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

NCT05439902 | Recruiting

• 1 other identifier: NIMAO/2021-1/EB-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (4)

• 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)

Secondary Outcomes (26)

• Urinary symptoms between groups

  Start of first intervention phase (Day 0)

• Urinary symptoms between groups

  End of first intervention phase (Day 30)

• Urinary symptoms between groups

  Start of first intervention phase (Day 60)

• Urinary symptoms between groups

  End of first intervention phase (Day 90)

• Post-mictional residue between groups

  Start of first intervention phase (Day 0)

Study Arms (2)

Tamsulosin

EXPERIMENTAL

Drug: Tamsulosin

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Tamsulosin DRUG

One 0.4mg Tamsulosin capsule taken per day for 30 days

Tamsulosin

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (1)

CHU de Nîmes

Nîmes, France

RECRUITING

MeSH Terms

Conditions

Multiple Sclerosis; Dysuria; Lower Urinary Tract Symptoms; Urinary Retention

Interventions

Tamsulosin

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds

Study Officials

• Stéphane DROUPY

  CHU de Nimes

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stéphane DROUPY

CONTACT

04.66.68.32.30; stephane.droupy@chu-nimes.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 27, 2022
• First Posted: June 30, 2022
• Study Start: October 5, 2022
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: June 25, 2024

Record last verified: 2024-06

Locations

FR (1)