Backround: This study evaluates a transobturator approach for placement of a tension-free mid-urethral sling. We present our experience with the Monarc sling with emphasis on safety and efficacy for the treatment of stress urinary incontinence (SUI) and its relation to urge incontinence.
Methods: 115 female subjects were implanted with the Monarc™ Subfascial Hammock (American Medical Systems, Minnetonka, MN), between July 2003 and June 2004 in an IRB approved prospective multi-center study. Inclusion criteria were confirmed SUI due to urethral hypermobility. Urodynamic testing (UDT), cough-stress test, Q-Tip test, one-hour pad test, and POP-Q examination were done pre-operatively. Procedural, 4-8 week and 6 month post-op follow-up data were gathered.
Results: Mean age was 56.8 years (30-88 years). Mean pre-op ALPP was 75 cm H2O (0-258 cm). Mean blood loss was 34cc (2-250cc). 50 of the 115 subjects had concomitant repairs. Mean time to urinate was 13.7 hours (<1-144 hours) for subjects who underwent Monarc only and 18.7 hours (0-96 hours) for concomitant repairs. 74% of subjects treated with Monarc alone went home without a catheter. Currently, 73 subjects have completed 6-month follow-up with an objective cure rate of 89.6%. Patient subjective reports indicate that 87% (60 patients) were completely dry or substantially continent. Average pad use/day decreased from 2 pads (0-11 pads) pre-op to 0.2 pads (0-3 pads) at 6 months. Improvements in global QOL scores were statistically significant (p<0.001). 15% (6) subjects reported pre-op urge symptoms; all reported no urge at 6 months. 93 non-device related and 23 device-related AEs were reported in 43 (37.4 %) subjects. Device related AEs included: 3 (2.7%) UTI, 3 (2.7%) mesh extrusion, 2 (1.8%) pain (abdominal, musculoskeletal), and 1(0.9%) each urinary retention, bacterial vaginosis, dysuria, incomplete bladder emptying, leg numbness, rectocele and abscess of groin incision (suture removed, resolved). Treatment failure resulting in revision of the sling occurred in 5 (4.3 %), and sling extrusion into the vagina resulted in 1 (0.9%) revision.
Conclusion: Preliminary data shows the Monarc sling procedure to be a safe and effective treatment of SUI. Urge resolved in all patients who had pre-op urge. No urethral, bladder, bowel or vascular perforations or hematomas were reported. One patient reported leg numbness that resolved spontaneously. No nerve injuries were reported and no groin pain seen in patients beyond the immediate post-operative period. Long-term follow-up data are necessary; subjects will be followed through 24 months.

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