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

NCT03336424 | Unknown

• 1 other identifier: FM292
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis; Urinary Bladder, Neurogenic; Urodynamics

Keywords

MS; Multiple sclerosis; urinary Bladder, Neurogenic; Urodynamics; Randomized controlled trial

Outcome Measures

Primary Outcomes (2)

• 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).

  6 months

• 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).

  6 months

Study Arms (2)

Non-invasive investigations group

EXPERIMENTAL

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

Diagnostic Test: Non-invasive investigations

Invasive investigations group

EXPERIMENTAL

urodynamic study including: cystomanometry, pressure flow study, EMG

Diagnostic Test: Non-invasive investigations; Diagnostic Test: Invasive investigations

Interventions

Non-invasive investigations DIAGNOSTIC_TEST

Ultrasound, blood tests, urine analysis and culture, uroflowmetry

Invasive investigations group; Non-invasive investigations group

Invasive investigations DIAGNOSTIC_TEST

Cystomanometry, pressure flow study, EMG

Invasive investigations group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• MS with urinary symptoms

You may not qualify if:

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

Sponsors & Collaborators

• Saint-Joseph University: lead

Study Sites (1)

Saint Joseph University

Beirut, Lebanon

Location

MeSH Terms

Conditions

Multiple Sclerosis; Urinary Bladder, Neurogenic

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Neurologic Manifestations; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Elie EL HELOU, MD

  Saint-Joseph University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallel study, where group A receives non-invasive investigations and group B receives Invasive investigations.

Study Record Dates

• First Submitted: November 6, 2017
• First Posted: November 8, 2017
• Study Start: October 1, 2017
• Primary Completion: August 1, 2019
• Study Completion: October 1, 2019
• Last Updated: September 6, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

LE (1)