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

NCT ID: NCT03336424

Last Updated: 2018-09-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-01

Study Completion Date

2019-10-31

Brief Summary

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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

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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.

Conditions

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Multiple Sclerosis Urinary Bladder, Neurogenic Urodynamics

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Parallel study, where group A receives non-invasive investigations and group B receives Invasive investigations.
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Non-invasive investigations group

Non-invasive investigations include: ultrasound, blood exam, urine analysis and culture, uroflowmetry

Group Type EXPERIMENTAL

Non-invasive investigations

Intervention Type DIAGNOSTIC_TEST

Ultrasound, blood tests, urine analysis and culture, uroflowmetry

Invasive investigations group

urodynamic study including: cystomanometry, pressure flow study, EMG

Group Type EXPERIMENTAL

Non-invasive investigations

Intervention Type DIAGNOSTIC_TEST

Ultrasound, blood tests, urine analysis and culture, uroflowmetry

Invasive investigations

Intervention Type DIAGNOSTIC_TEST

Cystomanometry, pressure flow study, EMG

Interventions

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Non-invasive investigations

Ultrasound, blood tests, urine analysis and culture, uroflowmetry

Intervention Type DIAGNOSTIC_TEST

Invasive investigations

Cystomanometry, pressure flow study, EMG

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* MS with urinary symptoms

Exclusion Criteria

* BPH LUTS
* Bladder cancer
* prostate cancer
* urethral stenosis
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Saint-Joseph University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Elie EL HELOU, MD

Role: PRINCIPAL_INVESTIGATOR

Saint-Joseph University

Locations

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Saint Joseph University

Beirut, , Lebanon

Site Status

Countries

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Lebanon

Other Identifiers

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FM292

Identifier Type: -

Identifier Source: org_study_id

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