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Prospective RCT on Post Prostatectomy Urine Leak

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02367404
Recruitment Status : Unknown
Verified September 2016 by Institut Mutualiste Montsouris.
Recruitment status was:  Recruiting
First Posted : February 20, 2015
Last Update Posted : September 13, 2016
Sponsor:
Information provided by (Responsible Party):
Institut Mutualiste Montsouris

Study Description
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Brief 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).

Condition or disease Intervention/treatment Phase
Prostate Cancer Urinary Incontinence Drug: Duloxetine Behavioral: Pelvic Floor Muscle Training Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
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
Study Start Date : May 2015
Estimated Primary Completion Date : February 2017
Estimated Study Completion Date : June 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: Cymbalta
Active Comparator: Duloxetine + PMFT
Duloxetine 60mg for 3 months PMFT weekly for 3 months
 Drug: Duloxetine
Duloxetine 60mg OD for 3 months
Other Name: Cymbalta

Behavioral: Pelvic Floor Muscle Training
PMFT weekly for 3 months
Other Name: Pelvic Physiotherqpy
Active Comparator: Pelvic Floor Muscle Training
PMFT weekly for 3 months
 Behavioral: Pelvic Floor Muscle Training
PMFT weekly for 3 months
Other Name: Pelvic Physiotherqpy


Outcome Measures
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Primary Outcome Measures :
  1. Urinary continence proportion [ Time Frame: 6 months ]
    Proportion of patient achieving continence at 6 months


Secondary Outcome Measures :
  1. Urinary continence time [ Time Frame: 6 months ]
    time to achieve continence

  2. Urinary quality of life [ Time Frame: 6 months ]
    Quality of life tested in relation to incontinence using questionnaire at 6 months


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02367404


Contacts
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Contact: Rafael Sanchez-Salas, MD 0156616617 rafael.sanchez-salas@imm.fr

Locations
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France
Institut Mutualiste montsouris Recruiting
Paris, France, 75014
Sponsors and Collaborators
Institut Mutualiste Montsouris
Investigators
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Principal Investigator: Rafael Sanchez-Salas, MD Institute Mutualiste Montsouris
More Information
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Responsible Party: Institut Mutualiste Montsouris
ClinicalTrials.gov Identifier: NCT02367404    
Other Study ID Numbers: URO-01-2014
First Posted: February 20, 2015    Key Record Dates
Last Update Posted: September 13, 2016
Last Verified: September 2016
Additional relevant MeSH terms:
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Urinary Incontinence
Urogenital Diseases
Male Urogenital Diseases
Urination Disorders
Urologic Diseases
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Lower Urinary Tract Symptoms
Urological Manifestations
Duloxetine Hydrochloride
Serotonin and Noradrenaline Reuptake Inhibitors
 Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Antidepressive Agents
Psychotropic Drugs
Dopamine Agents