Efficacy of Alpha-blockers (Tamsulosin) in the Treatment of Symptomatic Dysuria in Multiple Sclerosis in Women

Multiple Sclerosis Clinical Trial

— ALPHA-SEP  

Official title:

Efficacy of Alpha-blockers (Tamsulosin) in the Treatment of Symptomatic Dysuria in Multiple Sclerosis in Women

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05439902
• Other study ID #: NIMAO/2021-1/EB-01
• Status: Recruiting
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Dysuria
• Lower Urinary Tract Symptoms
• Multiple Sclerosis
• Sclerosis
• Urinary Retention
• Voiding Dysfunction

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)