James Adam Greenberg, MD, is associate professor of obstetrics and gynecology at Harvard Medical School and chief of gynecology at Brigham & Women’s Faulkner Hospital in Boston, Massachusetts.

James Greenberg, MD

Shabnam Gupta, MD, is a minimally invasive gynecologic surgery fellow at Brigham & Women’s Hospital and degree candidate at the Harvard T.H. Chan School of Public Health.

Uterine fibroids (also known as leiomyomas or myomas) are the most common pelvic tumors found in women and the most common indication for hysterectomy.

There is a nearly 70% prevalence in premenopausal White women and over 80% prevalence in premenopausal Black women. These tumors can cause symptoms including abnormal uterine bleeding with heavy menses, pelvic pain (both menstrual and nonmenstrual), bulk symptoms (eg, abdominal distention, bowel or bladder dysfunction, early satiety), and reproductive issues (eg, recurrent pregnancy loss, infertility).

Figure 1. Treatment Options for Management of Uterine Fibroids

Treatment options for fibroids can be divided into 3 approaches: temporizing measures to shrink fibroids, destruction of in situ fibroid tissue, or removal of fibroids 

. Temporizing measures often employ hormonal medications that exert influence on the hypothalamic-pituitary-gonadal axis. The gonadotropin-releasing hormone (GnRH)-agonist analogue (leuprolide) and GnRH-antagonist (elagolix and relugolix) work by decreasing pituitary secretion of luteinizing hormone and follicle-stimulating hormone, resulting in reduced ovarian follicular activity, anovulation, and low serum concentration of estradiol and progesterone. While fibroid size decreases in response to decreased estrogen and progesterone, these medications can have adverse effects, including hot flashes and reduced bone mineral density, which limit their long-term use. Additionally, these medications have a very limited effect on reducing fibroid size, which is not helpful for women affected by bulk symptoms.

Women who do not desire or do not respond to medical management, or those who have contraindications to these options, may elect surgical treatment. While hysterectomy is the only definitive surgical treatment, uterus-sparing procedures are often sought due to their less invasive and fertility-sparing nature. Surgical management of fibroids can be divided into resective and nonresective procedures. Myomectomy is a procedure in which fibroids are resected from the uterus via transabdominal, laparoscopic, or hysteroscopic approaches.

Techniques to reduce the size of fibroid tissue without overt resection include uterine fibroid embolization, focused ultrasound (FUS), which can be performed under magnetic resonance guidance (MRgFUS) or ultrasound guidance (USgHIFU), and radiofrequency (RF) ablation (RFA). Here, we will focus on nonresective RFA technology for management of uterine fibroids, with an emphasis on understanding the basic principles underlying this technology.

Figure 2. Timeline of Radiofrequency Use in Surgery

Abbreviations: L-RFA, laparoscopic radiofrequency ablation; RF, radiofrequency; T-RFA, transcervical radiofrequency ablation.

Electrosurgery first came about in the 1920s. William Bovie, PhD, was an American inventor and scientist. He completed his PhD in plant physiology at Harvard University in 1914. He was credited with conceptualizing biophysics and inventing a crude monopolar RF electrode in 1928 (now widely used in surgery and called the Bovie). In the 1990s, RF energy was first suggested to ablate liver tumors. Since then, RFA has been applied to treat cancers in the adrenal gland, breast, kidney, bone, lung, pancreas, and thyroid, and it is also used for nerve ablation in the treatment of pain syndromes. Bruce Lee, MD, was first reported to use RFA on uterine fibroids in 2002. He spearheaded the creation of a laparoscopic ultrasound-guided approach to treat fibroids using RF energy, known as the Acessa procedure (Hologic). This device received FDA approval in 2012. In parallel, another technology focused on a transcervical approach to RF fibroid ablation began its development in 2005. That technology, Sonata(Gynesonics), a RFA device using an incisionless transcervical approach to ablate fibroids, was cleared by the FDA in 2018 

Abbreviations: RFA, radiofrequency ablation; RF, radiofrequency. 

RF waves have the longest wavelength, lowest frequency, and lowest energy on the electromagnetic spectrum (RF range, 3 kHz-300 GHz; medical RF range, 450 kHz-500 kHz). These characteristics make application of RF waves an ideal candidate for controlled and predictable ablation of human tissue. A generator creates alternating current that is transmitted to target tissue via exposed electrode 

. Current travels back to electrode return pads (grounding) to complete the circuit. In electrosurgery, typically there is a cathode or point where electrical current leaves a polarized electrical device.

This is known as the active electrode, and the RFA probe tip functions as the cathode in the system. The electrical current transfers energy to surrounding structures through a process termed energy flux. A small cross-sectional area of the probe tip leads to high energy flux at the area in closest proximity to the active electrode. Monopolar electrical systems require return dispersive electrodes, which are typically used in the form of pads placed transversely on the patient’s anterior thighs, in order to close the electrical circuit. The large cross-sectional area of the dispersive electrodes leads to a very small energy flux and therefore serves as a safe way to disperse the energy return in the circuit. It is important to ensure proper placement of dispersive electrodes because any break of the closed circuit can cause electrical shorts that result in patient burns.

Factors influencing size and shape of ablation

A few essential concepts should be considered when thinking about the use of RF waves to ablate tissue. Factors that influence the size and shape of the ablation zone include tissue temperature, tissue conductivity, and arrangement of electrodes.

The RF probe itself is not the source of heat. It generates an alternating electromagnetic field that causes adjacent molecules (composed of mostly water) to vibrate. These particles in motion generate heat, which is transmitted farther by tissue conductivity. The temperature drops exponentially as distance from the source electrode increases. Further, temperature rise has predictable cellular effects. At temperatures greater than 60 °C, cell death occurs. Between 60 °C and 99 °C, tissue desiccation and protein coagulation occurs. At temperatures greater than 100 °C, vaporization and charring may occur. Both the temperature reached and the duration of exposure are important. Human tissue is very sensitive to temperature changes and the time to reach cell death differs depending on the temperature. For example, at 55 °C, tissue death occurs within 2 seconds. At 100 °C, cell death is effectively instantaneous. This is not a desired outcome in application of RFA, as charred tissue insulates and prevents transmission of heat. Instead, a slow, methodical deposition of energy is more effective in ablating target tissue rather than a rapid and high temperature rise.

Safely calculating the size of the targeted-tissue ablation is crucial to both laparoscopic and transcervical RFA (L-RFA, T-RFA), and both technologies assume maximal tissue damage when calculating the ablation times. One limitation of RFA is its need for good electrical and thermal conductivity to achieve tissue injury. In vivo, maximal ablations are challenging due to “heat sinks” and insulators. The electromagnetic waves that are needed to ablate tissue propagate only through viable cells. Heat sinks, such as blood vessels that reduce simple thermal conduction and/or charring of tissue that insulates against simple thermal conduction, can reduce tissue temperature and thus yield submaximal ablations. An appreciation for these principles has enabled engineers to develop devices with predictable ablation zones to maximize the target tissue ablation and minimize surrounding tissue damage when applying this technology to patients.

By understanding electromagnetic and thermal conductivity principles of tissue ablation, one can quickly see that a single electrode will yield a cylindrical ablation zone rather than the spherical injury that is desired. To overcome this limitation, engineers have developed several different electrode designs (plain, cooled, wet, expandable, and bipolar) with varying combinations employed to achieve the desired application.

 The details and advantages of these features go beyond the scope of this review, but both Acessa and Sonata employ plain, expandable,
multitined electrodes.

Both L-RFA and T-RFA are safe and effective procedures once surgeons have been appropriately trained on their use. While both technologies utilize ultrasound guidance to direct placement of monopolar, expandable, multitined RF electrodes into myomas, they do differ in how they achieve this.

(Used with permission: Yu et al. JSLS. 2020)

The Acessa ProVu System enables percutaneous, laparoscopic sonography-guided RFA of uterine fibroids. A standard 5-mm laparoscope is used in combination with a 10-mm reusable laparoscopic ultrasound probe and a separate disposable RF handpiece, which enters the abdomen through a small adjacent percutaneous incision. The ultrasound probe is placed directly on the uterine serosa to identify the location and size of the fibroids. Next, using the Acessa Guidance System, electromagnetic spatial tracking is employed to orient and position the handpiece. The handpiece is advanced to the fibroid and carefully inserted 1 cm into the fibroid capsule. The electrode array is deployed into the fibroid and appropriate placement confirmed. The ablation process is initiated by depressing a foot pedal. The RF generator then begins to heat the tissue. Once the tissue target temperature (95 °C) is reached, the ablation time begins. After the ablation duration is complete, the foot pedal is again depressed to stop the procedure. The electrode arrays are then retracted, and the handpiece tip is allowed to cool for 60 seconds prior to removing from the target tissue. Hemostasis is obtained by switching the device to coagulation mode and continuously pressing the foot pedal to cauterize the penetrated tissue as the handpiece is removed from the uterus. The next fibroid can then be targeted in the same manner 

Abbreviations: RF, radiofrequency; US, ultrasound

Abbreviations: IUUS, intrauterine ultrasound

(Used with permission: Galen DI .BioMed Eng Online.2015 and Brucker et al. IJGO.2014)

The Sonata System enables sonography-guided RFA of uterine fibroids using an incisionless, transcervical approach. The device design consists of a reusable curvilinear intrauterine ultrasound probe and a single-use RFA handpiece that combine into a single unit. The cervix is serially dilated to 27F to accommodate the 8.4-mm diameter of the assembled device (combined ultrasound probe and RFA handpiece).

The RFA handpiece also comes equipped with a port for infusing hypotonic fluid into the endometrial cavity as needed for acoustic coupling. In our experience, backfilling the bladder with sterile water can help achieve greater contrast of adjacent pelvic structures. The device is advanced to the fundus and a survey is performed to identify the size and location of fibroids. Once the surgical planning is complete, the first fibroid is identified on the screen.

The SMART (Setting Margins on Ablation in Real-Time) Guide graphical overlay is visible on the ultrasound image. This provides the user with essential information for targeting the treatment area prior to deploying electrodes and initiating the ablation process. The inner red ellipse indicates the intended ablation zone. The outer green ellipse indicates the thermal safety border and distance from the needle electrodes at which tissue is safe from potential thermal damage. The ultrasound probe tip is articulated to 45° or 60°, depending on the angle needed for optimal visualization. The ablation size and depth can be adjusted to maximize the target area and minimize thermal injury to adjacent structures. The minimum size is 20 mm × 13 mm, and the maximum size is 49 mm × 42 mm.

Once the desired ablation zone has been set, a sharp cannula is deployed from the shaft of the RFA handpiece, penetrating the fibroid tissue and stabilizing the device. The first safety rotation is then performed to confirm that the thermal safety border is within the uterine serosa, and that no unintended organs are within the green ellipse margins. Adjustments to the anticipated ablation zone are made as needed. The needle electrodes are then deployed, and a second safety rotation is performed. Traction on the tenaculum can help to delineate the serosal border and assist with visualization of adjacent bladder and bowel. Once safety has been confirmed, the device is held steady, and the footswitch is pressed to start the ablation process.

The Sonata System operates at 460 kHz. As the RF energy is applied to the tissue, the tissue temperature rises and results in subsequent thermal fixation and coagulative necrosis. Depending on the size of the ablation, RF energy delivery time ranges from 1.5 to 7 minutes after reaching the target temperature of 105 °C. Close observation of the display screen should be employed throughout the entire ablation process. Once the ablation is complete, the RF generator will automatically turn off. The needle electrodes and introducer can then be retracted, and the ultrasound probe can be articulated back to 0°. A subsequent ablation can then be performed on the same fibroid or on additional fibroids targeted in the same manner 

For both procedures, we have found that fibroid mapping at the start of the procedure helps surgeons develop a strategy for the procedure’s ablations and improves with communication about what was done. Mapping is easy. Before any ablations are performed, a systematic ultrasound of the uterus is performed and the size, type, and location of each identified myoma is recorded. For T-RFA, we start with the ultrasound probe placed at the fundus and directed anteriorly. We then rotate the probe clockwise and record all the identified myomas in numerical order by their location on a clock with 3 o’clock at the patient’s left. Once this is completed at the fundus, we pull the probe back to the mid-uterus and then lower uterine segment and repeat the mapping process. Having completed our mapping, we then proceed with the ablations and recording them based on how the myomas were mapped (for example, our first ablation might be recorded on myoma No. 3 in our map).

At their core, L-RFA and T-FA are almost identical with their reliance on ultrasound to guide the placement of an array of RF electrodes into myomas via a sharp, central trocar. However, the design differences necessitated to accommodate a laparoscopic vs a transcervical approach imbue each system with distinct advantages and disadvantages when comparing the 2 

. In our limited experience, with its combined intracavitary ultrasound/electrode device, T-RFA tends to more easily and efficiently treat myomas that are smaller (< 8 cm) and closer to the cavity (FIGO types 1, 2, 3, 4) while the L-RFA’s separate laparoscopic electrodes and ultrasound components allow it to better address larger myomas (> 10 cm) and myomas that are farther from the cavity (types 6, 7). Both are similar for the treatment of type 5 and type 2 to 5 myomas. It should be noted that the American College of Obstetricians and Gynecologists (ACOG) Practice Bulletin 228 (2021) indicated L-RFA and T-RFA are similarly effective.

Although the pathologies of patients with fibroids may be histologically similar, the approaches to addressing the symptoms related to their fibroids should be individualized based on the size and location of the fibroids and each patient’s needs and expectations. Given the numerous nonextirpative interventions for treating uterine fibroids, it is imperative that clinicians manage patient expectations. While seemingly intuitive, patients need to clearly understand that their fibroids are still in situ and that symptom improvement will likely be appreciated over time rather than immediately. Also, patients whose myomas have an intracavitary component should be counseled to expect both discharge and passage of tissue as the myoma sloughs off ablated material.

Contraindications for use of both L-RFA and T-RFA include current pregnancy, presence of intratubal implants, active pelvic infection, and/or suspected gynecologic malignancy or premalignancy. Additionally, these approaches should be used with caution in patients who have coagulopathy, metal implants in their lower extremities, or very thin thighs where the electrodes overlap. In addition, the safety and efficacy of these approaches have not been well established in women desiring future fertility and those with adenomyosis, although further studies are being conducted to better understand these populations. Limitations also include no tissue sampling with current designs. Thus, clinicians must carefully select patients and counsel patients when appropriate on the very small risk of occult malignancy.

While neither L-RFA nor T-RFA is contraindicated for use in women desiring future pregnancies, as of the writing of this review, neither L-RFA nor T-RFA is approved by the FDA for labeling that suggests there are adequate safety data in this regard. Reflecting that, the instructions for use for both Acessa and Sonata clearly state that the safety and effectiveness of their technologies in women who are planning future pregnancies has not been established.

Nonetheless, an increasing body of data on pregnancies after both L-RFA and T-RFA suggests that these technologies may be compatible with safe future fertility as one might expect based on experience with the thermal ablation of myomas using MRgFUS, which in 2015 received FDA approval for use in patients desiring future fertility.

The introduction of devices capable of safely delivering RF energy to ablate fibroids offers patients desiring uterine preservation an exciting new array of minimally invasive options that were previously unavailable. Both L-RFA and T-RFA are in their infancy, and gynecologists who take care of women with fibroids should acquaint themselves with these technologies so that patients can be appropriately counseled regarding the best options to address their symptoms.

Stewart EA. Clinical practice. uterine fibroids. 

. 2015;372(17):1646-1655. doi:10.1056/NEJMcp1411029

Barbieri RL. New hormonal medical treatment is an important advance for AUB caused by uterine fibroids. 

. 2020;32(8). Accessed January 10, 2022. https://cdn.mdedge.com/files/s3fs-public/issues/articles/obgm0320808_editorial.pdf

Hong K, Georgiades C. Radiofrequency ablation: mechanism of action and devices. 

. 2010;21(8 Suppl):S179-S186. doi:10.1016/j.jvir.2010.04.008

Mulier S, Miao Y, Mulier P, et al. Electrodes and multiple electrode systems for radio frequency ablation: a proposal for updated terminology. 

. 2006;574:57-73. doi:10.1007/0-387-29512-7-8

Krämer B, Hahn M, Taran F-A, Kraemer D, Isaacson KB, Brucker SY. Interim analysis of a randomized controlled trial comparing laparoscopic radiofrequency volumetric thermal ablation of uterine fibroids with laparoscopic myomectomy. 

. 2016;133(2):206-211. doi:10.1016/j.ijgo.2015.10.008

Acessa ProVu System user guide. Acessa. Accessed January 10, 2022. https://

www.hologic.com/package-inserts/gyn-surgical-

products/acessa-laparoscopic-radiofrequency-ablation

Sonata System instructions for use, with technical appendix. Gynesonics. Accessed January 10, 2022. https://gynesonics.com/us/wp-content/uploads/sites/2/2021/11/LS-03818-009.C_REF-009-IFU-Sonata-2.2-11-15-21.pdf

Berman JM, Shashoua A, Olson C, Brucker S, Thiel JA, Bhagavath B. Case series of reproductive outcomes after laparoscopic radiofrequency ablation of symptomatic myomas. 

. 2020;27(3):639-645. doi:10.1016/j.jmig.2019.06.009

Christoffel L, Bends R, Toub D, et al. Pregnancy outcomes after transcervical radiofrequency ablation of uterine fibroids with the sonata system. 

. Published online November 17, 2021. doi:10.1089/gyn.2021.0136

Premarket Approval (PMA) supplement: Exablate. FDA. Updated January 10, 2022. Accessed Accessed January 12, 2022.­­­ https://

www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P040003S015.

Articles

Understanding the technology behind a newer uterus-sparing option for the management of uterine fibroids.

Radiofrequency ablation for fibroids

As a proud wound closure materials geek, I view 3 patents as the most significant modern inventions in the field: US patent 3,297,033

  for polyglycolic acid suture (1967), US patent 8,721,681 B2

  for barbed suture (2014) and US patent 5,530,037

  for sterilizing cyanoacrylate (1996). The last of the triad essentially enabled Krazy® Glue (Elmer’s Products, Westerville, OH) to become Dermabond® (Ethicon, Inc., Somerville, NJ) and changed the way millions of wounds have been and will be reapproximated.

 Topical Skin Adhesive is sterile 2-octyl cyanoacrylate contained in a 0.8-g ampoule encased in a proprietary dispenser for single use. While each manufacturer of a 2-octyl cyanoacrylate topical skin adhesive claims their version is the best due to special additives and processes that alter the viscosity, as a user, the biggest differences seem to be in the dispensers. With its unique felt tip and pressure-producing wings, the LiquiBand Exceed

 dispenser was by far the best topical skin adhesive dispenser I have ever used. It consistently produced an even distribution of adhesive over wounds without clogging, enabling me to use all 0.8 g of glue.    

Advanced Medical Solutions, Ltd., neither invented cyanoacrylate nor figured out how to sterilize it so I can’t give them too many cleverness points. However, their felt-tipped, winged dispenser is a big improvement over the competition so kudos to them.

2-octyl cyanoacrylate is essentially a commodity product that will usually be subject to bundled pricing and thus highly variable in its cost. From my perspective, the real value discriminator between products is the dispensers. With some dispensers, the tips clog before all of the adhesive is delivered, often necessitating opening a second applicator and doubling the cost. With the LiquiBand Exceed

 dispenser I was able to use all of the adhesive in the ampoule every time. THAT…is good value.

This is simple. If you use topical skin adhesives for wound closure, you should try LiquiBand Exceed

 to see for yourself and your institution whether this is a good alternative to what you are currently using.

The views of the author are personal opinions and do not necessarily represent the views of 

Schmitt EE, inventor; American Cyanamid Company, assignee. Surgical Sutures. US patent 3,297,033. January 10, 1967.

Ruff, GL, inventor; Ethicon, Inc. assignee. Barbed suture in combination with surgical needle. US patent 8,721,681 B2. May 13, 2014.

McDonnell PF, inventor; Loctite, Ltd, assignee. Sterilized cyanoacrylate adhesive composition, and a method of making such a composition. US patent 5,530,037. June 25, 1996.

Dr. James Greenberg gives his review of the LiquiBand Exceed Topical Skin Adhesive.

Tools Test Drive: LiquiBand Exceed Topical Skin Adhesive

I am as tormented by suboptimal laparoscopic views as I am about greasy fingerprints on my glasses and it is with this hate-inspired passion that I evaluated Buffalo Filter’s LaparoVue

 Visibility System is a single-use, disposable system designed to eliminate fogging while cleaning laparoscopes and trocars during a procedure. The system is actually three-fold: a hub with warming and cleaning ports, 2 VueTip

 trocar swabs and a microfiber cleaning cloth. The meat of the system is a molded silicone, battery-powered box with 2 ports (1 for warming and white balancing, 1 for cleaning and defogging) and a detachable scope cradle. The battery provides the energy for both the warming unit and projecting LED light that accentuates the ports. The base of the hub is detachable to cradle the scope horizontally while it is being warmed. Both ports have flexible seals that accommodate scopes from 3 mm to 12 mm without an adapter. The 2 VueTip

 trocar swabs are plunger-like, radiopaque swabs designed to fit into 5-mm and 12-mm trocars. Finally, the microfiber cleaning cloth is…a microfiber cleaning cloth. 

 Visibility System was excellent. Mindlessly easy to use, it kept my laparoscopes defogged and smudge-free and provided a good platform on which to rest the scopes while they were not in use. In short, it did exactly what it was supposed to do and did it very well. 

, it is hard to give the engineers at Buffalo Filter too much ingenuity credit since this system is simply an improved D-HELP (now, ClearifyTM from Medtronic, LLC). With regard to the improvements, Buffalo Filter did a nice job fine-tuning this product but the real innovation points still have to go to the D-HELP peeps for coming up with the  original idea.

I am somewhat biased against single-use devices. Their cost never goes down with amortization and creating more medical waste landfill is not a good idea. However, there is little point in spending a fortune on an expensive laparoscopy system only to have condensation and drops of blood and fat blur your 4K picture. For small cases, the LaparoVue

 is probably not worth it. But, for more complex procedures it seems like short money. 

Consistent, high-quality imaging is essential for laparoscopic procedures. As optical technology evolves, advances in both resolution and lighting will likely offer future surgeons pictures that will make current technology seem like black and white TV. Regardless of how it’s done, each OR team needs an efficient system to keep their scopes clean. For quick cases, a moist sponge is probably fine. For longer, more complex cases, the LaparoVue

: The author reports no conflicts of interest with regard to the content of this review.

James Greenberg, MD, reviews the LaparoVue Visibility System, a single-use, disposable system designed to eliminate fogging while cleaning laparoscopes and trocars during a procedure.

LaparoVue Visibility System

Creating a hysterotomy during cesarean delivery is as basic a skill as exists in the practice of obstetrics. Unfortunately, about 0.7% to 1.9% of the time while cutting into the uterus, babies are cut as well.

 While at first glance that percentage may seem low, when one takes into consideration that about 1.5 million cesarean deliveries are performed every year in the United States, this small percentage amounts to about 10,500 unnecessary injuries, especially when the appropriate number should be closer to zero!

To minimize the risk of iatrogenic scalpel injuries to babies at the time of cesarean delivery, Ecomed Solutions has introduced the Sureglide cesarean delivery safety scalpel. Its straightforward design offers a stainless steel surgical blade encased in a plastic handle that extends past the blade and forms into a pointed tip. The idea is to use the plastic tip to enter the uterus and then extend the hysterotomy by cutting up and away from the baby. Not surprisingly, in trial use in the operating room, Sureglide worked exactly as expected. With the blade facing up, the tip is pushed through the serosa and myometrium. The hand holding the device is then gently rocked back and pushed forward while the blade safely and efficiently creates a hysterotomy. Easy. Quick. Safe.

On the innovation front, Sureglide is a little wanting as its doppelgÃ¤nger C Safe has been on the market for several years. In my opinion the 2 devices look, feel and perform almost identically and because C Safe was first, it gets all the innovation points.

By medical device standards, Sureglide is pretty inexpensive ($18 each) but it is still more costly than a #10 scalpel blade. That said, the value play is really about how many cut babies you and your hospital are willing to tolerate.

I have opined before that I think it is time we made newborn lacerations at the time of cesarean delivery a “never” event because we have the technology to essentially eliminate the problem. While rising healthcare costs are always an issue, I am pretty confident most parents would pay for this device themselves out-of-pocket if they knew it could prevent an accidental laceration to their baby.

1. Alexander JM, Leveno KJ, Hauth J, et al. Fetal injury associated with cesarean delivery. 

2. Smith JF, Hernandez C, Wax JR. Fetal laceration injury at cesarean delivery. 


Vaginal dryness and dyspareunia are issues for which every gynecologist needs suggestions and options to provide to patients. By at least one account, genitourinary syndrome of menopause (GSM) and GSM-like symptoms affect about 15% of premenopausal women and 40% to 54% of postmenopausal women

 and those numbers do not fully encompass the entire universe of sexual lubricant needs. While estrogens may serve as the prescription cornerstone of therapy to address GSM, over-the-counter (OTC) lubricants found in the pharmacy are more widely used by patients and their partners than prescription solutions and therefore, providers should be aware of what is on the shelves in this niche. One of those products is Ã¼berlube.

According to company lore, in 2002 childhood friends Stephen Magnusen and Frank Zwergel came up with the idea of Ã¼berlube with the intention of creating “a lightweight lubricant with log-lasting performance… that doesn’t leave a sticky residue.” Though they set out to make a lubricant with a broad variety of applications including massage oil, moisturizer, hair gel, lock grease or even shoe polish, Ã¼berlube found its way into sex-product stores, where it soon became a “go to” for couples seeking a lubricant for using during sex.

Ãberlube has 4 ingredients: dimethicone, dimethiconol, cyclomethicone and tocopheryl acetate. The first 3 are all polymeric organosilicon compounds commonly referred to as silicones, and tocopheryl acetate is the ester of acetic acid and vitamin E. All the ingredients are non-toxic and can even be ingested. The formula naturally does not harbor bacteria, yeasts or molds so it needs no preservatives, alcohols or antimicrobial additives. It is sold in 3 sizes: a 14-mL travel size, a standard 50-mL clear spray bottle or a larger 100-mL clear spray bottle.

In testing between my ungloved fingers and on my gloved fingers during bimanual exams, Ã¼berlube had a silkier feel and was lubricious without being messy. In my non-scientific, uncontrolled, un-blinded survey of patients to whom I had recommended Ã¼berlube as a lubricant option for intercourse with their partners, every one thought it was better than anything they had previously tried.

Though I am no chemist, I am pretty sure Ã¼berlube is different from almost everything else out there. Its combination of safety, excellent lubrication and lack of mess is unique and might earn it a spot in the lubricant hall of fame.

For sexual lubricants, the value of the product has to be individualized because each person is going to have a different degree of discomfort and a different desire to fix the problem. That said, a 50-mL bottle of Ã¼berlube at $18 is not the same financial commitment as investing in a 4-year college education, so I think it is money well spent on trying a bottle if GSM is a significant problem.

The world of lubricants goes well beyond car engines, bars and Washington, DC. In the sexual lubricant niche, silicone-based Ã¼berlube is a newer option that many patients may find helpful. A bottle sits on my desk for patients to sample and I have recommended it many times with many satisfied users.

1. Gandhi J, Chen A, Dagur G, et al. Genitourinary syndrome of menopause: an overview of clinical manifestations, pathophysiology, etiology, evaluation, and management. 

NEXT: TruClear ULTRA Mini tissue removal device

TruClear ULTRA Mini tissue removal device

Circa 1998, Dr Mark Hans Emanuel in the Netherlands went into his garage with an orthopedic shaver and came out with the first hysteroscopic mechanical tissue morcellator. Five years later in 2003, Smith & Nephew received 510(k) clearance from the FDA and the Smith & Nephew IUR Morcellation System (now TruClear, owned by Medtronic) was ready for clinical use in the US. Some 14 years and tens of thousands of hysteroscopic morcellation procedures later, hysteroscope mechanical tissue morcellation is a standard for many gynecologists for resecting intracavitary uterine pathology.

For those physicians who have been practicing in a cave and are unfamiliar with hysteroscopic mechanical morcellation here is a quick primer. Hysteroscopic mechanical morcellators utilize device-specific operating hysteroscopes with integrated optics, inflow and outflow channels and large open central lumens through which proprietary morcellator devices can pass. They function best with high inflow/outflow fluid management systems that can accommodate the large fluid burdens that accompany the procedures due to the need to replace the distention media that is suctioned off removing morcellated tissue. The TruClear system is available in 2 sizes: TruClear 8.0, a 9 mm (27 Fr) hysteroscope for larger pathology and the nimbler TruClear 5C or 5.0, a 5.7 mm (17 Fr) hysteroscope for smaller pathology. The business ends of these systems are single-use tissue removal devices that pass through the central lumens and simultaneously morcellate and aspirate targeted tissues. They come in 2 designs: a rotating serrated blade for softer tissues (i.e. polyps, retained POCs) and a more robust reciprocating, guillotine-style cutting blade for denser tissues (i.e. submucus myomas). Until now, only the larger TruClear 8.0 had a reciprocating cutting bladder but the Ultra Mini changes that.

TruClear ULTRA Mini tissue removal device is a single-use, stainless steel, 2.9 mm OD instrument designed to function with the TruClear 5C or 5.0 hysteroscope set. Like its 4.0-mm OD cousin, the TruClear ULTRA Plus device has a reciprocating, guillotine-style cutting blade designed to resect denser tissues. But unlike its zaftig relative, the ULTRA Mini fits through a 5.7 mm hysteroscope.

In use in the OR, the ULTRA Mini was a tissue-chomping beast. The company claims that ULTRA Mini resects tissue at 4.4 grams/minute. While this is Usain Bolt range speed (typical myoma resection rates for morcellators are more in the range of 1.87-3.77 grams/minute

), nothing in my initial OR experience left me doubting it. In this niche, ULTRA Mini is best-in-class. If Medronic can just redesign the TruClear 5C or 5.0 hysteroscopes with glass-rod rather than fiber optic lens, the whole system would be close to perfect.

While the bulk of users may not appreciate it, ULTRA Mini is an impressive innovative accomplishment. As these devices get smaller and smaller, the engineering challenges get exponentially greater. Reciprocating speeds, blade angles, tissue clearance etc. all have narrow tolerances with each component potentially killing performance. I have no idea exactly how the engineers used this combination of stainless stain tubes and blades with silicone and chromium coatings to make this device work but they did and they did it well.

ULTRA Mini is not cheap. If fact, at $1097 it is the Bentley of hysteroscopic instruments. That said, there are two considerations. First, nobody pays list. Second, we are talking value not cost. In that regard the real questions should be, “does this device allow surgeons to accomplish what they set out to accomplish, how efficiently were they able to do it and was it worth it?” In a recent metaanalysis, Shazly et al. demonstrate that as compared with hysteroscopic loop resections, hysteroscopic morcellation procedures were faster and more complete.

 So, depending on your hospital’s OR costs and your surgeons’ skill sets, this device may be a better value than it first appears. While this hardly ends the argument, I do think it is an important consideration when valuing this technology.

In my opinion, hysteroscopic mechanical morcellation is an evolving alternative to traditional loop resectoscopy that just got even more enticing with the introduction of the TruClear™ ULTRA Mini tissue removal device. With the combination of its small size and large tissue resecting potential, I think ULTRA Mini will alter the hysteroscopy landscape as surgeons assimilate this new technology’s potential into their practices.

1. Meulenbroeks D, Hamerlynck TW, Saglam-Kara S, Van Rijssel NK, Van Vliet HA, Schoot BC. Hysteroscopic Tissue Removal Systems: A Randomized In Vitro Comparison. 

2. Shazly SA, Laughlin-Tommaso SK, Breitkopf DM, Hopkins MR, Burnett TL, Green IC, Farrell AM, Murad MH, Famuyide AO. Hysteroscopic Morcellation Versus Resection for the Treatment of Uterine Cavitary Lesions: A Systematic Review and Meta-analysis. 

Dr Greenberg reports his thoughts on the Sureglide device and preventing lacerations during cesarean, Überlube and helping women with vaginal dryness and dyspareunia, and TruClear ULTRA Mini tissue removal device for mechanical morcellation.

Tools Test Drive: Sureglide, Überlube, and TruClear

	This anti-stick solution is designed to keep instruments clean.


Photo courtesy of Eagle Surgical Products

	Core surgical rule: hemorrhage bad; hemostasis good. With that insightful gem out of the way, let’s turn our focus to electrosurgery, in which electrical current is employed to coagulate bleeding blood vessels by denaturing blood and blood vessel proteins. While that technique is generally effective, the process often results in unwanted sticking and char build-up on the coagulating device. Because both of those effects are detrimental to achieving hemostasis, preventing them is important. Electro Lube

	Approved by the US Food and Drug Administration in 2004, Electro Lube

is typically recognized by surgeons as “that yellow goop” that is applied to Da Vinci monopolar scissors to minimize the risk of current arcing. While it is helpful for minimizing arcing, its real modus operandi is preventing sticking and char buildup during electrosurgery. Derived from soybean oil, it is a lecithin-based phospholipid mixture that is non-synthetic, non-flammable, and non-allergenic. It comes in a sterile single-use 8-cc plastic vial and is applied to the tip of any electrosurgical instrument prior to the instrument’s use.

worked exactly as expected. In my parlance, it was just like good sports referees: If you don’t notice them, they are doing their job. In our operating room (OR), the Storz RoBi bipolar Maryland forceps is our go-to coagulation workhorse. With Electro Lube

applied, I have yet to need to clean an instrument during a case or to experience sticking to tissues. 

	Instrument sticking and char build up is definitely a real problem in certain coagulation-heavy procedures. When there is active bleeding, you really want a fully functional coagulation instrument and Electro Lube

is the “grease that helps the wheel turn.” In addition, less char build-up means less scraping and less scraping means less damage to expensive, delicate surgical instruments. Given all these pluses, I think this soybean oil byproduct is pretty clever.

	I don’t think that a bottle of Electro Lube

needs to be opened for every OR case but I do think every OR needs to stock it. In this day and age, surgery-particularly minimally invasive surgery-is too refined to allow something as common as char build-up to reduce an instrument’s functionality when something as simple as Electro Lube

NEXT: WiCAM Wireless Digital Endoscope Camera & LED Light Source

	WiCAM Wireless Digital Endoscope Camera & LED Light Source

	Through the generosity of the Greek deity Prometheus, man was introduced to fire. Let there be no doubt, fire was a major enabling technology in humankind’s evolution and ranks only below the iPhone as the most significant advance since we arose from primordial muck. Given this legacy, it should be of little surprise that once again, Prometheus is trying to change mankind; only this time, instead of fire, we are getting an untethered endoscopic camera and light source.

CAM Wireless Digital Endoscope Camera and LED Light Source has multiple components that integrate to make any standard endoscope (cystoscope, hysteroscope, laparoscope, etc.) cordless. The camera is a standard-sized, lightweight (.35 lb, 158 g) device with a standard c-coupler that fits onto any standard eyepiece. Real-time images are wirelessly transmitted from the camera head to a USB receiver plugged into a monitor, laptop or tablet and a rechargeable battery screws a lightweight LED light source directly onto any standard light port.

	In use for an office hysteroscopy, the Prometheus wireless digital endoscope camera and LED light source was pretty “wow.” When stationary, the picture was excellent with full 640 x 480 resolution and the light was comparable to what I am used to. There were only 2 buts. But #1: During rapid movement of the camera there were occasions when the image deteriorated as the transmission speed lagged behind the image. This problem is minimized by keeping the camera and tablet at high power and selecting another channel on the camera and receiver if there is interference but it is still a little annoying. But #2: The company is a little vague about the cleaning and sterilization protocols for the devices. The company says they intend to remedy this issue with proprietary sterile drapes or bags but, as of this writing, they are not available.

	Game changer alert! This wireless product may be the first of its kind that you use but it will not be the last. Rather, I suspect within short order most of our wired cameras and light cords will go the way of wooden teeth, iron lungs, and written medical records.

	The Prometheus wireless digital endoscope camera and LED light source is super cool. After years of using scopes with camera heads connected to cameras via wires and illuminated by light transmitted through fiber-optic cords, the fully wireless Prometheus almost defies belief. For those of us old enough to remember our first mobile phone experience, this camera has that same otherworldly feel. The device does present some challenges. It has some digital lagging issues when it is moved too quickly and the company definitely needs to clarify its cleaning and sterilization procedures. But overall, I am convinced this is the future of office endoscopy and perhaps OR endoscopy as well.

Dr Greenberg reports on his results with an anti-stick solution for electrosurgery and a wireless endoscope camera.

Tools Test Drive: Electro Lube and WiCAM

	The views of the author are personal opinions and do not necessarily represent the views of 

	Dr Greenberg personally tests all the products he reviews. He has no conflicts of interest with these products or the companies that produce them.

	The LED revolution is upon us and it is high time that operating rooms opened their eyes to the reality that illuminating the deepest crevices of the human body is no longer the domain of the classic over-hanging OR lights but rather the cool, white lumens emitted by disposable LED “bulbs” on point-of-contact instruments.

	Whether on retractors, suction-irrigators, speculums, or headlamps, short-life LED devices will soon be to surgeons what wifi is to electronics: results without wires. The Clear-Trac V vaginal retractor is part of this burgeoning niche market.

	It is hard to imagine a simpler medical device than Clear-Trac V. In essence it is an L-shaped piece of rigid plastic with an LED-bulb welded to it. It comes in one size: 140 mm x 53 mm, and it is powered by a low-voltage mercury-free alkaline button battery that allows the device to be disposed of as regular, nontoxic medical waste (after exposure to bodily fluids, etc). Don’t look for more, that’s it. The device is intended as a single-use product and comes in an individual sterile packet with 25 devices per box. It is simple, lightweight, and intuitive.

More: CryoProbe and OptiSpec product reviews

	In clinical use, Clear-Trac V provided outstanding light and tissue retraction. I used it during a vaginal hysterectomy to retract the sidewalls and for the first time in many years, I actually saw all the deeper tissues without having to shift my fat head out of the light. While it is not sufficient to completely replace overhead lights, Clear-Trac V is more than adequate to replace the headlamps with the Twenty Thousand Leagues Under the Sea umbilical cords that these require. As the product catches on, I would expect a broader line of retractor options, but for now this is a pretty good start.

	My biggest complaint is the relatively short battery life (only about 30 minutes of peak power). While the battery life can be preserved by replacing the tab, this is annoying and I took away a star for this reason. Also, my green soul prefers reusables to disposables but, given the importance of good light in surgery, I think this small contribution to the landfill is worth it.

	Clear-Trac V is not overwhelmingly innovative. In fact, I was blown away that this technology is not already available from a broad array of vendors. That said, until there was Velcro there was no Velcro, so hats off to OBP for coming up with this because I do believe it will change the market.

	Clear-Trac V is a really good device for getting light into deep spaces. It is simple, intuitive, and relatively inexpensive. For pelvic surgeons who don’t get the light they want or are still using headlamps, this product is definitely worth a try. When coupled with one of the illuminated suction-tips on the market, Clear-Trac V will provide better visualization of deeper spaces than most of what is being used today.

NEXT: MiniLap Percutaneous System with MiniGrip Handle

	MiniLap Percutaneous System with MiniGrip handle

	In the MIGS, SILS, LESS, NOTES race to the smallest and fewest, I am not sure what counts. A 5-mm trocar definitely counts as a port. A 20-G (0.9081 mm) spinal needle definitely does not count as a port. What about 2.4 mm? We’ll need to decide because Teleflex’s MiniLap Percutaneous System is ready to grab some attention.

	With an outer diameter of 2.4 mm, the MiniLap instruments with the MiniGrip are amazingly thin but surprisingly strong and versatile. All the instruments in the line are sterile, single-use, and come with an integrated, retractable needle tip that allows for direct percutaneous insertion of the device without a trocar. The line comes with 2 handle styles-MiniGrip pistol style or standard 3-finger grip. There are also 4 jaw options, each with a wingspan of 12.5 mm that is more than adequate to grasp most tissues.

	In the OR, the MiniLap generally performed better than I expected (which is rare). The shaft was much more durable than I anticipated and the grip on the tissues was superb. I liked the rotatable functionality and I thought the pistol-grip was ergonomically comfortable. And the incision -forget about it (because I almost did it was so unnoticeable)!

Next: Pro-Nox and Alexis CES product reviews

	The only thing I did not like was the mechanism to retract the grasper and arm the needle for percutaneous insertion. I thought it was sticky, somewhat persnickety, and in general felt a little fragile. Because I suspect this will be easily remedied in future iterations, I am not too concerned.

	MiniLap is a game-changer in disposable laparoscopic instruments. Its incredible strength-to-shaft ratio makes it very useful as a surgical tool and its 2.4 mm-ness is amazing. The device looks and feels so similar to other devices that it is difficult to give it that fifth star but that should not diminish the accomplishment of getting all that punch into such a small package.

	The MiniLap Percutaneous System is a real winner. For surgeons looking to do more with less this is a must. Want better triangular for “single-port” procedures? Use this. Struggling and need another hand to move tissues out of the way? This is your answer. Does 2.4 mm count as a port? I say no. Should your hospital be stocking this device? I say yes.

Dr Greenberg test drives 2 new products to see if they can be of use in your practice.