RESUMEN
OBJECTIVE OF THE STUDY: To compare short term results of tension free vaginal tape - obturator (TVT-O) and the tension free vaginal tape Seccure in the treatment of urodynamic stress urinary incontinence (USI). DESIGN: Randomize trial. SETTINGS: Department of Gynecology and Obstetrics, First Medical Faculty, Charles University; General Teaching Hospital, Prague. MATERIAL AND METHODS: This single-centre 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 evaluation of ICIQ - UI SH (when patients ticked "Never" / "Urine does not leak" in answer to Question 6: When does urine leak?). RESULTS: 197 women with proved SUI were randomized into three groups - TVT-O (68), TVT-S H (64) and TVT-S U (65). Each patient allocated to a treatment group received the planned surgery. There were no differences in each group in pre-operative characteristics. Three months after surgery were analyzed 65 women in TVT-O group, 61 in TVT-S H and 60 in TVT-S U. 95.4% subjects in the TVT-O group, 82% in the TVT-S H group and 76.7% in the TVT-S U group had stress test negative (p=0.006). 90.8% subjects in the TVT-O group, 82% in the TVT-S H group and 78.3% in the TVT-S U group were subjectively continent (NS). CONCLUSIONS: Our study demonstrated a significantly lower objective cure rate in the single incision TVT S group compared to the TVT-O group three months after surgery.
