Abstract

Background

To date, standard recommendations for the management of stress urinary incontinence (SUI) would be either pelvic floor muscle training (PFMT) or surgery. A new form of drug treatment with a serotonin‐noradrenaline reuptake inhibitor (SNRI), duloxetine, may now have a place in treatment of this condition.

Objectives

To determine whether a SNRI is better than placebo (or no treatment, other pharmacological and non‐pharmacological therapies, or surgery) in the treatment of women with SUI, or mixed urinary incontinence that includes stress incontinence (MUI), or both and which doses should be used.

Search methods

We searched the Cochrane Incontinence Group Specialised Register (searched 5th March 2007), CENTRAL (The Cochrane Library 2006, Issue 4), MEDLINE (January 1966 to January 2007), MEDLINE In‐Process & Other Non‐Indexed Citations (7 February 2007) and the reference lists of relevant articles.

Selection criteria

All randomised or quasi‐randomised controlled trials of treatment for SUI or MUI, in which at least one management arm involved a SNRI.

Data collection and analysis

Two authors evaluated the trials for appropriateness for inclusion and methodological quality. Three authors performed the data extraction using predetermined criteria. Analyses were performed using the Cochrane Review Manager software, RevMan.

Main results

Ten randomised trials were included, involving 3944 adults with predominantly SUI, randomised to receive duloxetine or placebo and/ or PFMT. All arms in individual trials were comparable for various baseline characteristics. Treatment duration was between three weeks and 12 weeks.

Duloxetine was significantly better than placebo in terms of improving patients' quality of life (weighted mean difference 5.26, 95% confidence interval 3.84 to 6.68. P less than 0.00001) and perception of improvement. Individual studies demonstrated a significant reduction in the Incontinence Episode Frequency (IEF) by approximately 50% during treatment with duloxetine. With regard to objective cure, however, meta‐analysis of stress pad test and 24 hour pad weight change failed to demonstrate a benefit for duloxetine over placebo though data were relatively few. Subjective cure favoured duloxetine, albeit with a small effect size (3%). One trial suggested that duloxetine was better than pelvic floor muscle training alone in reducing IEF (P less than 0.05) based on median percentage decrease in IEF per week. Although significant side effects were commonly associated with duloxetine, they were reported as acceptable.

Authors' conclusions

The available evidence suggests that duloxetine treatment can significantly improve the quality of life of patients with stress urinary incontinence, but it is unclear whether or not benefits are sustainable. Adverse effects are common but not serious. About one in three participants allocated duloxetine reported adverse effects (most commonly nausea) related to treatment, and about one in eight allocated duloxetine stopped treatment as a consequence.

Author(s)

Paramananthan Mariappan, Ammar A Alhasso, Adrian Grant, James MO N'Dow

Abstract

Plain language summary

Duloxetine can improve the quality of life of patients with stress urinary incontinence, long‐term effects of the treatment are unclear.

Stress urinary incontinence is involuntary urine leakage on coughing or exertion. The trials reviewed compared duloxetine against dummy placebo tablets and also pelvic floor muscle training in women with predominantly stress urinary incontinence. Duloxetine reduced the frequency of episodes of incontinence and improved quality of life scores. However, it had little impact on the numbers cured and commonly had side effects, especially nausea. More studies comparing a serotonin and noradrenaline reuptake inhibitor with placebo and surgery are required, especially if conducted independently of pharmaceutical companies.

Author(s)

Paramananthan Mariappan, Ammar A Alhasso, Adrian Grant, James MO N'Dow

Reviewer's Conclusions

Authors' conclusions 

Implications for practice 

This review suggests that duloxetine versus placebo improves incontinence episodes and quality of life in patients with predominantly SUI, although the differences were small. There were, however, only limited usable objective data in favour of duloxetine and it is uncertain if these benefits are sustained long‐term. Data from the trials included in this review would suggest that duloxetine commonly has side effects ‐ most often nausea ‐ and that these lead to between 1 in 6 and 1 in 8 stopping treatment. This raises questions about its acceptability in normal clinical practice. There is no RCT‐based evidence at present with which to judge whether or not duloxetine is a cost‐effective alternative to current approaches to care such as pelvic floor muscle training and surgery.

Implications for research 

Research is needed to clarify whether management policies incorporating duloxetine are clinically effective and cost‐effective compared with current approaches such as pelvic floor muscle training, injection therapy and more invasive surgery in patients with varying severity of stress urinary incontinence. In trials that include participants with mixed incontinence, attempts should be made to assess the effects of duloxetine, if any, on the urge incontinence component. Such RCTs will need to be long‐term to clarify when treatment is prolonged and after it has stopped (a) whether the short‐term efficacy of duloxetine is sustained, and (b) whether the safety profile remains acceptable.

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