Efficacy of Clean Intermittent Self-catheterization in Combination With Anticholinergic Drugs for Treatment of Bladder Dysfunction in Multiple Sclerosis
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 24
- 试验地点
- 5
- 主要终点
- Percent Change From Baseline in Frequency of Micturition Per Day at 8 Weeks.
研究概览
简要总结
The aims of this prospective, randomized study are:
- To assess the effect of clean intermittent catheterization (CIC)
- To investigate if MS patients will have symptom reduction (urgency, frequency, nocturia and incontinence) when using CIC in combination with anticholinergic drugs
- To identify at what volume of Postvoid Residual (PVR) urine, starting CIC improves bladder control and QoL
- To increase the evidence of CIC, and support clinical guidelines of bladder management in MS patients
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision of informed consent
- •Male and female patients aged 18 years and over
- •MS patients that are already currently treated or eligible for treatment with anticholinergic drugs
- •Patient with previously confirmed multiple sclerosis according to McDonald Criteria and level of disability less than 6.5 on the Kutzke scale and have been stable for 6 months
- •The patient has all or any bladder symptoms; urgency, frequency, incontinence, nocturia, PVR
- •The patient has Frequency symptoms > 8 voiding per 24 h
- •The patient has PVR > 50 ml, measured at two repetitive bladder scan measurements during the screening phase as well as the randomization visit
- •Adequate mobility to lower limbs, sufficient hand function and ability to practice CIC at least three times daily
排除标准
- •Pregnancy
- •Ongoing symptomatic Urinary Tract Infection (UTI) as judged by investigator
- •Involvement in the planning and conduct of the study (applies to both Astra Tech staff or staff at the study site)
- •The patient practices CIC prior the study
- •The patient has undergone a sphincterectomy
- •Progressive "Relapsing- remitting MS" as judged by the investigator
- •Severe non-compliance to protocol as judged by the investigator and/or Astra Tech
- •The patient is participating in other study that might have an impact on the outcome of this, as judged by investigator
- •PVR > 250 ml, measured at two repetitive bladder scan measurements during the screening phase as well as the randomization visit and or if Bladder Voiding Efficiency (BVE) at visit 2 (randomization) is 50% or less than visit 1 (screening)
研究组 & 干预措施
CIC using LoFric Primo
Anticholinergic medication according to clinical practice and investigator´s judgement and start of CIC using LoFric Primo catheters, i.e. Drug + Device.
干预措施: CIC using LoFric Primo (Device)
CIC using LoFric Primo
Anticholinergic medication according to clinical practice and investigator´s judgement and start of CIC using LoFric Primo catheters, i.e. Drug + Device.
干预措施: Anticholinergic medication (Drug)
Anticholinergic medication
Anticholinergic medication according to clinical practice and investigator´s judgement, i.e. Drug.
干预措施: Anticholinergic medication (Drug)
结局指标
主要结局
Percent Change From Baseline in Frequency of Micturition Per Day at 8 Weeks.
时间窗: Baseline and 8 weeks after randomization.
Number of micturitions per day was assessed using a patient diary during three days at baseline and after 8 weeks of treatment. The relative change in mean number of micturitions was compared between the groups. The change was calculated as percent change = ((measure at 8 weeks - measure at baseline)/measure at baseline)\*100%.
次要结局
未报告次要终点