Prospective RCT on Post Prostatectomy Urine Leak

Summary

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).

Timeline

Start

2015-05

Primary completion

2017-02

Completion

2017-06

Drugs

Indications