Duloxetine in treatment of mild to moderate post-surgical incontinence

Let us be clear up front … Duloxetine (Cymbalta®) has not been approved anywhere in the world that we are aware of as a treatment for post-surgical incontinence in men treated for prostate cancer, and there has never been a large, randomized, double-blind Phase III trial to try to demonstrate such activity. However, over the years there have been several small trials that appear to suggest activity of duloxetine as an agent that can help with mild to moderate incontinence in men after a radical prostatectomy.

In one of the most recent such studies, Collado-Serra et al. have shown that duloxetine is a possible form of alternative treatment for established stress urinary incontinence in men following a radical prostatectomy, and that the effects of duloxetine in their patients were mild and conditioned — at least in part — by the frequency of the side effects.

Their study used an  initial 30 mg dose of duloxetine once daily. The dose was subsequently increased to 60 mg/day. Patient responses to therapy were tracked using the International Consultation on Incontinence Questionnaire-Urinary Incontinence short form (ICIQ-UI-SF) and the average numbers of pads used per patient per day.

Their study results were as follows:

  • 68 patients were enrolled between June 2006 and July 2007.
  • The average (median) age of the patients was 68 years (range, 52 to 79 years).
  • The median duration of duloxetine treatment was 5.56 months (range, 1 to 18 months).
  • Between the baseline and the 3-month clinic visit, there was a statistically significant increase in patients’ level of continence based on
    • A reduction in the ICIQ-UI-SF score from 13 to 9 (P < 0.001)
    • A reduction in the average number of pads used per day (from 2 to 1 pad,  P < 0.001)
  • At the end of the follow-up period,
    • 74 percent of patients had a reduced ICIQ-UI-SF score compared to baseline.
    • 57 percent of patients had decreased the number of pads used daily.
  • 32/68 patients (47 percent) had side effects to duloxetine therapy
  • 17/68 patients (25 percent) stopped treatment because of adverse effects to duloxetine.

While it is clear that responses to duloxetine can vary considerably in terms of both efficacy in improvement of continence and degree of side effects of the therapy, it also seems clear that for some patients duloxetine may be able to improve continence post-surgery with few or limited side effects. Its greatest value is likely to be in men who use duloxetine in combination with pelvic floor exercises (Kegel exercises) and who show an early response to such treatment.

The “New” Prostate Cancer InfoLink is of the opinion that, for men with mild to moderate incontinence several months after their surgery, duloxetine therapy certainly merits a discussion with their physicians, but if you want to try this form of therapy, you need to have a full understanding of the adverse effects associated with this drug.

    • The common side effects include nausea, dry mouth, sleepiness, fatigue, constipation, dizziness, decreased appetite, and increased sweating.
    • Because duloxetine can cause sleepiness and dizziness, patients should not drive a car or operate hazardous machinery until they know how use of duloxetine can affect them.
    • Drugs like duloxetine can increase suicidal thoughts and behaviors (however, these effects are most particularly observed in children, teenagers, and young adults).

For more detail about the side effects and risks associated with duloxetine therapy, please see the full prescribing information.

Of course if one is depressed about one’s incontinence, duloxetine may be able to help with that depression while it is also helping to reduce the degree of one’s incontinence.

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