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

Not Applicable

• Conditions: Urodynamics; Urinary Bladder, Neurogenic; Multiple Sclerosis
• Interventions: Diagnostic Test: Non-invasive investigations; Diagnostic Test: Invasive investigations

• Registration Number: NCT03336424
• Lead Sponsor: Saint-Joseph University

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.

Study Timeline

• Study Start: 2017-10-01
• Study First Submitted: 2017-11-06
• Study First Submitted QC: 2017-11-06
• Study First Posted: 2017-11-08
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-05
• Last Update Posted: 2018-09-06
• Primary Completion: 2019-08
• Study Completion: 2019-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• MS with urinary symptoms

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Invasive investigations group	Non-invasive investigations	urodynamic study including: cystomanometry, pressure flow study, EMG
Invasive investigations group	Invasive investigations	urodynamic study including: cystomanometry, pressure flow study, EMG
Non-invasive investigations group	Non-invasive investigations	Non-invasive investigations include: ultrasound, blood exam, urine analysis and culture, uroflowmetry

Primary Outcome Measures

Name	Time	Method
urinary symptoms	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).
urinary quality of life	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).

Trial Locations

Locations (1)

Saint Joseph University; 🇱🇧 Beyrouth, Lebanon