Adjustable Continence Therapy for Female Sui

Abstract

Since December 1999 a new adjustable device for female stress urinary incontinence called the ACT (Adjustable Continence Therapy) has been used in a multicentre study. The two year follow-up of the Italian multicentre study is presented.

Material & Methods

A group of 37 female patients, affected by SUI was evaluated before and after the positioning of the ACT with physical examination, urodynamic study and quality of life questionnaires (I-QOL) Mean age was 58,5 (range 21.9 – 84.6). 59% (22/37) had type II SUI while 42% (15/37) had type III SUI. 57% (21/37) had had prior urogenital surgery. The ACT device consists of an adjustable silicon balloon, a subcutaneously positioned titanium port and a two lumen tube in between. The devices are positioned via a percutaneous perineal approach, using either local or regional anaesthesia. A 2 cm skin incision is made on each labia majora and through these incisions a delivery trocar is directed toward the bladder neck. The trocar is manoeuvred into the desired position using tactile guidance and an image intensifier (III). Each ACT device is then inserted via the delivery tool. Each balloon is positioned lateral to the bladder neck, proximal to the vesico-vaginal space, below the endopelvic fascia. Each balloon is then filled with one to two millilitres of the isotonic contrast/sterile water mixture with X rays confirmation of the correct location. The injection ports attached to each balloon are then positioned subcutaneously in each labia majora; the balloons are subsequently adjusted, if this is required.

Results

15 patients reached 24 months of follow-up. 46% of them were dry at physical examination and wear no pads. Additional 26% were significantly improved. This group of patients had to wear 1 pad/daily. 56% of the patients required one adjustment to achieve continence, 10% two adjustments, 10% three adjustments 24% need no adjustments. No cases of urinary retention were reported out of 37 cases. One patient had a transient dyspareunia.

Conclusions

70 % of our patients where dry or substantially improved and the patients quality of life increases significantly, this results includes mainly the patient with sever intrinsic sphincter deficiency and failed previous incontinence surgery. The ability to post-operatively adjust the ACT permits to reach the appropriate volume to each patient. However a longer follow up and a bigger number of procedures are required for definitive conclusions.