To assess the efficacy and complications associated with the use of the tension-free vaginal tape (TVT)-Secur system device for the treatment of female stress urinary incontinence (SUI) based on a 3-year follow-up.Methods:
Women with SUI were randomly allocated to either the U- or H-type groups depending on the TVT-Secur approach used. Patients were questioned about continence and satisfaction 1, 2, and 3 years after surgery. Patients were assessed postoperatively by questionnaires including Sandvik, Incontinence Quality of Life (I-QoL), Bristol Female Lower Urinary Tract Symptoms-Scored Form (BF-LUTS), incontinence visual analogue scale (I-VAS), and benefit, satisfaction, and willingness to continue questionnaire. Cure was regarded as no leakage on the Sandvik questionnaire.Results:
A total of 115 patients with SUI were included in this study (U-type: 53, H-type: 62). A total of 102 patients were followed-up for 3 years (U-type: 47, H-type: 55). The overall cure rate at the 1-, 2-, and 3-year follow-ups was 87.8, 83.0, and 79.4%, respectively, and there was no difference in the cure rate between the U-and H-type approaches. Approximately 83.4 and 83.3% of patients were satisfied with the surgical outcome at the 1- and 3-year follow-ups. I-QoL, BFLUTS-SF, and I-VAS were improved from baseline regardless of the approach used at the 1- and 2-year follow-ups. Complications included intraoperative vaginal wall perforation (three cases), voiding difficulties such as immediate postoperative retention, and urgency episodes.Conclusions:
Both U- and H-type approaches of TVT-Secur for the treatment of female SUI remains efficacious, safe, and satisfactory for up to 3 years after surgery.