Stress urinary incontinence (SUI) accounts for approximately 50% of incontinence occurrences in women (1). Several surgical techniques, including urethropexy, needle-assisted bladder neck suspension, and colposuspension have been used to treat SUI. In 1995, Ulmsten et al (2) introduced the tension-free vaginal tape procedure (TVT), utilizing a suburethral retropubic sling made out of synthetic material.
The TVT procedure has shown to be simpler and more cost-effective in comparison to other surgeries, and has become a preferred surgical treatment of SUI (3). Ethicon was the first manufacturer to produce a TVT surgical kit, the Gynecare TVT. The kit includes a synthetic mesh sling in a plastic sheath and two introducer needles with handles. Other companies (American Medical Systems, Boston Scientific, BARD, Caldera, and Coloplast) have created their own variations of the retropubic sling system differing by the type of mesh, and the length and composition of the introducer needle handles.
In response to a 2008 warning from the FDA regarding surgical complications associated with synthetic mesh implants, several companies discontinued producing certain sling kits (4). The aim of the current review was to provide a comprehensive summary on the currently available retropubic sling systems, and to compare the slings in terms of reported side effects, treatment outcomes, and patient acceptability. A general web search was conducted to identify all past and presently used retropubic sling kits. Manufacturers’ websites were then examined for product names and descriptions, and specific products were then searched in the peer-reviewed literature using PubMed, Google Scholar, and the Cochrane Library databases. The FDA’s Manufacturer and User Facility Device Experience Database (MAUDE) was also used to identify potential adverse events associated with the sling kits.
Results of this literature review revealed 38 peer-reviewed articles published between 1995 and 2014 that examined side effects, treatment outcomes, and patient acceptability of eight retropubic sling kits: Advantage and Lynx (Boston Scientific), Align (Bard), Desara (Caldera), Gynecare TVT (Ethicon), SPARC and RetroArc Retropubic Sling System (American Medical Systems), and Supris (Coloplast). The search also revealed four sling kits that have been discontinued by the manufacturer: Avaulta Plus, Pelvilace, and Uretex (Bard) and ProteGen (Boston Scientific).
The majority of the studies were conducted on the Gynecare TVT, which was also reported as being the most widely used retropubic sling system (5). Although research showed that the sling was associated with several negative side effects, such as urinary tract infections, bladder perforation, and hematoma, the Gynecare TVT had positive treatment outcomes for the majority of patients, with objective cure rates ranging from 81.3% to 91.3% and subjective cure rates ranging from 77% to 92% (6-15). The SPARC was the second most cited retropubic sling system in the literature, and was also shown to have generally positive outcomes, with objective cure rates ranging from 76% to 90.4% and subjective cure rates ranging from 52% to 75% (16-18). Side effects associated with the SPARC included urinary retention and de novo overactive bladder symptoms (16,17,19,20). Comparison studies revealed that the Gynecare TVT and the SPARC varied only slightly in terms of reported side effects. The Gynecare TVT was associated with greater instances of decreased urinary stream, whereas the SPARC was associated with greater instances of acute urinary retention (21,22). Despite these differences, the two slings were highly similar in terms of efficacy and positive patient outcomes (21-26). The Advantage was the next most frequently cited sling system. Results indicated that users of the Advantage most commonly experienced persistent SUI and de novo overactive bladder symptoms, but data on treatment outcomes and patient satisfaction ratings were not available for this sling (26-28). Lastly, results of one study examining the Lynx revealed that the sling had a reported success rate of 90.2% for treating SUI (29). Side effects reported with the use of this sling included vaginal extrusion and de novo overactive bladder symptoms (29). Comparison studies on the Gynecare TVT, Advantage, Align, and Lynx indicated no significant differences between the slings in regard to side effects or patient outcomes (21-26, 30, 31). There were no existing studies on the RetroArc, Desara, and Surpris sling systems.
In conclusion, the majority of the literature examined in this study reported on the Gynecare TVT, which has been shown to have similar rates of experienced side effects and positive treatment outcomes in comparison to its competitors. However, given that there was a disproportionate amount of research on each sling kit, it was not possible to accurately compare the different kits. More research is needed to determine if there are any significant differences between the various slings in terms of efficacy and patient acceptability. At this time, the decision regarding which sling kit to use in surgery is based on the medical provider’s preference, training, and past experience.
References:
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Written by:
Christina P. Moldovan, M.A., Michelle E. Marinone, B.A., and Andrea Staack, M.D., Ph.D.
Department of Psychology, Loma Linda University, Loma Linda, California, United States of America; School of Medicine, Loma Linda University, Loma Linda, California, United States of America; Department of Urology, Loma Linda University Medical Center, Loma Linda, California, United States of America.
Abstract: Transvaginal Retropubic Sling Systems: Efficacy and Patient Acceptability