Abstract
Background and objectives: Stress urinary incontinence (SUI) is the most common type of urinary incontinence, affecting approximately 46% of adult women. After failure of conservative treatment, the mid-urethral sling (MUS) is considered the most effective and safe surgical procedure for SUI. In 2012, Waltregny et al. introduced a new trans-obturator tension-free vaginal tape (TVT) procedure, named TVT-abbrevo (TVT-A). The aim of the present study is to evaluate the efficacy and safety of the TVT-A procedure in women with pure SUI at 5-year follow-up. Materials and Methods: All women who complained of pure SUI symptoms with concomitant urodynamic stress incontinence (USI) were prospectively enrolled and treated with the TVT-A procedure. Postoperative subjective outcome measures included: International Consultation on Incontinence Questionnaire-Short Form (ICI-Q SF), Patient Global Impression of Improvement (PGI-I) scale, and patient degree of satisfaction scale. A PGI-I score ≤ 2 and a patient-satisfaction score ≥8 were used to define subjective success. Objective success was defined as the absence of urine leakage during a cough stress test. Adverse events were collected according to the Clavien-Dindo classification during follow-up. Results: Univariable analysis was used to investigate outcomes. Fifty women who met the inclusion criteria underwent TVT-A implantation. At 5 years after TVT-A implantation, 38 out of 45 (84.4%) patients were subjectively cured (p for trend 0.05), and 40 out of 45 (88.9%) patients were objectively cured (p for trend 0.04). A significant trend of de novo OAB symptoms was reported (22.2% [10/45]) at the 5-year follow-up. No serious early or late complications such as urethral/bladder injury, persistent groin-thigh pain, and sexual dysfunction that required mesh removal were detected. The univariate analysis did not reveal any risk factors (i.e., age, body mass index (BMI), menopause, obstetric factors, and preoperative ICIQ- SF questionnaire) statistically associated with failure of the TVT-A procedure. Conclusions: In conclusion, the 5-year follow-up results of this study demonstrated that TVT-A is a safe and effective option for treatment of SUI with a very low rate of post-operative groin-thigh pain.