Midurethral sling procedures are minimally invasive surgeries for stress urinary incontinence that use a trocar system to place a narrow ribbon of polypropylene mesh under the midurethra. The peer-reviewed scientific literature on these procedures is abundant and midurethral slings are the most well-studied incontinence procedure ever. Systematic reviews of the literature demonstrate that midurethral slings are safer and more (or equally) effective as traditional procedures. The midurethral sling is the worldwide standard for the treatment of female stress urinary incontinence and >3 million procedures have been performed. The Food and Drug Administration and international scientific review agencies have consistently differentiated transvaginal mesh for stress urinary incontinence from transvaginal mesh for prolapse. In the recruitment of patients to participate in transvaginal mesh litigation, plaintiff lawyers have not made the distinction between stress urinary incontinence and prolapse procedures because more women have received midurethral slings than transvaginal mesh for prolapse by an order of magnitude. The litigation costs of defending their products have forced several companies that manufactured midurethral slings to leave the marketplace. It is not inconceivable that midurethral slings could become absent from the US market. If that happens, then US women with stress urinary incontinence will be harmed because they will not have access in this country to the best and safest stress urinary incontinence surgical procedure ever developed. It may be time for the Institute of Medicine or another comparable national agency to provide evidence-based recommendations on the midurethral sling.
The evidence for midurethral slings
Before midurethral slings (MUS) were developed in the late 1990s, most women who needed surgery for stress urinary incontinence (SUI) were treated with what are now called traditional procedures. These traditional procedures involved suturing of periurethral tissue to retropubic structures (colpopexy) or harvesting autologous material to place a sling under the urethra (pubovaginal slings). These surgical procedures, compared to current MUS, usually involved larger incisions, more overnight hospital stays, prolonged recoveries, and more time off work, and placed the patient at higher risk for major surgery complications like venous thromboembolism and wound infections. The advent of a minimally invasive procedure like the MUS, in which a trocar system places a 1-cm wide ribbon of polypropylene mesh under the midurethra, revolutionized the management of SUI. These minimally invasive procedures result in less blood loss, less pain, fewer venous thromboembolisms, fewer surgical-site infections, faster recovery, and better cosmetic outcomes. The MUS procedure has a shorter learning curve, is standardized and reproducible, and high success rates are consistently reported in numerous studies. MUS improve quality of life and, probably because of its beneficial effect on incontinence, improve sexual function. Systematic reviews of numerous studies comparing MUS with traditional SUI surgical procedures confirm that the MUS has all the benefits of a minimally invasive procedure, with less blood loss, less operative time, fewer hospital stays, fewer hematomas, and fewer wound infections ( Table ). The MUS has equivalent or better objective or subjective success rates, and has lower rates of new-onset urinary symptoms than traditional slings. With the exception of bladder or vaginal perforations, MUS have similar or better complication rates. An intraoperative bladder perforation is managed simply by a repeat placement of the device and 1-3 days of bladder drainage, and has no long-term consequences. Vaginal perforations are also managed with repeat placement of the device and have no long-term consequences. Urinary retention after a MUS is managed with a sling release and not an extensive urethrolysis procedure that may be required after traditional procedures. The durability of the MUS is demonstrated for at least 17 years. In the most recent Cochrane review the authors concluded, “Mid-urethral sling operations have been the most extensively researched surgical treatment for SUI in women and have a good safety profile. Irrespective of the routes traversed, they are highly effective in the short and medium term, and accruing evidence demonstrates their effectiveness in the long term.”
| MUS vs open retropubic colpopexy | ||
|---|---|---|
| Favors MUS | Favors both or no difference | Favors open retropubic colpopexy |
| Overall cure rates Objective cure rates Blood loss Postoperative pain Operation time Hospital stay Bowel injury Wound infection Hematomas | Objective cure rate by pad test Subjective cure rate Other complications besides bladder or vaginal perforations | Bladder or vaginal perforations Return to operating room for retention, erosion, OAB symptoms, groin pain |
| MUS vs laparoscopic retropubic colpopexy | ||
|---|---|---|
| Favors MUS | Favors both or no difference | Favors laparoscopic colpopexy |
| Objective cure rates Operation time Hospital stay | Subjective cure rates | |
| MUS vs traditional (pubovaginal) sling | ||
|---|---|---|
| Favors MUS | Favors both or no difference | Favors pubovaginal sling |
| Subjective cure rates Storage lower urinary tract symptoms Reoperation Operation time Blood loss Hospital stay Perioperative complications except for bladder perforation Postoperative voiding dysfunction Detrusor symptoms | Overall cure rates Subjective cure rates Hematoma Voiding lower urinary tract symptoms | Bladder perforations Vaginal perforation Urinary tract infection |
MUS–the worldwide standard
Throughout the world the MUS procedure became the standard surgical treatment for SUI. Because procedure codes in the United States do not distinguish between different types of slings, the best data on the types of incontinence procedures being performed are obtained outside the United States, but the trend was similar in the United States. By 2005, >7000 MUS were performed annually in the United Kingdom and other procedures totaled <1000. More women sought care because now they had a safe, effective procedure that brought back their quality of life with a minimal investment of pain, recovery, or lost time. At the time of a 2014 United Kingdom report, 13,500 women annually underwent MUS procedures. In the United States, in the Urinary Incontinence Treatment Network Value of Urodynamic Evaluation trial, when 53 urogynecologists or urologists could perform whatever procedure they wanted for SUI, 93% of the procedures were MUS. Surveys of members of the American Urogynecologic Society (AUGS) showed that even after 2011, 99% of AUGS members who did sling surgery for SUI use a MUS. Worldwide, 3.6 million MUS were sold from 2005 through 2013. The MUS is the worldwide standard. Clinical researchers are no longer interested in comparing MUS with traditional procedures; instead, research is directed at what type of MUS is best.
MUS–the worldwide standard
Throughout the world the MUS procedure became the standard surgical treatment for SUI. Because procedure codes in the United States do not distinguish between different types of slings, the best data on the types of incontinence procedures being performed are obtained outside the United States, but the trend was similar in the United States. By 2005, >7000 MUS were performed annually in the United Kingdom and other procedures totaled <1000. More women sought care because now they had a safe, effective procedure that brought back their quality of life with a minimal investment of pain, recovery, or lost time. At the time of a 2014 United Kingdom report, 13,500 women annually underwent MUS procedures. In the United States, in the Urinary Incontinence Treatment Network Value of Urodynamic Evaluation trial, when 53 urogynecologists or urologists could perform whatever procedure they wanted for SUI, 93% of the procedures were MUS. Surveys of members of the American Urogynecologic Society (AUGS) showed that even after 2011, 99% of AUGS members who did sling surgery for SUI use a MUS. Worldwide, 3.6 million MUS were sold from 2005 through 2013. The MUS is the worldwide standard. Clinical researchers are no longer interested in comparing MUS with traditional procedures; instead, research is directed at what type of MUS is best.
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