Strict leak- and pad-free continence after RALP: is this the real truth?

The issue of complete continence after radical prostatectomy is a subject that few in the urologic surgery community have addressed in thorough detail. However, a new article based on data from a single-institution series of patients at the University of Chicago may have finally opened the doors to some honesty about this topic.

Reynolds and colleagues set out to develop a strict and specific definition of continence — which they characterize as “leak-free and pad-free” or LFPF — and to apply it to outcomes of patients after robot-assisted radical prostatectomy (RALP) at their institution.

Between February 2003 and September 2007, the authors collected reviewable data on pre- and post-surgical continence for 1,005/1,500 patients treated for prostate cancer with a RALP at a single institution. Specific responses to urinary function and continence items were reviewed at baseline (prior to surgery) and at 1, 3, 6, 12, and 24 months after surgery.

Based on the authors’ strict definition of LFPF continence, they observed the following:*

  • Before surgery, 734/1,005 (73 percent) of these patients were LFPF.
  • After surgery, the proportion of patients who were LFPF at specific time periods was
    • 4 percent (40/1,005) at 1 month
    • 9 percent (90/1,005) at 3 months
    • 17 percent (171/1,005) at 6 months
    • 24 percent (241/1,005) at 12 months
    • 28 percent (281/1,005) at 24 months

In other words, although about three-quarters of the patients were LFPF before surgery, only about a quarter were LFPF at 1 year after surgery, and that didn’t increase much at 2 years after surgery.

When Reynolds et al. applied less strict definitions of continence:

  • At 24 months post-surgery, 677/1,005 (68 percent) of patients reported no pad use
  • Also at 24 months post-surgery, 905/1,005 (90 percent) of patients reported either no pad use or the use of a security pad.

Finally, when patients were stratified by their baseline LFPF status:

  • Patients who were not LFPF at baseline had higher baseline international prostate symptom score scores, lower urinary function scores, lower urinary bother scores, and larger prostate weights.
  • Patients who were LFPF at baseline disproportionately regained LFPF continence starting 6 months after surgery compared with those not LFPF at baseline: 20 vs 9 percent at 6 months, 27 vs 15 percent at 12 months, and  33 vs 15 percent at 24 months.

The authors conclude, first and foremost, that “a strict definition of urinary continence results in more conservative postoperative outcomes.” They go on to state that, “Preoperative LFPF status can be predictive of postoperative LFPF continence. However, only one-third of patients LFPF at baseline returned to LFPF at 24 months.”

Now we should not immediately conclude that every surgeon who tells all his patients that they will be fully continent after surgery has been lying for years. However, what this study absolutely does do is “level the playing field” with regard to what everyone means by continence.

Continence for the patient has and always will mean what Reynolds and colleagues have defined as “leak-free and pad-free.” Post-surgical continence at that level appears to be attainable in about a third of the patients who were LFPF before surgery. The question The “New” Prostate Cancer InfoLink would ask, based on this paper, is whether we can actually define a secondary and acceptable level of continence so that we can give reasonable expections for another 50 percent of patients. On the basis of these data, it would appear that we can state with a reasonable level of confidence that, 2 years post-surgery:

  • 28 percent of patients can expect to be LFPF
  • An additional 40 percent of patients can expect to pad-free but not leak-free
  • An additional 22 percent of patients can expect to be wearing a security pad
  • The remaining 10 percent of patients will have some level of significant incontinence

This appears to be a good basis for communication of risk of incontinence (at least for patients undergoing RALP at the University of Chicago) moving forward. It would be gratifying to believe that all surgical and other treatment type groups would make the attempt to report post-treatment continence rates with this level of accuracy moving forward. The “New” Prostate Cancer InfoLink would like to congratulate Dr. Reynolds and his coauthors for carrying out this detailed study and making these data available. We hope that other groups will follow suit, and soon.

Patients are encouraged, from now on, to specifically ask their surgeons whether their post-surgical incontinence rates are categorized into those who are LFPF, pad-free, or wearing security pads at 2 years post-surgery. We assume that at least some surgeons will be able to improve on the rates published by Reynolds et al.

*Editorial note: This paragraph was modified on November 20, 2009 because several readers were confused by the original way in which the results of the study were presented.

13 Responses

  1. This sort of candor in a single institution study is refreshing. Every patient is entitled to have reasonable, evidence-based expectations as they make treatment decisions.

    It would be interesting (at least to me) to see a similar study for patients who underwent open surgery at the same institution. My questions: Are the continence results different in any material respect between open and RALP when done by good docs at a good institution?

  2. Dear Geoff:

    Assuming that the surgeons have similar levels of skill and experience with the technique of their choice, The “New” Prostate Cancer InfoLink does not believe that there is any significant difference between incontinence rates following radical prostatectomy using “open,” laparoscopic, or robot-assisted laparoscopic methods.

    It should be said that in one trial, conducted at Memorial Sloan-Kettering Cancer Center, where they compared “open” and non-robot-assisted laparoscopic (LRP) techniques some years ago, the patients treated with LRP were “much less likely to become continent” than those treated with open radical retropubic prostatectomy, and the authors further state that “this was an unexpected finding of our analysis.” However, LRP is generally considered to be the hardest of the three techniques to learn to do well.

  3. The article makes me start to wonder if future generations will look at the last 20 years of prostate cancer treatment as a ritual mutilation, somewhat akin to female circumcision as practiced in some Muslim countries.

  4. Do the authors define what a “pad” is? Is a paper towel or panty liner a pad?

  5. I haven’t seen the full paper, but I think it would be safe to assume that anything being worn with the intention of absorbing a possible leak, such as a paper towel or a panty liner, would indeed qualify under the definition of a “pad.”

  6. I believe the current thinking is that there is no improvement in incontinence after a year, and some sort of sling or valve implant can then be considered. Does this study imply that there can be significant improvement between 12 and 24 months?

  7. I think we need to distinguish between serious incontinence that might actually need treatment and minor incontinence that most would consider to be an irritation bordering on annoying at times.

    If there is still serious inability to control one’s urinary function a year after treatment, then it is unlikely there is going to be significant improvement. By contrast, minor incontinence that has just taken longer than average to recover to something approaching normality may continue to improve for as much as 2 years. But at the end of the day there are exceptions to every “rule.” Humans have a profound ability to demonstrate their individuality!

  8. I’m just curious: how was “continence” defined before? There had to be some guideline???

  9. This has always been a big part of the problem. There has been no “standardized” way in which the continence of men post-radical prostatectomy has been assessed.

  10. Is there any equivalent study for EBRT and/or brachytherapy patients?

  11. Not that we are aware of. As far as we know, this is the first report of this type using any form of first-line treatment.

  12. The one thing this tells me is that you don’t want to have a prostatectomy at the University of Chicago.

    Really, I don’t see how you can rely on statistics that don’t consider the surgeon’s experience.

  13. That is exactly why we would like to see other groups report their results to this level of accuracy! The University of Chicago has had the good grace to be completely honest. Hopefully others will now be prepared to do the same. The Chicago results may actually be very close to what is observed at most major academic medical centers.

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