JAN-FEB 2018 SUPPLEMENT ISSUE

ThermiVa: An Important Development for Female Pelvic Health

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It's a very exciting time” in female pelvic health, says Knoxville, TN urogynecologist Jeffrey R. Dell, MD. “To some degree, we're really at the frontier stage of using these modalities, lasers and radio frequency, in the pelvic floor to treat a range of conditions that really up until the last three or four years was not part of a mainstream approach to female pelvic floor health.”

With the excitement comes some confusion, says Dr. Dell, “not only for physicians but patients, because there are so many different products coming to the market and so many different claims being made.” Nonetheless, Dr. Dell believes the focus on new technologies is positive.

“I think we're going to continue to have the opportunity to enhance patients' quality of life across a range of conditions that really significantly and negatively impact their quality of life, but with lower risk to essentially no risk with almost no recovery or downtime. That's a positive thing,” Dr. Dell says.

Radio frequency (RF) delivery technologies, such as ThermiVa, are now emerging as important tools for supporting female pelvic floor health.

“I think one of the things that's helpful in terms of thinking about all of these different types of energy platforms is to look at the last 10-year history of plastic surgery's and dermatology's experience,” Dr. Dell says. He offers the analogy of facial treatments. “Those specialties would say that these various different energy platforms have different strengths. And while there is some overlap in terms of similarly of response that one type of energy platform may have with another, there are some significant differences regarding strengths of one energy platform over another.” Just as the approach for dealing aesthetically with the aging process on the face may require a range of different types of energy sources, so might treatment of the pelvic floor require combination approaches.

Radio frequency is emerging as an important tool in the toolkit. “Radiofrequency has some tremendous benefits and strengths when it comes to dealing with laxity of the skin,” Dr. Dell observes. “It has a robust effect of allowing for some tissue tightening, because of its immediate and longer term effects on collagen leading to tightening of that skin. And so those applications in the pelvic floor would be for patients who are complaining of things being loose after multiple childbirths or their tissue is beginning to sag and doesn't have the look and feel that it used to in the younger years. Radio frequency historically has tremendous strengths in that arena.”

For their part, CO2 lasers, “may best address the aging process with regard to dryness and the severe thinning of vaginal and vulvar tissue that is a part of the natural aging response after menopause, but also in some disease state conditions, one of which is lichen sclerosus,” Dr. Dell remarks.

Urinary incontinence is a concern for many women. Earlier interventions, such as slings, mesh, and surgical implants, have been associated with litigation, Dr. Dell notes. This has led to, “a desire on the part of the population to have noninvasive, nonsurgical procedures that might improve quality of life with less risk and recovery.” Energy-based procedures have the opportunity to excel in this area.

As aesthetic specialists, gynecologists, and urogynecologists continue to evaluate the technologies and provide treatments, there is opportunity to better elucidate the role of each type of technology. In the future, Dr. Dell hopes to see more standardized terminology that can be understood across the spectrum of different specialties of physicians so that doctors are speaking the same language. He'd also like to see some more objective, rigorously designed trials of the various devices.

Update on Female Pelvic Health

The exciting potential for non-surgical, device-based treatment of the female pelvic floor notwithstanding, Dr. Dell offers a word of caution: “The female pelvic floor can be fairly complex. There currently is a blurring among these procedures between what's being used for aesthetic changes of the female genitalia and pelvic floor versus what's being used to attempt to try to enhance the sexual experience and feeling of the tissue, whether or not it changes in looks.”

Adding an additional layer of complexity, “aesthetic and sexual response enhancing procedures overlap with true pathology or disease states where we're dealing with significant incontinence issues, significant prolapse issues and potentially even a condition like lichen sclerosus which is a disease process of which one to two percent of patients can develop squamous cell cancer.”

Anyone assessing and treating patients must understand female pelvic floor health and be prepared to recognize their limitations. “I think the critical point here is that it's important for non-gynecology based physicians who are using these platforms to carefully assess which patients are good candidates for these newer procedures and which patients need specialized or subspecialized evaluation before proceeding,” Dr. Dell offers. Not only is it important for the patient's health, but it also avoids treatment dissatisfaction. “Without proper assessment and treatment planning, patients may not respond very well to the energy platform that is better suited for mild laxity or for a very mild type of incontinence and not for more a severe situation.”

At his New York plastic surgery practice, Z. Paul Lorenc, MD says that ThermiVa radio frequency treatment is very popular and effective. ThermiVa is a non-invasive, non-ablative, non-surgical treatment that is performed in the office with no anesthesia required.

In Dr. Lorenc's office, aestheticians administer the treatment. There is no downtime associated with the ThermiVa procedure.

Dr. Lorenc notes that ThermiVa treatment addresses a range of vaginal symptoms, “whether post-menopausal or post-child birth. Whether it's laxity or lack of lubrication and so forth.” He says he has “very happy patients.”

“There is no question that these different energy platforms are doing some fantastic things to enhance the quality of life of patients,” Dr. Dell says.

An Opportunity

Physicians have an opportunity both to learn more about the activity of available systems and to enhance the level of service they provide their female patients. “While new treatment modalities in the female pelvic floor are exciting and enhancing the quality of life of our patients, it is important that we continue to develop structure and treatment protocols with science to back them up,” Dr. Dell says.

The demand for understanding the technology and providing treatment is significant, suggests Dr. Lorenc. “I think the market's huge. I don't think—I know the market is huge. Consider all the women that are on hormone replacement or need hormone therapy, imagine if that can be taken away by a procedure. I think that would be fantastic.” Practices can capitalize on patient demand via internal marketing, he believes. And support from the companies to educate the public and the medical community is, “going to potentiate this several fold,” he predicts.

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