1. Duloxetine for mild to moderate postprostatectomy incontinence: preliminary results of a randomised, placebo-controlled trial.
- Author
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Cornu JN, Merlet B, Ciofu C, Mouly S, Peyrat L, Sèbe P, Yiou R, Vallancien G, Debrix I, Laribi K, Cussenot O, and Haab F
- Subjects
- Adrenergic Uptake Inhibitors adverse effects, Aged, Aged, 80 and over, Chi-Square Distribution, Double-Blind Method, Duloxetine Hydrochloride, Humans, Male, Middle Aged, Paris, Pilot Projects, Placebo Effect, Prospective Studies, Quality of Life, Selective Serotonin Reuptake Inhibitors adverse effects, Surveys and Questionnaires, Thiophenes adverse effects, Time Factors, Treatment Outcome, Urinary Incontinence etiology, Adrenergic Uptake Inhibitors therapeutic use, Prostatectomy adverse effects, Selective Serotonin Reuptake Inhibitors therapeutic use, Thiophenes therapeutic use, Urinary Incontinence prevention & control
- Abstract
Background: Duloxetine is effective in the management of stress urinary incontinence (SUI) in women but has been poorly evaluated in the treatment of SUI following radical prostatectomy (RP)., Objective: To establish the superiority of duloxetine over placebo in SUI after RP., Design, Setting, and Participants: We conducted a prospective, randomised, placebo-controlled, double-blind, monocentric superiority trial. After a placebo run-in period of 2 wk, patients with SUI after RP were randomised to receive either 80mg of duloxetine daily or matching placebo for 3 mo., Measurements: The primary outcome measure was the relative variation in incontinence episodes frequency (IEF) at the end of study compared to baseline. Secondary outcomes included quality of life (QoL) measures (Incontinence Impact Questionnaire Short Form [IIQ-SF], Urogenital Distress Inventory Short Form [UDI-SF], Incontinence Quality of Life [I-QoL]), symptom scores (Urinary Symptom Profile [USP] questionnaire, International Consultation on Incontinence/World Health Organisation Short Form questionnaire [ICIQ-SF], the Beck Depression Inventory [BDI-II] questionnaire), 1-h pad test, and assessment of adverse events., Results and Limitations: Thirty-one patients were randomised to either the treatment (n=16) or control group (n=15). Reduction in IEF was significant with duloxetine compared to placebo (mean±standard deviation [SD] variation: -52.2%±38.6 [range: -100 to +46] vs +19.0%±43.5 [range: -53 to +104]; mean difference: 71.2%; 95% confidence interval [CI] for the difference: 41.0-101.4; p<0.0001). IIQ-SF total score, UDI-SF total score, SUI subscore of the USP questionnaire, and question 3 of the ICIQ-SF questionnaire showed improvement in the duloxetine group (p=0.006, p=0.02, p=0.0004, and p=0.003, respectively). Both treatments were well tolerated throughout the study period., Conclusions: Duloxetine is effective in the treatment of incontinence symptoms and improves QoL in patients with SUI after RP., (Copyright © 2010 European Association of Urology. Published by Elsevier B.V. All rights reserved.)
- Published
- 2011
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