Prospective multi-centre study of adjustable single-incision mini-sling (Ajust(®) ) in the management of stress urinary incontinence in women: 1-year follow-up study.

ABSTRACT

OBJECTIVES: To determine whether an adjustable single-incision mini-sling (SIMS, Ajust(®) ) is safe and effective in the management of female stress urinary incontinence (SUI) at 12 months follow-up. To determine whether it is feasible to be performed under local anesthesia (LA). MATERIALS AND METHODS: The present study is a multicentre prospective cohort study in which 90 female patients underwent SIMS-Ajust(®) using a standardized insertion technique. The last 45 women were offered the procedure under LA. All patients completed their 12-month follow-up. RESULTS: The patient-reported success rate, using Patient Global Impression of Improvement (PGI-I), was 80% at 12 months follow-up and a further 6% (n= 5) reported themselves to be 'improved'. In all, 32/45 (71%) patients agreed to undergo the procedure under LA while one patient required conversion to general anaesthetic. There was no organ damage or requirement for blood transfusion. Significantly lower rates of blood loss (P= 0.025) and postoperative voiding difficulties (P= 0.026) were seen in the LA group. The re-operation rate for SUI was 6% at 12 months. CONCLUSIONS: SIMS (Ajust) appears to be a safe procedure, which is feasible under LA. SIMS (Ajust) have an 80% patient-reported success rate at 12 months follow-up.