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Multiple sclerosis (MS) is the leading non-traumatic cause of severe acquired disability in young people. The disease is defined by relapses, which can affect all neurological functions depending on the location of the new inflammatory lesion(s). The disease can thus manifest itself through bladder and bowel disorders (BWS), which affect approximately 80% of MS patients in all stages. Lower urinary tract dysfunction has a significant negative impact on the quality of life of patients and places a significant burden on the healthcare system in terms of resource allocation. In addition, there is a risk of long-term chronic renal failure, an infectious risk (recurrent cystitis and/or pyelonephritis, sometimes life-threatening) and a lithiasis risk.
The most frequently observed urinary symptoms are: urinary frequency, urgency with or without urinary incontinence, dysuria and chronic retention of urine. These disorders most often combine bladder hyperactivity and dysuria. This dysuria may be responsible for recurrent urinary tract infections, lithiasis, alteration of renal function.
The only therapeutic class currently used to treat dysuria in MS is alpha-blockers. Tamsulosin, alfusozin and doxazosin induce relaxation of the urethral smooth sphincter and prostatic urethral muscle fibers, facilitating the removal of subvesical obstruction and bladder emptying.
The study investigators hypothesize that treatment with tamsulosin 0.4 mg daily in adult MS patients with dysuria will result in symptom improvement as assessed by the International Prostate Symptom Score (IPSS) and Urinary Symptom Profile (USP) scores, a decrease in post-void residual, and an improvement in urine flow and quality of life.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tamsulosin | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tamsulosin | Drug | One 0.4mg Tamsulosin capsule taken per day for 30 days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Urinary symptoms between groups | Measured using the International Prostate Symptom Scale (IPSS), scoring ranging from 0-35 | Start of first intervention phase (Day 0) |
| Urinary symptoms between groups | Measured using the International Prostate Symptom Scale (IPSS), scoring ranging from 0-35 | End of first intervention phase (Day 30) |
| Urinary symptoms between groups | Measured using the International Prostate Symptom Scale (IPSS), scoring ranging from 0-35 | Start of first intervention phase (Day 60) |
| Urinary symptoms between groups | Measured using the International Prostate Symptom Scale (IPSS), scoring ranging from 0-35 | End of first intervention phase (Day 90) |
| Measure | Description | Time Frame |
|---|---|---|
| Urinary symptoms between groups | Measured using the Urinary Symptom Profile (USP) questionnaire: score ranging from 0-39 | Start of first intervention phase (Day 0) |
| Urinary symptoms between groups |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Stéphane DROUPY | Contact | 04.66.68.32.30 | stephane.droupy@chu-nimes.fr |
| Name | Affiliation | Role |
|---|---|---|
| Stéphane DROUPY | CHU de Nimes | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Nîmes | Recruiting | Nîmes | France |
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One month of intervention of drug or placebo followed by one month wash-out period and then final one month intervention with the remaining treatment not received in the first cycle.
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| Placebo |
| Drug |
one placebo capsule per day for 30 days. with identical appearance (color and size) to the experimental drug, composed of microcrystalline cellulose |
|
Measured using the Urinary Symptom Profile (USP) questionnaire: score ranging from 0-39
| End of first intervention phase (Day 30) |
| Urinary symptoms between groups | Measured using the Urinary Symptom Profile (USP) questionnaire: score ranging from 0-39 | Start of first intervention phase (Day 60) |
| Urinary symptoms between groups | Measured using the Urinary Symptom Profile (USP) questionnaire: score ranging from 0-39 | End of first intervention phase (Day 90) |
| Post-mictional residue between groups | ml, measured with BladderScan | Start of first intervention phase (Day 0) |
| Post-mictional residue between groups | ml, measured with BladderScan | End of first intervention phase (Day 30) |
| Post-mictional residue between groups | ml, measured with BladderScan | Start of first intervention phase (Day 60) |
| Post-mictional residue between groups | ml, measured with BladderScan | End of first intervention phase (Day 90) |
| Maximum urine flow rate between groups | ml/s | Start of first intervention phase (Day 0) |
| Maximum urine flow rate between groups | ml/s | End of first intervention phase (Day 30) |
| Maximum urine flow rate between groups | ml/s | Start of first intervention phase (Day 60) |
| Maximum urine flow rate between groups | ml/s | End of first intervention phase (Day 90) |
| Quality of life linked to urinary dysfunction between groups | Qualiveen-30 questionnaire; score 0-4 | Start of first intervention phase (Day 0) |
| Quality of life linked to urinary dysfunction between groups | Qualiveen-30 questionnaire; score 0-4 | End of first intervention phase (Day 30) |
| Quality of life linked to urinary dysfunction between groups | Qualiveen-30 questionnaire; score 0-4 | Start of first intervention phase (Day 60) |
| Quality of life linked to urinary dysfunction between groups | Qualiveen-30 questionnaire; score 0-4 | End of first intervention phase (Day 90) |
| Quality of life between groups | EQ-5D questionnaire; score 0-100 | Start of first intervention phase (Day 0) |
| Quality of life between groups | EQ-5D questionnaire; score 0-100 | End of first intervention phase (Day 30) |
| Quality of life between groups | EQ-5D questionnaire; score 0-100 | Start of first intervention phase (Day 60) |
| Quality of life between groups | EQ-5D questionnaire; score 0-100 | End of first intervention phase (Day 90) |
| Fatigue between groups | Modified Fatigue Impact Scale; score 0-84 | Start of first intervention phase (Day 0) |
| Fatigue between groups | Modified Fatigue Impact Scale; score 0-84 | End of first intervention phase (Day 30) |
| Fatigue between groups | Modified Fatigue Impact Scale; score 0-84 | Start of first intervention phase (Day 60) |
| Fatigue between groups | Modified Fatigue Impact Scale; score 0-84 | End of first intervention phase (Day 90) |
| Drug safety | Yes/no occurence of the following adverse events: headache, asthenia, gastrointestinal disorders, orthostatic hypotension | End of first intervention phase (Day 30) |
| Drug safety | Yes/no occurence of the following adverse events: headache, asthenia, gastrointestinal disorders, orthostatic hypotension | End of first intervention phase (Day 90) |
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D053159 | Dysuria |
| D059411 | Lower Urinary Tract Symptoms |
| D016055 | Urinary Retention |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D000077409 | Tamsulosin |
| ID | Term |
|---|---|
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
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