BERKELEY, CA (UroToday.com) - Male stress urinary incontinence (SUI) is a challenging problem for men following radical prostatectomy (RP).

Treatment of SUI after RP with an entirely new system, the ProACTTM (Uromedica, Plymouth, MN, USA), has been recently introduced. The ProACT system is an adjustable permanent implant designed to achieve continence through increased outlet resistance in male patients with SUI. The ProACT is comprised of an expandable silicone balloon attached to a re-injectable titanium port through a tube. Every patient requires two balloons, placed to either side of the vesico-urethral anastomosis, just above the pelvic diaphragm. A specially designed trocar is used to insert the balloons through a transperineal route. The two titanium ports are placed into a subcutaneous parascrotal position in order to allow an easy percutaneous access for postoperative filling of the balloons. This allows the adjustability of the device by modifying the level of obstruction needed to achieve continence.

The ProACT system implantation is performed using fluoroscopy or transrectal ultrasonography (TRUS) for guidance under general anaesthesia or spinal blockage. The objectives of this pilot study were to evaluate if a TRUS-guided ProACT system implantation under local anaesthesia in patients with SUI after RP was feasible, safe and well tolerated. Reasons to develop ProACT system implantation under local anaesthesia in a day hospital setting include quick recovery after surgery, fast return to a normal diet, decreased use of anaesthesia resources, treatment of patients in poor conditions to receive general anaesthesia due to severe comorbidity and cost advantages.

Feasibility was demonstrated by the fact that all the procedures were always completed under local anaesthesia without any need of general anaesthesia. No perioperative complications or device migrations due to early mobilization occurred suggesting the safety of the technique. Data regarding subjective discomfort, pain intensity scales and patient approval are satisfactory. In fact, discomfort of catheter and transrectal ultrasound probe insertion are minimal and generally well tolerated by patients which had a RP and had in their experience one or more TRUS and the indwelling catheter. Burning and discomfort during local anaesthetic administration were minimal as well. Objective data from validated pain scales may be considered more than satisfactory.

Finally, all patients declared to be satisfied with having the operation done under local anaesthesia, would choose to have the procedure again and would recommend it to their families and friends.

The technique combines the advantages of TRUS-guided ProACT implantation (excellent imaging of the anatomical landmarks during the entire procedure without radiation exposure) with those of a day surgery procedure under local anaesthesia.

Written by
Andrea Gregori, MD, as part of Beyond the Abstract on UroToday.com. This initiative offers a method of publishing for the professional urology community. Authors are given an opportunity to expand on the circumstances, limitations etc... of their research by referencing the published abstract.

Implantation of an Adjustable Continence Therapy System Using Local Anesthesia in Patients With Post-Radical Prostatectomy Stress Urinary Incontinence: A Pilot Study - Abstract

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