Maurizio Serati1, Andrea Braga2, Stavros Athanasiou3, Giovanni A Tommaselli4, Giorgio Caccia2, Marco Torella5, Fabio Ghezzi6, Stefano Salvatore7. 1. Department of Obstetrics and Gynecology, University of Insubria, Varese, Italy. Electronic address: mauserati@hotmail.com. 2. Department of Obstetrics and Gynecology, EOC-Beata Vergine Hospital, Mendrisio, Switzerland. 3. First Department of Obstetrics and Gynecology, University of Athens, "Alexandra" Hospital, Athens, Greece. 4. Department of Obstetrics and Gynecology, University of Naples Federico II, Naples, Italy. 5. Department of Obstetrics and Gynecology, Second Faculty, Naples, Italy. 6. Department of Obstetrics and Gynecology, University of Insubria, Varese, Italy. 7. Obstetrics and Gynecology Unit, Vita-Salute University and IRCCS San Raffaele Hospital, Milan, Italy.
Abstract
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.
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.
Authors: Andrea Braga; Giorgio Caccia; Giovanni Ruggeri; Luca Regusci; Andrea Papadia; Maurizio Serati Journal: Int Urogynecol J Date: 2019-08-28 Impact factor: 2.894
Authors: Hyung Ho Lee; Dae Keun Kim; Jae Won Park; Suk Young Lee; Woo Jin Ko; Young Sig Kim Journal: Int Urogynecol J Date: 2019-11-28 Impact factor: 2.894