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  • Prospective RCT on Post Prostatectomy Urine Leak
Clinical trial

Prospective RCT on Post Prostatectomy Urine Leak

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Last updated:1st Mar 2015

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).


Study Type: Interventional
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Estimated Enrollment: 240
Study Start Date: March 2015
Estimated Study Completion Date: February 2016
Estimated Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)


Arms:
- No Intervention: Control
- Active Comparator: Duloxetine
- Active Comparator: Duloxetine + PMFT
- Active Comparator: Pelvic Floor Muscle Training

Category Value
Study start date 2015-03-01

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