**6. Adjustable Continence Therapy (ACT) system**

The efficacy, safety & technical feasibility of the ACT was initially reported in 2009 as a novel device for the treatment of recurrent female SUI. (Aboseif et al. 2009) The device is intended to be a minimally invasive implantable device that provides support at the urethrovesical junction and enhances urethral coaptation. Its unique advantage is that it is also adjustable allowing for further optimization of the device post-operatively.

Placement of the ACT device is via bilateral small incisions between the labia majora and minora at the level of the urethral meatus with a specially designed trocar. Fluoroscopic and digital guidance is used to identify a point just distal to the urethrovesical junction where the balloons are placed. The balloons are then inflated with 1-1.5 mL of isotonic contrast solution. The subcutaneous inflation ports are then placed in a pocket in a superior ventral portion of each labia majora and the skin is closed with subcuticular absorbable suture. (Aboseif et al. 2009; Kocjancic et al. 2010)

The initial experience with the ACT system showed a complication rate of 24.4% (38 of 156 patients). Complications included port erosion, urinary retention, balloon erosion or migration and worsening incontinence. 18.3% (28 of 153) of patients underwent explantation within the first year, however 50% of explanted cases then underwent replacement. Since the development of the device, improvement in the technical related learning curve has led to reduced rates of complications.

Refractory Stress Urinary Incontinence 237

neurological diseases. (Rutman et al. 2006) It has more recently been described in patients with multiple failed surgeries for SUI. (Mourtzinos et al. 2008) The procedural details of the spiral

Notable surgical steps different from other suburethral slings are as follows: Two parallel distal oblique incisions are made in the anterior vaginal wall. The retropubic space is entered and a complete urethrolysis is performed by detaching the urethropelvic ligaments from the arcus tendineous fascia pelvis and freeing all retropubic adhesions. The urethral dissection is started in the mid-urethral area just proximal to the pubo-urethral ligaments and carried proximally to free the rest of the urethra and the bladder neck. Then a suburethral tunnel is created in the anterior vaginal wall 1.5 cm from the urethral meatus. Polypropylene mesh measuring approximately 1 X 15 cm is passed dorsally, between the urethra and the pubis. The ends of the mesh are crossed ventrally through the previously made vaginal tunnel. This maneuver creates a complete circle of mesh around the urethra. A suprapubic puncture is made just above the symphysis and a double-pronged needle (Cook Urological, Inc., Spencer, IN) is passed under finger control through the fascia and retropubic space to the vaginal incision. The previously placed 0-polyglactin sutures from the polypropylene mesh are transferred to the suprapubic incision. This is repeated on the

Between August 1999 and October 2004, 47 patients underwent placement of a spiral sling. (Rutman et al. 2006) This initial patient population was initially selected because of congenital or neurologic diseases, however, the technique was later expanded to include those patients with multiple failed surgeries for SUI and an incompetent lead pipe urethra. Of the 47 patients, seven were lost to follow-up. The mean age of the remaining 40 patients was 59.0 years (23-86). This represented a complex cohort of patients with 98% having failed a prior anti-incontinence surgery. The patients had undergone a mean of 2.6 previous antiincontinence surgeries and used an average of 6 pads per day. There were two patients who had previous augmentation cystoplasty and were performing self-intermittent catheterization but had significant SUI between catheterizations. All patients were considered candidates for urethral closure and continent diversion as a salvage procedure. In this group of 40 patients, the average follow-up was 12 months (6-37). There were no intraoperative complications. The de-novo urge incontinence rate was 7.4%. Of the 27 patients with preoperative urge incontinence (UI), 9 (33%) had resolution of their symptoms with the procedure. One of the patients had persistent refractory UI and subsequently underwent a sacral neuromodulation procedure. No patient experienced de novo retention after the spiral sling. The four patients who were performing self-intermittent catheterization pre-operatively continued to do so after the procedure. There were no urethral or vaginal erosions. The mean number of pads decreased from 6.0 preoperatively to 0.9 postoperatively (P<0.005). 78% of patients reported improvements of 90% or greater. Patients reported a mean improvement of symptoms of 87% after surgery. Ultimately, three patients underwent bladder neck closure

More recently, the spiral sling technique was described in 46 patients with multiple failed surgeries for SUI excluding patients with neurologic or congenital anomalies. (Mourtzinos, et al. 2008) The mean age of the study population was 62 years and the mean follow-up was 15 months (6 to 45 months). All patients had failed a prior anti-incontinence surgery. There were no intraoperative complications and no cases of permanent urinary retention postoperatively

sling are not widely published and will therefore be reviewed here in detail.

contralateral side and the sutures are tied without tension.

and continent augmentation and were considered failures.

At a mean follow-up of 72 months (range 12-84), 68% of patients (n=29) reported themselves dry. (Kocjancic et al. 2010) All of these patients had at least one prior pelvic surgery for SUI. The researchers reported 12 month urodynamic data (n=30 patients) which showed a statistically significant increase in VLPP from a mean baseline of 51.06 24.38 to 86.0 21.44 cm H2O (p<0.01). Complications requiring device removal developed in 21.1% of patients.

Most recently, Aboseif and colleagues presented a series of 89 patients with the ACT device. (Aboseif et al. 2011) They reported that 47% of the patients were dry at 1 year and 92% overall were subjectively improved. Pads per day and incontinence episodes were significantly improved, in addition to outcomes on standardized questionnaires. Their complication rate was similar to previously published studies with an explant rate of 21.7%. Proponents of the ACT device, that are proficient in placement and adjustment, report it is effective, simple and safe.
