Duloxetine for Mild to Moderate Postprostatectomy Incontinence: Preliminary Results of a Randomised, Placebo-Controlled Trial

• Published in: European urology 2011-01, Vol.59 (1), p.148-154
• Main Authors: Cornu, Jean-Nicolas, Merlet, Benoit, Ciofu, Calin, Mouly, Stéphane, Peyrat, Laurence, Sèbe, Philippe, Yiou, René, Vallancien, Guy, Debrix, Isabelle, Laribi, Karim, Cussenot, Olivier, Haab, François
• Format: Article
• Language: English
• Subjects: Adrenergic Uptake Inhibitors - adverse effects; Adrenergic Uptake Inhibitors - therapeutic use; Aged; Aged, 80 and over; Biological and medical sciences; Chi-Square Distribution; Double-Blind Method; Duloxetine; Duloxetine Hydrochloride; Humans; Male; Medical sciences; Middle Aged; Nephrology. Urinary tract diseases; Paris; Pilot Projects; Placebo Effect; Prospective Studies; Prostatectomy; Prostatectomy - adverse effects; Quality of Life; Randomised controlled trial; Serotonin Uptake Inhibitors - adverse effects; Serotonin Uptake Inhibitors - therapeutic use; Stress; Surveys and Questionnaires; Thiophenes - adverse effects; Thiophenes - therapeutic use; Time Factors; Treatment Outcome; Urinary incontinence; Urinary Incontinence - etiology; Urinary Incontinence - prevention & control; Urinary system involvement in other diseases. Miscellaneous; Urinary tract. Prostate gland; Urology
• ISSN: 0302-2838; 1873-7560
• DOI: 10.1016/j.eururo.2010.10.031

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 80 mg 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.