Your guidebook for getting results with Medtronic Bladder Control Therapy Delivered by the NURO System TAKE BACK CONTROL.

Transcription

1 Your guidebook for getting results with Medtronic Bladder Control Therapy Delivered by the NURO System TAKE BACK CONTROL.

2 RESET. RESTORE. * REGAIN CONTROL. Congratulations! You ve decided to try a therapy that can help you use the bathroom less often, leave worry behind, and resume the activities you love. That s a huge step. You likely have questions about what comes next. This guidebook has answers. Use it to understand what to expect during the first 12 weeks of your therapy and how to keep getting the results you want over time. GETTING STARTED Here are five things you can do to make sure you get the best possible results. A. Fill out your weekly tracker B. Schedule all 12 weekly appointments C. Complete all 12 sessions D. Sign up for weekly support (see page 11) E. Visit medtronic.com/oab to learn more * Restored function is defined as a measurable reduction in urinary frequency and/or urinary incontinence episodes following treatment. 2 3

3 HOW DOES IT WORK? Medtronic Bladder Control Therapy delivered by the NURO System restores bladder function* by delivering gentle stimulation to the tibial nerve. The NURO System stimulates the tibial nerve through an acupuncture-like needle placed in the skin near your ankle. The therapy is delivered at your doctor s office and lasts about 30 minutes. Initial treatment consists of 12 weekly, 30-minute sessions. WHAT DOES IT FEEL LIKE? Don t worry this therapy is convenient and comfortable. The sensation is not painful, although you may feel a slight tingling in your heel. You ll be free to read, listen to music, or catch up on during the sessions. WHY DOES MY DOCTOR CALL IT PTNM? This therapy is known as percutaneous tibial neuromodulation or PTNM. Your doctor may also call it percutaneous tibial nerve stimulation (PTNS). Its name comes from what the therapy does it stimulates the tibial nerve, which is located in your leg where the tibia (shinbone) connects to the ankle. The tibial nerve connects to nerves responsible for bladder function. MAKE THE MOST OF YOUR THERAPY This therapy can help you take back control of your bladder and your life. It doesn t cause side effects* like medications can, and it doesn t ever require self-catheterization. Here s what you can do to help ensure you get the most benefit from your treatment. A. Use the tracker on Page 13. Keeping track of your symptoms and how you re feeling about them helps you see your progress. It also helps your doctor understand how things are going for you. B. Stick with it. Initial treatment is 12 weeks and it is critical that you attend and complete all 12 weekly sessions. If you skip a session or stop too soon, you won t know if the therapy works for you. C. Think ahead. After completion of your 12 weekly sessions, results can be maintained with one session every three to four weeks. D. Let us help. We can answer your questions, offer encouragement, and help you have a better experience. Visit medtronic.com/signup or use the form on page 11 and sign up for Support Link. * Restored function with PTNM is defined as a measurable reduction in urinary frequency and/or urinary incontinence episodes following treatment. * Most common side effects of PTNM are temporary and include mild pain and inflammation at or near the stimulation site. 4 5

4 WHAT TO EXPECT Your therapy starts with a 12-week journey. Here s what to expect along the way. WEEKS 1 TO 3: START IT UP! You ve taken the most important step the first one. Remember to use the weekly tracker to record any improvements and write down how you re feeling. It s an important tool for sharing your progress. WEEKS 4 TO 6: STICK WITH IT! Many people do not see significant improvements in the first few weeks. If you re one of them don t worry. This doesn t mean the therapy won t work for you. Keep going to your sessions and, if you haven t already, sign up for Support Link. Use the form on page 11 or online at: medtronic.com/signup. WEEKS 7 TO 9: THINK AHEAD! You re past halfway in your 12-week journey. Time to celebrate! It s also time to look at the discussion guide, which is on page 10 of this guidebook and available at medtronic.com/oab. Use it to talk with your doctor about sustaining the relief you are feeling with monthly maintenance sessions or considering other therapies for overactive bladder (OAB). WEEKS 10 TO 12: KEEP GOING! If you are starting to see benefits by now that s great! If not don t stop. It is critical you attend and complete all 12 weekly sessions. If you skip a session or stop too soon, you won t know if the therapy works for you. Once you have completed your 12 sessions, you and your doctor will talk about your results. Bring your weekly tracker (found on pages 13-14) and be ready to set up a maintenance plan or consider other therapies to try. Your 12-week journey: Schedule all 12 of your sessions, fill in the dates below, and check off the weeks as you go. In addition, be sure to use your weekly tracker, located on pages of this guidebook to track how you are feeling about your progress toward symptom relief. WEEK 1 WEEK 2 WEEK 3 WEEK 4 WEEK 5 WEEK 6 WEEK 7 WEEK 8 WEEK 9 WEEK 10 WEEK 11 WEEK 12 MILESTONE: Your first 12 weeks are 25% done! NOTE: If you haven t already, sign up for Support Link. Use the form on page 11 or online at: medtronic.com/signup MILESTONE: Your first 12 weeks are 50% done! NOTE: Review the discussion guide on page 10 to prepare for discussions with your doctor about maintenance therapy. MILESTONE: Your first 12 weeks are 75% done! MILESTONE: You completed your 12-week journey! 6 7

5 WHY DOESN T THIS THERAPY WORK IMMEDIATELY? For such a simple organ, the bladder is really complicated. To work properly, it requires the coordination of several parts of the brain and both voluntary and involuntary muscle movement. While it s not clear what causes overactive bladder (OAB) in the first place, research suggests that OAB is linked with poor brainbladder communication. This therapy is thought to restore* these lines of communication. But it can only do so gradually. WHAT IS MAINTENANCE THERAPY? Imagine a future when you see friends and family more often, worry less about accidents, and make decisions that aren t based on the location of the nearest bathroom. That s the real potential of this therapy. You can maintain your results over time with maintenance therapy. Following your initial treatment of 12 weekly, 30-minute sessions, you can maintain benefits and results on maintenance therapy. When you are on maintenance therapy, treatments are every three to four weeks rather than every week. These maintenance sessions are exactly the same as the first 12, and can be scheduled at a time that is convenient for you. GET THE SUPPORT YOU NEED You are not alone in having OAB and you are not alone when it comes to support. Whether you have decided to move forward with this therapy or still have questions about what to expect, Medtronic helps you find the answers. Here are two ways to find support: A. Visit us online. The easiest way to learn more is at medtronic.com/oab. You ll find more details about PTNM, as well as the weekly tracker and discussion guide. B. Join Support Link. Support Link offers best-in-class support for you during your therapy journey. And it includes information and resources on overactive bladder and the therapy. With your doctor s approval, our team can call you to provide education, personalized encouragement, and capture your information from the weekly tracker. This is important since it will help your physician understand your treatment progress and may be used for insurance purposes. As a member of Support Link, you ll receive a call approximately once a month during the first 12 weeks of your treatment and then periodically during maintenance mode. To sign up, fill out the form on the next page or online at medtronic.com/signup. It s very important that you and your Support Link Specialist connect during your treatment journey. Watch for our call. Your caller ID will display either Medtronic or If we cannot reach you, or you do not receive an initial call from us within a week of starting your OAB therapy, please call us toll free: If your physician or nurse requested you to fill out the consent form on page 11 of this brochure and you have not heard from us in a week, please call us toll free: WHAT IF THIS THERAPY IS NOT THE ANSWER? If bladder control therapy with PTNM does not provide the relief you need, rest assured it is not the only option. Ask your doctor about the InterStim System also known as sacral neuromodulation, or SNM and whether it could work for you. * Restored bladder function is defined as a measurable reduction in urinary frequency and/or urinary incontinence episodes 8 following treatments. 9

6 STAY IN CONTROL. You re almost done with your first 12 therapy sessions. Now is a great time to start thinking about maintenance therapy, which begins after week 12 and is essential to helping you stay in control and see continued results. REMOVE TO EXPOSE ADHESIVE JOIN SUPPORTLINK This is a new treatment for you. If allowed by your physician, we ll call you throughout your PTNM treatment journey to help answer your questions, provide education, resources, and capture your progress. We re here to help guide you through. Sign up today! Use this discussion guide at your appointments starting at week 8 of therapy. Use it to talk with your doctor about maintenance therapy and make a plan that works for you. ARE YOU HAPPY WITH YOUR THERAPY RESULTS? ASK YOUR DOCTOR THESE QUESTIONS: A. What should I do after my 12 weeks of therapy? B. What will happen if I discontinue this therapy after 12 weeks? C. Are maintenance therapy sessions any different than the ones I just finished? D. How often should I come in for maintenance therapy? E. What can I do to make sure I get the most from my maintenance therapy sessions? F. Will my insurance cover maintenance therapy? NOT SURE YOU WANT TO CONTINUE THERAPY? TELL YOUR DOCTOR WHY AND ASK THESE QUESTIONS: A. What are some other treatment options I could try? B. Is Medtronic Bladder Control Therapy using the InterStim System an option for me? C. Where can I go to learn more about the InterStim System? DISCUSSION NOTES 10 Your contact information. Please print. Patient First Name: Last Name: Address: City: State: ZIP: Phone: * Patient s Physician Name: Clinic Name: Patient Signature: (if 18 years old or older) Date: o Bladder Control Therapy delivered by the NURO System To submit this form, please mail it to 7000 Central Ave. NE, RCE230, Minneapolis, MN , or fax it to To receive a copy of this consent, please call , or us at rs.neuropatientsupport@medtronic.com. Let us know how you would like to receive it ( , mail, or fax). *It is important to provide your address as communications will be sent to you electronically. Caregiver First Name: Last Name: Address: City: State: ZIP: Phone: Caregiver Signature: Date: Relationship to Patient SUPPORT PROGRAM AGREEMENT By completing and submitting this form, you are granting Medtronic permission to add your personal information, including your contact information and basic healthcare information, to its patient database, and to share that information with Medtronic representatives and healthcare providers, as appropriate. We may conduct analyses on information collected in order to make improvements to and provide training on our operations, products, services, and customer communications. Medtronic may de-identify data collected, combining it with data collected from other sources. Lastly, information provided may be shared with your physician for treatment considerations or other purposes. You also agree to being contacted by Medtronic in the future by mail, telephone, or by non-password protected electronic communications, such as s or text messages. Medtronic may exchange information with you regarding our products or services, inquire about your experience, or determine how Medtronic can support you through your journey. Medtronic respects the confidentiality of your personal information. If at any time you wish to revoke all or part of this permission, you can us at rs.neuropatientsupport@medtronic.com or send a request in writing to: Medtronic Patient Support, 7000 Central Ave NE, RCE 230, Minneapolis, MN This permission will expire 10 years after the date of your signature. If you live in Maryland, the consent expires automatically in one year. We may contact you then to see if you would like to renew it. Rev.: GU-PTNM-WS-1

7 TRACK YOUR PROGRESS. Use the weekly tracker on the back of this page to record your experience with Medtronic Bladder Control Therapy delivered by the NURO System. Track your progress each week and bring the tracker with you to every session, so you can share your progress. Remember, the therapy takes time to work. Stick with it! NO POSTAGE NECESSARY IF MAILED IN THE UNITED STATES MEDTRONIC MS RCE CENTRAL AVENUE NE MINNEAPOLIS MN POSTAGE WILL BE PAID BY ADDRESSEE BUSINESS REPLY MAIL FIRST-CLASS MAIL PERMIT NO MINNEAPOLIS MN We hope you are on your way to regaining control. Please bring your tracker to every session. At the last weekly session, the details in the tracker will be important when you and your doctor determine next steps in your treatment program. Learn more at medtronic.com/oab 13

8 YOUR WEEKLY TRACKER On a scale of 1-7, rank how you perceive your symptoms when compared to before the treatment (1 being much worse than expected and 7 being much better than expected). Review this tracker and your scores with your doctor at each visit. WEEKS TREATMENT DATE Much worse than expected HOW ARE YOUR SYMPTOMS? Same as expected Much better than expected NOTES I gave up after meds didn t work I had no idea these other options existed. Lori, receiving bladder control therapy with percutaneous tibial neuromodulation (PTNM) Actual patient not pictured

9 Medtronic NURO Percutaneous Tibial Neuromodulation (PTNM) treats overactive bladder and associated symptoms of urinary urgency, urinary frequency, and urge incontinence. PTNM is not intended for patients with pacemakers or implantable defibrillators, patients prone to excessive bleeding, patients with nerve damage that could impact either percutaneous tibial nerve or pelvic floor function, or on patients who are pregnant or planning pregnancy. Do not use if the skin in the area of use is compromised. Exercise caution for patients with heart problems. Adverse events are typically temporary, and include mild pain, minor inflammation and bleeding near treatment site. This therapy is not for everyone. Please consult your physician to decide whether PTNM is right for you. A prescription is required. For further information, please call Medtronic at USA Rx Only Rev 0915 InterStim Therapy for Urinary Control: InterStim Therapy treats urinary retention (inability to completely empty the bladder) and the symptoms of overactive bladder, including urinary urge incontinence (leakage) and significant symptoms of urgency-frequency. It should be used after you have tried other treatments such as medications and behavioral therapy and they have not worked, or you could not tolerate them. InterStim Therapy for Urinary Control is not intended for patients with a urinary blockage. Safety and effectiveness have not been established for pregnancy and delivery; patients under the age of 16; or for patients with neurological diseases such as multiple sclerosis. InterStim Therapy for Bowel Control: InterStim Therapy treats chronic fecal incontinence (an accident or leaking involving stool). It should be used after you have tried other treatments such as medications and dietary modifications and they have not worked, or if you are not a candidate for them. Safety and effectiveness have not been established for pregnancy and delivery; patients under the age of 18; or for patients with progressive, systemic neurological diseases. InterStim Therapy for Urinary Control and for Bowel Control: You should have a successful trial assessment before receiving InterStim Therapy. You cannot have diathermy (deep heat treatment from electromagnetic energy) if you have an InterStim device. In addition to risks related to surgery, complications can include pain at the implant sites, new pain, infection, lead (thin wire) movement/migration, device problems, interactions with certain other devices or diagnostic equipment such as MRI, undesirable changes in urinary or bowel function, and uncomfortable stimulation (sometimes described as a jolting or shocking feeling). This therapy is not for everyone. Please consult your physician to decide whether InterStim Therapy is right for you. A prescription is required. For further information, please call Medtronic at and/or consult Medtronic s website at USA Rx Only. Rev 0311 Medtronic Inc. 710 Medtronic Pkwy. Minneapolis, MN USA Tel medtronic.com UC a EN 2016 Medtronic. Printed in USA.