Multiple SclerosisALPHA-SEPNCT05439902
Efficacy of Alpha-blockers (Tamsulosin) in the Treatment of Symptomatic Dysuria in Multiple Sclerosis in Women
A study testing Tamsulosin in people with Multiple Sclerosis and Dysuria, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
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). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Multiple Sclerosis, Dysuria, Lower Urinary Tract Symptoms
- What is being tested?
- Tamsulosin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 5 Oct 2022to Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 14Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU de Nîmes
Nîmes
Anissa Megzari, 04.66.68.42.36, drc@chu-nimes.fr
Eric Thouvenot
About this study
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.
Read more
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
- Being tested
- Tamsulosin, Placebo
- Medical subject headings
- Multiple Sclerosis, Dysuria, Lower Urinary Tract Symptoms, Urinary Retention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TamsulosinDrug
One 0.4mg Tamsulosin capsule taken per day for 30 days
PlaceboDrug
one placebo capsule per day for 30 days. with identical appearance (color and size) to the experimental drug, composed of microcrystalline cellulose
| Study group | Role | What they receive |
|---|---|---|
| Tamsulosin | Experimental | Not described Receives: Drug: Tamsulosin |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary symptoms between groups
Measured using the International Prostate Symptom Scale (IPSS), scoring ranging from 0-35
Measured: Start of first intervention phase (Day 0)
Urinary symptoms between groups
Measured using the International Prostate Symptom Scale (IPSS), scoring ranging from 0-35
Measured: End of first intervention phase (Day 30)
Urinary symptoms between groups
Measured using the International Prostate Symptom Scale (IPSS), scoring ranging from 0-35
Measured: Start of first intervention phase (Day 60)
Urinary symptoms between groups
Measured using the International Prostate Symptom Scale (IPSS), scoring ranging from 0-35
Measured: End of first intervention phase (Day 90)
Secondary outcomes (26)
Urinary symptoms between groups
Measured using the Urinary Symptom Profile (USP) questionnaire: score ranging from 0-39
Measured: Start of first intervention phase (Day 0)
Urinary symptoms between groups
Measured using the Urinary Symptom Profile (USP) questionnaire: score ranging from 0-39
Measured: End of first intervention phase (Day 30)
Urinary symptoms between groups
Measured using the Urinary Symptom Profile (USP) questionnaire: score ranging from 0-39
Measured: Start of first intervention phase (Day 60)
Urinary symptoms between groups
Measured using the Urinary Symptom Profile (USP) questionnaire: score ranging from 0-39
Measured: End of first intervention phase (Day 90)
Post-mictional residue between groups
ml, measured with BladderScan
Measured: Start of first intervention phase (Day 0)
Post-mictional residue between groups
ml, measured with BladderScan
Measured: End of first intervention phase (Day 30)
Post-mictional residue between groups
ml, measured with BladderScan
Measured: Start of first intervention phase (Day 60)
Post-mictional residue between groups
ml, measured with BladderScan
Measured: End of first intervention phase (Day 90)
Maximum urine flow rate between groups
ml/s
Measured: Start of first intervention phase (Day 0)
Maximum urine flow rate between groups
ml/s
Measured: End of first intervention phase (Day 30)
Maximum urine flow rate between groups
ml/s
Measured: Start of first intervention phase (Day 60)
Maximum urine flow rate between groups
ml/s
Measured: End of first intervention phase (Day 90)
Quality of life linked to urinary dysfunction between groups
Qualiveen-30 questionnaire; score 0-4
Measured: Start of first intervention phase (Day 0)
Quality of life linked to urinary dysfunction between groups
Qualiveen-30 questionnaire; score 0-4
Measured: End of first intervention phase (Day 30)
Quality of life linked to urinary dysfunction between groups
Qualiveen-30 questionnaire; score 0-4
Measured: Start of first intervention phase (Day 60)
Quality of life linked to urinary dysfunction between groups
Qualiveen-30 questionnaire; score 0-4
Measured: End of first intervention phase (Day 90)
Quality of life between groups
EQ-5D questionnaire; score 0-100
Measured: Start of first intervention phase (Day 0)
Quality of life between groups
EQ-5D questionnaire; score 0-100
Measured: End of first intervention phase (Day 30)
Quality of life between groups
EQ-5D questionnaire; score 0-100
Measured: Start of first intervention phase (Day 60)
Quality of life between groups
EQ-5D questionnaire; score 0-100
Measured: End of first intervention phase (Day 90)
Fatigue between groups
Modified Fatigue Impact Scale; score 0-84
Measured: Start of first intervention phase (Day 0)
Fatigue between groups
Modified Fatigue Impact Scale; score 0-84
Measured: End of first intervention phase (Day 30)
Fatigue between groups
Modified Fatigue Impact Scale; score 0-84
Measured: Start of first intervention phase (Day 60)
Fatigue between groups
Modified Fatigue Impact Scale; score 0-84
Measured: End of first intervention phase (Day 90)
Drug safety
Yes/no occurence of the following adverse events: headache, asthenia, gastrointestinal disorders, orthostatic hypotension
Measured: End of first intervention phase (Day 30)
Drug safety
Yes/no occurence of the following adverse events: headache, asthenia, gastrointestinal disorders, orthostatic hypotension
Measured: End of first intervention phase (Day 90)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2022
- Study start5 Oct 2022
- Primary completionMar 2026 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stéphane DROUPY, Principal investigator, CHU de Nimes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05439902
- Sponsor's protocol ID
- NIMAO/2021-1/EB-01
- Acronym
- ALPHA-SEP
- Status last verified
- Jun 2024
- First submitted
- 27 Jun 2022
- Last updated
- 25 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Alpha-blockers (Tamsulosin) in the Treatment of Symptomatic Dysuria in Multiple Sclerosis in Women
- ClinicalTrials.gov ID
- NCT05439902
- Acronym / sponsor ID
- ALPHA-SEP / NIMAO/2021-1/EB-01
- Conditions
- Multiple Sclerosis, Dysuria, Lower Urinary Tract Symptoms, Voiding Dysfunction, Urinary Retention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 5 Oct 2022 (actual)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 30 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Tamsulosin | Experimental | Drug: Tamsulosin |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TamsulosinOne 0.4mg Tamsulosin capsule taken per day for 30 days | Drug | Tamsulosin |
| Placeboone placebo capsule per day for 30 days. with identical appearance (color and size) to the experimental drug, composed of microcrystalline cellulose | Drug | Placebo |
Primary outcome
Urinary symptoms between groups
Time frame: Start of first intervention phase (Day 0)
Measured using the International Prostate Symptom Scale (IPSS), scoring ranging from 0-35
Urinary symptoms between groups
Time frame: End of first intervention phase (Day 30)
Measured using the International Prostate Symptom Scale (IPSS), scoring ranging from 0-35
Urinary symptoms between groups
Time frame: Start of first intervention phase (Day 60)
Measured using the International Prostate Symptom Scale (IPSS), scoring ranging from 0-35
Urinary symptoms between groups
Time frame: End of first intervention phase (Day 90)
Measured using the International Prostate Symptom Scale (IPSS), scoring ranging from 0-35
26 secondary outcomes
Urinary symptoms between groups
Time frame: Start of first intervention phase (Day 0)
Urinary symptoms between groups
Time frame: End of first intervention phase (Day 30)
Urinary symptoms between groups
Time frame: Start of first intervention phase (Day 60)
Urinary symptoms between groups
Time frame: End of first intervention phase (Day 90)
Post-mictional residue between groups
Time frame: Start of first intervention phase (Day 0)
Post-mictional residue between groups
Time frame: End of first intervention phase (Day 30)
Post-mictional residue between groups
Time frame: Start of first intervention phase (Day 60)
Post-mictional residue between groups
Time frame: End of first intervention phase (Day 90)
Maximum urine flow rate between groups
Time frame: Start of first intervention phase (Day 0)
Maximum urine flow rate between groups
Time frame: End of first intervention phase (Day 30)
Maximum urine flow rate between groups
Time frame: Start of first intervention phase (Day 60)
Maximum urine flow rate between groups
Time frame: End of first intervention phase (Day 90)
Quality of life linked to urinary dysfunction between groups
Time frame: Start of first intervention phase (Day 0)
Quality of life linked to urinary dysfunction between groups
Time frame: End of first intervention phase (Day 30)
Quality of life linked to urinary dysfunction between groups
Time frame: Start of first intervention phase (Day 60)
Quality of life linked to urinary dysfunction between groups
Time frame: End of first intervention phase (Day 90)
Quality of life between groups
Time frame: Start of first intervention phase (Day 0)
Quality of life between groups
Time frame: End of first intervention phase (Day 30)
Quality of life between groups
Time frame: Start of first intervention phase (Day 60)
Quality of life between groups
Time frame: End of first intervention phase (Day 90)
Fatigue between groups
Time frame: Start of first intervention phase (Day 0)
Fatigue between groups
Time frame: End of first intervention phase (Day 30)
Fatigue between groups
Time frame: Start of first intervention phase (Day 60)
Fatigue between groups
Time frame: End of first intervention phase (Day 90)
Drug safety
Time frame: End of first intervention phase (Day 30)
Drug safety
Time frame: End of first intervention phase (Day 90)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stéphane DROUPY principal investigator
CHU de Nimes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tamsulosin in people with Multiple Sclerosis and Dysuria, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stéphane DROUPY (04.66.68.32.30, stephane.droupy@chu-nimes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urinary symptoms between groups (time frame: Start of first intervention phase (Day 0)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2024.