Adjustable Continence Therapy for the treatment of male stress urinary incontinence: a single-centre study.

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.