Urinary Disorders in Patients With Multiple Sclerosis: Invasive Vs Non-invasive Investigations.

September 5, 2018 updated by: Saint-Joseph University

Prospective Randomized Controlled Trial Comparing the Non-invasive vs the Invasive Investigations in Multiple Sclerosis Patients With Urinary Disorders.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Lebanon
      • Beyrouth, Lebanon
        • Saint Joseph University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • MS with urinary symptoms

Exclusion Criteria:

  • BPH LUTS
  • Bladder cancer
  • prostate cancer
  • urethral stenosis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Non-invasive investigations group
Non-invasive investigations include: ultrasound, blood exam, urine analysis and culture, uroflowmetry
Diagnostic test: Non-invasive investigations
Ultrasound, blood tests, urine analysis and culture, uroflowmetry
Experimental: Invasive investigations group
urodynamic study including: cystomanometry, pressure flow study, EMG
Diagnostic test: Non-invasive investigations
Ultrasound, blood tests, urine analysis and culture, uroflowmetry
Diagnostic test: Invasive investigations
Cystomanometry, pressure flow study, EMG

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
urinary symptoms
Time Frame: 6 months
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).
6 months
urinary quality of life
Time Frame: 6 months
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).
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Saint-Joseph University

Investigators

  • Principal Investigator: Elie EL HELOU, MD, Saint-Joseph University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2017

Primary Completion (Anticipated)

August 1, 2019

Study Completion (Anticipated)

October 1, 2019

Study Registration Dates

First Submitted

November 6, 2017

First Submitted That Met QC Criteria

November 6, 2017

First Posted (Actual)

November 8, 2017

Study Record Updates

Last Update Posted (Actual)

September 6, 2018

Last Update Submitted That Met QC Criteria

September 5, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FM292

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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