UroToday - The role of duloxetine in the treatment of women with stress urinary incontinence (SUI) remains somewhat unclear. The randomised trial evidence does seem to indicate that it is an effective treatment. A Cochrane database review examined nine randomised controlled trials (RCT) and found an overall decrease of 50% in incontinence episode frequency, together with significant improvements in quality of life and perception of improvement [1]. However meta-analysis of objective cure parameters (namely pad weight testing) revealed no benefit of duloxetine over placebo. Relatively few trials included in the review actually included objective outcome measures however, so it is difficult to comment on the validity of this finding. As we discuss in the article, being a participant in an RCT may confer behavioural benefits that lead to an improvement in incontinence. With a placebo effect of up to 40%, a great deal of the overall treatment effect of duloxetine may be due to behavioural interventions. One must also remember that women taking part in trials also tend to be young and healthy with no comorbidities. In real life, this is often not the case. Age, raised Body Mass Index and chronic lung disease are both associated with stress and urge urinary incontinence [2]. A higher incidence of these factors in patients outside RCTs may lead to the lower treatment effect seen in observational studies.

Concerns about side effects and toxicity have also been expressed. Indeed, although Duloxetine has been approved for the treatment of SUI in Europe and Canada, it did not gain approval from the Food and Drug Administration amid concerns about liver toxicity and suicidal ideation and is not marketed in the US for this indication. These concerns, together with doubts about the efficacy of duloxetine have prompted some authors to recommend that it should not be used in women with SUI [3].

Another important question is whether women want to take a medication for SUI, when an effective and minimally invasive surgical treatment is available. Almost 70% of women find the option of taking regular medications for life for incontinence unacceptable [4]. It is known that women may not re-present for therapy of incontinence if their prescribed treatment fails or becomes less effective, for a variety of reasons including a lack of knowledge of other treatment options and an unwillingness to bother their health care providers with persisting symptoms [5]. It is therefore of some importance to comprehensively counsel patients regarding efficacy, side effects and alternative treatments prior to commencing treatment. Our own qualitative studies of patient preferences for treatment indicate that women with troublesome incontinence are more likely to want the most efficacious treatment for their symptoms, even if this involves a surgical procedure rather than simply taking a medication [Basu and Duckett, unpublished data].

Duloxetine remains an option for medical treatment of SUI outside of the US. In the UK, it is recommended for use only in those for whom surgery is contraindicated or who decline surgery [7], and it may well be that this is the role it ultimately fulfils. The initial promise it showed as a viable alternative to surgery has unfortunately been superceded by concerns about side effects and relatively low efficacy. Certain women however may still benefit from its use, although careful patient counselling is necessary.

Maya Basu, MD and Jonathan R.A. Duckett, MD as part of Beyond the Abstract on UroToday.

References

1. Mariappan P, Ballantyne Z, N'Dow J, Alhasso A. Serotonin and noradrenaline reuptake inhibitors (SNRI) for stress urinary incontinence in adults. Cochrane Database Syst Rev 2005; 20(3): CD004742

2. Rohr G, StØvring H, Christensen K, Gaist D, Nybo H, Kragstrup J. Characteristics of middle aged and elderly women with incontinence. Scand J Prim Health Care 2005; 23(4): 203-208

3. Duloxetine: new drug. For stress urinary incontinence: too much risk, too little benefit. Prescrire Int 2005; 14(80): 218-220

4. Robinson D, Anders K, Cardozo L, Bidmead J, Dixon A, Balmforth J, Rufford J. What do women want: interpretation of the concept of cure. J Pelvic Med Surg 2003; 9: 273-277

5. Basu M, Duckett J. Barriers to seeking treatment for women with recurrent or persistent symptoms in urogynaecology. BJOG 2009; 116(5): 726-730

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