The TMOD is a totally implantable, one-piece artificial urinary sphincter () consisting of an occlusive tape and a conduit tape, connected to a control mechanism. The conduit tape originates at the control mechanism and the occlusive tape connects to the conduit tape. The conduit tape is of sufficient length to allow placement of the occlusive tape at the bulbous or penoscrotal urethra without creating undue tension on the conduit tape. The scrotally implanted control mechanism consists of a titanium casing, housing a three-metal alloy spring that applies tension to sutures running through the conduit and occlusive tapes. The control mechanism has ON and OFF buttons and is covered with a flexible silicone boot that prevents tissue in-growth. The boot has a port for injection of saline into the device that displaces air and creates an isotonic interior. This same port is designed for antibiotic flushing per surgeon discretion. In the ON position, the occlusive tape contracts and is designed to apply radial pressure to the urethra of 50–80cm of water. The degree of radial pressure was chosen from clinical experience with the AUS 800 in order to limit urine leakage while minimizing urethral perfusion. There is a locking clip that locks the occlusive tape to itself to form an annular occlusive ring around the urethra. This can easily be unclipped for tape removal if repositioning or removal of the TMOD is required. Suture tabs are attached to both the control mechanism and occlusive tape to anchor the device in place and prevent migration .
Knight et al. presented 9 male patients (mean age 66 years) with urodynamically proven stress incontinence due to radical prostatectomy treated with implantation of FlowSecure sphincter. The patients were followed for a minimum period of 12 months. All 9 patients recovered well from surgery. Two devices had to be removed for technical reasons. The mean leakage for the remaining 7 patients prior to implantation was 771 ± 658mL corresponding to a continence index of 54%. Twelve months later the leakage had statistically significantly reduced to 52 ± 36mL (P ]. In another study by Rodriguez et al. 100 patients with stress urinary incontinence of various etiologies underwent bulbar urethra (96%) or bladder neck (4%) implantation of a FlowSecure device. All patients had tried conservative treatments and also 59 patients had undergone unsuccessful surgical procedures (suburethral slings, bulking agents, Proact, and AUS-800). Nine patients had undergone previous pelvic radiotherapy. At implantation the sphincters' pressure was left at atmospheric level in all cases. Patients attended for initial pressurization 2–4 weeks postoperatively and were recalled at two-week periods for evaluation and repeat pressurization, if it was required. Overall, 3 pressurizations procedures were required to achieve socially satisfactory continence in 89 patients. The implanting procedure lasted in average 38–47 minutes. Mean inpatient stay was 4.3 days. 53 patients had postoperative self-limited scrotal hematoma. Implants had to be removed in 28 patients (28%) due to early infection (8%), late infection secondary to pressurization procedures (5%), perforation of the pump at pressurization (9%), and mechanical failure (6%). No erosions were noted .
Artificial Urinary Sphincter Implant (AMS 800) -- help ..
The Artificial Urinary Sphincter (AUS) 800 (American Medical Systems, Minnetonka, MN, USA), despite the new surgical treatment options (slings, injection of bulking agents, stem-cell therapy), remains the gold standard for persistent moderate-to-severe stress urinary incontinence due to Intrinsic Sphincter Deficiency (ISD) [, , ]. In effort to keep the good success rates and improve some disadvantages of AUS 800 (high cost, complications, and relative difficult insertion), four new devices have been developed in recent years . We attempt to present technical characteristics and insertion procedures for these devices and to report safety and efficacy data, where they are available.