Efficacy of Alpha-blockers (Tamsulosin) in the Treatment of Symptomatic Dysuria in Multiple Sclerosis in Women
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Urinary symptoms between groups
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Tamsulosin
干预措施: Tamsulosin (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Urinary symptoms between groups
时间窗: End of first intervention phase (Day 90)
Measured using the International Prostate Symptom Scale (IPSS), scoring ranging from 0-35
次要结局
- Maximum urine flow rate between groups(End of first intervention phase (Day 90))
- Quality of life linked to urinary dysfunction between groups(End of first intervention phase (Day 90))
- Quality of life between groups(End of first intervention phase (Day 90))
- Urinary symptoms between groups(End of first intervention phase (Day 90))
- Post-mictional residue between groups(End of first intervention phase (Day 90))
- Fatigue between groups(End of first intervention phase (Day 90))
- Drug safety(End of first intervention phase (Day 90))