Introduction and Objectives:
Balloons inserted around the urethra represent a new method for treating women with stress urinary incontinence (SUI). The current balloons do not permit an adjustment of the urethral compression necessary to promote continence and rely solely on the surgeon's subjective impression. Usually more than a single procedure is necessary to keep the patients dry. We present a new specially developed adjustable device (ACT) used to correct female SUI.

Methods:
Nine patients with ages varying from 34 to 54 years (mean 42.2) and no previous therapy for urinary incontinence underwent the procedure between Jul. 1999 and Jan.2000. Six had type II and three type III SUI. All had video-urodynamic studies done pre-operatively. The device is a small silicon balloon filled with 1-2cc of diluted contrast, with a valve in its extremity. Through this valve, one can percutaneously adjust the volume of the balloon post-operatively, if necessary. One balloon was positioned on each side of the urethra close to the bladder neck using specially developed introducers. The valvular segment of the device was placed subcutaneously in the major labia. Patients were discharged on the second PO day and kept on oral cefalosporins for 14 days.

Results:
All patients became totally dry after the procedure. The balloons were easily positioned in the proximal urethra. One patient with no complications demanded to have the device removed on the sixth post-operative week. Complications included one bladder perforation during balloon implantation; distal migration of one balloon and one balloon and valve extrusions. All complications were easily corrected and after a mean follow up of 6 months, all patients remained dry and apt.

Conclusions:
The ACT device promotes urinary continence in women. It is easily adjustable and if necessary can be removed without difficulties. Complication rates were similar to other previously reported peri-uretral devices and were easily manageable. All patients remain totally dry on follow up.