PHYSICIAN SATISFACTION WITH THE SPARC™ SUPRAPUBIC SLING SYSTEM: AN OPINION-BASED SURVEY

E. Stanford,* J. Dell⁺

* St. Mary’s/Good Samaritan Hospitals Centralia, IL

+ Institute for Female Pelvic Medicine, Knoxville, TN

OBJECTIVES:  The SPARC™ Female Sling System (American Medical Systems, Inc., Minnetonka, Minnesota) is a synthetic, self-fixating sling designed to correct stress urinary incontinence (SUI) in women and is minimally invasive to implant.  The SPARC system uses a from-the-top surgical approach (suprapubic).

MATERIALS AND METHODS:  An opinion-based survey was completed by 47 urogynecologists and urologists experienced in performing incontinence surgeries to evaluate experience with, and impressions of, the SPARC suprapubic sling system.  Survey questions focused on current SPARC and past TVT (Ethicon, New Brunswick, New Jersey) experience.

RESULTS:  Two-hundred and thirty-seven patients received the SPARC suprapubic sling system between June and December, 2002.  The median patient age was 53.7 years (range:  23-98 years).  In 70%, the SPARC sling was done alone without concomitant prolapse repairs.  In 30.9% of procedures, the sling was adjusted after plastic sheath removal:  60.3% of cases moved it closer to the urethra; 39.7% moved it away from the urethra.  In cases where the sling was adjusted after sheath removal, 76% reported that the SPARC was less difficult to adjust than TVT, 22% found no difference in difficulty between either sling, and 1% reported more difficulty in adjusting the SPARC than TVT.  Ninety percent of physicians found the adjustment allowed by SPARC’s resorbable suture is of at least some benefit.  The median blood loss reported with the SPARC procedures was 25 cc’s; half the blood loss reported for TVT procedures.  A paired, one-way t-test demonstrated that blood loss with SPARC was 10% less than that of TVT (.95t39=2.5, p < .01).  Bladder perforations occurred in 9.3% of the initial SPARC cases indicating a learning curve and a spectrum of surgeon experience.  No other complications were reported.  Most physicians (69.3%, with 24.5% showing no difference in comfort level during implantation) were comfortable with the suprapubic approach as compared to the approach taken with TVT.

CONCLUSIONS:  Physicians demonstrated, in a large, multi-center, opinion-based survey, that there are benefits during the implantation of the self-fixating, SPARC™ Female Sling System.  Bladder perforations are reported but no other complications were noted.  The surgeons reported greater ease of sling adjustment after sheath removal, slightly less blood loss, and an equal or greater comfort level with the approach taken to implant the device.

Disclosure - Grant/Research: E. Stanford, Ortho-McNeil & AMS; Advisory Board: E. Stanford, Ortho-McNeil; J. Dell, Ortho-McNeil & Bard; Preceptor: E. Stanford, Caldera.