Randomized trial of a comparison of the efficacy of TVT-O and single-incision tape TVT SECUR systems in the treatment of stress urinary incontinent women—2-year follow-up

• Published in: International Urogynecology Journal 2012-10, Vol.23 (10), p.1403-1412
• Main Authors: Masata, Jaromir, Svabik, Kamil, Zvara, Karel, Drahoradova, Petra, El Haddad, Rachid, Hubka, Petr, Martan, Alois
• Format: Article
• Language: English
• Subjects: Aged; Cough; Female; Follow-Up Studies; Gynecologic Surgical Procedures - methods; Gynecology; Humans; Longitudinal Studies; Medicine; Medicine & Public Health; Middle Aged; Original Article; Suburethral Slings; Surveys and Questionnaires; Treatment Failure; Treatment Outcome; Urinary Incontinence, Stress - surgery; Urology
• ISSN: 0937-3462; 1433-3023
• DOI: 10.1007/s00192-012-1662-x

Introduction and hypothesis The aim of this study was to compare the efficacy of the use of tension-free vaginal tape obturator (TVT-O) and single-incision TVT SECUR, hammock and U approach (TVT-S, H and U), in the treatment of urodynamic stress urinary incontinence (SUI). Methods This single-center randomized three-arm trial compared the objective and subjective efficacy and early failure rate of the TVT-O and TVT-S H and U approach by objective criteria (cough test) and subjective criteria using the International Consultation on Incontinence Questionnaire—Short Form (ICIQ-UI SF). The objective efficacy rate was defined as the number of patients with a negative cough stress test. Subjective cure was defined by no stress leakage of urine after surgery based on the evaluation of ICIQ-UI SH (when patients ticked “Never”/“Urine does not leak” in answer to question 6: When does urine leak?). Objective and subjective efficacy were evaluated using Last Failure Carried Forward analysis, i.e., final analysis also included patients with early failure. To describe outcome at different time points, the Last Observation Carried Forward method was also implemented. Results One hundred ninety-seven women with proven SUI were randomized into three groups—TVT-O ( n  = 68), TVT-S H ( n  = 64), and TVT-S U ( n  = 65). Each patient allocated to a treatment group received the planned surgery. There were no differences in each group in preoperative characteristics. Median follow-up after surgery was 2 years (SD, 0.8; range, 0.1 to 3.8 years). Of the subjects, 92.6% in the TVT-O group, 68.8% in the TVT-S H group, and 69.2% in the TVT-S U group had negative stress test ( p