Although urinary incontinence is one of the most common chronic diseases in women, we still don’t understand its pathophysiology, and treatments have been, of necessity, empiric rather than directed at a specific cause. Fortunately, this bleak scenario may be changing, and I think that is the most exciting news about urinary incontinence in 2005.
Urethral deficiency by any name is still a deficiency
Ironically, the most basic description of urinary incontinence may be the most revealing: Incontinence occurs when the urethra cannot stay closed and fails to hold urine in the bladder, where it should be stored until the “right” time and place for emptying. This description applies equally well to women with stress or urge symptoms, but let’s focus on stress incontinence for now.
By that line of thinking, the urethra is deficient in all women with stress incontinence. I believe this to be true, despite the arbitrary label—intrinsic sphincter deficiency, or ISD—that we apply to women with only the most severe symptoms of stress incontinence.
Surgery does not end the quest
Because surgery focuses on eliminating symptoms, it should come as no surprise that incontinence procedures continue to proliferate while we search for the Holy Grail: the perfect surgery that will effectively and durably “fix” the problem without complications or side effects. However, unless we find and correct the underlying problem that gave rise to the incontinence in the first place, we are doomed to fail in our search.
Doom? Failure? Where is the exciting news I promised?
CARE trial underscores efficacy of Burch procedure
Brubaker L, for the Pelvic Floor Disorders Network. Burch colposuspension at the time of sacrocolpopexy in stress continent women reduces bothersome stress urinary symptoms: The CARE randomized trial. Abstract presented at the American Urogynecologic Society Meeting, September 15–17, 2005, Atlanta.
If you have an exceptional memory, you will recall that, in this Update on Urinary Incontinence last year, results from the CARE trial were promised in 2006. Good news! Early results are available now, at least a year before expected.
Superior results with Burch changed the course of the CARE study
The CARE trial (Colpopexy And Urinary Reduction Efforts) was designed to determine the effect of Burch versus no Burch in women without stress incontinence symptoms but with advanced prolapse who were undergoing abdominal sacrocolpopexy. The trial was sponsored by the National Institute of Child Health and Human Development (NICHD) and performed by the Pelvic Floor Disorders Network of investigators from 7 clinical sites and a central coordinating center.
The original sample size was set at 480 women, to be randomized equally to Burch or no Burch, with the primary stress outcome at 3 months after surgery. However, at the first interim analysis, when about half the sample (232 women) had reached the primary outcome, the results showed such a striking benefit in the Burch group that the Data and Safety Monitoring Board for the Pelvic Floor Disorders Network recommended that enrollment be halted while all women continued to receive scheduled follow-up. Therefore, in February 2005, enrollment in the trial was closed, with 322 women randomized to 1 of the 2 arms.
The following results were presented at the annual meeting of the American Urogynecologic Society in September:
- Stress incontinence symptoms were reduced by about half in women after abdominal sacrocolpopexy (from 44% in the no-Burch group to 24% in the Burch group).
- Stress symptom severity improved with Burch. More women (62%) in the no-Burch stress incontinence group were bothered by their symptoms, compared to 32% of women in the Burch group.
- Urge symptoms were no different with Burch. More surprising, women in both groups had similar levels of symptoms measured as the urge endpoint, which included urge incontinence, urgency, frequency, nocturia, or enuresis; or treatment for any of those 5 symptoms. Almost 33% of women in the Burch group met the urge endpoint, compared with 38% in the no-Burch group (difference not statistically significant).
- Serious adverse events were not significantly different between the 2 groups.
Many more questions will be addressed with further analysis of CARE trial data, such as results of urodynamic testing with and without prolapse reduction, and the potential for predicting which subgroup benefits most when Burch is performed. Long-term follow-up data will address durability of results related to incontinence and prolapse. Follow-up is scheduled for 2 years in the CARE trial, and for up to 10 years in the Extended-CARE trial.