Daphné Lizée, Jean Nicolas Cornu, Marco Torella, Maurizio Serati, Stefano Salvatore, Andrea Braga, Elena Cattoni, Ricarda M. Bauer, François Haab, Gabriele Siesto, Serati, M, Bauer, R, Cornu, Jn, Cattoni, E, Braga, A, Siesto, G, Lizée, D, Haab, F, Torella, Marco, Salvatore, S., Serati, M., Bauer, R., Cornu, J. N., Cattoni, E., Braga, A., Siesto, G., Lizée, D., Haab, F., Torella, M., and Salvatore, Stefano
Background Inside-out tension-free vaginal transobturator tape (TVT-O) is currently one of the most effective and popular procedures for the surgical treatment of female stress urinary incontinence (SUI), but data reporting long-term outcomes are scarce. Objective To evaluate the efficacy and safety of TVT-O 5-yr implantation for management of pure SUI in women. Design, setting, and participants A prospective observational study was conducted in four tertiary reference centers. Consecutive women presenting 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 without any associated procedure. Outcome measurements and statistical analysis Data regarding subjective outcomes (International Consultation on Incontinence-Short Form [ICIQ-SF], Patient Global Impression of Improvement, patient satisfaction scores), objective cure (stress test) rates, and adverse events were collected during follow-up. Multivariable analyses were performed to investigate outcomes. Results and limitations Of the 191 women included, 21 (11.0%) had previously undergone a failed anti-incontinence surgical procedure. Six (3.1%) patients were lost to follow-up. The 5-yr subjective and objective cure rates were 90.3% and 90.8%, respectively. De novo overactive bladder (OAB) was reported by 24.3% of patients at 5-yr follow-up. Median ICIQ-SF score significantly improved from 17 (interquartile range [IQR]:16–17) preoperatively to 0 (IQR: 0–2) ( p Failure of a previous anti-incontinence procedure was the only independent predictor of subjective recurrence of SUI (hazard ratio [HR]: 4.4; p =0.009) or objective (HR: 3.7; p =0.02). No predictive factor of de novo OAB was identified. Conclusions TVT-O implantation is a highly effective option for the treatment of women with pure SUI, showing a very high cure rate and a low incidence of complications after 5-yr follow-up.