Last updated on February 2018

Prospective RCT on Post Prostatectomy Urine Leak

Brief description of study


Primary: Comparison of proportion of patient achieving continence between the four arms at 6 months.

  • 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).

Clinical Study Identifier: NCT02367404

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