Prospective Randomized Study of MiniArc and Ajust Single Incision Sling Procedures.

ABSTRACT

OBJECTIVES: The aim of this study was to evaluate the efficacy of the Ajust and MiniArc system mini-sling anti-incontinence procedures for female stress urinary incontinence, at a minimum of 24 months after surgery. METHODS: This prospective, randomized, multicenter study included 66 women with previously untreated stress urinary incontinence, and 63 patients completed the study. These women were randomly divided into two groups; the first group of patients underwent operations using the Ajust (n = 33) technique, while the second group were treated with the MiniArc (n = 33) technique. The efficacy of the Ajust and MiniArc procedures (n = 31/32) was evaluated at an average of 28/29 months (minimum24 months) after the procedures. Subjective assessment of the cure rate and the leakage of urine was based on the International Consultation on Incontinence Questionnaire - Short Form (ICIQ-UI SF) and five-point Likert scale. Objective assessment of leakage of urine was assessed by the cough test. RESULTS: Subjective assessment by the ICIQ-UI SF questionnaire showed that 93.5-96.9% of patients were dry or improved 28/29 months after the Ajust/MiniArc operations. Based on evaluation by means of the Likert scale, 83.9/81.3% of patients in the Ajust/MiniArc group were dry or improved. Objective assessment by cough test showed that 93.5/81.3% of patients had negative results for this test 28/29 months after the Ajust/MiniArc procedures. CONCLUSIONS: The cure rates of the Ajust and MiniArc procedures are very good with the follow-up of 24 months.