[French multicentre prospective study of the use of ACT balloons (Uromedica, Inc., Plymouth, Min, U.S.A.; Medtronic, Minneapolis, U.S.A.) for the treatment of female stress urinary incontinence].

OBJECTIVE

French multicentre prospective study to evaluate the efficacy and feasibility of ACT (Adjustable Continence Therapy) balloons for the management of female stress urinary incontinence (SUI).

MATERIALS AND

METHODS

The ACT system comprises two adjustable balloons implanted on either side of the bladder neck in order to restore continence. The feasibility of this technique was evaluated perioperatively. Adverse events were recorded to evaluate the acceptability of the technique. Evaluation of efficacy was based on individual interviews to determine the severity of incontinence (use of pads and quality of life questionnaire (I-QoL)) and by Direct Visual Stress Testing (DVST).

RESULTS

68 patients with SUI were included. The mean operating time was 31.8 +/- 11.7 minutes. The ACT was implanted with no particular difficulties in 91% of cases. Evaluation of patients (mean follow-up: 2 years) after implantation revealed a marked improvement of incontinence (87%), DVST (85%) and I-Qol (score: 75/100). The ACT was removed in 18 patients for various reasons and was reimplanted in 6 cases. The ACTI was removed in 8 patients at their request due to complete absence of efficacy.

CONCLUSION

ACT balloon implantation is a new, reversible and promising minimally invasive technique for the management of female stress urinary incontinence. The possibility of percutaneous adjustment of the size of the balloons according to clinical efficacy appears to be an essential advantage of this technique.