Abstract
This study examines the safety of the inside-out transobturator approach for transvaginal tape (TVT-O™, Gynaecare) treatment in stress urinary incontinence (SUI) in women based on a French registry of patients. A total of 984 women from 86 centres were enrolled in the study. Patients with predominant overactive bladder or significant pelvic organ prolapse were excluded from the study. Perioperative and post-operative complications were reported as well as urinary function at 4 and 12 weeks. Pain was assessed by the patients using a visual analog scale (VAS). The overall perioperative complication rate was 2.2%. The most commonly reported morbidities were vaginal wall perforation (1.3%) followed by haematoma (0.7%). Post-operative complication rate was 5.2%; the most common complication was residual pain (2.7%). The other complications of paravesical haematoma, urinary retention, vaginal erosion and re-intervention had an incidence of less than 1.0%. This study demonstrates that the transobturator transvaginal tape approach to the treatment of SUI is a safe procedure.
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Johnson & Johnson, France provided support for the electronic database and investigator meetings. All data analyses were independent of Johnson & Johnson.
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Collinet, P., Ciofu, C., Costa, P. et al. The safety of the inside-out transobturator approach for transvaginal tape (TVT-O) treatment in stress urinary incontinence: French registry data on 984 women. Int Urogynecol J 19, 711–715 (2008). https://doi.org/10.1007/s00192-007-0514-6
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DOI: https://doi.org/10.1007/s00192-007-0514-6