and welcome to today's webinar. I'm Bhoomi Davey-Heliker, and I'll be your moderator. Before we begin, I'd like to go over some instructions. We'll take questions at the end of the webinar, but you can submit them at any time by typing them into the question box at the bottom of the screen. Today's webinar is titled Troubleshooting Safer Neuromodulation and is being presented by Dr. Steven Siegel. Dr. Siegel is an FPMRS specialist and serves as the director of the Minnesota Urology Centers for Female Urology and Continence Care. Dr. Siegel is internationally recognized for his work related to urinary incontinence and voiding dysfunction. He has served as the business section editor for the Urology Practice Journal from its inception until 2020. Dr. Siegel has trained over 30 fellows, some of whom have been recognized as top doctors and top doctors for women in their communities of practice. In 2018, he was AUGS recipient of the National Association for Continence Care Champion Award. He received the Christina Manthos Award for demonstrating extraordinary mentoring skills in supporting the careers of female urologists from the Society of Women in Urology in 2011. He was honored with the David C. Utes Award for Urologic Advancement and Innovation from the Minnesota Urologic Society in 2002. He is a recent past president of the North Central Section of the AUA in 2020, or sorry, 2010, a board member and a chairman of the Practice Standards Committee of SUFU. He previously served as a founding member and president of the International Society for Pelvic Neuromodulation. We're honored and excited to hear from Dr. Siegel today. Well, thank you, and welcome to those of you that are participating. And I hope that this is a discussion that will invite questions. I certainly think that we'll have time for questions. And I think it's a reality of safety neuromodulation that there can be problems when you're implanting a device that you're intending to change the way a person functions. They're dependent on the device for the change in function. And things that can go wrong, either with patient selection or implant technique or lead fractures, those types of things, or inevitable changes in life like pregnancy, need for MRI, those types of things, can be a source of problems. And having a good set of strategies to deal with those I think is critical to being a successful surgeon using these techniques. These are my disclosures. I'm pretty much involved in a number of different companies that are inventing or marketing current devices. And I am going to talk a little bit about off-label use of sacral neuromodulation and MRI in this discussion. That soon will be a moot point, I think. So these are the common problems that are likely to be faced, problems with wound complications and infection. The rate in recent studies have been 3% or less. But still, that is one of the most concerning immediate complications of the procedure. The most common reason for reoperation has to do with lack of efficacy or declining efficacy over time. And there are strategies that one could adapt in order to try to deal with that in an efficient fashion. So we'll talk about that quite a bit. A patient's going to have painful stimulation, and that may relate to the lead position. Pain at the generator site is another common source of problems. And then there's a set of other issues, such as what if the patient needs an MRI and they have a device that's MRI noncompliant for the study that they need. What do we do about that situation? And what about pregnancy, patients that have this device and then are fortunate enough to become pregnant, how do we plan for managing their situation during the pregnancy? And then lastly, issues related to retained lead fragments. So the best way to deal with an infection is to prevent it. The perioperative antibiotics and PrEP is really the key to that. Our routine use is exactly the same as what our orthopedic surgeons use for joint replacements. I didn't have to reinvent the wheel. The OR staff know exactly what the infection rate is for those procedures. It's a critical measure of quality. And we just went right down the line and followed all of their recommendations. So these are what they are. The patients do a PIVICLENSE shower the night before and the morning of the procedure. So we have them either buy this in the store or send them home with a bottle of PIVICLENSE. They have something called a sagecloth, which is a glucohexanate cloth, and the nursing staff wipes down the area of surgery with these cloths. If you don't know what they are, they're using them in your hospital for the orthopedic surgeries, so just ask. And then as far as our antibiotic prophylaxis, if the patient is not allergic to penicillin, then we'll use a cephalosporin routinely. If they are, we'll use vancomycin. I do perform intraoperative irrigation with an antibiotic solution. I'm not sure what evidence there is for that. That's the one thing that the orthopedic surgeons don't routinely do. And then for the skin prep, we wipe down the skin with alcohol that de-fats the skin, and then we use DuraPrep on the skin. And then we use an Ioban dressing. And once you wipe down the skin with alcohol and then you use the DuraPrep, the Ioban really sticks like a second skin. So the only part of the field that is exposed is the area where we make your incision. And I should say, I didn't have it included in this, but I don't spread the buttocks, cheeks during the procedure. I don't think that that's necessary at all in order to see bellows. If you're doing it because that's the way that you've always done it, I challenge you to try without it. I think you would be just fine without it. And that way, we use a big Ioban sheet. The actual one we use is for a C-section drape, so it has a pocket for fluids to collect in. And that's big enough to go over the lower back and the upper buttocks. And then I just gently spread the cheeks, and then they come back together, and the Ioban kind of sticks down in the intergluteal fold. And you can see very subtle bellows with that without any problem. As far as things that you can do during the procedure with the IPG, pocket size and depth, I think, are critical. So you want it to be about two centimeters deep, and you want the pocket to be not too large or too small for your device. And you have to be careful to use good hemostasis and avoid finger dissection of the pocket. I also use irrigation here. And then there's something called a Tyrex pouch, which I don't have that much experience with. But it's a good thing to know about. Basically, it's an antibiotic-coated pouch that dissolves locally. It adds about $1,000 of cost to the case. So I can't really see using this routinely. But if I had a patient who had a history of an MRSA infection, I was concerned about that. I think it would be worth it. They get very much higher MICs surrounding this pouch for months following the procedure than you would with the intravenous antibiotics. And it really is a good problem preventer for you in certain situations. So as far as infection management after, if you're doing a staged trial and you're worried about whether the incision for your, between the lead and the lead connection where you're going to put the IPG is not looking good, the easiest thing to do is just to remove the staged lead and then come back in a few months and do the procedure as a full implant. So I wouldn't hesitate to do that if I was at all concerned about redness or drainage. I get a lot of calls from colleagues, what should I do? It's been, I've had a draining sinus for a period of time or, you know, it's red. And then I give the pacing antibiotics and it gets better. And then it gets red again and it's sore. Pretty much when you have an obvious infection, the only thing that you can do is to remove the implanted devices. And that includes both the lead and the generator, both. You can't really leave anything behind. I had, for most of my career, excised the capsule and assumed that that was important for healing. Recently, I have not been doing that routinely and I have not observed any problems in not doing that, so maybe I should qualify. I think if there's an infection, it's not a bad idea to excise the capsule. If there's no infection, I'm not sure it's necessary. I would avoid primary closure of these incisions. I just don't think that is a practical way when there's, you know, pus in the incision. So allow them to heal by secondary attention and packing. And a vacuum wound care system really does speed up the healing. It is something that you have to negotiate with the patient's insurance and you need a wound ostomy nurse to manage it. But that can be a nice tip if you have a patient who otherwise might have a hard time reaching back or a family member who isn't comfortable with the task of helping replace a gauze dressing a couple times a day. So this is the most common issue related to reoperation, and I think it's important. We don't just operate on patients because their battery is dead. The most common reason we operate on a patient is because their battery is okay, but they're having lack of or declining efficacy over time. And the best thing to do here is to make sure you're choosing the right patients and use objective data to make sure that the patient really did improve from their baseline and not make these decisions based on hunches or wishful thinking. I think a staged technique is more likely to not produce a false positive that the patient benefits from a couple, three weeks of a trial than I think that the chances that they are going to do well in the long term is pretty good. Percutaneous techniques or P&E, this is what I always ask a patient when they're coming to see me, and they say, well, this isn't working for me. And I would say, well, did you ever have any success with the therapy? And they might say, no, I never did. And then I would say, well, surely you must have had a trial. Was that an office trial or was that a trial with the first half of the surgery? And they say, oh, well, I had that trial in the office, and that was great. I thought it was a miracle. And I didn't have any symptoms. I felt the stimulation comfortably. It was in the vagina. But ever since the surgery was done, I just haven't felt it in the same place, and I haven't had the same degree of control. So, you know, that patient is basically telling you that they need their lead replaced, that they are a successful candidate for the therapy, but there was a flub in placing the lead. On the other hand, sometimes they'll say, well, they had a staged trial, and I'll say, well, did you have a benefit? And, you know, I'm not sure the reality of the situation, then looking back on that years ago. But sometimes they say, I wasn't really convinced, but the doctor said it would be good for me. Well, you know, at that point, kind of all bets are off. And that's where I think it's really helpful to have some diary information. But in that patient, you may wind up having to do a repeat trial on that patient. But I used to think this was more important, getting sensory feedback during lead placement, and I still think that sensory information is critical. But as we become more comfortable with optimal lead placement techniques, I think you can anticipate what the sensory information is going to be based on the position of the x-ray in space, on the AP and lateral views, the pattern of motor response, which is bellows first at a threshold under two, and then toe shortly thereafter. If they're getting a lot of foot and a little bellows, that patient is going to complain when they're awake that it's going down their leg. So that's not a good way to leave the lead. And usually, that means you have to steer the lead more caudally. If they're getting a lot of bellows and no toe, that patient is probably going to say that they feel the stimulation mostly in the anal area, which doesn't mean that it won't work. But my prejudice is that the patient should feel it comfortably in the genital area. So the lower the threshold, the more similar the response is across all four contacts, the pattern of bellows first and then toe at a slightly higher threshold, generally means it's going to be comfortable and they're going to feel it in the vaginal or perineal area. I used to say genital because not all of my patients are females. And the gold standard would be to use EMG during the lead placement. I had the privilege of learning this from Tom Benson. But it is a barrier to doing the therapy. A lot of you may be not comfortable or don't have access. But getting a C-MAP with the contacts generally means that you're next to the nerve and you're going to get a good response. Some people have advocated doing programming afterwards with that. But I haven't found it necessary for years. The more comfortable I've been with optimal lead placement technique, I think the less of this problem of lack of or declining efficacy I have. But I am a lot better at placing leads now than I was, say, five, 10 years ago. And I've seen patients who I replaced their – I did their implant five, 10 years ago. Now they're coming back for battery exchange or for revising the system in some way. And I think I can do a better job of placing the lead now than I did then. So these are some lead problems. After a fall, these leads can be fragile and they can break. And if you have impedance showing over 4,000 ohms, that means that there's an open circuit in the system. And, you know, there's four filaments in the lead. So not all four of them are breaking. Sometimes it's just one. And so you can program around that. And, you know, if all of the combinations with contact three have an impedance of over 4,000 ohms, then you know that contact three, the filament is broken. And so if you include pairs of electrodes that don't include contact three, you can program around that to some extent. If you don't, the patient can have intermittent shocks. When that electrode, you know, comes together, they get a zap. And then when it separates apart, it goes away. And so that – those intermittent shocks tend to be a sign or symptom of lead fracture. The patients can also have migration. And I'll talk about a specific case of that. But I usually place mine now where the contact number three is just at the anterior surface of the sacrum. So if I am worried about change in lead position, I can always get an x-ray and see if that has changed any. Also, you know, are they feeling it in a different place than they were initially? That can give you some indication that there might have been some migration. And there's a unique case that I think you should be aware of, which is that because of the design of the tines that are like an arrow, the lead can go in deeper. It can't necessarily come out unless there's a major trauma to the patient, like a car accident or something like that. But the lead can migrate anteriorly. And this is particularly a problem in thin patients. So, you know, here's an example. This was in the literature of a paper from Shlomo Raz. And I have from the literature with an exclamation point just because of the horrendous positioning of the lead. And since I'm talking to a bunch of urogynecologists, I'll just point out that this interstim for dummies lead is the official lead of the Rosetta trial. And the, you can see from the soft tissue that the patient is a thin patient. And what happens in thin patients is that they get a little knuckle in the skin right underneath the presacral skin where the lead is bending around and going towards the battery. And you've probably felt those before. In a fat patient, it's not as big of a problem. But in the thin patient, if they sit on a hard surface, that lead is short enough that it can actually push forward and the tines will hold it in place. So the way that you can mitigate that is in this picture I'm showing making a skipping incision. So this is a technique that is off label but since we're talking about it for our own purposes and we're not being sponsored by anybody we can say these things. But anyway, just making sure that that lead lays flat before I curve it around is one technique. And then you're seeing also the use of the lead introducer for tunneling. And the other key piece that I don't want you to miss is this sen that I'm holding in my left hand in the picture on the far right. Your incision should be big enough to insert a sen and that you see fat in there and you should lift up on that sen so that you are careful not to curve this lead around in the skin. That's what traps it there. And oftentimes the reason that you get a little knuckle is because you made too small of an incision. So making a big enough incision the size of a sen which is less than a centimeter is still not a big incision. Lifting up on that and then digging deep inside with the tunneler is one way to prevent this knuckling phenomenon in a thin patient. So if you're having a patient who's having problems with the lead it might make sense to repeat a staged implant. Usually we try to program around whatever issues there are. That's the first thing to do. But after you've gone through all of the different programs that are reasonable to try and the patient hasn't had a benefit, I often will do a staged trial on the other side. That's the most conservative approach. And so that allows me to use the original lead as like the don't be. There's something wrong with that lead placement. It's not working. I want to put in another lead and I want it to do something different than the first lead in space. And so sometimes I have pictures showing that the old lead and the new lead. I generally remove the old lead after I'm done. I also like to do it on the opposite side. The reason for that is that in case I have trouble getting that lead out and I have to dissect down to the times, I'm not worried about the anchoring of my new lead on the same side. And then you can just come back as a second stage and connect that new lead to the generator. A lot of times I'll ask the patient if they're okay with my judgment. And if I can clearly see that, and this could be my own lead. So I'm not talking about somebody else, but gosh, I don't know what I was thinking that day. That lead doesn't really look like it's up to my standards today. It's too lateral in the frame and it's too inferior or whatever. Here's a new lead. I'm getting perfect responses. It's in a much better position. The patient had a good P&E trial in the office. I'll just hook them up at the same time. But that's not as conservative as just doing a stage trial and coming back another time. And then if you've done the stage trial on the opposite side and neither the old nor the new trial is working, then maybe you have to admit that this isn't the therapy for the patient and remove both of the leads. And really there isn't any evidence to suggest at this time that bilateral implant is a better option for patients. I think there might be room for consideration of bilateral, but it would be bilateral with two well-placed leads, not a kind of okay lead and a well-placed lead. And I think that there hasn't really been sufficient work done to demonstrate the value of that approach. I wouldn't rule it out for the future. So this is a really interesting patient and she is one of my very first patients that I implanted prior to interstim approval by the FDA. And she, I mean, the good news of this story, it might look like, oh my God, but the good news is that she has had excellent benefit from this therapy for over 26 years now. But the first lead that was placed, and I have a color coded here in yellow. I'm gonna take that yellow away for a second. You can see that that's a bone anchored lead. There's no radio opaque markers on it. In the lateral view, you can see that the lead is just anchored to the bone laterally as opposed to these other time leads that are going in straighter. And so you could forgive me, at that time we were doing even the permanently placed lead with bone anchoring. We were doing that as a blind procedure. We didn't really know any better. So you can see it's not really in far enough. It is kind of low in the foramen compared to the ultimate lead that we replaced it with, which is the more superior lead on the left-sided image. And, but you can see, I don't wanna show you that one, but you can see that it's very medial. It's in the most medial portion of the foramen. So this was early on, and I think she had a battery change. In those days, the batteries lasted for 10 plus years. She had a battery change, and then she was having problems, and she was living in another city in the Midwest. I won't say where, but anyway, there was a world-renowned expert in neuromodulation there. And I said, you know, you don't have to travel to Minnesota. Just go see this particular doctor. And I'm sure that that doctor will be able to take it. Said, he went ahead and put this new lead in. So that's the new lead, and that's the time lead. And he did not take out the old lead. So at this time, there were two leads present. And, you know, he didn't because it was anchored to the bone, and that would have been too much trouble, I guess. And so what the patient said is that this lead, the red lead, never really worked as well as the original yellow lead. She didn't, it didn't feel exactly the same place. It wasn't as comfortable. And although she said that she couldn't live without it, her degree of urinary control was not as good as it was, as good as she knew that she could be with the therapy. So eventually it was time for that battery to be changed. And she went back to the surgeon and she said, her understanding was, I think the lead worked better on the other side. And the surgeon said, well, I don't think there's gonna be any room for another lead on the other side. You know, there's already a lead there. And you are doing pretty well, dearie. And sometimes, you know, better is the enemy of good. So he basically refused to replace the lead. So the patient called me and she came back to see me in Minnesota. And I looked at these x-rays and I said, yeah, I think I can fix that. Neither one of those leads really looks like it's in an optimal position. So I did, I put this lead in with the green arrow. You see, it's much more cephalad. It's in further. It's equally medial, which this other interim lead was not. And as soon as she woke up in the recovery room and we turned it on, she goes, oh, that feels like it's home again. And she actually did better. This was about 24 years out. 24 years out, she did better with this therapy than she has ever done. You know, she's a fortunate gal. She didn't have a lot of comorbidities. She just had this one problem. And I just wanna tweak you a little bit. You know, I mentioned the Rosetta trial already. Do you think any of your patients, after having Botox one and a half times a year for 24 years, are gonna ever say that they're doing better than they ever were? I just throw that out there for you. Okay, so pain at the IPG site. So this can be due to positioning. You wanna make sure that it's positioned lateral to the sacral margin and below the posterior superior iliac crest, and at least a couple centimeters below the skin. You wanna make sure that, you know, the pocket size is right for the device, not too small or too large. If it's too large, it can flip around or you can get a seroma and you can have problems with the IPG being flippy in that space. It may be that this next wave of smaller devices will be advantageous for pain at the IPG site. I don't know if that's been proven for sure, but that makes sense to me that they would. Sometimes if you have pain at the IPG site and you're programmed in a monopolar way, the can is being used for feedback. So programming them in a bipolar way can take away some of the discomfort. Sorry, that's my dog in the background. But here's a kind of an example of setting up for a stage lead. And you can see that the line labeled A is the lateral aspect of the sacral margin. The line labeled B is the posterior superior iliac crest. The line labeled C is where the future IPG is gonna go. And my incision there, the lateral incision is just for the connection of the lead to the lead extension for the stage trial. And this was a case, this was an actual case that I had been referred to by one of the colorectal surgeons in our community. So this superior incision here, she was very uncomfortable and the device was too superficial. This is a thin patient. So the surgeon went back and made a deeper incision here and fixed it that way. But then the patient had the same problem. So then she came to see me. And it shouldn't be touching the posterior superior iliac crest or the sacral edge. And you can see that that device is touching both. So I just made a lower incision and made sure that it was lateral to the sacral edge and below the posterior superior iliac crest and the patient didn't have a problem. So that's just kind of a rookie mistake that I think most of us should be able to avoid. So troubleshooting IPG pain. I wanna just start at the bottom of this. So the reality is that a lot of the patients that we're seeing that need InterStim because they have urinary frequency and urgency have high tone pelvic floor muscle dysfunction. You know, there may be a pelvic pain component. There may be a problem with mobility in their hips and their lower extremities, the lower back. A lot of these patients have pain anyway. And so, you know, we put this device kind of near the SI joint and then they have pain in their SI joint. And it seems like everybody's brain goes into a fog. And the only thing they can possibly imagine is that it must be this device that's causing the pain. And that's often not right. You know, those come in and they'll say, it's pressing on my sciatic nerve, you know. And I show them a picture from the human anatomy project, you know. Well, it's in subcutaneous fat, which is overlying fascia, which is overlying muscle, which is overlying the gluteus maximus, which is overlying the gluteus medius minimus. And then underneath that is your sciatic nerve. So how is this little, you know, 22 CC device actually pressing on your nerve? That doesn't really make any sense. So, and also doing a pelvic examination and palpating their obturator and terni, the levators and so forth. A lot of times they can, they'll have referred pain. So the point is, don't get locked into thinking that this is only related to the IPG. There are other reasons for pain in that area. And we need to think about the patient as a whole. But, you know, certainly conservatively management reprogramming, using bipolar settings, sometimes in patients who have chronic pain using low dose tricyclics. One of the things that I used to find really hard to get ahold of is a lidocaine patch, because for some reason, those are like a billion dollars. But now Shaq advertises them on TV and the patient can go get a Solange patch as an over-the-counter thing at Walmart or Walgreens. And that really works well for temporary relief of the pain at the IPG site. So that's something that you can do kind of early on during the healing phases, or if you're trying to separate out a central pain versus a local pain. Reposition or replace, you saw that example. Make sure it's not on a bony prominence. Make it usually deeper, more inferior. Sometimes putting it over to the opposite side. But I think in general, I'm sure there are those of you that feel that, you know, operating for pain is very successful experience on endometriosis. But pain is usually a lousy indication for doing surgery. So I really think it's important to think of the patient as a whole and try to rule out other possibilities before. And when I do operate for pain, I have to tell the patient that I'm not sure that this is gonna resolve the problem. And, you know, I mean, I'm just being honest with them about that. Okay, so MRI patients need to be warned about this concern when you're giving them a non-MRI compatible device, but also when you're reoperating on the patient, because if you leave the lead fragment behind, that can be a problem for them. A lot of times the person who's asking for the MRI isn't really carefully considering the fact that there are alternative forms of study. So they just say, let's get an MRI because that's what I always get for this problem. But sometimes an ultrasound of the liver is okay for evaluating the hemangioma, or sometimes a CT myelogram is adequate for evaluating the spine. And sometimes in rare instances, I don't wanna, you know, be over-generalized with this, sometimes clinical judgment is a good substitute for an MRI. And, you know, I say that because a lot of times the patient gets their damn MRI after whatever, and then it doesn't lead to any change in the patient management. So, you know, if we can have a reasonable discussion and prevent the patient from having an unnecessary surgery for an MRI that isn't going to be of that much value for the patient, I think that's your first go-to. But I think the key to this is gonna be, there's a host of devices. Now the Axonix device, soon Medtronic will have their InterStim Micro and their SureScan lead for the InterStim 2 device that are MRI compatible. So we're not gonna have these issues, but we still have a legacy group of patients that have these concerns, and so we have to think about them. So I wanna talk a minute about timely retention, and that can be a problem with MRIs too, because it's the lead that's the problem. So if you leave a fragment of the lead behind when you're doing a revision, then actually even if you wind up putting in an Axonix device or an MRI compatible device, that patient can't have an MRI. So this is gonna be a problem and a source of concern. So these leads may not pull out easily after they've been implanted for many months, and that means that there's an increased risk of a fracture or leaving a portion behind. Sometimes they can break even near the capsule where you're dragging it towards where the IPG was. That's not as bad of a situation because although points off for style, you have a piece of debris there, it's not going to heat up the nerve. It's just gonna heat up the fat, and I don't really think that an MRI is counter-indicative in that situation. But you have to discuss with the patient before, and you have to say there's a chance that the lead could break, and if it is gonna be broken, then there could be consequences for you. Sometimes the patients don't care. They say, well, you know, I already have another thing that makes me not have an MRI, so it doesn't really matter. And that takes some of the pressure off. And this is what the ICS Committee for Best Practices came up with, is that the lead should be removed from the pre-sacral position. So you can make a small incision and try to, and gent, I'm sorry, to retract gently in the direction that the lead was put in. But if it doesn't come with gentle tension, then to set down, sometimes all the way down to the tines. And usually the incision has to be on the inferior side of the lead because the lead is angling inferiorly. So, and it needs to be big enough so that you can get a retractor in there and you can see what you need to see. And sometimes if you're looking for a fragment, using fluoroscopy is helpful. I use an instrument called a lead lander, which is a retractor that's sometimes used for spinal surgery. And it's got three prongs on one side and four prongs on the other side. So I put that in the incision and then I can use those prongs as a grid and I can know where the lead fragment is, which prong it's close to and do my dissection in that area. Sometimes stiffening the lead with a stylet before you pull it can be helpful in making sure that it extracts more completely. I just wanted to show you, this is what I call a ghost lead. So you can see in the left image, leads typically break in this way, but there's no filaments in that lead. So you have the marker that's for depth and then you have the four platinum iridium contacts. And then there's a new lead that's in a better position, but you can see that the filament is in place in the more cephalad one. One time I had a patient who had a lead that I placed removed elsewhere and they did not tell her that they left a fragment behind. So she found out when she had an MRI of her spine and there wasn't any problem with the MRI of her spine, but they said, oh, well, you have a lead fragment there. So she went ballistic and I think part of it was because she wasn't told. And she went to the doctor at the institution where they took the lead out and which was a world famous institution. And the doctor said that he didn't think that he could or should take the lead fragment out. So she wanted me to do it and she called me up and asked if I would take it out. And so I talked to a neurosurgeon, this was many years ago. And I thought, well, you know, I might have to do a foramenotomy in order to get that lead out. And she said, oh, well, what are the contacts made of? I said, well, the platinum iridium. And she said, oh, well, you know, we put grids with platinum iridium contacts underneath the cranium on patients with either seizures or brain tumors so that we can then map out where the abnormal activity is. And so I just took this out of a journal. Here's a platinum iridium grid on a brain with an MRI scan of the brain with a grid full of these contacts on it. And, you know, they're looking for the concentration of energy in different spots. I mean, it's frustrating that we could not get a colleague in radiology to do an MRI in this situation when clearly it does not appear that there's a lot of risk. The fact is that there's no antenna going to these contacts to concentrate the energy. Also, Howard Goldman did a study where he clipped the electrode at five centimeters and then he did an MRI in the shadow box and showed that there was no increase in heat that was significant. And he defined that as one degree Celsius. So on the face of it, it really doesn't look like it's a problem, but there's a medical legal concern, which I think it's best just not to believe the leak fragment. So I want to talk about pregnancy for a second. Patients need to be warned that the use of these devices during pregnancy is not something that we know for sure is safe. We don't really know heavy evidence that it's not, but patients should be advised to turn off while they're trying to get pregnant or as soon as possible once they know they are pregnant. Theoretically, it'd be during the first trimester that the patient would be at, the fetus would be at most at risk, you would think. One time I had a patient who had severe pelvic pain and was on a whole bunch of drugs for that. She got off all of those things, and, but she was worried about turning her device off during her pregnancy. So she went to see a neonatologist, I guess, and the discussion was very practical. He said, well, the best thing to do is keep it off. If you can't do that, then the second best thing would be to keep it down at a lower level for as long as possible. We, there were a couple articles that looked at risk associated with pregnancy and some of the patients who had idiopathic non-restrictive urinary retention and recurrent urinary tract infection in pilo. When we turned the device off, they developed UTIs in pilo during pregnancy. So clearly there's a balance of factors that may mean that, you know, the known is more scary than the unknown. I don't know. I mean, I think you have to use clinical judgment here. I have noticed that sometimes it doesn't work the same after vaginal delivery. I don't think that in itself is a reason for doing a C-section. But a lot of these patients, as I mentioned, have high tone pelvic floor muscle dysfunction. That's the underlying problem that they have. And in those patients, I don't know whether it might make more sense to do a C-section with some form of preemptive anesthesia like a spinal. My understanding of these patients tells me that that might be a good suggestion for my patients who are high tone pelvic floor muscle dysfunction patients. Maybe some of you have a reason that's different than that. But that's something that I do tend to warn those pelvic floor people about. So staying out of trouble, the best things are patient selection. Make sure you have the right patient. Minimizing the risk of infection as we discussed. Using optimal lead placement techniques, which help you predict where the patient is gonna feel it and they're gonna feel it comfortably. Doing an adequate trial length staged implant if there's any question. Using smaller IPG size or making sure that the pocket is the right size for the IPG and positioning it so that it's not on the posterior superior iliac crest or the lateral sacral edge. And I think a whole host of these problems will be solved when we go to MRI compatible devices. But if you're converting a patient who had an MRI non-compatible device to an MRI compatible device, you will have to take the lead out in order to make that be successful. And so there are concerns about lead fragments and so forth related to that. So I just have a couple more slides to crystallize things. So triggers for revising the lead. If the implant was not as successful as the P&E, we talked about that. Check an AP and lateral x-ray and make sure that that lead is as high and medial as possible in the frame and that it has the appropriate space and it contacts both the AP and lateral view. Check the sensation and thresholds, make sure they're comfortable. We're aiming for genital perineal rectal or anal sensation. We don't want a radiation into the tailbone or lower extremity. And I will say that precise lead placement is particularly important for the patients who have a component of pain or who have a purely sensory disorder like urgency and frequency without urgent incontinence. I think that you have a patient with fecal incontinence, you put that lead anywhere in the right zip code and they're gonna be good. But if you have a patient who has OAB dry with pelvic pain, some of you might be foolish enough to put the label interstitial cystitis on that patient. I wouldn't personally. But anyway, they don't tolerate being stimulated in the piriformis on the way to the nerve. They don't tolerate any extraneous stimulation. It has to be on the nerve and stimulating at the lowest possible thresholds in order to be successful. So again, triggers for revising the decline efficacy after original success, after we've ruled out other causes and we talked about pelvic floor muscle dysfunction being one, but this is saying, hey, it's not working and maybe they become obstructed for some reason or they have normal pressure hydrocephalus or some other problem that's come along 10 years after their initial implant. Usually try to work around this with reprogramming and use the standard set of reprogramming instructions. And then of course, if the lead is fractured and you can't program around it, it needs to be revised. And triggers for revising the IPT if it's impending end of life. Sometimes you can just let it burn out and then have the patient seek you when their problem comes back. You certainly wouldn't wanna manage your cardiac pacemaker like that, but we can afford to in this. And some patients don't wanna live without it. So then you have to be more on top. I usually try to have the patients come back once a year to just keep track of that. If they need an MRI, and that may require lead replacement, we talked about that. And lack of efficacy if the IPG is at end of life and it can't communicate. And this is something, if you're replacing the IPG, if you're replacing the lead, let's just say that for some of the other reasons we talked about, the lead needs to be replaced. How, what's the trigger for replacing the battery? I generally think my own thought is if the battery is a year or more old, I would replace it. I suppose if the insurance companies could weigh in, they might be a little bit more strict. But since the manufacturer says three to five years, we typically get six to seven, but that could be a third of the battery life. That would be what I would argue. I don't believe that. If thresholds are under one, the battery should last six to seven years. But I would tend to replace the IPG if it's more than a year old. Also pain at the IPG site, if the pain persists with the device off, it's questionable as to whether the device is really the cause of it, but it certainly would be if it's overbony prominence or it's flippy, it's too superficial and may need to be repositioned. If the pain stops when the device is off, that might mean there's a fracture in the lead. So changing the programming to use bipolar programming or around the lead fracture are good strategies. I just wanna put in a plug. I do a ton of Botox. I know I personally think it's an inferior form of therapy for patients who have refractory overactive bladder compared to neuromodulation therapies. But here are situations where you might wanna use Botox as an additive or simultaneous treatment. If you have a patient who is not quite good enough with neuromodulation alone, sometimes adding Botox could be, even in low doses, additionally efficacious. If you have a patient who has dual indications and only their fecal incontinence is improved, that usually means that the lead could be positioned better, but you could treat that patient with Botox for their bladder and the lead for their fecal incontinence. Pregnancy is an interesting issue. If you have a patient who's trying to get pregnant, if you really wanna be a great doctor, you might say to the patient, look, let's go ahead and treat you with Botox for your overactive bladder before you become pregnant. And then we can turn off your interstim and you'll have six to nine months where you have a safe window of being pregnant and having your first trimester. I think that's a cool idea and it might be something that you recommend to your patient. And also as a bridge to revision, so if you have a patient who you had to explant because of infection, you might go ahead and do a Botox at the time of you're doing the explant or as a separate procedure and allow that wound to heal and not come back. Or if a revision is required, but you're not ready to do it for some period of time for some reason, you're waiting for a new device, then maybe you can bridge them with Botox. Okay, well, that's all I have to say. And I hope that I've stimulated some discussion. So I'm open to any questions. Thank you, Dr. Siegel. That was a tremendous presentation with lots of really valuable pearls. Our audience does have several questions. So I'll get into them. The first one is, do you give antibiotics orally for infection prophylaxis between stage one and stage two? No. Have you in the past or is this, this has just always been your practice? Well, I used to give patients five days of antibiotics. And after I either did stage one or stage two implant or a full implant, I always used to give patients five days of antibiotics. But I always did that knowing that the ID doctor said that you're just treating yourself, that it's the dose that you're giving the patient in the perioperative period, that's the critical thing. And so one day I was talking to one of my former fellows, who Travis Bullock in St. Louis, and he just said, yeah, I just stopped doing it. You know, it didn't really make any sense and I've never had a problem. So I listened to him and I stopped doing it. And so now I don't anymore. And I, you know, it's gonna take hundreds of patients to know if there's any difference when you're only having a, you know, one or 2% infection rate, but I haven't noticed any further problems. Our next question is, what are your thoughts on a visually well-placed lead that lacks motor response on deep electrodes, but ends up with a good sensory response? I didn't hear the first part of what you said. What are my thoughts about? It's a lead that's visually well-placed. Yeah. Has good sensory response, but lacks motor response in the deep electrodes. So the distal most electrode doesn't have good motor response. Well, I mean, we know that the history of this therapy is blind placement led to, you know, excellent symptom control for a large proportion of the patients. So you don't have to have a lead that is optimally placed by today's standards to have success. And I would encourage you to try to get it that way, but if you've tried and you can't get it, for me, that might mean I tried on one side, I tried different angles on that side, then I went to the other side, you know, so if I've tried all those tricks, then I'll settle for something less than what I would consider to be ideal. It doesn't mean it's not going to work. So I guess that's the answer to the question is if it works, then there's not a problem. Any experience or pearls for patients with flaccid paralysis of anal sphincters and urinary retention resulting from cauda equina? Yeah. Well, okay. First of all, according to the labeling, this therapy is not appropriate for patients who have a neurogenic origin of their voiding dysfunction. So a patient who has cauda equina syndrome by definition has a neurogenic bladder. So that probably isn't your ideal case. Now, having said that, since, you know, we're just talking as doctors here and we're not being sponsored by somebody that has to worry about FDA labeling, I would say if a patient has a flaccid anal sphincter and lacks a bulbocavernosis reflex, so the sacral arc has been disrupted, it probably is not likely that that patient is going to have success from the therapy. You know, if you're sticking needles in their back and they're not saying, ouch, that, you know, they came in walking with the walker with the tennis balls on it, that patient is probably not a good candidate for sacral neuromodulation, but there could be partial degrees. You know, maybe one side is more affected than another. So, you know, I don't know for sure, I wouldn't rule it out, but I would say in general, that's a poor candidate for sacral neuromodulation and it's probably not gonna work for that patient. Thanks, Ben. We have time for one more question. If you use CMAP for placement, do you look for equal signals from the anal sphincter and toe, and do you prefer one over the other? Yeah, I, well, I don't usually, when I do it, I only measure the CMAP at the anal sphincter, external anal sphincter. So I, so for me, you know, that's the key. Now, I wanna get a toe. If you don't get a toe, the patient generally doesn't feel it in the genital area, they feel it more in the anal area. And it doesn't mean it doesn't work, but I want a toe and I want it soon afterwards. But that's, I would use the CMAP just on the external anal sphincter. That's what I've done in the past. Got it. Well, Dr. Siegel, on behalf of the Oggs Education Committee, I'd like to thank you and everyone for joining us today and for a tremendous presentation. Our next webinar is titled Finding Efficiencies in Enjoying Your Practice, and will be presented by Dr. Ryan Stratford on July 15th. Thank you, everyone. Have a good night. Thanks. Thank you.

Troubleshooting Safer Neuromodulation

urinary incontinence

voiding dysfunction

risks and complications

patient selection

lead placement

device positioning

infection prevention

wound complications

Botox