Adjustable continence therapy for severe intrinsic sphincter deficiency and recurrent female stress urinary incontinence: long-term experience.

Purpose: ACT® was developed to treat female stress urinary incontinence resulting from intrinsic sphincter deficiency by increasing urethral resistance. We evaluated the implantation procedure and assessed patient outcomes at our center. Materials and Methods: The adjustable continence device consists of 2 silicone balloons on either side of the proximal urethra under the bladder neck, each attached to a titanium port buried in the labia to allow postoperative titration. Urodynamic assessment was done in 57 female patients in whom previous pelvic surgery had failed. Pad use and an incontinence quality of life questionnaire were evaluated before ACT implantation, postoperatively at 1, 3, 6 and 12 months, and annually thereafter. Patients recorded the overall impression and percent of improvement postoperatively based on the Patient Global Impression Index and a visual analog scale. Results: Mean followup was 72 months (range 12 to 84). At 6-year followup in 29 patients mean pad use improved from 5.6 daily at baseline to 0.41 and intrinsic sphincter deficiency improved from 27.2 to 78.6 (p <0.001). As measured on the visual analog scale, 68% of patients considered themselves dry. On the Patient Global Impression Index questionnaire 64% were very much improved, 23% were much improved and 13% were only minimally improved or unchanged. No patients considered themselves worse after the procedure. Complications necessitating device removal developed in 21.1% of patients. Conclusions: Relative ease of insertion and the ability to tailor this therapy to individual needs makes this an attractive option for the challenging treatment for recurrent stress urinary incontinence due to intrinsic sphincter deficiency.