Diagnosis and Management of Complex Pelvic Floor Disorders in Women

Nitti et al compared Botox 100 U to placebo in 557 patients that were refractory to anticholinergics [45]. Botox decreased the frequency of daily urinary incontinence episodes vs placebo (–2.65 vs –0.87, P < 0.001) and 22.9% vs 6.5% of patients became completely continent. A 5.4% rate of urinary retention occurred and UTI was the most common side effect (16%) in those receiving active drug. A dose of 100 U is recommended to limit side effects while maintaining efficacy [46].

Comparision of a daily anticholinergic (solifenacin) versus Botox 100 U for 6 months was done in a randomized double-blind, double-placebo-controlled trial [47]. Patients underwent saline injection or took an oral placebo in the anticholinergic and Botox groups, respectively. Complete resolution of urinary symptoms occurred in 13% of the medication group and 27% of the Botox group ( P = 0.003). Dry mouth was more common in the medication group (46% vs. 31%) and the Botox group had a higher rate of catheter use and urinary tract infections (5% vs. 0%; 33% vs. 13%). Quality of life measures have also been shown to improve significantly following Botox injection [45,48].

When considering whether Botox is appropriate for a particular patient, physicians must determine whether the patient is willing and able to perform clean intermittent catheterization. Contraindications include active UTI, urinary retention, unwilling or unable to do clean intermittent catheterization, and known hypersenstivitiy to botulinum toxin type A. Although the definition of urinary retention and the PVR at which clean intermittent catheterization should be initiated varies, one study found a 94% rate of urinary retention with a preoperative PVR > 100 mL [49].

Botox can be administered in the clinic with or without local anesthetic but general anesthetic may be used in patients who might be poorly tolerant of the procedure. Using flexible or rigid cystoscopy, the bladder is filled to 100 to 200 mL. An injection needle is used to inject 0.5 cc aliquots of reconstituted onabotulinumtoxinA in 20 areas spaced 1 cm apart. Periprocedure antibiotics are recommended by the manufacturer but actual usage varies [50]. Patients should understand that the effects of Botox may take up to 4 weeks and an appointment should be scheduled within 2 weeks to evaluate PVR and any other adverse reactions. Repeat injections are needed between 3 to 9 months as symptoms return; however, efficacy is maintained with subsequent treatments [51].

Neuromodulation

Additional third-line treatment options include sacral or posterior tibial nerve neuromodulation. Sacral neuromodulation has been FDA approved for treatment of urgency, frequency and urgency incontinence since 1997. Also known as InterStim (Medtronic, Minneapolis, MN), this involves placement of a tined electrode adjacent to the S3 nerve root and is thought to result in modulation of the afferent nerve signals from the bladder to the spinal cord and the pontine micturition center.

Since the FDA approved sacral neuromodulation, long-term results for this therapy have been positive. A multicenter study with a 5-year follow-up showed a statistically significant reduction in daily leakage episodes, number of daily voids, and increase in voided volume, with a 5-year success rate of 68% for urgency incontinence and 56% for urgency/frequency [52]. Al-Zahrani et al followed 96 patients (35% with urgency incontinence) for a mean of 50.7 months and approximately 85% of the incontinent patients remained improved [53]. Conversely, Groen et al observed a gradual decrease in success rate from 1 month to 5 years in 60 women with urge incontinence, with only 15% completely continent at 5 years [54].