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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
Saint-Joseph University
About
Eligibility
Locations
Arms
Outcomes
Full info

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

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
November 6, 2017
Last Updated
September 5, 2018
Sponsor
Saint-Joseph University
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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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