TY - JOUR
T1 - Tension-free Vaginal Tape-Obturator for Treatment of Pure Urodynamic Stress Urinary Incontinence
T2 - Efficacy and Adverse Effects at 10-year Follow-up
AU - Serati, Maurizio
AU - Braga, Andrea
AU - Athanasiou, Stavros
AU - Tommaselli, Giovanni A.
AU - Caccia, Giorgio
AU - Torella, Marco
AU - Ghezzi, Fabio
AU - Salvatore, Stefano
PY - 2016
Y1 - 2016
N2 - Background: Inside-out transobturator tape (tension-free vaginal tape-obturator [TVT-O]) is currently one of the most effective and popular procedures for the surgical treatment of female stress urinary incontinence (SUI). However, data reporting long-term outcomes are lacking. Objective: To assess the efficacy and safety of TVT-O 10 yr after implantation for the treatment of female pure SUI. Design, setting, and participants: A multicenter, prospective study was conducted in five tertiary referral centers in three countries. All consecutive women with urodynamically proven pure SUI treated by TVT-O were included. Patients with mixed incontinence and/or anatomic evidence of pelvic organ prolapse were excluded. Intervention: TVT-O implantation. Outcome measurements and statistical analysis: Data regarding subjective outcomes (International Consultation on Incontinence Questionnaire-Short Form, Patient Global Impression of Improvement, and patient satisfaction scores), objective cure (stress test) rates, and adverse events were collected during follow-up. Univariable analysis was performed to investigate outcomes. Results and limitations: One hundred sixty-eight women had TVT-O implantation. At 10-yr follow-up, 160 patients (95%) were available for the evaluation. We did not find any significant change of the surgical outcomes during this time. At 10 yr after surgery, 155 of 160 patients (97%) declared themselves cured (p=0.7). Similarly, at 10-yr evaluation, 148 of 160 patients (92%) were objectively cured. No significant deterioration of objective cure rates was observed over time (p=0.4). The history of failure of previous anti-incontinence procedures (hazard ratio: 5.34; 95% CI, 2.61-11.9; . p=0.009) was the only predictor of recurrence of SUI. The onset of de novo overactive bladder was reported by 23 of 160 patients (14%) at 10-yr follow-up. No other late complications were reported. Conclusions: The 10-yr results of this study showed that TVT-O is a highly effective and safe option for the treatment of SUI. Patient summary: At long-term follow up, tension-free vaginal tape-obturator is highly effective and safe for the treatment of stress urinary incontinence. The 10-yr results of this study showed that tension-free vaginal tape-obturator is a highly effective and safe option for the treatment of stress urinary incontinence.
AB - Background: Inside-out transobturator tape (tension-free vaginal tape-obturator [TVT-O]) is currently one of the most effective and popular procedures for the surgical treatment of female stress urinary incontinence (SUI). However, data reporting long-term outcomes are lacking. Objective: To assess the efficacy and safety of TVT-O 10 yr after implantation for the treatment of female pure SUI. Design, setting, and participants: A multicenter, prospective study was conducted in five tertiary referral centers in three countries. All consecutive women with urodynamically proven pure SUI treated by TVT-O were included. Patients with mixed incontinence and/or anatomic evidence of pelvic organ prolapse were excluded. Intervention: TVT-O implantation. Outcome measurements and statistical analysis: Data regarding subjective outcomes (International Consultation on Incontinence Questionnaire-Short Form, Patient Global Impression of Improvement, and patient satisfaction scores), objective cure (stress test) rates, and adverse events were collected during follow-up. Univariable analysis was performed to investigate outcomes. Results and limitations: One hundred sixty-eight women had TVT-O implantation. At 10-yr follow-up, 160 patients (95%) were available for the evaluation. We did not find any significant change of the surgical outcomes during this time. At 10 yr after surgery, 155 of 160 patients (97%) declared themselves cured (p=0.7). Similarly, at 10-yr evaluation, 148 of 160 patients (92%) were objectively cured. No significant deterioration of objective cure rates was observed over time (p=0.4). The history of failure of previous anti-incontinence procedures (hazard ratio: 5.34; 95% CI, 2.61-11.9; . p=0.009) was the only predictor of recurrence of SUI. The onset of de novo overactive bladder was reported by 23 of 160 patients (14%) at 10-yr follow-up. No other late complications were reported. Conclusions: The 10-yr results of this study showed that TVT-O is a highly effective and safe option for the treatment of SUI. Patient summary: At long-term follow up, tension-free vaginal tape-obturator is highly effective and safe for the treatment of stress urinary incontinence. The 10-yr results of this study showed that tension-free vaginal tape-obturator is a highly effective and safe option for the treatment of stress urinary incontinence.
KW - Long-term follow-up
KW - Sling
KW - Stress urinary incontinence
KW - Tension-free vaginal tape-obturator
KW - TVT-O
KW - Urinary incontinence
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U2 - 10.1016/j.eururo.2016.08.054
DO - 10.1016/j.eururo.2016.08.054
M3 - Article
AN - SCOPUS:84994480592
JO - European Urology
JF - European Urology
SN - 0302-2838
ER -