Adjustable bladder support shows improvement in SUI, QoL

May 20, 2008

An adjustable bladder support offers an effective, minimally invasive strategy for treating stress urinary incontinence (SUI), an investigator in a multicenter trial reported at the AUA annual meeting.

An adjustable bladder support offers an effective, minimally invasive strategy for treating stress urinary incontinence (SUI), an investigator in a multicenter trial reported at the AUA annual meeting.

Implantation of the adjustable continence therapy (ACT) system (Uromedica, Plymouth, MN) led to significant improvement in SUI symptoms and quality of life after 1 year, said Sherif Aboseif, MD, of Kaiser Permanente in Los Angeles. Three-fourths of patients who received the devices had at least a one-point improvement in the Stamey score, and most patients expressed satisfaction with the device and its effectiveness.

"ACT is an effective procedure for recurrent SUI," Dr. Aboseif said. "It requires a simple implantation technique, and is associated with minimal postoperative recovery. The system can be adjusted postoperatively. The complication rate is low, and the device can be easily re-implanted."

The ACT system consists of two silicone balloons placed at the bladder neck to increase urethral coaptation and provide support. The balloons can be adjusted postoperatively to meet the specific needs of each patient.

Dr. Aboseif reported findings from a clinical trial involving 161 patients, 107 of whom have been followed for at least a year. Principal objectives of the trial were to assess the therapy system's efficacy (change in Stamey score and provocative pad weight test), safety, change in patient-reported quality of life, technical feasibility, and adjustability.

Among the patients followed for at least 1 year, 76.6% had one-point or greater improvement in Stamey score. Multiple quality of life assessments revealed significant improvement in the 12 months after implantation of the ACT device (p<.001). The mean provocative pad weight decreased from 49.7 grams at baseline to 11.9 grams at 1 year (p<.001).

The patients required an average of 2.1 balloon adjustments during the first 12 months. Adverse events were reported in 56.2% of the patients, and investigators judged the events to be mild in 81% of cases. Dr. Aboseif said 29 patients required device explantation because of balloon or port migration or erosion, but 17 of the 29 patients underwent repeat implantation.