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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05439902
Other study ID # NIMAO/2021-1/EB-01
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 5, 2022
Est. completion date March 2024

Study information

Verified date October 2023
Source Centre Hospitalier Universitaire de Nimes
Contact Elsa Bey
Phone 06.68.63.61.36
Email elsa.bey@chu-nimes.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date March 2024
Est. primary completion date March 2024
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: - The patient must have given their free and informed consent and signed the consent form - The patient must be a member or beneficiary of a health insurance plan - Patient with multiple sclerosis (EDSS score < 7.5). - Moderate to severe dysuria (IPSS score > 7) due to bladder sphincter dyssynergia confirmed by complete urodynamic workup. - Patient under stable treatment. Exclusion Criteria: - The subject is participating in another category 1 interventional study, or a trial involving a non-CE marked or CE marked off-label medical device or is in a period of exclusion determined by a previous study - The subject refuses to sign the consent - It is impossible to give the subject informed information - The patient is under safeguard of justice or state guardianship - Hypersensitivity to tamsulosin hydrochloride, including angioedema induced by the drug or any of the excipients. - History of orthostatic hypotension. - Severe hepatic impairment. - Concomitant treatment with diclofenac, warfarin, CYP3A4 inhibitors. - - Patient with complete urinary retention at the time of the pre-inclusion consultation, requiring management by intermittent self-catheterization or, failing that, an indwelling bladder catheter from the outset. - Major medical or psychiatric illness that, in the opinion of the investigator, would place the subject at risk or could compromise compliance with the study protocol. - Presence of another neurological pathology (excluding MS). - Swallowing problems that compromise oral medication. - Scheduled cataract surgery within 4 months. - Pregnant, parturient or breastfeeding patient.

Study Design


Intervention

Drug:
Tamsulosin
One 0.4mg Tamsulosin capsule taken per day for 30 days
Placebo
one placebo capsule per day for 30 days. with identical appearance (color and size) to the experimental drug, composed of microcrystalline cellulose

Locations

Country Name City State
France CHU de Nîmes Nîmes

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Urinary symptoms between groups Measured using the International Prostate Symptom Scale (IPSS), scoring ranging from 0-35 Start of first intervention phase (Day 0)
Primary Urinary symptoms between groups Measured using the International Prostate Symptom Scale (IPSS), scoring ranging from 0-35 End of first intervention phase (Day 30)
Primary Urinary symptoms between groups Measured using the International Prostate Symptom Scale (IPSS), scoring ranging from 0-35 Start of first intervention phase (Day 60)
Primary Urinary symptoms between groups Measured using the International Prostate Symptom Scale (IPSS), scoring ranging from 0-35 End of first intervention phase (Day 90)
Secondary Urinary symptoms between groups Measured using the Urinary Symptom Profile (USP) questionnaire: score ranging from 0-39 Start of first intervention phase (Day 0)
Secondary Urinary symptoms between groups Measured using the Urinary Symptom Profile (USP) questionnaire: score ranging from 0-39 End of first intervention phase (Day 30)
Secondary Urinary symptoms between groups Measured using the Urinary Symptom Profile (USP) questionnaire: score ranging from 0-39 Start of first intervention phase (Day 60)
Secondary Urinary symptoms between groups Measured using the Urinary Symptom Profile (USP) questionnaire: score ranging from 0-39 End of first intervention phase (Day 90)
Secondary Post-mictional residue between groups ml, measured with BladderScan Start of first intervention phase (Day 0)
Secondary Post-mictional residue between groups ml, measured with BladderScan End of first intervention phase (Day 30)
Secondary Post-mictional residue between groups ml, measured with BladderScan Start of first intervention phase (Day 60)
Secondary Post-mictional residue between groups ml, measured with BladderScan End of first intervention phase (Day 90)
Secondary Maximum urine flow rate between groups ml/s Start of first intervention phase (Day 0)
Secondary Maximum urine flow rate between groups ml/s End of first intervention phase (Day 30)
Secondary Maximum urine flow rate between groups ml/s Start of first intervention phase (Day 60)
Secondary Maximum urine flow rate between groups ml/s End of first intervention phase (Day 90)
Secondary Quality of life linked to urinary dysfunction between groups Qualiveen-30 questionnaire; score 0-4 Start of first intervention phase (Day 0)
Secondary Quality of life linked to urinary dysfunction between groups Qualiveen-30 questionnaire; score 0-4 End of first intervention phase (Day 30)
Secondary Quality of life linked to urinary dysfunction between groups Qualiveen-30 questionnaire; score 0-4 Start of first intervention phase (Day 60)
Secondary Quality of life linked to urinary dysfunction between groups Qualiveen-30 questionnaire; score 0-4 End of first intervention phase (Day 90)
Secondary Quality of life between groups EQ-5D questionnaire; score 0-100 Start of first intervention phase (Day 0)
Secondary Quality of life between groups EQ-5D questionnaire; score 0-100 End of first intervention phase (Day 30)
Secondary Quality of life between groups EQ-5D questionnaire; score 0-100 Start of first intervention phase (Day 60)
Secondary Quality of life between groups EQ-5D questionnaire; score 0-100 End of first intervention phase (Day 90)
Secondary Fatigue between groups Modified Fatigue Impact Scale; score 0-84 Start of first intervention phase (Day 0)
Secondary Fatigue between groups Modified Fatigue Impact Scale; score 0-84 End of first intervention phase (Day 30)
Secondary Fatigue between groups Modified Fatigue Impact Scale; score 0-84 Start of first intervention phase (Day 60)
Secondary Fatigue between groups Modified Fatigue Impact Scale; score 0-84 End of first intervention phase (Day 90)
Secondary Drug safety Yes/no occurence of the following adverse events: headache, asthenia, gastrointestinal disorders, orthostatic hypotension End of first intervention phase (Day 30)
Secondary Drug safety Yes/no occurence of the following adverse events: headache, asthenia, gastrointestinal disorders, orthostatic hypotension End of first intervention phase (Day 90)
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