As many as one out of three women experience urinary leaking with cough, sneeze, exercise or certain activities that increase abdominal pressure. Until the mid-1990’s, most treatments had either poor success rates or increased morbidity with complications like urinary retention, severe postoperative pain or protracted recovery. In 1996, the Tension-free Vaginal Tape (TVT), also known as the midurethral sling, was introduced to treat stress urinary incontinence (SUI). These devices offered physicians a resource to treat SUI in the context of a procedure that could provide high success rates (95 percent) and low risk rates (one percent).
Over the next five years, the popularity of TVT led to the development of a myriad of alternative devices and procedures. Many that the FDA approved came through a 510K process for “related” devices. In fact, an entire new line of products for prolapse of the anterior and posterior vaginal walls, apex of the vagina and uterus were developed based on being similar to the TVT device.
Unfortunately, these devices had an entirely different set of risks and benefits, which were not anticipated. This grouping of unrelated procedures continues to cause confusion among patients, clinicians and the public. From 2000 to 2009, surgery for SUI increased 27 percent in the United States and might have continued to rise, but in 2008 the FDA released a series of reports noting concern with these devices and problematic patient outcomes. These concerns were revised in 2011 to focus on the vaginal mesh kits for prolapse, but the damage to the reputation of the midurethral sling for SUI had already been done.
In the United States, from 2010 to 2014 there was an overall decrease in midurethral sling volume and surgical treatment of SUI for the first time in years despite the FDA clarifying their concern statement in 2011. In this country, treatment of SUI remains relatively unchanged with midurethral slings dominating as the preferred surgery. However, in 2018, the United Kingdom had a paradigm shift toward complete withdrawal of synthetic midurethral slings. As practice patterns have changed, many physicians find they must seek alternative treatment options which have their own sets of pros and cons.
The four main available options are pubovaginal sling (biologic), Burch urethropexy, transurethral bulking, and synthetic midurethral slings. Pubovaginal slings have approximately 85 to 90 percent efficacy, but if autologous fascia is used, this sling can have significant morbidity due to harvesting the fascia from the rectus or fascia lata. They also have a relatively high rate of urinary retention and voiding dysfunction.
Burch urethropexy requires either an open abdominal incision or laparoscopic access to the abdomen, making it more invasive than the sling procedures. Its success rate is 85 percent but tends have less success with the more severe types of SUI.
Classically, bulking procedures are used as secondary procedures and have approximately a 60 to65 percent success rate over a shorter term follow when compared to the slings and urethropexy.
Finally, the midurethral sling is the least invasive of the surgical approaches, has a 90 to 95 percent success rate, and its main risk is voiding dysfunction that occurs in less than one percent of patients when performed by high volume surgeons. Mesh-related complications with midurethral slings can be nearly eliminated by using correct surgical technique.
In the current environment, surgeons must consider all approaches when treating SUI. There is even a movement in European countries to use bulking agents as a primary SUI procedure as they no longer have readily available access to synthetic midurethral slings. Primary treatment with bulking agents is even being discussed in treatment algorithms in the United States as well. Each patient should be approached in a personalized manner, assessing her unique history, goals and acceptable outcomes in order to tailor a specific surgery to meet her needs.
Brent A Parnell, MD is a Urogynecologist with the Alabama Center for Urogynecology and Pelvic Pain at the Women’s Medical Center at Brookwood Baptist Medical Center.
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