**1. Introduction**

232 Urinary Incontinence

Wu, MP.& Huang, KH. (2008). Tension-free midurethral sling surgeries for stress urinary

Wu, MP. Long, CY & Liang, CC.(2010). Staged or concomitant surgery for correcting pelvic

Wunasekera, P.; Sazaki, J. & Walker, G. (2007). Pelvic organ prolapse: don't forget

Young, SB.; Daman, JJ. & Bony, LG. (2001). Vaginal paravaginal repair: one-year outcomes.

568X

0140-6736

9378

No.4, pp.93-98, ISSN 1994-568X

incontinence. *Incont Pelvic Floor Dysfunct,* 53-60. Vol. 2, No.2, pp.53-60, ISSN 1994-

organ prolapse and stress urinary incontinence. *Incont Pelvic Floor Dysfunct,* Vol. 4,

developing countries. *Lancet;* Vol. 369, No. 9575, (May 2007), pp.1789-1790, ISSN

*Am J Obstet Gynecol,* Vol. 185, No. 6, (December 2001), pp. 1360-1366, ISSN 0002-

Treatment of stress urinary incontinence (SUI) caused by urethral hypermobility or intrinsic sphincter deficiency with urethral sling procedures may yield up to a 80-90% success rate depending on the definition of success. (Nilsson et al. 2001; Liapis et al. 2002; Rodriguez & Raz 2003; Nilsson et al. 2004; Ward & Hilton 2004) In a minority of patients, however, there is persistence or worse incontinence after surgical therapy. In the general population, risk factors for midurethral sling (MUS) failure are BMI >25, mixed incontinence, intrinsic sphincter deficiency, diabetes mellitus, advanced patient age >75 years old and prior continence surgery. (Cammu et al. 2009; Stav et al. 2010) Potential surgery related reasons for failure include improper adjustment of the sling or misplacement of the suburethral tape. Female patients with urethral incompetence and severe incontinence due to multiple failed surgeries, neurologic injury, or congenital anomalies represent a unique surgical challenge.

Patients with neurologic conditions have sacral arc lesions with paralysis of the skeletal musculature and an open urethra. All other patients who have failed multiple sling and anti-incontinence procedures may have severe symptoms of SUI and an open urethra with a low valsalva leak point pressure. These patients often have an incompetent, difficult to compress, urethra likely due to a combination of urethral denervation, and violation of the periurethral fascia, as well as their underlying risk factors for SUI. (Bump & Norton 1998) These patients have been shown to have low chances of cure after repeat anti-incontinence surgery and be more likely to suffer from complications including retention, osteomyelitis, and pelvic abscess. (Petrou & Frank 2001)

In the recurrent or refractory stress urinary incontinence female patient, a routine sling procedure providing only posterior support will not typically yield an appropriate response. Management options include repeat placement of a "tight" pubovaginal sling or replacement of a different type of sling, a spiral sling, periurethral bulking agents, adjustable continence therapy (ACT) device and the artificial urinary sphincter (AUS) prior to bladder neck closure with continent urinary diversion. This manuscript will review the evaluation and management options for recurrent stress urinary incontinence in this challenging population.

#### **2. Evaluation**

There are a significant number of patients in the United States that undergo successful sling placement for SUI, however a minority will present with persistent or recurrent

Refractory Stress Urinary Incontinence 235

Investigators have reported the use of periurethral bulking agents after failed sling procedures for SUI, but no randomized studies have been reported. However, a recent report looking at intermediate follow up has reported some success. Macroplastique and Durasphere were used as periurethral bulking agents in 23 women following a failed midurethral sling procedure. (Lee et al. 2010) Macroplastique was used in 21 patients and Durasphere was used in 2 patients with a median interval between sling placement and periurethral bulking agent injection of 12 months (range 3-65). With intermediate follow up at a median of 10 months (range 6-34 months), 8 of 23 patients (35%) of all patients reported "cure" whereas 92% reported they had benefited from the procedure. Notably, 77% of the women reported satisfaction from the

The literature is maturing with regard to the appropriate choice for a repeat sling following midurethral sling for SUI. Stav and colleagues reviewed the cases of 1225 retrospectively identified women who underwent either a retropubic or transobturator sling. 91% of these patients completed a telephone interview questionnaire. (Stav et al. 2010) The majority of these women had a retropubic sling as opposed to a transobturator sling. Mean follow up was 50 months. Their re-operation rate for failure was 14%. Repeat retropubic sling placement was significantly more successful than utilizing a transobturator approach (71% vs 48%, p=0.04). Repeat slings were placed without removal of the previous sling. Most surgeons will opt to use a retropubic sling for recurrent incontinence and rather than a transobturator sling because of the greater urethral tension generated. Management options also include repeat placement of a "tight" pubovaginal sling with the intent of putting the

patient in urinary retention. This can be done utilizing autologous fascia as well.

also adjustable allowing for further optimization of the device post-operatively.

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

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.

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

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

(Aboseif et al. 2009; Kocjancic et al. 2010)

to reduced rates of complications.

procedure, perhaps noting the relative simplicity and ease of placement.

**5. Revision urethral sling surgery** 

incontinence. Recurrent stress urinary incontinence after urethral sling surgery (transvaginal tape and transobturator tape) and common complications such as urinary tract infection and de novo urge urinary incontinence need to be fully evaluated. It is also important when determining the etiology of surgical failure to identify whether the patient has refractory SUI by determining whether there was any period of cure or improvement. Recurrent stress urinary incontinence warrants at a minimum: complete history and physical examination and urinalysis. Most physicians would advocate urodynamic testing in cases of failed previous surgery for incontinence. (Houwert et al. 2010; Walsh & Moore 2010) Cystoscopic evaluation is easy to perform in the clinic and should be utilized to determine if there is evidence of sling erosion or misplacement. Ultimately, the determination must be made whether this leakage is due to bladder or outlet dysfunction.

If there is evidence of flank or pelvic pain, a retroperitoneal ultrasound with evaluation of the bladder is necessary to evaluation for obstruction and or injury to the ureteral orifices. Urodynamics with or without fluoroscopy is useful to further characterize the physiology of the bladder. While there is no published data regarding routine use, most practices use routine urodynamic evaluation of failed anti-incontinence patients prior to a repeat procedure. (Rutman et al. 2006; Rodriguez et al. 2010; Walsh & Moore 2010)

Some urologists routinely use dynamic T2-weighted MRI to look at the anatomic defects seen in pelvic floor dysfunction. A vaginal examination might demonstrate a change in the patient's pelvic floor anatomy, such as evidence of prolapse. Many researchers have used dynamic MRI to evaluate the female pelvis and delineate the possible components of pelvic floor dysfunction. This requires experience using this modality and a radiologist that can interpret the test in a useful way. In the cost-saving climate of health care today, dynamic T2 MRI can likely only be used in the setting of severe refractory incontinence or neurologic conditions.
