Last updated on February 2018

Prospective RCT on Post Prostatectomy Urine Leak


Brief description of study

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).

Clinical Study Identifier: NCT02367404

Find a site near you

Start Over

Recruitment Status: Open


Brief Description Eligibility Contact Research Team


Receive Emails About New Clinical Trials!

Sign up for our FREE service to receive email notifications when clinical trials are posted in the medical category of interest to you.