MEDICAL BREAKTHROUGHS RESEARCH SUMMARY

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1 TOPIC: Relief for Pelvic Pain REPORT: MB #4082 MEDICAL BREAKTHROUGHS RESEARCH SUMMARY BACKGROUND: As many as one in four women suffer from chronic pelvic pain. Pudendal neuralgia (PN) is a condition in which there is pain in the lower central pelvic regions due to the pudendal nerve. Symptoms can include pelvic pain, sexual dysfunction, and difficulty with urination. People who suffer from PN may also have difficulty with defecation and a feeling that a foreign object may be in the body. Pain may be worse upon sitting and less when standing or laying down. PN can be triggered by bicycling, squatting exercise, direct falls on the tailbone, repeated vaginal infections and chronic constipation. The pain could be a stinging, burning, stabbing or cramping sensation. (Source: TREATMENT: Image guided anesthetic and steroid blocks of the pudendal nerve are commonly used for treatment of PN. Symptoms often return once the local anesthetics wears off and steroids may or may not relieve symptoms for a longer period of time. If steroids do relieve the pain, it usually begins to improve about two weeks after the block, with improvements continuing for up to four to five weeks. Two to three steroids injections may be sufficient, alone, to cure the problem. After the injection, the pain may worsen for a period of two to ten days due to the steroids. (Source: al_neuralgia_brochure.pdf ) NEW TECHNOLOGY: The option to freeze the pudendal nerve may be bringing relief to millions of women who didn t find relief from steroid injections or other treatment for pudendal neuralgia. Dr. J. David Prologo, an interventional radiologist at the Emory School of Medicine had been freezing nerve pain for years, but was quite hesitant to use the same technique on the pudendal nerve. He just finished a study freezing dorsal penile nerves for premature ejaculation when a female patient asked if he would perform the procedure on her to stop her PN symptoms. After consulting colleagues in urology and gynecology and researching current treatments for PN, he decided to go forward with the procedure. Dr. Prologo started documenting his work on the women he treated for PN. So far, 95% of the women he has treated have said that their pain is completely gone and 60% of them have not experienced any side-effects. (Source: Dr. J. David Prologo) FOR MORE INFORMATION ON THIS REPORT, PLEASE CONTACT: Alysia Satchel Senior Manager, Media Relations Emory Johns Creek Hospital [email protected] If this story or any other Ivanhoe story has impacted your life or prompted you or someone you know to seek or change treatments, please let us know by contacting Marjorie Bekaert Thomas at [email protected]

2 J. David Prologo, M.D., Interventional Radiologist in the Department of Radiology and Imaging Sciences at the Emory University School of Medicine, talks about a new way to treat pudendal neuralgia. Interview conducted by Ivanhoe Broadcast News in February Dr. Prologo: We put this into tumors, we put this into spots of pain, nerves, whatever it is that we want to ablate, to freeze and shut down the activity. This was originally created to freeze and treat cancer, which we do. From there we started to freeze cancer for the purposes of decreasing pain. Many patients had cancer all over their body and their bones which was causing them pain and no treatment. We started to freeze cancer and patients got relief. From there we started to freeze nerves for patients who had nerve related pain. And that evolved in to absolutely novel and brand new treatments for conditions that were otherwise refractory to treatment. Pudendal neuralgia in particular is a great example because that is a condition in which young women who have had traumatic births or otherwise young people who have had surgery or other traumas or even bike riders who get a condition of pelvic pain from over sensitivity of that nerve. It s debilitating patients who can t sit down, and whenever they come to see me they re always standing when I walk in to the room because they can t sit down. This nerve rides in your pelvis underneath the bones that you sit on. You can imagine that if that bone is sensitive that you can t sit and you re uncomfortable then you can t concentrate on the things you want to do, like parent your children or teach your class if you re a teacher or whatever work you have to do to support your family. And for so many years patients only had the options of narcotics, which come with side effects and aren t always the best choice for young people who are functional and want to work. Surgery was attempted in multiple settings but often times cause the adhesions that you had mentioned and recurrence of pain. The bottom line is patients didn t have great options. There s a whole population of people in the world walking around with this pain and no options. A patient who came to me and said do you think this is going to help me, and I wish I could take credit for the idea, is now a young person who s functioning and working. We froze the patient s nerve. This nerve that was so hypersensitive causing the patient so much pain and debilitation, we shut down the signals in that nerve and that person s pain went away. Then the word got out that we could do that and now we re seeing pudendal neuralgia patients. I moved from Cleveland, Ohio to Atlanta and in the last six months and we ve probably done forty patients of which half have been from across the continental US or other countries. That s pudendal neuralgia. That s the idea we use image guidance to place this because without image guidance you can t get to this nerve. And in the past, interventional radiologists have used image guidance to do other things. To do biopsies and to treat traumas, but it s a new idea for interventional radiologists to use our technology, to use CT scans and MRI s to guide our needles to nerves that doctors otherwise couldn t reach, and treat pain. That s what s new. Does it have side effects? Dr. Prologo: We haven t seen any side effects. In the beginning, there was a long list of potential problems with this that we could imagine because it hadn t been done before. But after doing fifty to sixty

3 patients, we haven t seen any side effects. We did recently have one patient who did not improve, who went on to have surgery. How long have you been doing this? Dr. Prologo: Three or four years. When you freeze the nerve, you said that ball is an ice ball? Dr. Prologo: It s literally an ice ball. It s a decreased temperature of minus forty degrees centigrade. Does it melt? Dr. Prologo: The ice ball melts. When the nerve freezes and then melts, when the temperature goes down and then back up it causes the signals in the nerve to stop. Basically you ve got a nerve that is sending pain signal, pain signal, pain signal and after you freeze it and then thaw it those pain signals stop. And all of a sudden your brain is not receiving all these signals about pain. How do you know which nerve it is? Dr. Prologo: The anatomy of the human body is luckily, for doctors, reproducible. Across each patient we know what nerves supply what parts of the body. A patient with an amputation for example, comes in and says I ve got pain in the bottom of my foot. Well I know what nerves supplies the bottom of the foot so I can trace it back to the residual limb and then freeze that so it s not signals. As far as pudendal neuralgia goes, it s called pudendal neuralgia because the patient s symptoms are attributed to that part of the pelvis supplied by the pudendal nerve. We know when we shut down that pudendal nerve we re going to shut down the pain in that distribution. For years people would have thought that if we could somehow shut down this nerve and they tried to do it with surgery that this would work, but there s no way to get to the nerve until you start using image guidance. That what s new, the marriage of image guided interventional radiology, which was used for so many other things, the marriage of that with these pain syndromes, that s what s new. And that s what s opening the doors for treatment for amputees or for patients with pudendal neuralgia or patients with metastatic disease in their hip we can shut down the nerve, called an obturator nerve. Are there other reasons for that kind of pelvic pain? Dr. Prologo: Pudendal neuralgia is well characterized. There are five criteria called the NANTES criteria that were delineated in this conference in France twenty years ago. And we can identify the pudendal neuralgia patients by their description when they meet these criteria, but there are certainly other causes of pelvic pain that can also be treated by interventional radiology such as pelvic congestion syndrome. This is a pelvic pain syndrome that can present like pudendal neuralgia and we would have to talk to the patients and tease out their symptoms. If they were to have the symptoms attributable to pelvic congestion syndrome where their veins are incompetent it s a different description. Its heaviness, its constant as opposed to the pudendal neuralgia patients who are worsened by sitting and they have a history of trauma. We do have to tease out the potential underlying causes all of which though can be treated now when in the past these patients didn t have options. Are there people who have that and don t qualify for this? Dr. Prologo: I don t think so. If they meet the diagnostic criteria of pudendal neuralgia, if they ve had a trauma and they have pain in that distribution that s worsened by sitting. When the patients come in with this description and the diagnosis of pudendal neuralgia and often times years and years of unsuccessful

4 treatment the first thing we do is we bring them in to the CT scanner and we do sort of a dress rehearsal. We inject bupivacaine which is like lidocaine to temporarily shut down that nerve. That s a temporary effect that only lasts for that day. But we can say to the patient this is how you re going to feel when we shut the nerve down; does this help you, is this tolerable? And this is a diagnostic maneuver that allows us to be sure the patient s pain is coming from this. When we inject this patient with bupivacaine, if they don t get better we don t do the ablation. So when the ice ball melts where does it go? Dr. Prologo: The body will absorb this small amount. This ablation zone is really only one centimeter by three centimeters. It s a very small amount of water that is ultimately absorbed by the body. And about ninety five percent plus of the pudendal neuralgia patients report complete resolution of their symptoms. Not even a minor improvement but a cure. It s quite remarkable. And the few it hasn t gotten worse? Dr. Prologo: Recently, we did have a patient who reported worsening of her pain after the procedure. She eventually went on to surgery. What other kind of pain do you treat? Dr. Prologo: We had a patient with so many other pains and so many of the nerves that we know are responsible for carrying pain signals are not accessible to the pain doctor. They are accessible to us because of image guidance. Example, patients with breast cancer who get radiation to this area of their body can have nerves damaged causing pain in their extremity, their shoulder. Patients are sentenced to a life of medication management. Because it s not safe to stick a needle there without image guidance because of the lung and all the arteries that supply the brain and many other structures that you wouldn t want to hit with a needle. Interventional radiologists are trained to use image guidance to precisely place needles within millimeters of a target for so many different reasons. And now we can use that same training and that same technology to place a needle to that damaged nerve that would otherwise be inaccessible. And inject medication or even freeze that area for that patient s treatment. That s just one example and the examples go on and on. We ve had patients who ve had trauma and damage to a nerve in their hip that s deep in their pelvis and not accessible for a needle injection. You might think, to draw another comparison, everyone is familiar with getting a steroid injection in their shoulder. That s something that a pain medicine doctor can do without image guidance, using land marks, using your bones. It is the same idea for deeper structures around the spine. Deeper structures around your hip that can t be injected just at the bedside without image guidance are all now accessible for treatment initiation or a treatment injection of a drug because of interventional radiology. When you freeze it does it kind of damage the nerve? Dr. Prologo: The nerve is a cell; its particular job is to transmit signals either in or out. Out so you can move or in so you can feel pain when you put your hand on a stove or you ve been injured. What the change in temperature does to the nerve is it freezes the structures inside the cell and shuts down the machine of sending signals. END OF INTERVIEW

5 This information is intended for additional research purposes only. It is not to be used as a prescription or advice from Ivanhoe Broadcast News, Inc. or any medical professional interviewed. Ivanhoe Broadcast News, Inc. assumes no responsibility for the depth or accuracy of physician statements. Procedures or medicines apply to different people and medical factors; always consult your physician on medical matters. If you would like more information, please contact: Alysia Satchel Media Relations [email protected] Sign up for a free weekly on Medical Breakthroughs called First to Know by clicking here.