Minimally Invasive Treatment Options for Female Incontinence

By Howard B. Goldman MD, FACS

Overactive bladder (OAB) is a very common condition that can significantly impact a patient’s quality of life. The incidence increases with age and may affect over 30 percent of women over age 70. The hallmark symptom of OAB is urinary urgency, but women may suffer from urinary frequency, urgency incontinence and nocturia as well. The impact on one’s quality of life can be huge, and the costs associated with untreated OAB, including pads and other absorbent products, can be significant.1

A simple history, physical exam and urinalysis are enough to make the diagnosis. Initial treatment includes behavioral and fluid modification and pelvic floor exercises. Second-line treatment includes anticholinergic medications. A significant number of patients either do not respond to or suffer side effects from these medications. Constipation, dry mouth and dry eyes are only a few of the anticholinergic side effects seen; and in the geriatric population, which may be utilizing multiple medications, this increase in anticholinergic load can be a significant problem.2 There is a newer class of medications, the beta-3 agonists, that appear to have the same efficacy as the anticholinergics but without the dry mouth and some of the other anticholinergic side effects.

For refractory patients who either do not respond to or cannot tolerate conservative or medical management, third-line therapy with various types of neuromodulation can prove quite successful. From least to most invasive, posterior tibial nerve stimulation (PTNS), botulinum toxin injection (BTX) and sacral neuromodulation (SNS) are available.

Posterior Tibial Nerve Stimulation

Figure 1

PTNS involves placing a very fine needle next to the posterior tibial nerve (above the ankle) and stimulating the nerve for 30 minutes weekly for 12 weeks (see figure 1). If a patient has a satisfactory response, maintenance stimulation is continued every four to six weeks indefinitely. Level I evidence demonstrates the effectiveness of this therapy.

A randomized trial comparing PTNS with a sham demonstrated 55 percent moderate to marked improvement in the arm receiving active treatment while only 20 percent in the sham group reported improvement.3 This therapy is extremely easy to perform, is done in the office and has almost no side effects. It is limited by the frequent visits needed for the stimulation. Devices that can be used at home by the patient without requiring needle placement are currently under study.

Injection of Botulinum Toxin into the Bladder

Botulinum toxin, a muscle paralytic agent, has multiple therapeutic uses. For OAB it is commonly used and can be quite effective and is typically done in the office. Once it’s ensured that the patient’s urine is clear, lidocaine is instilled into the bladder via a catheter and allowed to dwell for about 20 minutes to anesthetize the bladder lining. Following that, 100 units of Botox® are injected under direct vision via a cystoscope in 20 locations in the bladder wall. This typically takes 5 to 10 minutes and is generally well tolerated. In select cases, this procedure can be done under sedation.

There are multiple studies evaluating the efficacy of this intervention. Overall, about 80 percent of patients demonstrate improvement after BTX injection. The number of voids per day is decreased by about 30 percent, the number of urgency episodes by about 45 percent, and the number of urgency incontinence episodes per day by roughly 65 percent. Approximately 45 percent of patients become continent.4 The most important potential adverse event is incomplete emptying or urinary retention requiring intermittent catheterization (IC), which occurs in about 10 percent of patients. Thus, it is critical that any patient considering BTX treatment be advised of this risk and be agreeable to temporary IC if necessary.

As BTX wears off with time, the IC is usually needed for a few days to weeks. Some geriatric patients may be at higher risk of needing IC because their baseline bladder emptying efficiency may already be diminished. Patients are also at higher risk for urinary tract infection after BTX treatment probably because of changes in emptying efficiency. The effect of BTX lasts five to 10 months, so patients generally need to be treated twice a year. Overall, many patients have significant improvement from this minimally invasive treatment.

Sacral Neuromodulation

Figure 2

SNS involves percutaneous placement of a lead near the third sacral nerve to modulate bladder function. Ultimately, there is low-level continuous stimulation, which normalizes bladder activity. There is an initial trial phase during which a wire is placed under fluoroscopic guidance with either local anesthesia or sedation and attached to an externally worn stimulator. If during the following one to three weeks, the patient reports at least a 50 percent improvement in symptoms, a complete system, including a pulse generator (very similar to a cardiac pacemaker) is implanted in the upper buttock (see figure 2). Once the appropriate stimulation settings are programmed, the device runs continuously without any need for patient input. This part of the procedure is done under sedation or general anesthesia.

Up to 75 percent of patients have a good response to this therapy, and while there is some evidence that the success rate may be lower in older patients, the majority of properly selected patients will receive significant benefit.5 This procedure is minimally invasive and very well tolerated and the risks, which include infection, pain and loss of efficacy, can be easily remedied. In a worst case scenario, removal of the device leaves the patient back at her baseline.

While initial conservative and medical management may be helpful for some patients, many — particularly in the geriatric population — will either not respond to or tolerate such treatments. For geriatric patients with refractory OAB, PTNS, BTX or SNS are excellent minimally invasive options that are generally well-tolerated and can significantly improve the geriatric patient’s quality of life.

Dr. Goldman is Vice Chairman for Quality at the Glickman Urologic Institute and a staff member in the Section of Female Pelvic Medicine and Reconstructive Surgery. He is on the faculty of the Cleveland Clinic Lerner College of Medicine.

References:

1. Brubaker L, Chapple C, Coyne KS, Kopp Z. Patient-reported outcomes in overactive bladder: importance for determining clinical effectiveness of treatment. Urology 2006;68(Suppl):3–8.
2. Chapple CR, Martinez-Garcia R, Selvaggi L et al.; STAR Study Group. A comparison of the efficacy and tolerability of solifenacin succinate and extended release tolterodine at treating overactive bladder syndrome: results of the STAR trial. Eur. Urol. 2005;48(3):464–470.
3. Peters KM, Carrico DJ, Perez-Marrero RA et al. Randomized trial of percutaneous tibial nerve stimulation versus sham efficacy in the treatment of overactive bladder syndrome: results from the SUmiT trial. J. Urol. 2010;183(4):1438–1443.
4. Flynn MK, Amundsen CL, Perevich M, Liu F, Webster GD. Outcome of a randomized, double-blind, placebo controlled trial of botulinum A toxin for refractory overactive bladder. J. Urol. 2009;181(6):2608–2615.
5. van Kerrebroeck PE, van Voskuilen AC, Heesakkers JP et al. Results of sacral neuromodulation therapy for urinary voiding dysfunction: outcomes of a prospective, worldwide clinical study. J. Urol. 2007;178(5):2029–2034.