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• W2007248621 abstract "Study Objective: To evaluate the safety and efficacy of a specific transobturator (TOT) technique. Design: Two monitored non-randomized, prospective, multi-centered studies sharing comparable objectives, patient eligibility criteria, and follow-up intervals were merged. The primary efficacy outcome measure was a cough stress test. Secondary efficacy outcomes included: Stamey incontinence grade, IIQ-7, UDI-6 and quality of life (QoL). Complications were recorded at each follow-up. Setting: University and community Urogynecology and Urology centers. Patients: Eligibility criteria included: women >18 years old, SUI or mixed urinary incontinence, no prior synthetic tape surgery, not pregnant, no urinary or vaginal infection, and <150 mL post-void residual. Intervention: Each subject received transobturator placement of a monofilament polypropylene, ultra-light weight, macroporous, midurethral tape (Aris (TM), Coloplast, Denmark). Measurements and Main Results: One-hundred and seventeen (117) women (mean age 55.1 y, range 29–87 y) underwent transobturator tape surgery. Eighty-nine (89) completed the study with a mean follow-up time of 12.5 ± 1.4 months. SUI (60%) or mixed urinary incontinence (40%) was urodynamically confirmed prior to surgery. Peri-operative measures were: blood loss >200 mL (3/116); length of stay: outpatient (66/117), <23 hours (48/117), >1 day (3/117); length of catheterization: none (54/117), <23 hours (54/117), >1 day (9/117). A negative cough stress test at 12-months was recorded in 86/88 (98%) (p<0.0001). Secondary outcome measures at 12-months all showed statistically significant improvements including QoL (P<0.0001). Complications at 12-months were 5 patients with vaginal exposure of tape all treated as outpatients and 2 patients with new-onset overactive bladder symptoms.Tabled 1Post-Operative Measurements and Statistical Significance from BaselineObjectiveMeasureAll patients Pre-operativePre-operative6 months12 months∗Three patients had one or more unreported test resultsP value (baseline v 12 months)Primary effectivenessNegative Cough Stress Test7/117 (6%)5/89 (5.6%)72/79 (91%)86/88 (98%)McNemar X2 p<0.0001Stamey grade1.51 ± 0.831.51 ± 0.83n=79 0.39 ± 0.79n=88 0.56 ± 0.93Paired t-test p<0.0001Pad Use0: 22 1-2: 51 3-5: 37 >5: 70: 16 1-2: 36 3-5: 31 >5: 00: 55 1-2: 22 3-5: 3 >5: 00: 61 1-2: 22 3-5: 3 >5: 2McNemar X2 p<0.001Secondary effectivenessIIQ-742.3 ± 26.7n=89 42.2 ± 26.1n=78 6.9 ± 18.7n=88 6.5 ± 14.8p<0.0001UDI-655.2 ± 20.2n=89 55.9 ± 20.6n=78 14.5 ± 16.7n=87 15.5 ± 17.7Paired t-test p<0.0001Improved QoL5.0 ± 0.954.9 ± 0.97n=78 1.03 ± 1.40n=88 1.2 ± 1.6Paired t-test p<0.0001∗ Three patients had one or more unreported test results Open table in a new tab Conclusion: This final analysis of merged outcome data from two multicenter, prospective trials on a transobturator midurethral tape shows that the procedure is safe and effective in treating SUI and mixed incontinence with significantly improved QoL which is maintained 1 year after surgery." @default.
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• W2007248621 date "2010-11-01" @default.
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• W2007248621 title "Two Prospective Clinical Trials of Transobturator Midurethral Tape for Stress Urinary Incontinence: Analysis of Final Merged Outcome Data" @default.
• W2007248621 doi "https://doi.org/10.1016/j.jmig.2010.08.299" @default.
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