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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorCentre Hospitalier Universitaire de Nīmes

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Crossover

Treatments tested in this trial

  • Tamsulosin

    Drug

    One 0.4mg Tamsulosin capsule taken per day for 30 days

  • Placebo

    Drug

    one placebo capsule per day for 30 days. with identical appearance (color and size) to the experimental drug, composed of microcrystalline cellulose

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: TamsulosinExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Urinary symptoms between groups

Measured using the International Prostate Symptom Scale (IPSS), scoring ranging from 0-35

Time frame
Start of first intervention phase (Day 0)
2

Urinary symptoms between groups

Measured using the International Prostate Symptom Scale (IPSS), scoring ranging from 0-35

Time frame
End of first intervention phase (Day 30)
3

Urinary symptoms between groups

Measured using the International Prostate Symptom Scale (IPSS), scoring ranging from 0-35

Time frame
Start of first intervention phase (Day 60)
4

Urinary symptoms between groups

Measured using the International Prostate Symptom Scale (IPSS), scoring ranging from 0-35

Time frame
End of first intervention phase (Day 90)

Secondary outcomes

1

Urinary symptoms between groups

Measured using the Urinary Symptom Profile (USP) questionnaire: score ranging from 0-39

Time frame
Start of first intervention phase (Day 0)
2

Urinary symptoms between groups

Measured using the Urinary Symptom Profile (USP) questionnaire: score ranging from 0-39

Time frame
End of first intervention phase (Day 30)
3

Urinary symptoms between groups

Measured using the Urinary Symptom Profile (USP) questionnaire: score ranging from 0-39

Time frame
Start of first intervention phase (Day 60)
4

Urinary symptoms between groups

Measured using the Urinary Symptom Profile (USP) questionnaire: score ranging from 0-39

Time frame
End of first intervention phase (Day 90)

Other outcomes

Sponsors and contacts

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