Prospective RCT on Post Prostatectomy Urine Leak

Study Overview
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Brief Summary
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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 pador 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).

Official Title
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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

Conditions
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Prostate Cancer, Urinary Incontinence

Intervention / Treatment
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* Drug: Duloxetine
* Behavioral: Pelvic Floor Muscle Training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1. All consecutive patients undergoing Robotic Assisted Radical Prostatectomy for clinically organ confined prostate cancer Exclusion Criteria: Prior urethral, bladder or prostate surgery Pelvic radiotherapy. Overactive bladder Known neurological disease associated to LUTS Hepatic impairment with hepatic insufficiency. Severe renal impairment (creatinine clearance < 30ml/min) Hypersensitivity to duloxetine Uncontrolled hypertension Narrow angle glaucoma Post-operative criteria: Post-void residual urine volume > 100ml measured 15 days after the RARP
Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Keigel's exercise | |
| Active Comparator: Duloxetine<br>Duloxetine 60mg for 3 months | Drug: Duloxetine<br>* Duloxetine 60mg OD for 3 months<br>* Other names: Cymbalta;|
| Active Comparator: Duloxetine + PMFT<br>Duloxetine 60mg for 3 months PMFT weekly for 3 months | Drug: Duloxetine<br>* Duloxetine 60mg OD for 3 months<br>* Other names: Cymbalta;Behavioral: Pelvic Floor Muscle Training<br>* PMFT weekly for 3 months<br>* Other names: Pelvic Physiotherqpy;|
| Active Comparator: Pelvic Floor Muscle Training<br>PMFT weekly for 3 months | Behavioral: Pelvic Floor Muscle Training<br>* PMFT weekly for 3 months<br>* Other names: Pelvic Physiotherqpy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urinary continence proportion | Proportion of patient achieving continence at 6 months | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urinary continence time | time to achieve continence | 6 months | 
| Urinary quality of life | Quality of life tested in relation to incontinence using questionnaire at 6 months | 6 months |