NCT02367404

Prospective RCT on Post Prostatectomy Urine Leak

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 240 (estimated)
• Sponsor: Institut Mutualiste Montsouris · Academic / Other
• Sex: Male
• Age: —
• Healthy volunteers: Not accepted

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).

Conditions

• Prostate Cancer
• Urinary Incontinence

Interventions

Type	Name	Description
DRUG	Duloxetine	Duloxetine 60mg OD for 3 months
BEHAVIORAL	Pelvic Floor Muscle Training	PMFT weekly for 3 months

Timeline

• Start date: 2015-05-01
• Primary completion: 2017-02-01
• Completion: 2017-06-01
• First posted: 2015-02-20
• Last updated: 2016-09-13

Locations

1 site across 1 country: France