F. Scieri

Transrectal Ultrasound–Guided Implantation of Adjustable Continence Therapy (ProACT): Surgical Technique and Clinical Results After a Mean Follow-Up of 2 Years

BACKGROUND Treatment for stress urinary incontinence (SUI) after radical prostatectomy (RP) with the male Adjustable Continence Therapy (ProACT) system, implanted using fluoroscopy for guidance, has been described with promising clinical results. OBJECTIVE This retrospective study aims to describe the surgical technique in detail and to evaluate the continence recovery and complication rate of a cohort of male patients with SUI after RP. All patients were treated with a modified technique that uses transrectal ultrasound (TRUS) for guidance and that may be performed under local anaesthesia. DESIGN, SETTING, AND PARTICIPANTS Between June 2005 and March 2009, we operated on 79 consecutive patients with post-RP urodynamic intrinsic sphincter deficiency. SURGICAL PROCEDURE ProACT system implantation was performed with TRUS guidance under general or local anaesthesia. MEASUREMENTS Perioperative data and adverse events were recorded in all patients. Outcome data (24-h pad test, number of pads per day (PPD) used by patients, a validated incontinence quality of life questionnaire) were analysed in the 62 of 79 patients who completed the postoperative system adjustments. In this group of patients, the mean follow-up is 25 mo. RESULTS AND LIMITATIONS According to the 24-h pad test and the mean number of PPD used, 41 patients were dry (66.1%), 16 patients improved (25.8%), and 5 patients failed treatment (8%). The dry rate in previously irradiated patients was 35.7%. Complications included intraoperative bladder perforations (2 of 79; 2.5%), transient urinary retention (1 of 79; 1.2%), migrations (3 of 79; 3.8%), and erosions (2 of 79; 2.5%). According to the degree of incontinence, the dry rate in patients with mild, moderate, and severe incontinence was, respectively, 85%, 63.6%, and 33.3%. CONCLUSIONS TRUS guidance for ProACT implantation results in success and complication rates that compare favourably with published data using fluoroscopy for guidance. Previous radiotherapy and severe incontinence seem to be a relative contraindication. Larger series and longer follow-up are progressing to establish long-term efficacy.

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.

236 TRANSRECTAL ULTRASOUND-GUIDED IMPLANTATION OF THE PROACT (TM) SYSTEM IN PATIENTS WITH POST-RADICAL PROSTATECTOMY STRESS URINARY INCONTINENCE: CLINICAL RESULTS AFTER A MEAN FOLLOW-UP OF 2 YEARS

Hypothesis / aims of study The ProACTTM system (male Adjustable Continence Therapy, Uromedica, Plymouth, MN, USA) is an adjustable, permanent device for post-radical prostatectomy stress urinary incontinence. Initially, as first described by Huebner and Schlarp, system implantation was performed under fluoroscopic guidance [1]. More recently, the safety and feasibility of Trans Rectal UltraSound (TRUS) guided ProACTTM system implantation has been demonstrated in order to improve placement and ensure reproducible results [2]. TRUS provides excellent imaging of all anatomical landmarks during the entire procedure without radiation exposure and seems to offer considerable advantages over fluoroscopy in terms of safety and accuracy [2]. This study aims to evaluate the continence recovery of a cohort of male patients with stress urinary incontinence after radical prostatectomy, all treated with the TRUS-guided ProACTTM system implantation. We report our findings at a mean of 2 years. To our knowledge this is the largest series with the longest follow up on TRUS-guided ProACTTM system implantation.