A new way to use O-Shot® technology to improve fertility in women

Transcript

This is a very important, extremely important article about the very difficult and heart-wrenching problem of how to help a woman become pregnant who is struggling with a particular form of infertility where the lining of the endometrial cavity is or the endometrium is too thin. If you think about it, and this was pointed out in the article, it's really miraculous that a woman can have bleeding and shedding of the endometrium every month throughout her reproductive years without scarring. Any other tissue in the body would have trouble with scarring. But unfortunately, there are some women who do scar, it's talked about in this study, is Asherman's syndrome where intrauterine adhesions happen, which the miracle is that all women don't have that as this bleeding and shedding takes place every month. Or then some people just seem to have somewhat genetic propensity to it. And then there is this lactobacillus-dominant endometrial microbiome that's supposed to be happening and sometimes that happens to not be the case. There's something other than lactobacillus dominating the endometrial microbiome.

And I know that there are those who poo-pooed the studies of putting yogurt in the vagina, but just as a sideline, it makes sense. There's only two places I know of in nature where lactobacilli live, the woman's vagina, the endometrial cavity and in yogurt. So unflavored yogurt, it really just does help change the flora and there are studies to support that. How many studies we need to make it a prescription accepted thing, I don't know. But I know this, if there was a medicine that had the same sort of biological and logical reasoning for working and I had a patent behind it, you'd see ads about it on television. But anyway, that's a sideline. The bottom line is that some people don't have lactobacillus-dominant endometrial microbiome and some women do have scarring and some people do have thinning.

So there were two studies that are referenced in this article about using PRP, which is known in dentistry and known in wound healing, plastic surgery, orthopedics for 20 years. This is not new science in those arenas, but as pointed out here, it's new to the arena of gynecologists. And you see gynecologist jumping up and down saying, "There's no research to support this." Well, this as in using PRP or platelet rich plasma to help women with urogynecological problems, it's because they've lived in a bubble where this research hasn't existed. If you read dental research or if you talk with dentists, orthopedists, they've quit debating about whether platelet rich plasma does anything. It's not the magic cure-all be-all, but their discussions are on a deeper level about what does it do and what can we do with it and what can we not do with it.

Hence, you're starting to see, as pointed out here, that there has been minimal investigations in date in gynecology about PRP, but minimal in relations to other domains or specialties like dentistry and orthopedics, but still a growing number. And hopefully in the next 10 years, it's usually 20 years for a new idea to take effect, we're 10 years in with the O-Shot®, so probably in the next 10 years it will become widely done. Just watch, it will happen.

So what's happened is there've been two people published studies showing that infusing the uterine cavity or in bathing the endometrium with PRP helps rejuvenate the tissue to make it healthier, to enhance the probabilities of becoming pregnant for a woman with the problems that happen with endometrial thinning. So hence, this study to say, "Okay, we have those clinical reports. Let's look on a cellular basis in vitro, in a culture, outside of the body with those cell types and see what happens with platelet rich plasma."

So they use saline as a control. They use platelet rich plasma and platelet poor plasma, and they found that platelet rich plasma does enhance the growth of the right kind of tissue and migration of the right kind of cells to the right place for the same things you see in dentistry to prevent scarring and to grow healthier, more vascular tissue, which in theory would explain why they saw the effect in the two studies that were done to show that it may actually help women with this as a cause of their infertility. The other thing is that we have in vitro studies showing that PRP, which is what your body normally makes ... It's not some esoteric thing. When you scraped your knee as a child, PRP is what caused the scab and the healing and the regeneration of the skin. PRP's what happens every time you have surgery or you have a wound. That's how it heals. The platelets bring growth factors, the [inaudible 00:05:11] cascade happens and you recruit stem cells to the area and you grow new tissue.

It's not a new idea. It's been around since people have been wounded. When people fought in the middle ages with swords, the PRP healed the wound. So it's not a new idea. The newness is, how can we take what's already happening in the body and harness that to help people with disease. The other thing is because we know that's part of the healing process, we have multiple studies showing that PRP has anti-microbial ... It acts as an antibiotic. And it could be that's another reason that's happening, because it may help take care of the bad microbes and therefore help the good microbes or lactobacilli flourish.

That's a reach for the explanation, but it's in line. It's not homeopathy or some weird idea from outer space. Homeopathy as not in nutrition as some people apply it, but homeopathy is one part in 10 million somehow make something happen, which doesn't happen. So this is not homeopathy. This is a logical thing that's backed up by every time you heal a wound and by 20 years of research in other arenas and now it's finally becoming more commonly done. We've done it with the O-Shot® now for the past 10 years to help rejuvenate the tissue around the urethra. It doesn't work in everybody, just like antibiotics don't' working in everybody. 5 to 10% of people in the hospital with pneumonia still die, even with antibiotics. 30% of the people in the intensive care unit with pneumonia still die even with antibiotics. But we don't say antibiotics don't work. They just don't work all the time because sometimes a person, their milieu or their body's not able to heal itself for whatever reason.

In the same way, maybe the problem isn't the vagina. Maybe the problem with infertility is hormonal issues or low sperm count with a man. This isn't the end-all, be-all, cure-all, but it's a very intelligently designed way to help a woman who has endometrial thinning or scarring of the endometrium as a cause for her infertility and it should definitely be studied. The problem is, as we found with the O-Shot® procedure, funding is difficult because there's no patent on blood, so yay for these investigators who had to do this out of their own pocket as we have had to done with the O-Shot®. I've spent over $300,000 just in a couple of years with research on the O-Shot®. More coming. We'll spend another 100,000 this year. It's funded by the physicians in our group, who by the way, should be giving money back and almost all of us do, if a patient isn't happy.

You can't be preying on people's pocketbook if you're not keeping their money, if they're not happy. I started taking cash in 2003. I've never kept a penny of a patient who wasn't happy. In that case, we've lost our money and we've lost our time and we're very sorry the person isn't well and we try to find something else to help them. Every procedure is with risk and without 100% guarantee. Every procedure has risk and every procedure is without 100% guarantee. So there's a consent form with our procedure. If you have the O-Shot® or if you have PRP infused into your endometrium, you should read the consent form. You should understand that you don't have to be treated at all. You certainly don't have to be treated with PRP. You should make sure that someone in our group has agreed to use FDA devices that are designed to prepare platelet rich plasma to go back into the body.

If things don't work well, you should discuss it with your physician and continue to demand that someone help you. Don't give up. Sexual function is so important. It's more than about pleasure. It's about relationships. It's about the psychology of feeling whole. It's about even spiritual enlightenment. Hence, the ideas of chastity when it comes to spiritual enlightenment in many cultures and religions. Sexuality has to do with creativity and personality. So it's not just about pleasure, it's about part of the foundation. Emerson said it was the scaffolding of love, hence the scaffolding of our families to build. Maybe you don't need a scaffolding after the empire is built, but it helps build the building of your relationship with your lover. So consider this talk with your physician about it. If your physician wants training, we have training. We have teachers around the world. We have over 2000 doctors in our group. We have people in over a dozen medical schools. We have ongoing research. Read it, think about it, talk with your doctor about it, and let's push our tools for healing women.

It breaks my heart when, when it comes to sexual dysfunction, we keep offering women vibrators and lubes or psychological. Everything's not in your head. If you have an endometrium that's thin, that's not in your head. That's in your endometrium. If you have scarring from having a big baby that tore the vagina, that's not in your head. Hence, the treatment is not psychological medicines that affect the brain. And there's better treatments than just a lube and a vibrator. We have so much better science than we did. I hope that you'll investigate. Read the science for yourself. Don't just blindly listen to the naysayers. Usually, 20 years for a new procedure to take effect in medicine. Read the science. Talk with your doctor and take care of your body and value your sexuality. I hope this helps you or someone you love.

Read the research-->>(click)-->In vitro evidence that platelet-rich plasma stimulates cellular processesinvolved in endometrial regeneration<--

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Cellular Medicine Association

Ultimate Intimacy

Cindy Barshop: Hey ladies, we're here at The VSPOT, which is a women's intimate health spa. And my name is Cindy Barshop and we're here with renowned Dr. Carolyn Delucia, world renowned gynecologist. And we're here to tell you the truth about women's intimate health and vaginal rejuvenation. So first of all, vaginal rejuvenation is not saying, "I want a cute vagina." It's saying that we want more intimacy. We don't want to suffer in silence with what? Let me just think of a few of the things, dryness, inability to orgasm, difficulty to orgasm, after you have a baby, some looseness, yes, that's possible. It doesn't pop back.

Carolyn Delucia: And losing urine.

Cindy Barshop: That was my big problem was the losing urine. So those are just a few of the things that we're going to address. But why are we talking about it now? Because it's super, super important to get the word out. We're trying to educate people. And the most unbelievable way to educate people is the way Carolyn did it, is she put out a book, a simple, unbelievable, the greatest book about everything. Even your child should know. Well, not child, let's say mid age, like after menstruation, to really find out. So just please Carolyn, tell us a little bit about it.

Carolyn Delucia: Thank you, Cindy. The book I wrote is called Ultimate Intimacy: The Revolutionary Science of Female Sexual Health. It's available on amazon.com right now on an ebook. And the reason I wrote the book, as Cindy has mentioned, is that we have all been suffering. Women suffer every day. You may be suffering from not having comfortable intercourse with your partner and stopping from even being intimate because of pain, because of lack of pleasure. Why are we going through this when women have a solution? And there-

Cindy Barshop: Because there's not enough information out there. That is the facts.

Carolyn Delucia: That's right.

Cindy Barshop: And that's why Carolyn came out with the book. Honestly, Carolyn, I even read through the book super quick and I was like, "Whoa, finally people have the truth. They have the options." You know, what do I do for looseness?

Carolyn Delucia: Yeah, exactly. So in the whole book, we'll go through what traditionally has been done, what the problem is, what solutions we have now, and what is to come in the future. There's so much promising information out there for women and these conditions. Never having to go through those lonely times, when you're sitting there wondering, "Do I even like my partner anymore? Is it me? Is something different?" And you torture and torment yourself.

Cindy Barshop: Is it in my head? I hate that. It always goes to women, it's in your head. It's horrible. It's not.

Carolyn Delucia: It's not. And there are ways to treat this. So the book goes through all of those topics. And my goal was to really educate women that there are solutions to everything we're experiencing, and we provide them here at The VSPOT. But there are many other physicians, as well, and I give resources to that in the book.

Cindy Barshop: Let's stop suffering in silence, ladies.

Carolyn Delucia: Yes.

Cindy Barshop: Excuse me. Let's let our friends know that there are solutions out there and join together. It's like the year of the woman. Yay.

Carolyn Delucia: Yay.


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Dr. Oscar Aguirre discusses urinary incontinence

Transcript

Dr. Pelosi: Our next speaker is Dr. Oscar Aguirre from Colorado. If you don't know Oscar he is an urogynecologist who's been performing cosmetic vaginal procedures for a very long time ... surgical and non-surgical, and he's going to speak to us about his experience with the Viveve System, the radiofrequency with the active cooling.

Dr. Aguirre: Good morning. Thank you, Dr. Pelosi, for inviting me and wanted to talk about the Viveve System and how I incorporate that into my practice initially and some good work being done on showing its efficacy for stress incontinence. As [Marco 00:01:00] mentioned ... Which is my forward? So as he mentioned I am a urogynecologist. I'm in Denver, Colorado. This is the focus of my practice, I started first off as a urogynecologist but then added cosmetogynecology in 2007 as Dr. Pelosi mentioned, and then some body contouring.

Dr. Aguirre: So at first my practice is, I called it pelvic specialty care. I thought that was great as a urogynecologist concentrating on what you see here on the left side. As most urogynecologists, we concentrate on the pelvic floor, we're dealing with incontinence, pelvic relaxation, pelvic surgery, of course. In 2005, when the meshes came out, then doing Sacral Neuromodulation for voiding dysfunction, fecal incontinence, and adding Botox for that as well.

Dr. Aguirre: But during this seven-year period of my early career, patients were always asking other things, saying, "Well, while you're doing my bladder repair, can you do something about my tummy? Is everything okay down there? I want my vagina to be tighter. I want it nicer or a smaller labia." So all these things weren't things that we were taught in residency, let alone, pelvic surgery fellowship. So, and then what changed things even worse, or even further was the 2011 FDA statement, with regards to mesh. So the practices are changing quite a bit.

Dr. Aguirre: But then, in 2006 or so, the robots started coming out, and I made a point of not specializing in doing any robotic surgery but decided to do more cosmetic surgery. So I went and got trained with Dr. Matlock, I went with Dr. Alinsod to see how he does this in the office, then went with the Pelosis to learn liposculpture. So, that was the change in my practice. So from 2006, I changed the identity of my practice and it's more pelvic surgery, intimate aesthetics. I thought that was cool.

Dr. Aguirre: But then, so where do the lasers come in? Where do the non-surgical rejuvenation treatments come in? From 2007 to 2013, I felt my practice reached a ceiling. I was focused on surgical rejuvenation, where patients weren't always looking for surgery. There was a small percentage of women who had really a normal exam, who wanted better sex, and their only option at the time was a vaginoplasty. I kind of felt bad. They were really at the stage one relaxation, and I'm doing surgery on them. And a lot of those women didn't want surgery, so vaginoplasty is a great option for the right patient but most women just want sex to be better. They may be already having good sex.

Dr. Aguirre: So, I tell patients, it's hard to make, I can't make good sex better surgically. I don't want to stand a risk of their being a problem. If they're having terrible sex, great. Hands down, vaginoplasty is probably the best option. And the majority of women with incontinence, they don't want surgery, and they certainly don't want a sling anymore, the majority of them.

Dr. Aguirre: Then in 2013, I saw Dr. Bader who gave a talk on vaginal lasers for tightening. I thought, “That doesn't work. How can that work for looseness? It's just a laser.” So, Alma was good enough to let me borrow the laser for a couple months, and my first patient was a surgical tech who volunteered. She didn't have an issue or a medical problem, she didn't have prolapse. She was willing to do it because, in her life, sex was good. I thought, at first, “No, this isn't real. I'm looking for someone with a problem.” And then she kind of slaps me on the hand, says, “Sex can always be better, stupid.”

Dr. Aguirre: That was a paradigm shift in my thinking and how I approach patients because the majority of our patients that we treat are doing well. They just want to be better in a non-surgical way, certainly. So then, came the fractional CO2 to my practice. Then I trained with Dr. Runels, I did the O-Shot®, and that combination is beautiful. So we heard a nice talk this morning about combination therapy, so combining laser with PRP. So why would I need to add Viveve, which is a very quick frequency, because a lot of my patients were still wanting that introital tightened. They had better sensation inside. The laser worked well for many features. The O-Shot® was great but they still wanted more, so it's like, “Oh, maybe she needs surgery.”

Dr. Aguirre: So, that's where, when we think about by in 2017 also, when I purchased the Viveve System, there were many other, there's a lot of, as Dr. Pelosi said there's an overcrowded market, but actually the non-surgical applications of what we're doing is a bigger [inaudible 00:06:08]. It's a larger piece of the pie of patients that want non-surgical treatments.

Chapter 14 Covers the O-Shot® Procedure

Dr. Aguirre: So, now it's how, combining all these modalities into our patients, all for, think of vaginal rejuvenation. The patients look at it as vaginal rejuvenation by leading to individually thinking what aspect of their symptoms are we trying to improve by introducing collagen deposition, improving tissue remodeling, etc. All those treatments, the goal is to improve lubrication, sensation, and bladder control. And to them, it's vaginal rejuvenation. To me it's incontinence, atrophy, it's more medical.

Dr. Aguirre: So, the reason for the Viveve is when I first heard of the randomized sham study, well controlled study demonstrating efficacy at one year for improving sexual sensation, I thought, well that's what I needed to add to my complimentary services. And it's great because I don't have to do the treatment. I have three nonmedical doctors in my office doing treatments. We have two systems, so it's a way of moving along with our patients. So I thought of combining them with the other treatments.

Dr. Aguirre: So how does it work? Really quickly so, Dr. Pelosi mentioned the tip of the system cools the surface of the skin while the RF goes deeper into the tissues. It treats down into the lamina propria. So now, it's effect on incontinence. So was it beneficial? Also, these patients are choosing mainly the Viveve for improving introital laxity. Many of these patients have incontinence, of course, and those symptoms are improving. Now I'm going to show some information, some data here on some early work on the feasibility study that now led the way towards the two studies, one an international study that just finished enrollment, and then a US study that will start enrollment, and I would happy to be a part of it later this year.

Dr. Aguirre: But to be brief, so, this is showing, it's kind of a busy slide, but there's five parameters that we're looking at. So a one-hour pad weight test is the most impressive. So if you look at one year out, or at the baseline scores was 7.3 grams of one hour, reduced down to ... threw me off there ... so reduced down to 3.2 at 12 months. So what this essentially shows that in one year 72% of patients showed a marked reduction in their pad weight test. So that's a one-time treatment demonstrating results at six months and even up to a year.

Dr. Aguirre: So then, looking at it in one year also, 52% of patients or subjects at one year showed a greater than 50% reduction in their padway test. And also, if you look at the more moderate stress incontinent patients, they also showed improvement. They actually showed, 67% of them showed a greater than 50% reduction in their incontinence in their pad weight test. So this is taking even more, pretty incontinent patients, making them relatively dry. And actually, 50% of them showed to demonstrate a cure rate defined as less than one gram of leakage in a one-hour pad weight test compared to seven and a half grams.

Dr. Aguirre: Again this shows that at four months, six months, and 12 months, it shows a persistent efficacy of the one-time treatment. And also looking at questionnaires UDI-6, IIQ-7. So, and then some additional clinical updates. So that was just the [Pita 00:10:08] study. The international LIBERATE study, which is what it's called, just finished enrollment earlier this year. We should have that data in about six months. That's the study done in Canada, with over 100 patients. And that LIBERATE U.S. study will be started later this year, hopefully. Our goal is to enroll more than 50 patients.

Dr. Aguirre: Then the Viveve II. I purchased it based on the Viveve I data, which I mentioned earlier, the pre-poll. So that study showed that in one year, women had three times more improvement in their vaginal sensation aside from placebo. So now this Viveve II study has been going on. It should finish enrollment later this year. That's in the U.S.

Dr. Aguirre: So then, what's my approach? If you think of, as a urogynecologist, so I see women with vaginal relaxation, and I'm always asking questions about their sexual function, their urinary function, valve function. So think of the female sexual dysfunction. It could be orgasm issues, could be incontinence with sex, could be dyspareunia, it could be looseness, it could be vaginal dryness, stress incontinence. You look at that whole picture, ask all those questions, and then what are our current traditional treatments? Well, we always say do Kegels, doing biofeedback, vaginal [inaudible 00:11:36]. Do they need a psychiatric evaluation? Would they benefit from testosterone? Maybe it's a sling, or reconstructive and cosmetic vaginal surgery, so from non-surgical to surgical.

Dr. Aguirre: And of those new treatments, I will add, depending, and offer depending on what their complaints are. So the Viveve if they, if on exam day on introital laxity and they complain of it, and they wanted their  to improve sensation and orgasm, and now they have incontinence. So a woman with those three symptoms, that's a great option for them. Now if she's 65 and post-menopausal entropic, then I'm gonna add fractional CO2 to it, to improve vaginal health, improve vaginal dryness and atrophy, and also probably prove helpful in incontinence.

Dr. Aguirre: If they wanna improve orgasm, then we'll add O-Shot®. So probably our most popular, common treatment in our office is doing this triad of treatments. So what works best is doing an O-Shot®, Viveve, and fractional CO2 at the first setting, and then having them come back two more times to finish their laser series.

Dr. Aguirre: But it all depends on what symptoms they're wanting to improve, and we as specialists in women's health think it's important for us to provide women with all their options for feminine rejuvenation and go beyond what's traditionally taught. We should listen to our patients, and it was mentioned earlier, hand a patient a mirror and have a discussion. Have them look at themselves and explain to them. It's a great time to educate them on, why are they feeling loose? Why are they incontinent? And then provide them with all the options, and then some realistic expectations, of course.

Dr. Aguirre: Thank you very much.

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Cystoscopy view of Urethra before and after the O-Shot® procedure

Case Report

48 year old G5P2 perimenopausal female presents with menorrhagia, uterovaginal prolapse and urinary incontinence. Patient demonstrated stress urinary incontinence on formal urodynamics testing (Laborie Medical). During preoperative counseling, patient expressed she did not want to have any polypropylene sling placed. Discussed the injection of platelet rich plasma (O Shot) and patient signed formal consent.

She underwent an uncomplicated robotically assisted total laparoscopic hysterectomy with anterior and posterior colporrhaphy. Patient’s blood was harvested and centrifuged utilizing the Stryker Vitagel kit. During the last step of the procedure, cystoscopy was performed (Figure 1) with a 30-degree cystoscope (Stryker). 4 cc of platelet rich plasma with 0.2 cc of 10% of CaCl was injected 1” from hymenal ring with 27 Gauge needle and 1 cc of platelet rich plasma with 0.05 of 10% of CaCl was injected into the clitoris.

5 minutes after the O shot was performed, a 30-degree cystoscope was inserted again which revealed ureteral jets bilaterally as well as the view of the urethral sphincter shown in Figure 2.

 

 

Postoperatively, patient came back to my office 1 week later. She did not have any urinary leakage and was satisfied with the outcome. Shown in Figure 3 and Figure 4 are before and after of the vaginoplasty.
These images are available in my realself.com gallery

Patient has signed permission to use her images as long as she was deidentified. This release waiver is signed and filed in my office.

Urethral Bulking for Female Stress Urinary Incontinence
There have been similar results described in the literature with synthetic soft tissue bulking agents such as Macroplastique. One of the side effects, however is granuloma formation.

Future
This case has inspired me to use formal urodynamics study how the urethral pressures change during the placement of platelet rich plasma in the Grafenberg spot. Using wireless Bluetooth catheters may quantify and guide to clinician with greater accuracy on where (and possibly how much) volume of platelet rich plasma to inject for optimal result with regard to treating urinary incontinence.

Edward Tangchitnob, MD, FACOG

Medical Director, Center of Excellence for Minimally Invasive Gynecologic Surgery
Master Surgeon in Robotic Surgery, Surgical Review Committee
www.tangchitnobMD.com


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Gynecologist Dr. Angel Paas discusses the O-Shot® Procedure

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