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Abstract
Objective. To evaluate the Adjustable Continence Therapy (ProACT™) device, a new device for the treatment of male stress urinary incontinence resulting from compromised sphincteric function. Material and methods. A total of 64 males with post-prostatectomy incontinence underwent ProACT implantation. Efficacy was assessed by means of a daily pad count, a direct visual stress test, administration of the Incontinence Quality of Life (IQOL) and patient global impression (PGI) questionnaires and use of a visual analogue scale (VAS) to assess improvement in incontinence. These assessments were performed at baseline, 1, 3, 6 and 12 months after the procedure and annually thereafter. Results. The pad count declined from a median of 5.2 at baseline to 2 at 6 months and to 1.54 at 12 months. The median baseline IQOL score was 31.7, and this improved to 62.5 at 6 months and to 71.1 at 12 months. In terms of postoperative daily pad usage, 43 patients (67%) were considered to be dry, 10 (15%) improved and 11 (17%) unchanged. In terms of the post operative PGI score, 42 patients (66%) considered themselves to have improved greatly, 10 (16%) to have improved quite a lot, 6 (9%) to have improved slightly and 6 (9%) to be unchanged. The average improvement based on the VAS was 80%. The average number of postoperative adjustments was three (range zero to nine). Complications included infection (2/64; 3%), erosion of balloons (5/64; 7.6%), migration (2/64; 3%) and balloon deflation (2/64; 3%). Device removal was required in 9/64 patients (14%) but was easily achieved using local anaesthesia, and this thus permitted further therapeutic intervention. New balloons were implanted following endoscopic confirmation of urethral healing. Conclusion. The ProACT device represents an efficacious treatment modality, which has an acceptable complication rate for a difficult group of patients.