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.
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.