Urinary Disorders in Patients With Multiple Sclerosis: Invasive Vs Non-invasive Investigations.
Primary Purpose
Multiple Sclerosis, Urinary Bladder, Neurogenic, Urodynamics
Status
Unknown status
Phase
Not Applicable
Locations
Lebanon
Study Type
Interventional
Intervention
Non-invasive investigations
Invasive investigations
Sponsored by
About this trial
This is an interventional diagnostic trial for Multiple Sclerosis focused on measuring MS, Multiple sclerosis, urinary Bladder, Neurogenic, Urodynamics, Randomized controlled trial
Eligibility Criteria
Inclusion Criteria:
- MS with urinary symptoms
Exclusion Criteria:
- BPH LUTS
- Bladder cancer
- prostate cancer
- urethral stenosis
Sites / Locations
- Saint Joseph University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Non-invasive investigations group
Invasive investigations group
Arm Description
Non-invasive investigations include: ultrasound, blood exam, urine analysis and culture, uroflowmetry
urodynamic study including: cystomanometry, pressure flow study, EMG
Outcomes
Primary Outcome Measures
urinary symptoms
filling and voiding urinary symptoms (UBQMS: Urinary Bothersome Questionnaire in Multiple Sclerosis), Voising Score Ranges from 0 to 3 ( 3 being most severe bother), Filling score ranges from 0 to 3 ( 3 being most severe bother).
urinary quality of life
SF-QUALIVEEN: Short Form - health related quality of life questionnaire for urinary disorders in patients with neurological conditions. score ranges from 0 to 4 ( 4 being the worst quality of life).
Secondary Outcome Measures
Full Information
NCT ID
NCT03336424
First Posted
November 6, 2017
Last Updated
September 5, 2018
Sponsor
Saint-Joseph University
1. Study Identification
Unique Protocol Identification Number
NCT03336424
Brief Title
Urinary Disorders in Patients With Multiple Sclerosis: Invasive Vs Non-invasive Investigations.
Official Title
Prospective Randomized Controlled Trial Comparing the Non-invasive vs the Invasive Investigations in Multiple Sclerosis Patients With Urinary Disorders.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2017 (Actual)
Primary Completion Date
August 2019 (Anticipated)
Study Completion Date
October 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Saint-Joseph University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The objective of the study is to describe the current status of MS patients with urinary disorders in Lebanon, and to demonstrate whether invasive investigations improve the management of these patients compared to an optimal non-invasive approach.
Detailed Description
All patients will be evaluated by an urologist, then randomized into 2 groups, the first group will benefit from non-invasive investigations and will be treated accordingly, the second group will benefit from an urodynamic assessment and will also be treated accordingly.
An evaluation will be made one month, 3 months and 6 months after the first visit.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis, Urinary Bladder, Neurogenic, Urodynamics
Keywords
MS, Multiple sclerosis, urinary Bladder, Neurogenic, Urodynamics, Randomized controlled trial
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel study, where group A receives non-invasive investigations and group B receives Invasive investigations.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Non-invasive investigations group
Arm Type
Experimental
Arm Description
Non-invasive investigations include: ultrasound, blood exam, urine analysis and culture, uroflowmetry
Arm Title
Invasive investigations group
Arm Type
Experimental
Arm Description
urodynamic study including: cystomanometry, pressure flow study, EMG
Intervention Type
Diagnostic Test
Intervention Name(s)
Non-invasive investigations
Intervention Description
Ultrasound, blood tests, urine analysis and culture, uroflowmetry
Intervention Type
Diagnostic Test
Intervention Name(s)
Invasive investigations
Intervention Description
Cystomanometry, pressure flow study, EMG
Primary Outcome Measure Information:
Title
urinary symptoms
Description
filling and voiding urinary symptoms (UBQMS: Urinary Bothersome Questionnaire in Multiple Sclerosis), Voising Score Ranges from 0 to 3 ( 3 being most severe bother), Filling score ranges from 0 to 3 ( 3 being most severe bother).
Time Frame
6 months
Title
urinary quality of life
Description
SF-QUALIVEEN: Short Form - health related quality of life questionnaire for urinary disorders in patients with neurological conditions. score ranges from 0 to 4 ( 4 being the worst quality of life).
Time Frame
6 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
MS with urinary symptoms
Exclusion Criteria:
BPH LUTS
Bladder cancer
prostate cancer
urethral stenosis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elie EL HELOU, MD
Organizational Affiliation
Saint-Joseph University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Saint Joseph University
City
Beyrouth
Country
Lebanon
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Urinary Disorders in Patients With Multiple Sclerosis: Invasive Vs Non-invasive Investigations.
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