Things go better with Burch
CARE trial: Burch colposuspension at the time of prolapse surgery improves postop urinary control
IN THIS ARTICLE
- Need for patient and physician education is great, and the CARE trial offers a valuable opportunity
- Potential for medicolegal risk if complications develop
- Payers may not be willing to reimburse for a prophylactic procedure
WEBER: Given how extensively the trial’s results were disseminated by the lay press, I think we have an important opportunity to educate both patients and health-care providers.
First, patients: For women who may be directly affected by the trial, knowledgeable clinicians should explain its results and limitations to help them reach a decision about their treatment.
For women who hear the trial’s results described incompletely or incorrectly (eg, “…2 stitches prevent incontinence…”), clinicians should take this opportunity to correct misunderstandings and educate women about incontinence, prolapse, and pelvic health in general.
For health-care providers, this trial reminds us of the extraordinarily high prevalence of pelvic floor disorders. Although current treatments are not perfect, virtually all women with pelvic floor disorders can be treated to substantially alleviate, if not eliminate, bothersome symptoms.
All clinicians should routinely inquire about pelvic symptoms and be prepared to initiate an evaluation or provide a referral.
Medicolegal fallout?
KOHLI: There is the question of medicolegal risk if complications occur after colposuspension when the patient had no complaints or evidence of stress incontinence at the time of preoperative urodynamic testing. I am not aware of any legal precedent in which a clinical study or data provided solid protection from a jury verdict. The study did not show increased risk or complication with the addition of the Burch procedure, but that may not be true for some surgeons and some patients.
Billing and coding
In terms of billing, how should we code for the Burch colposuspension when the patient had no demonstrable stress incontinence? Payment denials in this scenario seem likely. This may create a line of separation between what may be clinically indicated for the patient and what insurance companies are willing to pay for.
There may be the option to use the urethral hypermobility code (ICD 599.81) for the Burch colposuspension, but only time will tell if this will be reimbursed. I would be curious to hear the panel’s experience with reimbursement for a prophylactic procedure based on scientific data. Obviously, what is best for the patient is most important.
BRUBAKER: All these patients had urethral hypermobility, which is also an indication for a Burch colposuspension.
Is preoperative urodynamic testing useful?
- CARE trial data still to come
- Basic testing is probably helpful
WEBER: In the CARE trial, the relative level of protection from postoperative stress incontinence provided by the Burch procedure did not depend on the stress-test component (with prolapse reduced) of preoperative urodynamic testing. About 50% fewer women had postoperative stress incontinence after Burch, whether preoperative urodynamic testing showed positive or negative stress tests with prolapse reduction.
Although subsequent analyses (presented at the Society of Gynecologic Surgeons 2006 meeting; manuscript under review) focused on urodynamic testing and postoperative outcomes, the CARE trial was not designed primarily to determine whether women planning prolapse surgery benefit from preoperative urodynamic testing. Therefore, conclusions about the “need” for urodynamic testing should not be based only on the CARE trial.
Should urodynamic testing determine treatment?
Randomized trials that directly address the cost-benefit of urodynamic testing are urgently needed. For now, as is standard in good clinical practice, a test should be performed only if results will change recommendations or provide reliable and clinically important prognostic information about a patient’s outcome after intervention. Clinicians should determine whether urodynamic testing meets even 1 of these 2 minimum criteria.
I want to point out that the CARE trial did not address the utility of urodynamic testing.
BRUBAKER: It is clear that some women have stress incontinence despite the concomitant Burch colposuspension. If we learn that an alternative operation can perform better and that any urodynamic (or other clinical measure) can predict improved outcomes, I would consider resuming urodynamic testing.
WALTERS: At first glance, it appears that complex urodynamic testing is definitely not necessary if the goal is to improve outcomes of surgery. However, I believe the patient should undergo some components of urodynamic testing such as a void with a post-void residual urine volume and a basic bladder-filling study noting sensation and capacity. I also do a cough stress test with the prolapse reduced, although we may find that this does not predict postoperative function.
