Discussion Questions

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  What was the study rationale?

  
  
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  What was the study design?

  
  
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  How well did the study design address the question under investigation?

  
  
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  What outcomes were assessed?

  
  
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  Can you comment on the analysis plan and sample size?

  
  
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  What do the tables tell us?

  
  
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  How could the study be improved?

  
  
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  What is the take-home message?

Introduction

This month, Journal Club members discussed an article that focused on the value of pairing an incontinence procedure with sacrocolpopexy. Earlier work, the Colpopexy and Urinary Reduction Efforts (CARE) study, suggested that this approach lessened postoperative stress incontinence. This new study by Elser and colleagues was performed to further assess whether the 2 corrective procedures should be performed together. Its genesis is interesting. After a very thorough review of the CARE study, Elser et al identified a point that caused them to reconsider its results. The message, here, is that careful analysis of prior research can lead to new and exciting research questions!

George A. Macones, MD, MSCE, Associate Editor

Background

Macones: I’d like to thank you for participating in this meeting of the Journal Club. This should be intriguing, since we have 4 maternal-fetal medicine specialists discussing a urogynecology article! Actually, I think this should be great—oftentimes, fresh unbiased eyes can lead to some terrific insights.

This study focuses on the role of preoperative urodynamics when planning a surgical approach in women undergoing abdominal sacrocolpopexy. I would first like to congratulate the authors for this contribution. Urogynecology is quite a young specialty, and it is heartening to see some work that begins to address its key issues.

Macones: What was the rationale for this study?

Cahill: Actually, it is quite interesting. The debate in the past has pertained to the role for an incontinence procedure in women undergoing surgery for prolapse of considerable concern. On 1 hand, some argue that a significant number of women who undergo a procedure for prolapse will become incontinent. The other side is that if you do both procedures together, you can actually cause some postoperative symptoms of obstruction. I believe this led to a practice of using preoperative urodynamics to select which patients had an incontinence procedure at the time of prolapse surgery. However, I am guessing this practice was not based on hard data.

Then, the results of the CARE study, which randomized women undergoing sacrocolpopexy to either a BURCH procedure or no Burch procedure, were reported. This study was halted early when a significant decrease in postoperative incontinence was identified at 12 weeks in those randomized to a Burch procedure. However, Elser and colleagues noted that the incontinence rate in the CARE study was much higher than has been observed in other studies. That raises questions about how the results should be interpreted and whether they should be incorporated into practice.

Macones: Interesting. That is reminiscent of issues we have debated for several years in maternal-fetal medicine (MFM).

Cahill: Indeed. This is exactly the same issue that we saw in the randomized controlled trial (RCT) of 17-alpha hydroxyprogesterone caproate (17-OHP) for the prevention of recurrent spontaneous preterm birth. The primary outcome for that study was much higher than was expected or had been seen in prior studies, and many of us have been hesitant to translate the data into practice. In fact, I believe that is one of the reasons that the FDA has not yet approved 17-OHP.

Macones: Well, it is good to see that MFM practitioners are not the only ones with these sorts of complicated issues.