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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03336424
Enrollment
60
Registered
2017-11-08
Start date
2017-10-01
Completion date
2019-10-31
Last updated
2018-09-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis, Urinary Bladder, Neurogenic, Urodynamics

Keywords

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

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.

Interventions

DIAGNOSTIC_TESTNon-invasive investigations

Ultrasound, blood tests, urine analysis and culture, uroflowmetry

DIAGNOSTIC_TESTInvasive investigations

Cystomanometry, pressure flow study, EMG

Sponsors

Saint-Joseph University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Intervention model description

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

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* MS with urinary symptoms

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
urinary symptoms6 monthsfilling 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 life6 monthsSF-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).

Countries

Lebanon

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026