**8. Spiral sling procedure**

A newer technique initially described by Raz and colleagues is a transvaginal sling procedure in adult women that encircles the urethra providing circumferential coaptation. The spiral sling is a salvage procedure for a small, yet severe group of female patients with a totally incompetent urethra. The procedure was initially described in patients with congenital or

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

The AUS in the female population differs from the suburethral sling in that it does not provide a backboard or urethral support, but rather it attempts to mimic the sphincter mechanism of the urethra with circumferential compression. (Light & Scott 1985) The initial use of the AUS in women with incontinence was described in 1985 (Light & Scott 1985) and

Costa and colleagues evaluated the efficacy of the AMS 800 AUS in women with Type III incontinence and a negative Marshall test. (Costa et al. 2001) They described a modified surgical procedure through an abdominal approach. Of the 190 patients with working devices, continence was achieved in 88.7% and 81.8% of those with non-neurogenic and neurogenic bladders, respectively at a mean follow-up of 3.9 years. 51 patients had perioperative complications and a high percentage of patients had not undergone prior surgical therapy. Thomas and associates reported 12 year follow-up in 68 patients who underwent an AUS. (Thomas et al. 2002) Despite an 81% continence rate, 46% required removal or replacement for erosion or infection. They concluded by recommending an AUS in patients with SUI after failure of one anti-stress incontinence operation and rather than as a last resort. More recent series reports demonstrate the safety, efficacy and complication rates associated with female AUS implantation. (Chung et al. 2010; Vayleux et al. 2011) Importantly, while there is a high proportion of patients that continue to use the AUS after implantation, about 50% of them have required revision or replacement, usually within the first several years of implantation. Continence rate in these two studies indicates 65-70% for no pads and 73.5-83% for 0 to 1 pad per day. Satisfaction rates were high with a majority of patients reporting they would undergo AUS placement again if necessary. Additional modifications such as insertion of an AUS laparoscopically (Roupret et al. 2010) or with a large cuff (Revaux et al. 2010) have been

A newer technique initially described by Raz and colleagues is a transvaginal sling procedure in adult women that encircles the urethra providing circumferential coaptation. The spiral sling is a salvage procedure for a small, yet severe group of female patients with a totally incompetent urethra. The procedure was initially described in patients with congenital or

has since been well documented in the literature. (Vayleux et al. 2011)

proposed, however long-term data is lacking at this time.

**8. Spiral sling procedure** 

effective, simple and safe.

**7. Artificial urinary sphincter** 

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

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 contralateral side and the sutures are tied without tension.

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 and continent augmentation and were considered failures.

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

Refractory Stress Urinary Incontinence 239

patients include conservative management, endoscopic management with periurethral bulking, a repeat sling procedure, spiral slings, the artificial urinary sphincter and adjustable continence therapy devices or new technologies such as autologous stem cell injection. Variable success rates for all of these methods have been reported in the literature

Aboseif, S. R., E. I. Franke, et al. (2009). The adjustable continence therapy system for

Aboseif, S. R., P. Sassani, et al. (2011). Treatment of moderate to severe female stress urinary

Bump, R. C. and P. A. Norton (1998). Epidemiology and natural history of pelvic floor

Cammu, H., E. Van Den Abbeele, et al. (2009). Factors predictive of outcome in tension-free

Chung, E., A. Navaratnam, et al. (2010). Can artificial urinary sphincter be an effective

Costa, P., N. Mottet, et al. (2001). The use of an artificial urinary sphincter in women with type III incontinence and a negative Marshall test. *J Urol* 165(4): 1172-6. Houwert, R. M., J. P. Roovers, et al. (2010). When to perform urodynamics before mid-urethral sling surgery for female stress urinary incontinence? *Int Urogynecol J* 21(3): 303-9. Kocjancic, E., S. Crivellaro, et al. (2010). Adjustable continence therapy for severe intrinsic

Lee, H. N., Y. S. Lee, et al. (2010). Transurethral injection of bulking agent for treatment of failed mid-urethral sling procedures. *Int Urogynecol J* 21(12): 1479-83. Liapis, A., P. Bakas, et al. (2002). Burch colposuspension and tension-free vaginal tape in the management of stress urinary incontinence in women. *Eur Urol* 41(4): 469-73. Light, J. K. and F. B. Scott (1985). Management of urinary incontinence in women with the

Mingin, G. C., K. Youngren, et al. (2002). The rectus myofascial wrap in the management of

Mitterberger, M., G. M. Pinggera, et al. (2008). Adult stem cell therapy of female stress

Mourtzinos, A., M. G. Maher, et al. (2008). Spiral sling salvage anti-incontinence surgery for

Nilsson, C. G., C. Falconer, et al. (2004). Seven-year follow-up of the tension-free vaginal tape procedure for treatment of urinary incontinence. *Obstet Gynecol* 104(6): 1259-62.

women with refractory stress urinary incontinence: surgical outcome and satisfaction determined by patient-driven questionnaires. *Urology* 72(5): 1044-8;

recurrent female stress urinary incontinence: 1-year results of the North America

incontinence with the adjustable continence therapy (ACT) device after failed

vaginal tape procedure for urinary stress incontinence in a teaching hospital. *Int* 

salvage option in women following failed anti-incontinence surgery? *Int Urogynecol* 

sphincter deficiency and recurrent female stress urinary incontinence: long-term

depending on the length of follow up and the definition of cure.

Clinical Study Group. *J Urol* 181(5): 2187-91.

surgical repair. *World J Urol* 29(2): 249-53.

*Urogynecol J Pelvic Floor Dysfunct* 20(7): 775-80.

artificial urinary sphincter. *J Urol* 134(3): 476-8.

urinary incontinence. *Eur Urol* 53(1): 169-75.

discussion 1048-50.

urethral sphincter incompetence. *BJU Int* 90(6): 550-3.

experience. *J Urol* 184(3): 1017-21.

dysfunction. *Obstet Gynecol Clin North Am* 25(4): 723-46.

**11. References** 

*J* 22(3): 363-6.

requiring transvaginal urethrolysis. On patient driven subjective assessment, 49% of patients reported never experiencing SUI, and 72% experienced no or rare episodes of SUI. Overall patients reported a mean improvement of 84% with a decrease in daily pads from 5.5 to 1.0. Most patients were highly satisfied with their urinary symptoms after surgery (mean QoL of 1.4). In addition, there was no statistically significant difference between pre and postoperative symptoms of incomplete bladder emptying (P>0.05).

A review of the literature for alternatives to bladder neck closure revealed no existing circumferential sling procedure in the adult population. Mingin and colleagues described a transabdominal technique of a urethral sling using rectus muscle wrapped around the urethra for pediatric patients with congenital urethral incompetence. (Mingin et al. 2002) Of the 37 patients reported, 92% remained dry between catheterizations. The pediatric population is unlike this population since these patients had roughly three anti-incontinence surgeries with subsequent scarring and more difficult coaptation. The mechanism of cure of the transvaginal spiral sling is not completely understood. It likely supports the midurethral segment while preventing urethral descent and improving pressure transmission to the urethra. In addition, unlike a routine sling procedure, the spiral sling also provides circumferential coaptation to the urethra at the time of increases in intrabdominal pressure.

Raz and colleagues concluded that the spiral sling is an effective salvage transvaginal procedure that may be considered for a small subset of female patients with non-functional urethras as a last resort prior to urethral closure procedures. This includes patients with urethral incompetence caused by neurologic disease, congenital anomalies or iatrogenic injury from multiple failed anti-incontinence surgeries. The most comparable surgical alternative is the AUS which requires manual dexterity to operate the device and a more extensive dissection to implant all components. The initial outcomes look promising but longer follow-up will better define its role in refractory female incontinence and demonstrate the durability of the spiral sling.
