Charles Runels, MD: So urinary incontinence can be an extremely family and social disruption for you. Surprisingly common, it’s around half of the people by the time they reach 50. Half of women have incontinence and incontinence defining as interfering with your social life or your hygiene. You know a few drops doesn’t matter, but if you’re having to stop doing the things that you do or wear a pad that’s incontinence. And then occurs in one in 20 women in their twenties about 5% of women in their twenties. So young women may have to stop their cheerleading or their gymnastics because of incontinence. It’s not just from childbirth or from aging.
So it’s really important that we find better answers. We have surgical solutions, but before we go to surgery it’s nice if we can find something more quickly or acting with less trouble and less downtime.
So people are starting to look at using lasers. This is a really nice study that was published this month. Obstetrics and Gynecology Reproductive Biology, respected journal where they talk about using a laser. Now, the interesting about these lasers is that the depth of them is about the depth of two or three pieces of paper. It’s actually more shallow than a business card. So it’s really, a tiny pinpoint laser made holes that are in a grid, but it’s no deeper than several pieces of paper. So it’s reasonably safe and in the right hands it can really change lives.
So these people did this study showing that not only did it help many women with their incontinence, but it also as a side effect helped their sexuality. So worth looking at if you have this problem and asking your doctor about.
Now most of the leaders, and the thought leaders using lasers to help with urinary incontinence are also combining it with platelet rich plasma and a procedure called the O-Shot. And it seems to enhance the effects of it.
Lasers have been known to improve the results and the speed of healing for facial lasers for 15 years. So we’re seeing the same thing when you combine the laser with PRP. So ask your doctor about it. If you want to know more about it, there’s some links below this video to check out. Hope you find this helpful.
Charles Runels. Somewhere around one in eight women in the United States will eventually suffer with the effects of breast cancer. Thankfully most women who have breast cancer will survive it, but unfortunately they survive with some problems that might plague their love life. One of those is dyspareunia, or painful sexual intercourse, due to the fact that vagina may be dry with hormonal changes that are secondary to the treating of breast cancer. So it might be helpful to look at a couple of papers involving that.
This paper was published in SKINmed here on PubMed. You can see the whole paper if you click up here and find it. But these guys talked about using platelet rich plasma and how it uses the same technology, or the same bowel Segler strategies, that are used in the face and in growing hair, to help the tissue of the vagina become healthier, even when there’s no estrogen. Which it’s better to have estrogen on board, but if you can’t have it because of breast cancer, as much as you would like, this is a great way to help the tissue become healthier and more moist. And so this is one paper that talked about it.
Another one of my favorite research papers appeared in Menopause, a highly respected journal, where they use platelet rich plasma and documented that the pain from the sex went down because they were lubricating better after having an O sharp procedure done. So I highly recommend you forward this to anyone you know who may be struggling with this. There’s … breast cancer is … it’s not just about the cancer. It’s how it affects families and love relationships. So it’s a serious problem. And there are other ways to do it. You could use a lubrication, you could use lidocaine cream, but it seems to me nothing would be better than actually making the tissue healthier. So I’ll put links to this research below the video, and I hope you’ll share it with anyone who might be helped.
You might’ve seen this episode of the Housewives of Orange County that came out this month. A lot of press has been out and discussing what happened with Shannon Storms, and why she got the shot and what might be possible with it. I think might be helpful to actually go to the medical research and look at this paper that came out this year about actually seeing what happens with the behavior, and the sex drive and, the whole life of people who have platelet rich plasma injected into actually the ovaries.
So what this study did was they injected ovaries with PRP, which is just a … It’s the concentrate of the growth factors in the platelets of someone’s blood. And then they documented that the ovary started to create new hormones and creating a younger mindset within the woman’s body. Obviously your ovaries do more than make eggs.
They have to do with metabolism and how you think, and how things work. So they documented an improvement you see and clarity of thinking. Lots of things happened by waking up the ovaries. There’s also been recent studies showing that you can use platelet rich plasma to help a post-menopausal woman sometimes produce fertile eggs again.
But now what we do with our O-Shot®, what Shannon had, was instead of using it in the ovary, or instead of using in the face like with our vampire facelift, we’re using it in the genital tissue to restore blood flow and nerve function, and improve the sexuality and the urinary continence of women who might have problems with those things.
If you think this might be of help to you, I will put a link to the research below the video and also there’s a link to find one of our providers who would be happy to talk with you about it. I hope you found this helpful and you’ll send it to someone whom you think might be helped by it.
Hey, so I thought you might be interested in this article where this woman got an O-shot and not only did it make her sex better but somehow helped her to conceive. So, you can believe it or not believe it, but I think it’s a pretty simple concept to think that maybe if someone wants to have sex more they might be more likely to get pregnant. But more interesting, and it doesn’t cover that in this article, but some of the people in our O-shot group have demonstrated that you can actually inject the ovaries and a postmenopausal woman be able to become fertile again.
Some Italian doctors published that study about a year ago, but people in our group have been doing it now for several years. So really interesting, but it might be fun to actually go look at some of the research about it. If you go over to PubMed and you look at this article, it’s written by a Brazilian doctor Dr. [Nato 00:01:01] down in Brazil who sees so many patients as a gynecologist down there and documented the improvement in incontinence and in sexual function, which makes sense, PRP’s been around so long.
So if you go Google, if you just look at platelet-rich plasma in PubMed, there’s so much about it. I’ll just show you right now. If you just Google platelet-rich plasma on PubMed where all the good research lives, you’ll see there’s 11,000 papers. It’s been researched for the past 20 years, and if you think about what we’re doing, if you just look at the anatomy of the vagina, I’ll just pull it up here for you, and look at images here, what we’re doing is we’re coming in and rebuilding the tissue that’s right here between the vagina and the urethra, and this tissue correlates on ultrasound studies with the ability to have an orgasm. It correlates with continence. It becomes thin with menopause. We’ve known for 20 years, the orthopedic surgeons, the wound care doctors, that PRP helps rebuild healthy tissue with fibroblast and new blood vessels and new nerve.
But we’re just now beginning to explore this with research about how rebuilding tissue here using the same protocols can help with sex and can help with continence. So if you’re interested, you should call one of our doctors listed on the directory and have somebody check it out for you.
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.
Hello, I’m Charles Runels. I’m a physician who’s been taking care of women, thousands of women for the past 20 years, and I’d like to talk with you about a really serious problem, which is how to have comfortable, enjoyable sexual relations as a woman who has survived breast cancer.
They say around one in eight women will struggle with breast cancer. It’s personal to me because I have women in my family who have fought breast cancer and I’ve taken care of a hundreds of women who have suffered with the problem. And imagine what happens in the heartache from having survived the cancer, and now having pain when you try to have sexual relations with your husband.
Well, the things that have been tried for that are legion because it’s a really disheartening thing. Unlike say, lack of desire or trouble with orgasm, pain will cause people to start to avoid each other. So, a woman can be deeply in love with her husband and start to avoid him because she loves him and doesn’t want to say no to him. Yet, if she says yes, there’s pain. And so, love becomes associated with pain.
What a horrible thing.
So what’s been tried are things like lubricants and numbing medicine. But imagine that, you’re going to have sex but you’re going to put on lidocaine cream so you can’t feel the sex. It’s been a really difficult problem to solve. You can put the woman back on hormones, but now she has comfortable sex, but has to worry more about recurrence of her breast cancer.
So, I was looking at this research which pointed out some of the … this is just out recently, and it points out that there are people now who are doing laser therapies, and they mentioned this warning, some of the laser companies about using this as a way to treat the problem. Actually to expand upon that, the warning was not having to do with the possibilities of it helping so much as it had to do with the laser companies making claims to try to sell the laser that were not approved by the FDA.
So physicians who are using these lasers are often getting great results. It’s just that the person actually selling the laser or the companies were not following proper guidelines. So, that’s a possibility that’s fairly recent that could be used in place of some of the estrogen therapies.
So, we’re having a really wonderful result with this. Over 85% of our women are getting better with this after an O-Shot® placed in the anterior vaginal wall to wake up the Skene’s glands (or the periurethral glands) and help that tissue become healthier and for more comfortable sex to happen without having to be on estrogen.
I recommend that you contact one of our O-Shot® providers and discuss, it may not be right for you. I’m obviously not your physician, but I want you to be aware of this as a possibility, and I hope that you find it helpful for you or someone you love. You’ll find links to this research below this video.
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. 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.
Charles Runels: So I thought you might want to share this research that came out this month. It’s talking about using Botox to help with provoked vestibulodynia. In other words, it hurts when you touch the opening to the vagina, so the vestibule or the opening of the vagina, dynia or pain provoked by touch. This is a very severe problem, and although you may not suffer with it, I can tell you this right here really breaks up relationships, and if you know someone who’s suffering with this, I’d really like you to forward this to them, because it just came out this February of this year.
What they did was they took women and they divided them into three groups, and one group got saline, and then one group got 50 units of Botox, and another group got 100 units of Botox. They found by injecting the Botox, the group that got the Botox at three months and again at six months, they had significant decreases in their pain. I also think it might be helpful because of the anti-inflammatory effects of it, of injecting PRP in this region. We’re seeing that helps also with dyspareunia, especially with lichen sclerosis and with scarring. We’re not sure exactly what caused provoked vestibulodynia in many patients, so that could be a combination therapy.
RESULTS WILL VARY
There is not a lot more I can say about this except that the downside of it should be not bad […for most people, please see consent form, results will vary and no medical procedure is perfectly effective or perfectly predictable in either results or side effects]. The worst that’s going to happen is if it doesn’t work, and hopefully the good side is that if your body or your lover’s body responds as they did in this trial, it could really be life changing.
Consent Form<–
I hope you’ll give us a call if you think this might be something you want to try, so thank you very much.
Sophie Blackman does very brave reporting about her quest to find better sexual relations. Thousands of women will benefit.
Sophie Blackman reports the details of her experience with the O-Shot® procedure in this eye-opening report. Not only will the last 3 paragraphs make you laugh–if you have a heart–you’ll understand why sexual dysfunction can cause deep emotional hurt and why finding better ways to help women is so very very important. Here’s where to read the article (click)<–
