**2. Alternatives to the AMS 800 in the treatment of urinary incontinence**

Currently, the only device on the market, indicating the use and operational mode that resembles the AMS 800 in strengthening occluding the urethra is developed by Constrictor Inflatable Periurethral SILIMED (Rio de Janeiro – Brazil), a device consisting essentially of 2 parts - body and valve constriction (Fig 2).

Fig. 2. Periurethral constrictor SILIMED, a two-part device (constrictor cuff and self-sealing valve with tube) (Permission by SILIMED®).

The main functional difference between the two devices is that the force of the occlusive body Constrictor Inflatable Periurethral remains constant throughout the duration of use of the device. If necessary, the patient's physician can make periodic adjustments of pressure in order to increase or decrease the force of the occlusive body, through the injection or removal of saline through the valve device in an outpatient setting. Meanwhile, the literature indicates a technical difficulty related to the change in pressure in the system of the AMS 800, possible only after revision surgery for the exchange of the balloon pressure regulator (Mundy, 1991).

The medical and scientific literature presents both AMS 800 and the Constrictor Inflatable Periurethral (preliminary data) as trusted devices and with good durability. Any problems would be reversed, in most cases, for simple or surgical outpatient review, which would ensure good continence rates, according to the criteria of effectiveness adopted by different authors (Hussain et al. 2005; Mundy, 1991; Schiavini et al. , 2007; Vilar et al. 2004; Webster & Sherman, 2005).

Currently, the only device on the market, indicating the use and operational mode that resembles the AMS 800 in strengthening occluding the urethra is developed by Constrictor Inflatable Periurethral SILIMED (Rio de Janeiro – Brazil), a device consisting essentially of 2

Fig. 2. Periurethral constrictor SILIMED, a two-part device (constrictor cuff and self-sealing

The main functional difference between the two devices is that the force of the occlusive body Constrictor Inflatable Periurethral remains constant throughout the duration of use of the device. If necessary, the patient's physician can make periodic adjustments of pressure in order to increase or decrease the force of the occlusive body, through the injection or removal of saline through the valve device in an outpatient setting. Meanwhile, the literature indicates a technical difficulty related to the change in pressure in the system of the AMS 800, possible only after revision surgery for the exchange of the balloon pressure

The medical and scientific literature presents both AMS 800 and the Constrictor Inflatable Periurethral (preliminary data) as trusted devices and with good durability. Any problems would be reversed, in most cases, for simple or surgical outpatient review, which would ensure good continence rates, according to the criteria of effectiveness adopted by different authors (Hussain et al. 2005; Mundy, 1991; Schiavini et al. , 2007; Vilar et al. 2004; Webster &

**2. Alternatives to the AMS 800 in the treatment of urinary incontinence** 

parts - body and valve constriction (Fig 2).

valve with tube) (Permission by SILIMED®).

regulator (Mundy, 1991).

Sherman, 2005).

The relative simplicity of the Constrictor apparently does not interfere with its effectiveness. Studies of the groups of Dr. Salvador Vilar and Dr. João Schiavini Constrictor present with continence rates of around 85% during treatment, as mentioned ahead. Moreover, the Constrictor was also able to provide some patients voiding spontaneously, especially in adults with urinary incontinence after prostate surgery sphincter. Even in cases where intermittent catheterization was used, the rate of patient satisfaction were generally high (Vilar et al. 2004; Schiavini et al., 2007). The main results are described ahead.

#### **2.1 Constrictor treatment in patients with neurogenic urinary incontinence**

In 2000, Lima and colleagues from the Hospital Infantil Manoel Almeida, Federal University of Pernambuco - Recife, presented results on the use of inflatable Periurethral Constrictor for the treatment of urinary incontinence secondary to myelomeningocele. The 24 patients (14 men and 10 women) were in the age group 5 to 42 years, and were followed for an average of 4.2 years (1-84 months). Concomitant with the deployment of the device, 21 of these patients underwent cystoplasty to increase with the use of Deepithelialize colon. Twenty-one patients had a good result with the device in addition to being functional continents, giving a success rate of 87.5%. In 3 (12.5%) cases, the device was removed due to the occurrence of erosion and infection. At the end of the study, the authors stated that the use of inflatable Periurethral Constrictor would be a safe and effective in the treatment of long-term causes of neurogenic urinary incontinence (Lima et al., 2000).

In 2004, Vilar and colleagues presented a second study group related to the use of Constrictor Inflatable Periurethral the surgical treatment of urinary incontinence in 42 children (29 boys and 13 girls) with a mean age of 10.2 years (3 to 17 years ). The group consisted of 29 neurogenic patients, 12 with bladder exstrophy and 1 with megalouretra. Concomitant with the deployment of the device, augmentation cystoplasty was performed in 34 patients. Patients were followed for an average of 5.2 years (4 to 104 months). In 25 patients in the neurogenic group the device was functional and provided continence, which represented a rate of continent patients during treatment of 86%. In 4 (14%) patients, the device was removed due to erosion (3) and infection (1). The patient was continent and megalouretra urinated spontaneously. In the exstrophy group, 10 patients had their devices explanted due to erosion and incontinence. Only two kept the device and performed intermittent catheterization. The authors concluded that the Constrictor Periurethral would be a long-term alternative, safe and effective for the surgical treatment of urinary incontinence cause neurogenic sphincter in children. Like previously reported for other implants, the authors emphasized that the device should be used with caution in patients with bladder exstrophy (Vilar et al., 2004).

#### **2.2 Post-prostate surgery urinary incontinence.**

In 2007, Schiavini & Resende Jr and colleagues, University Hospital Pedro Ernesto, Rio de Janeiro, showed their initial experience with the use of inflatable Periurethral Constrictor.

In this study, eighteen patients had urinary incontinence after radical retropubic prostatectomy, and five were previously submitted to procedures for the treatment of

Treatment of Post-Prostatic Surgery Stress Urinary Incontinence 269

Fig. 3. Urologic Evaluation

**2.3 Surgical approach and intra-operative procedures** 

genital at least 5 minutes and drapes are placed.

The patient is subjected to anesthesia in the operating room after evaluation by the anesthesiologist. Prophylaxis with intravenous antibiotics (3rd generation cephalosporin) will be held 30 minutes before starting surgery. Will be held genital shaving and antisepsis

bladder neck strictures. In all patients, the body of the device was placed around the bulbar urethra, with activation of the device after 8 weeks. Patients were followed from 6 to 36 months. For the authors, successful treatment was predefined as the need to use a diaper until the day - social continence, together with patient satisfaction.

### **2.2.1 Preoperative evaluation**

The complete urologic evaluation was performed, including urine analysis, ultrasonography, cystography and urodynamic studies before to submit the patients to the surgery, respecting the inclusion and exclusion criteria previously established, as described below.
