OBJECTIVE: This study was a report on early U.S. experience, including safety and efficacy of the new transobturator (TOT) sling for stress urinary incontinence. METHODS: This a retrospective case series of the initial 210 consecutive cases of TOT slings from 2 U.S. centers performed from August 2002 to December 2004. Cure was defined as subjective resolution of stress incontinence. QOL data was obtained using the short forms of the IIQ and UDI. RESULTS: Follow-up data were available on 209 patients. The mean (standard deviation) for subjective and objective follow up was 8.7 (4.5) months and 4.1 (3.4) months, respectively. The mean values (range) for age, parity, and body mass index were 58.5 years (30–83), 2.4 (0–8), and 27.96 (15.6–48.7), respectively. Twenty percent (n=42) of patients had prior incontinence surgery. Preoperatively, 45.9% (n=96) had mixed incontinence and 8.6% (n=18) had voiding dysfunction. Forty-two (20%) patients underwent an isolated sling procedure and the remaining had additional procedures. One hundred eighty-four patients (88%, 95% confidence interval: 83–92%) reported cure of SUI, 4 (1.9%) patients were improved, and 22 (10.5%) failed. The statistically significant difference between the cured and failed groups was: 1) failed patients needed longer postoperative catheterization (3.6 days ± 6.5 vs 1.5 ± 2.2, P=0.02) and 2) patients who had other additional procedures were more likely to report a cure (91% vs 76%, P=0.01). Mean duration of postoperative catheterization was 1.2 days. There were 2 (0.9%) intraoperative complications, one cystotomy, and one urethral injury. Nineteen patients (9.1%) had post op complications: 2 hematomas, one erosion, and 16 with groin pain. Five (2.8%) patients developed obstructive voiding dysfunction. Of these, 4 patients underwent sling release and one patient needed intermittent self-catheterization for 4 weeks. Twenty-three (11%) patients developed de novo urge incontinence. Reoperation rate was 6.6% (n=14): 3 sling plications and 5 TVTs for recurrent SUI, 4 sling releases, and 2 vaginoplasties. Postoperative QOL data was available for 137 (65.5%) patients and the mean IIQ-7 score was 1.04 (standard deviation [SD] 2.78) and the mean UDI-6 score was 2.21(SD 2.80). CONCLUSION: Early data suggests that the TOT sling is safe and effective. Longer-term studies are needed.
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