any influence due to the fat there; if the patient is not satisfied with the experience, the electrode guidewire can be removed. In general, patients can be discharged home within 10 days. The control and adjustment of the electrical stimulator is carried out by an external controller, and the patient can adjust the amplitude of electrical stimulation to a comfortable feeling within the set range. 10.What will be the recovery after the surgery? A: One week after the surgery, the doctor will set the stimulation parameters through the medical programmable instrument. In order to make the parameters more suitable for you, the doctor will ask you how you feel during the program control. You will feel a slight tingling sensation, not a bumpy sensation, and over-stimulation is not beneficial. It should feel similar to the stimulation. A slight tingling sensation indicates that the system is on and working properly. After the procedure, you will be given a patient identification card that shows that you have a neurostimulator implanted in your body and indicates your physician. It is recommended that you bring your patient identification card with you. You will be followed up after the surgery to achieve the desired results. You may experience soreness and even pain in the wound area, especially in the lower back, for up to 2 weeks after surgery. You can put a small soft pillow to make it more comfortable when you sit. Of course, your doctor will also prescribe painkillers to relieve the pain. However, if the pain or localized redness persists after two weeks, please contact your doctor promptly. For the first 3-6 weeks, do not bend, twist, pull or lift heavy objects, and gradually increase your activity level as the wound heals. Return to your normal life as you feel comfortable or as instructed by your doctor. You can bathe, have sex, go to work, travel, walk, fish, work in the garden, etc. as usual. You may take medication for bladder disorders or not as advised by your doctor. 11. Can a bladder pacemaker (IntertStim) cure my urinary disorder problem? A: This treatment will not cure you 100%, but it can be very effective in treating and improving your symptoms and improving your quality of life. Your symptoms may return when the stimulator is turned off or not used for a long time. 12.Will the InterStim system affect my daily activities? A: Generally speaking, it will not. However, you may want to consult with your doctor about certain strenuous activities or heavy lifting (especially after surgery) that you may want to avoid. Generally, you should avoid twisting, stretching or lifting heavy objects for 3 to 6 weeks after surgery. 13.Will the menstrual period affect the urinary diary A: No, you should continue to keep a urinary diary for 2 weeks, recording the time of urination, the volume of urine, whether the urine is finished after each urination, the degree of urgency, whether the urine is leaking, the degree of distension in the abdomen before and after each bladder filling, including detailed statistics on night urination. 14.What if the battery runs out? Does replacing the battery require replacing the electrodes as well? A: When you have your stimulator installed, your doctor will help you assess your battery life. When your battery needs to be replaced, your doctor will help you replace it with a new one. During the battery replacement procedure, your doctor will also check whether your electrodes are still working properly, and if they are, then they will continue to be used. If the electrodes are normal, they will continue to be used. On the other hand, the electrodes will also be replaced. 15.Can the battery be charged? A: Not at the moment. But there will be rechargeable devices available in the future. 16.Can I check the condition of the battery by myself? A: Yes. You can use the patient remote control to check and it will tell you when the battery is dead and you need to contact your doctor. 17.I have received many treatments how can I be sure it is effective? A: The experiential treatment phase will allow you to visibly feel an improvement in your symptoms. Otherwise the treatment may not be effective for you. 18.Will my nerves be damaged during the procedure? A: Numerous clinical studies have shown that the sacral nerve is not damaged when the procedure is performed correctly. 19.What does it feel like during stimulation? A: Everyone may feel differently, but most people describe a slight pulling sensation at the pelvic floor bladder rather than a painful sensation. 20. How do I know that the experiential treatment was successful? A: At the end of the treatment, you can review your urinary diary and discuss the next steps with your doctor. Generally speaking, if there are no other problems and your symptoms improve during the treatment, then it is a success and you can consider permanent implantation. 21. Do I need to go to the hospital to adjust the parameters or can I adjust them myself? A: The doctor will help you adjust the parameters according to your symptoms. You can adjust the stimulation size through the patient controller within the range set by the doctor to effectively improve the symptoms of your urinary disorder and minimize the pain. 22.What other precautions should I take in my daily life? A: The InterStim system can be affected by objects in your daily life and at work, so you should be more aware of your surroundings. Most appliances do not interfere with the operation of the neurostimulator. A small number of appliances with permanent magnets (such as speakers or refrigerator doors) will turn the neurostimulator on or off when you get too close. Airport security doors and store security doors can also turn on or off the neurostimulator and you may feel a brief increase in stimulation (shock or jolt sensation) when you approach. Excessive proximity to industrial electronics (e.g. welding machines, induction furnaces) and high voltage power lines can interfere with the neurostimulator. Before undergoing other treatments or tests such as (MRI, ultrasound, thermography, radiation therapy, lithotripsy, electrocoagulation, cardiac fibrillation), please consult with your doctor and tell him/her that you have the InterStim system implanted. If the patient is accidentally disturbed by external influences that turn off the bladder pacemaker, the device can be easily and simply turned back on through the patient controller. 23. Where can I get more information about the Interstim Therapy System? A: You can come in for a consultation or contact me through the consultation website.