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Prospective RCT on Post Prostatectomy Urine Leak

NCT02367404 · Institut Mutualiste Montsouris · Updated 13 Sept 2016

What is being tested
Duloxetine; Pelvic Floor Muscle Training
For
Prostate Cancer; Urinary Incontinence
Kind of study
Tests a treatment or device on volunteers. Phase 3.
Who can join
Ages Not stated. About 240 people. The full rules are on the registry page.
Where
France
When
Starts or started May 2015, ends June 2017. Registered 20 Feb 2015.
Results
None posted yet.

In the researchers' words

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).
ClinicalTrials.gov, NCT02367404

Sites

  • Institut Mutualiste montsourisParis, France