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

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 Overview

• Status: Unknown
• Conditions: Urinary Incontinence; Prostate Cancer
• Intervention / Treatment: Drug: Duloxetine; Behavioral: Pelvic Floor Muscle Training

• Study Type: Interventional
• Enrollment (Anticipated): 240
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Rafael Sanchez-Salas, MD; Phone Number: 0156616617; Email: rafael.sanchez-salas@imm.fr

Study Locations

• France
  • Paris, France, 75014
    • Recruiting
    • Institut Mutualiste Montsouris

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

1. All consecutive patients undergoing Robotic Assisted Radical Prostatectomy for clinically organ confined prostate cancer

Exclusion Criteria:

1. Prior urethral, bladder or prostate surgery
2. Pelvic radiotherapy.
3. Overactive bladder
4. Known neurological disease associated to LUTS
5. Hepatic impairment with hepatic insufficiency.
6. Severe renal impairment (creatinine clearance < 30ml/min)
7. Hypersensitivity to duloxetine
8. Uncontrolled hypertension

9. Narrow angle glaucoma

   Post-operative criteria:

10. Post-void residual urine volume > 100ml measured 15 days after the RARP

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Institut Mutualiste Montsouris
• Investigators: Principal Investigator: Rafael Sanchez-Salas, MD, Institute Mutualiste Montsouris

Study record dates

Study Major Dates

• Study Start: May 1, 2015
• Primary Completion (Anticipated): February 1, 2017
• Study Completion (Anticipated): June 1, 2017

Study Registration Dates

• First Submitted: February 13, 2015
• First Submitted That Met QC Criteria: February 19, 2015
• First Posted (Estimate): February 20, 2015

Study Record Updates

• Last Update Posted (Estimate): September 13, 2016
• Last Update Submitted That Met QC Criteria: September 12, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Urinary Incontinence; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Psychotropic Drugs; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Antidepressive Agents; Dopamine Agents; Serotonin and Noradrenaline Reuptake Inhibitors; Duloxetine Hydrochloride
• Other Study ID Numbers: URO-01-2014