The ProACT system is an adjustable permanent implant designed to achieve continence through increased outlet resistance. It is composed of an expandable silicone balloon connected with a 2-lm conduit to a reinjectable titanium port; 1 lm contains a 15-cm × 0.8-mm wire, while the other is used for balloon inflation in order to increase the resistance. The device is available in two sizes: 12 and 14 cm. The shorter one is usually implanted in patients presenting a residual prostate after surgery for benign prostatic hyperplasia. The longer one is more useful in patients’ post-RP. In these patients, two balloons are placed on each side of the vesicourethral anastomosis just above the pelvic diaphragm. The balloons are inserted transperineally using a specially designed, sharp-tipped, removable trocar contained in a 4.6-mm diameter U-shaped sheath. The two titanium ports are placed into a subcutaneous parascrotal position to allow easy access in order to adjust the balloons after the placement (maximum, 8 ml) using a 23-gauge noncoring needle. This allows the device to be adjusted by modifying the level of coaptation needed to achieve continence (Video 19.1).

Incontinence evaluation must be standardized as the number of pads per day (PPD) needed by the patient, ranked as mild (1 or 2 PPD), moderate (3–5 PPD) and severe (>5 PPD or use of urinary condom). We evaluate all the patients with a 24-h pad test and pad count. The preoperative evaluation should moreover include a complete medical history, a voiding diary when possible, an incontinence quality of life questionnaire [8], a flexible cystoscopy and TRUS to exclude local recurrences and urethral/anastomosis strictures. In our opinion, urodynamic investigations are also suggested in order to exclude detrusor overactivity or compliance abnormalities even if some authors describe it as optional investigations together with cystoscopy [9]. The patient must have undergone prostate surgery at least 12 months before the implantation and be free from distant metastasis. We suggest an antibiotic prophylaxis with 2 g of ceftriaxone intravenous about 30 min before surgery. An antibiotic solution is also used to immerse the system elements before surgery and to irrigate the field during the procedure.

The patient is placed in the lithotomy position, and after the disinfection, a 14- or 16-Ch Foley bladder catheter is placed; it is filled with 40–50 ml of saline solution and helps a clear visualization of the urethra and the bladder neck during TRUS. The scrotum is held above the perineum with tape. The anal ring is isolated from the perineum with a drape, and TRUS is performed using a 7.5-MHz linear probe and a small convex probe. When we perform just a local anaesthesia, we use ropivacaine injected in the subcutaneous tissue around the perineal incision. Two horizontal 0.5–1-cm skin incisions are made in the perineum about 1 cm lateral to the median line and about 1.5 cm above the rectum, and then the deep local anaesthesia with 20 ml of ropivacaine 7.5 mg/ml is administered. A 20-gauge spinal needle is inserted through the skin incisions and directed bilaterally to the vesicourethral anastomosis under multiplanar TRUS guidance. With the linear probe, we monitor the advancement of the 20-gauge spinal needle towards the bladder neck, while thanks to the convex probe we monitor the distance from the urethra. The space for the balloon is created on each side of the vesicourethral anastomosis and in the pelvic diaphragm with a hydrodissection mechanism during the releasing of the anaesthetic. When no local anaesthesia is used, the dissection is performed with saline solution on a 20-gauge spinal needle.