Tension-free Vaginal Tape-Obturator for Treatment of Pure Urodynamic Stress Urinary Incontinence: Efficacy and Adverse Effects at 10-year Follow-up.
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.



To assess the efficacy and safety of TVT-O 10 yr after implantation for the treatment of female pure SUI.



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.



TVT-O implantation.



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.



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.



The 10-yr results of this study showed that TVT-O is a highly effective and safe option for the treatment of SUI.



At long-term follow up, tension-free vaginal tape-obturator is highly effective and safe for the treatment of stress urinary incontinence.
Department of Obstetrics and Gynecology, University of Insubria, Varese, Italy. Electronic address: mauserati@hotmail.com.
Maurizio
M
Serati
Department of Obstetrics and Gynecology, EOC-Beata Vergine Hospital, Mendrisio, Switzerland.
Andrea
A
Braga
First Department of Obstetrics and Gynecology, University of Athens, "Alexandra" Hospital, Athens, Greece.
Stavros
S
Athanasiou
Department of Obstetrics and Gynecology, University of Naples Federico II, Naples, Italy.
Giovanni A
GA
Tommaselli
Department of Obstetrics and Gynecology, EOC-Beata Vergine Hospital, Mendrisio, Switzerland.
Giorgio
G
Caccia
Department of Obstetrics and Gynecology, Second Faculty, Naples, Italy.
Marco
M
Torella
Department of Obstetrics and Gynecology, University of Insubria, Varese, Italy.
Fabio
F
Ghezzi
Obstetrics and Gynecology Unit, Vita-Salute University and IRCCS San Raffaele Hospital, Milan, Italy.
Stefano
S
Salvatore
D000368:Aged; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008875:Middle Aged; D011183:Postoperative Complications / Q000453:epidemiology; D016016:Proportional Hazards Models; D011446:Prospective Studies; D012008:Recurrence; D053825:Suburethral Slings; D011795:Surveys and Questionnaires; D016896:Treatment Outcome; D053201:Urinary Bladder, Overactive / Q000453:epidemiology; D014550:Urinary Incontinence, Stress / Q000175:diagnosis / Q000503:physiopathology / Q000601:surgery*; D014563:Urodynamics; D013520:Urologic Surgical Procedures / Q000379:methods*
Long-term follow-up; Sling; Stress urinary incontinence; TVT-O; Tension-free vaginal tape-obturator; Urinary incontinence