Implantation of an adjustable continence therapy system using local anesthesia in patients with post-radical prostatectomy stress urinary incontinence: a pilot study.

PURPOSE

We evaluated whether transrectal ultrasound guided ProACT system implantation in patients under local anesthesia and with stress urinary incontinence after radical prostatectomy is feasible in a day hospital setting, and is safe and well tolerated.

MATERIALS AND METHODS

The procedure was used in 11 consecutive patients (mean age 69.9 years) with stress urinary incontinence after undergoing radical prostatectomy between November 2006 and July 2007. The ProACT system was implanted with a transrectal ultrasound guided procedure after administration of local anesthesia (40 ml ropivacaine 7.5 mg/ml) in perineal skin, subcutaneous tissue, pelvic diaphragm and laterally to the anastomosis. During surgery any reason for discomfort was collected. Pain was evaluated with the visual analogue scale, Numeric Pain Intensity Scale and Simple Descriptive Pain Intensity Scale. Transrectal ultrasound was performed 7 days after surgery to exclude device migrations due to early patient mobilization.

RESULTS

The ProACT systems were successfully implanted in all patients under local anesthesia without any need for general anesthesia, and without perioperative surgical or anesthesia related complications. Subjective discomfort was minimal. Mean visual analogue scale was 13 mm (range 0 to 28). Mean Numeric Pain Intensity Scale was 1.4 points (range 0 to 4). On the Simple Descriptive Pain Intensity Scale 4 patients (36.3%) reported no pain, 5 (45.5%) reported mild pain and 2 (18.2%) reported moderate pain. Discharge from the hospital was possible for all patients after 6 hours. All transrectal ultrasound performed after 7 days excluded balloon migrations.

CONCLUSIONS

Transrectal ultrasound guided ProACT system implantation with the patient under local anesthesia only is feasible, safe, well tolerated and may be performed as a day surgery procedure.