Objectives:
Primary: Comparison of proportion of patient achieving continence between the four arms at 6
months.
Secondary:
- Comparison of time to achieve continence between the four arms.
- Comparison of urinary symptoms and quality of life improvement between the four arms.
- Assessment of adverse events in Duloxetine arms.
Primary outcome/ time frame: Proportion of patient achieving continence at 6 months.
Continence is defined as "using no pad"or "only security pad".
Secondary outcome:
- time to achieve continence
- Quality of life tested in relation to incontinence according to Visual Analog Scale
(VAS) and King's Health Questionnaire (KQH).
- Urinary symptoms measured with International Prostate Symptom Score (IPSS).
No. of subjects entered: 300 patients informed and included, 240 patients will be randomized.
Statistical methods
- Proportion of patients who achieve continence and time to achieve continence will be
compared between the four arms.
- Comparison of quality of life outcomes between the four arms
- Comparison of clinical variables that can affect the primary/secondary outcome -
univariate and multivariate analysis (ITT).