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A Prospective Randomized Controlled Study Comparing the Efficacy of Pelvic Floor Muscle Training and Oral Duloxetine in the Recovery of Continence After Robotic Assisted Radical Prostatectomy
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).
Age
All ages
Sex
MALE
Healthy Volunteers
No
Institut Mutualiste montsouris
Paris, France
Start Date
May 1, 2015
Primary Completion Date
February 1, 2017
Completion Date
June 1, 2017
Last Updated
September 13, 2016
240
ESTIMATED participants
Duloxetine
DRUG
Pelvic Floor Muscle Training
BEHAVIORAL
Lead Sponsor
Institut Mutualiste Montsouris
NCT06842498
NCT05691465
Data Source & Attribution
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View ClinicalTrials.gov Terms and ConditionsNCT04550494