TY - JOUR T1 - Comparison of the efficacy of tension-free vaginal tape obturator (TVT-O) and single-incision tension-free vaginal tape (Ajust™) in the treatment of female stress urinary incontinence: a 1-year follow-up randomized trial. AU - Masata,Jaromir, AU - Svabik,Kamil, AU - Zvara,Karel, AU - Hubka,Petr, AU - Toman,Ales, AU - Martan,Alois, Y1 - 2016/04/01/ PY - 2015/12/02/received PY - 2016/03/14/accepted PY - 2016/4/3/entrez PY - 2016/4/3/pubmed PY - 2017/8/9/medline KW - Ajust™ KW - Single incision midurethral sling KW - Stress urinary incontinence KW - Surgical treatment KW - TVT-O SP - 1497 EP - 505 JF - International urogynecology journal JO - Int Urogynecol J VL - 27 IS - 10 N2 - INTRODUCTION AND HYPOTHESIS: The aim of this study was to compare the efficacy of the tension-free vaginal tape obturator (TVT-O) and single-incision tension-free vaginal tape (Ajust™) in the treatment of stress urinary incontinence in a randomized two-arm study with a 1-year follow-up. METHODS: This single-centre randomized trial compared the objective and subjective cure rates of TVT-O and Ajust using objective criteria (cough test) and subjective criteria (International Consultation on Incontinence Questionnaire short form, ICIQ-UI SF). The objective cure rate was defined as the number of patients with a negative cough stress test. Subjective cure was defined as no stress leakage of urine after surgery based on the ICIQ-UI SF. The primary outcome was to establish differences in objective and subjective cure rates between the TVT-O and Ajust groups. We also compared postoperative pain profiles using a visual analogue scale (VAS), improvement in quality of life using the ICIQ- UI SF and the Incontinence Quality of Life questionnaire, and overall satisfaction with the surgical procedure using a VAS and a five-item Likert scale. Inclusion criteria were age over 18 years, signed informed consent, and urodynamic stress urinary incontinence. Following a power calculation, 50 patients were enrolled into each group (Ajust and TVT-O). RESULTS: The mean follow-up after surgery was 445 days (SD 157.6 days) in the TVT-O group and 451.8 days (SD 127.6 days) in the Ajust group (p = 76.6 %). At 1 year, 47 patients were evaluated in the TVT-O group and 49 in the Ajust group. No differences in subjective cure rates or objective cure rates were observed. In the Ajust and TVT-O groups, the rates for no subjective stress leakage were 89.8 % and 91.5 %, respectively (p = 1.0, OR 1.22, 95 % CI 0.24 - 6.58), and the rates for a negative stress test were 89.8 % and 87.2 %, respectively (p = 0.76, OR 0.77, 95 % CI 0.17 - 3.32). In the Ajust group two patients reported de novo pain during sexual intercourse. CONCLUSIONS: After a 1-year-follow-up, no significant differences were found with regard to subjective and objective outcomes between the single-incision tape Ajust and TVT-O. SN - 1433-3023 UR - https://www.unboundmedicine.com/medline/citation/27037563/Comparison_of_the_efficacy_of_tension_free_vaginal_tape_obturator__TVT_O__and_single_incision_tension_free_vaginal_tape__Ajust™__in_the_treatment_of_female_stress_urinary_incontinence:_a_1_year_follow_up_randomized_trial_ DB - PRIME DP - Unbound Medicine ER -