84 One year results of a French, multicentre, prospective clinical study of act® (adjustable continence therapy) for the treatment of female of stress urinary incontinence due to intrinsic sphincter deficiency

Introduction:  This Prospective, multicentre clinical investigation sought to assess the feasibility and efficacy of the adjustable balloons ACT® for treatment of female Stress Urinary Incontinence SUI with ISD. Materials and Methods:  The ACT® implant consists of a two-lumen conduit of variable length with an expandable silicone balloon (0.5–8 cc) on the proximal end and a distal subcutaneous titanium port. Two balloons were placed periurethrally at the bladder neck. Continence rate (no leakage during direct visual stress test with 250 ml placed in the bladder), improvement, failures, quality of life (I-QoL) and morbidity were assessed. Results:  Sixty-seven patients (62 ± 9.8-years-old) were implanted in France during 75 procedures (8 revisions). Average follow-up was 12 months. At baseline, urethral closure pressure was 22.5 ± 10.8 cm H2Oand 39 patients (58%) had previously undergone at least one surgery for SUI. Continence increased from 0% at baseline to 57% at1 year and I-QoL improved from 39.4 ± 19 at baseline to 63.7 ± 23.3 at one year. Balloon adjustment was required in 64% of patients. Complications included erosion (11%), spontaneously resolved retention (2%) and infection (4%). Conclusion:  ACT® offers a viable alternative for the treatment of SUI in female with ISD. The implantation is a minimally invasive and efficient procedure and stable over time therapy for patients with severe SUI with ISD. Implantation can be done under local anaesthesia. The positioning of ACT® treatment versus artificial urinary sphincter still needs to be determined.