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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non-invasive investigations group | Experimental | Non-invasive investigations include: ultrasound, blood exam, urine analysis and culture, uroflowmetry |
|
| Invasive investigations group | Experimental | urodynamic study including: cystomanometry, pressure flow study, EMG |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-invasive investigations | Diagnostic Test | Ultrasound, blood tests, urine analysis and culture, uroflowmetry |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elie EL HELOU, MD | Saint-Joseph University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Saint Joseph University | Beirut | Lebanon |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D001750 | Urinary Bladder, Neurogenic |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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Parallel study, where group A receives non-invasive investigations and group B receives Invasive investigations.
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| Invasive investigations | Diagnostic Test | Cystomanometry, pressure flow study, EMG |
|
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D009461 | Neurologic Manifestations |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |