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NCT03336424 Clinical Trial

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

Multiple Sclerosis Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT03336424
Other study ID # FM292
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date October 1, 2017
Est. completion date October 2019

Study information
Verified date September 2018
Source Saint-Joseph University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 60
Est. completion date October 2019
Est. primary completion date August 2019
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- MS with urinary symptoms

Exclusion Criteria:

- BPH LUTS

- Bladder cancer

- prostate cancer

- urethral stenosis

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Non-invasive investigations
Ultrasound, blood tests, urine analysis and culture, uroflowmetry
• Invasive investigations
Cystomanometry, pressure flow study, EMG

Locations
Country Name City State
Lebanon Saint Joseph University Beyrouth

Sponsors (1)
Lead Sponsor Collaborator
Saint-Joseph University

Country where clinical trial is conducted

Lebanon, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
Primary 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
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