Continence, quality of life improve with adjustable device

October 15, 2008

An adjustable urethral prosthesis significantly improved urinary symptoms, urine leakage, and quality of life in women with stress urinary incontinence who had failed to improve after prior therapy.

Three-fourths of these patients had at least a 1-point improvement in Stamey score during follow-up, and the average urine loss on provocative pad weight test decreased fourfold, Sherif R. Aboseif, MD, director, neurourology and reconstructive surgery, Kaiser Permanente Los Angeles, reported at the AUA annual meeting.

The procedure, known as Adjustable Continence Therapy (ACT, Uromedica, Plymouth, MN), "is an effective procedure for recurrent SUI," said Dr. Aboseif. "It requires a simple implantation technique and is associated with minimal postoperative recovery. The system can be adjusted postoperatively in the office. The complication rate is low, and the device can be easily re-implanted, should this be necessary."

Postoperatively, the balloons can be adjusted to meet the specific needs of each patient, beginning 4 to 6 weeks after implantation. Adjustments are performed via balloon inflation through a subcutaneously placed injection port linked by tubing to the balloons. Dr. Aboseif said changes in balloon inflation should be limited to 1 mL to 2 mL per adjustment.

The ACT procedure was evaluated in a multicenter trial of 162 patients whose stress incontinence had not improved after at least a 6-month trial of another type of therapy. Mean age of this group was 67.8 years, and about half had incontinence with hypermobility, while the other half of the patients were considered to have intrinsic sphincter deficiency.

Almost half of the patients had undergone two or more procedures for incontinence. In 84% of cases, surgery was the prior therapy that had failed to improve symptoms and urine leakage.

The principal objectives of the trial were to assess the ACT system's efficacy (change in Stamey score and provocative pad weight test), safety, change in patient-reported quality of life, technical feasibility, and adjustability.

Dr. Aboseif said 128 patients (79%) had completed a minimum of 12 months follow-up. Of those who didn't complete the 12-month visit, 0.6% had died of an unrelated cause, 4.3% had had the device permanently explanted, 4.3% were lost to follow-up, 6.2% had missed their 12-month visit, and 5.6% were not yet due for the 12-month visit.

Among the women who completed 12 months of follow-up, 77.3% had at least a 1-grade improvement in Stamey score. The provocative pad weight test averaged 54 grams at baseline and decreased to 11.6 grams at 12 months (p<.001).

Patients completed the Incontinence Quality of Life, Urogenital Distress Inventory, and Incontinence Impact Questionnaire at baseline and the end of the study. The mean score for each self-administered questionnaire improved significantly, with improvement in the range of 20 to 30 points with respect to baseline.

Dr. Aboseif reported that 42 patients (26%) had at least one device or procedure complication, the most common being balloon migration, port erosion, lack of improvement, and balloon erosion. Of those who had a complication, 29 patients underwent explant procedures, and 13 of the 29 had the ACT system re-implanted. Most of the complications were rated mild or moderate in severity.

The degree of difficulty of the device implantation was evaluated by surgeon reports. Dr. Aboseif said 71% of implant procedures were rated as having a mild degree of difficulty, 24% were considered moderately difficult, and 5% were of a severe degree of difficulty.

Patients required an average of two balloon adjustments during the first 12 months. Total balloon volume averaged 3.4 mL. Most adjustments occurred during the first 6 months after implantation.

"[ACT] involves a simple implantation technique and minimal postoperative recovery, after which the device can be adjusted to meet the needs of each patient. [It] has a low complication rate and can be easily reimplanted," Dr. Aboseif said.