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Introduction and Objectives
Male stress urinary incontinence is an unfortunate complication of post radical prostatectomy but may benefit from a number of minimally invasive techniques.
The ProACT™ (Adjustable Continence Therapy) is of interest due to the ability to post operatively adjust as required. The aim of this prospective single arm study was to evaluate the efficacy of this device and the merit of its adjustability over time.
The ProACT device consists of two opposing silicone balloons implanted para urethrally at the bladder neck, each connected to a titanium port situated in the scrotum to enable postoperative adjustments. Patients were considered following urodynamics to confirm Intrinsic Sphincter Deficiency in the absence of detrusor overactivity. We used Daily pad count; Quality of Life questionnaires; overall patient impression based on a global assessment score (PGI) questionnaire and Visual Analogical Scale as means of determining efficacy. Furthermore, operative details, adverse events, number of adjustments and balloon volumes were recorded at each of the postoperative visits. Mean Urethral Closure Pressures were measured at baseline and then post operatively following final adjustment.
Sixty five patients. underwent ProACT implantation. Operative time was 19 minutes (range10-35) with less than 20mls of blood loss in all cases. Mean follow up was 19.51 months (range 12-62) with all patients achieving12 months follow up. Post operatively, 68% of patients were shown to be dry (n = 44) as indicated by daily pad count, 16% improved (n =10) and a further 14% were unchanged. The postoperative PGI questionnaire showed 42 pts (65%) extremely improved, 10 pts (16%) very improved, 6 pts (9%) slightly improved. The IQoL increased from 31.7 at baseline to 63.4 at last follow-up (p< 0.005). Overall improvement was 80%. Balloon explanation occurred in eleven patients (17%) resulting from erosion (5), infection (2), migration (2) and balloon failure (2).
The ProACT is a minimally invasive surgical therapy for the treatment of male stress urinary incontinence, which is shown to be efficacious at 2 years. The results demonstrate a reduction in pad usage, an improvement in Quality of Life with a low rate of complications. ProACT is considered a first line surgical therapy in our practise, and we will continue to evaluate the long term outcomes of our patients.
Post prostatectomy; Adjustable Continence Therapy; outcome measures