NCT04707976招募中不适用
A Randomized Controlled Trial Comparing the Efficacy of Transanal Irrigation With Navina Smart Versus Standard Bowel Care in Patients With Multiple Sclerosis
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 92
- 试验地点
- 9
- 主要终点
- Change in fecal incontinence score.
研究概览
简要总结
A randomized, superiority, controlled, interventional, prospective, multicentre, post-market study of TAI with Navina™ Smart versus Standard Bowel Care performed in a population of 92 subjects suffering from Multiple Sclerosis and confirmed Neurogenic Bowel Dysfunction. The study is expected to last for a total of 8 weeks per subject with two scheduled site visits.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 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
- •For inclusion in the study, subjects must fulfil all of the following criteria:
- •Provision of informed consent.
- •Female or male aged 18 years or above.
- •Established diagnosis of MS according to McDonald criteria.
- •Patients with bowel symptoms post-dating and related to a diagnosis of MS.
- •Patients suffering from NBD symptoms defined by Wexner feacal incontinence score ≥10 and/or Cleveland Clinic constipation score ≥10 confirmed at Baseline.
- •Only TAI treatment naïve patient (not having previously used any particular TAI system).
- •Judged eligible for TAI as per standardized treatment pathway.
- •Able to read, write and understand information given to them regarding the study.
排除标准
- •Any of the following is regarded as a criterion for exclusion from the study:
- •Any confirmed or suspected diagnosis of anal or colorectal stenosis, active inflammatory bowel disease, acute diverticulitis, severe diverticulosis, colorectal cancer, ischemic colitis, history of life-threatening autonomic dysreflexia, bleeding disorders, unspecified peri-anal conditions.
- •Untreated rectal impaction.
- •Other significant neurological diseases (defined as all neurological diseases except for minor functional neurological syndromes or non-MS related neuro complications).
- •Opioid consumption ≤24 hours prior enrolment.
- •Previous colorectal surgery (including haemorrhoidectomy and fistulotomy), sphincter injury, perianal sepsis, rectal prolapse.
- •Performed endoscopic polypectomy within 4 weeks prior enrolment.
- •Ongoing, confirmed pregnancy or lactation.
- •Any neuromodulation that can affect the pelvic organ function.
- •Ongoing, symptomatic Urinary Tract Infection (UTI) at enrolment (defined as a positive urine culture of ≥10^3 CFU/ml of ≥1 bacterial species and presence of symptoms or signs compatible with UTI with no other identified source of infection).*
- •Current treatment with anticoagulants (exception acetylsalicylic acid or clopidogrel).
- •Current treatment with long-term systemic steroid medication (exception inhalation agents and/or local topical treatment).
- •Current treatment of prokinetics.
- •Involvement in the planning and conduct of the study (applies to both Wellspect HealthCare and site personnel).
- •Previous enrolment in the present study.
- •Simultaneous participation in another clinical study that may interfere with the present study as judged by the investigator.
- •Expected severe non-compliance to protocol as judged by the investigator.
- •Any other condition, as judged by the investigator, which might make follow-up or investigations inappropriate.
- •Any patient that according to the Declaration of Helsinki is unsuitable for enrolment.
- •Agranulocytosis (<0.5 10^9 / L) [Only applicable for Switzerland].
- •If symptoms and signs compatible with UTI is present but no urine culture test has been performed yet, a test should be performed, and the result received prior evaluating if the subject is eligible for study participation. After successful and completed treatment of a UTI, the subject may be rescheduled for Visit 1 in order to re-evaluate study participation.
研究组 & 干预措施
Navina Smart
Experimental
An electronic medical device to perform transanal irrigation. Treatment period 8 weeks.
干预措施: Navina Smart (Device)
Standard Bowel Care
Active Comparator
Supportive bowel care without using irrigation.
干预措施: Standard Bowel Care (Other)
结局指标
主要结局
Change in fecal incontinence score.
时间窗: 8 weeks
Relative change in Wexner fecal incontinence score at 8 weeks relative to Baseline in the TAI arm, compared to the SBC arm.
Change in fecal constipation score
时间窗: 8 weeks.
Relative change in Cleveland Clinic constipation score at 8 weeks relative to Baseline in the TAI arm, compared to the SBC arm.
次要结局
- Efficacy of TAI with Navina Smart vs. SBC(8 weeks)
- Navina Smart: Correlation APP/irrigation parameters(8 weeks.)
- Change in perception of impact of bowel symptoms on QoL(8 weeks)
- Change in bladder specific QoL(8 weeks)
- Change in NBD symptoms(4 weeks and 8 weeks)
- Study therapy adherence(4 weeks and 8 weeks)
- Frequency of UTI(8 weeks)
- Navina Smart: Correlation anorectal APP/irrigation parameters between responders/non-responders(8 weeks)
- Efficacy of TAI with Navina Smart vs. SBC(4 weeks)
- Navina Smart: Correlation APP/irrigation parameters(Up to 3 weeks)
- Navina Smart: Correlation APP/irrigation parameters(4 weeks)
- Navina Smart: Correlation anorectal APP/irrigation parameters between responders/non-responders(Up to 3 weeks)
- Navina Smart: Correlation anorectal APP/irrigation parameters between responders/non-responders(4 weeks)
研究者
研究点 (9)
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