NCT02367404

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
240

participants targeted

Target at P25-P50 for phase_3 prostate-cancer

Timeline
Completed

Started May 2015

Shorter than P25 for phase_3 prostate-cancer

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 13, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 20, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2015

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

September 13, 2016

Status Verified

September 1, 2016

Enrollment Period

1.8 years

First QC Date

February 13, 2015

Last Update Submit

September 12, 2016

Conditions

Prostate CancerUrinary Incontinence

Outcome Measures

Primary Outcomes (1)

  • Urinary continence proportion

    Proportion of patient achieving continence at 6 months

    6 months

Secondary Outcomes (2)

  • Urinary continence time

    6 months

  • Urinary quality of life

    6 months

Study Arms (4)

Control

NO INTERVENTION

Keigel's exercise

Duloxetine

ACTIVE COMPARATOR

Duloxetine 60mg for 3 months

Drug: Duloxetine

Duloxetine + PMFT

ACTIVE COMPARATOR

Duloxetine 60mg for 3 months PMFT weekly for 3 months

Drug: DuloxetineBehavioral: Pelvic Floor Muscle Training

Pelvic Floor Muscle Training

ACTIVE COMPARATOR

PMFT weekly for 3 months

Behavioral: Pelvic Floor Muscle Training

Interventions

DuloxetineDRUG

Duloxetine 60mg OD for 3 months

Also known as: Cymbalta
DuloxetineDuloxetine + PMFT
Pelvic Floor Muscle TrainingBEHAVIORAL

PMFT weekly for 3 months

Also known as: Pelvic Physiotherqpy
Duloxetine + PMFTPelvic Floor Muscle Training

Eligibility Criteria

Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut Mutualiste montsouris

Paris, 75014, France

RECRUITING

MeSH Terms

Conditions

Prostatic NeoplasmsUrinary Incontinence

Interventions

Duloxetine Hydrochloride

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital DiseasesUrination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ThiophenesSulfur CompoundsOrganic ChemicalsHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Rafael Sanchez-Salas, MD

    Institute Mutualiste Montsouris

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Rafael Sanchez-Salas, MD

CONTACT

0156616617rafael.sanchez-salas@imm.fr

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 13, 2015

First Posted

February 20, 2015

Study Start

May 1, 2015

Primary Completion

February 1, 2017

Study Completion

June 1, 2017

Last Updated

September 13, 2016

Record last verified: 2016-09

Locations

FR(1)