UPDATE ON URINARY INCONTINENCE

Urinary incontinence affects as many as 50% of adult women¹; 16% have bothersome symptoms² and as many as 10% undergo surgical correction of their condition.³ The prevalence of urinary incontinence increases with age; with the aging US population expected to more than double by 2050,⁴ more and more women will seek treatment.

This notion of a growing population of women who want treatment is supported by a recent article that evaluated trends in surgery for urinary incontinence between 1998 and 2007: The researchers found that the number of inpatient urinary incontinence surgeries nearly tripled over 1 decade.⁵

Therapeutic revolution

Introduction of the retropubic mid-urethral sling in 1996⁶ transformed the surgical management of stress incontinence; the procedure has become the gold standard. Subsequent iterations of the sling procedure include a transobturator approach⁷ (known as the “TOT” sling) and, more recently, single-incision slings—alternatives intended primarily to improve the safety profile and ease of the procedure while maintaining its efficacy.

The newer sling procedures—many including novel mesh materials, some delivered in kit form—came to market under the US Food and Drug Administration’s so-called 510(k) rule, however, allowing manufacturers to launch them with little or no data supporting safety and efficacy. Given those circumstances, the optimal surgical management of stress urinary incontinence (SUI) remains controversial, and surgeons must take into account individual patient characteristics and treatment goals when developing a plan for surgical management. Providers must also remember that not all women will opt for, or are good candidates for, surgical intervention. These women need alternatives to operative management.

In this Update, we review and comment on four published papers that 1) highlight recent developments in the treatment of SUI and 2) provide concrete guidance to clinicians for providing optimal management:

• A randomized trial of nonsurgical management of stress incontinence using a continence pessary, compared with behavioral therapy and with combined (pessary plus behavioral therapy) treatment (the ATLAS trial)
• A randomized clinical trial that compared the efficacy of retropubic slings and TOT slings, with 1-year follow-up (the TOMUS trial)
• A randomized clinical trial that compared the efficacy of retropubic slings and TOT slings in women who have intrinsic sphincter deficiency
• A meta-analysis of the safety and efficacy of single-incision slings.

Conservative therapy is still an important, effective option for SUI

Richter HE, Burgio KL, Brubaker L, et al; Pelvic Floor Disorders Network. Continence pessary compared with behavioral therapy or combined therapy for stress incontinence: a randomized controlled trial. Obstet Gynecol. 2010;115(3):609–617.

Conservative treatment options for SUI are limited. They include:

• a pessary
• behavioral/pelvic floor physical therapy
• duloxetine (Cymbalta), a serotonin and norepinephrine reuptake inhibitor antidepressant (as an off-label use).

Level-I evidence exists to support utilization of behavioral pelvic floor therapy, based on a Cochrane review.⁸ Yet, little evidence exists by which we can compare the efficacy of various incontinence pessaries and their efficacy when combined with behavioral therapy.

Study design. This multi-center, randomized trial was conducted to fill this gap in the evidence. Four hundred forty-six women who had SUI were randomized to three groups: pessary only (149); behavioral therapy only (146); and pessary plus behavioral therapy (151). Women 18 years and older who had either SUI alone or stress-predominant incontinence were eligible. At baseline, 20.7% of subjects had undergone nonsurgical incontinence treatment; 6.9% had had surgical management. There was no significant difference in regard to prior treatment among the study groups.

Behavioral therapy comprised four visits at 2-week intervals, conducted by a nurse or a physical therapist who had undergone standardized training. Visits focused on engaging pelvic floor muscles; subjects received a “prescription” for home practice.

Women in the pessary groups were fitted at as many as three clinic visits with an incontinence ring or dish.

Measures of primary outcomes included the Patient Global Impression of Improvement (PGI-I) and the stress incontinence subset of the Pelvic Floor Distress Inventory (PFDI) at 3 months (follow-up continued to 12 months).

Findings. At 3 months, 40% of subjects in the pessary-only group, 49% in the behavioral therapy-only group, and 53% in the combined group reported (on the PGI-I) that their symptoms were “much” or “very much” better. Furthermore, 33% in the pessary-only group, 49% in the behavioral therapy-only group, and 44% in the combined group reported (on the PFDI) no bothersome stress incontinence.

Only PFDI measures were significantly different between pessary and behavioral therapy groups. Both PFDI and PGI-I demonstrated a significant difference in combined therapy compared to a pessary, but not in combined therapy compared to behavioral therapy. Because combination therapy was not superior to both single-therapies, the researchers concluded that combination therapy was not superior to single therapy.