Objective: To evaluate the safety and efficacy of a new minimally invasive urological implant for incontinence after prostatectomy.
Patients and methods: The adjustable continence therapy device (ProACT, Uromedica, Plymouth, MN, USA) consists of two balloons placed via a perineal approach bilaterally at the bladder neck in patients after prostatectomy. Titanium ports, attached via discrete tubing to each balloon, are placed in the scrotum, allowing for separate volume adjustments of the balloons at any time during and after surgery. Changes in a quality-of-life questionnaire (I-QoL), pad usage and a subjective continence grading score were assessed in 117 consecutive men after implanting the Pro-ACT, at baseline and at 1, 3, 6, 12 and 24 months.
Results: After a mean (range) follow-up of 13 (3-54) months and with a mean of 3 (0-15) adjustments, 67% of men were dry, using at most one 'security' pad daily; 92% were significantly improved, and 8% showed no improvement. The I-QoL score improved from a median of 34.7 to 66.3 after 2 years (42 men; P < 0.001), the daily pad count decreased from a mean of 6 (1-24)/day to 1 (0-6)/day at 2 years (P < 0.001). Continence achieved at < or = 6 months after implantation through incremental adjustment remained durable at > or = 2 years in most patients. There were complications during and after surgery in 54 patients, mostly minor and decreasing with increasing expertise, primarily reflecting the development and refinement of the new surgical technique and its instrumentation. Re-implantation for complications was required in 32 patients, with a 75% success rate.
Conclusions: The ProACT peri-urethral prosthesis produces durable outcomes equivalent or better than other minimally invasive treatments for incontinence after prostatectomy. Its unique design allows for easy adjustment after surgery to achieve the desired urethral resistance, with no further surgical intervention, thus allowing for an optimum balance between voiding pressures and continence. The promising results reported here suggest that this may be an appropriate, effective and durable first-line treatment to offer men with stress urinary incontinence after prostatectomy.