此页面是自动翻译的，不保证翻译的准确性。请参阅 英文版 对于源文本。

Active Versus Passive Anal Sphincter Training in Patients With Fecal Incontinence (ACTIPAST)

2026年5月22日 更新者：Peter Liptak、University Hospital, Martin

Fecal incontinence is a disabling condition that can substantially impair quality of life. This study evaluates whether home-based anal electrical stimulation combined with active voluntary anal sphincter contraction is superior to electrical stimulation alone in patients with fecal incontinence.

The study is a prospective, randomized, parallel-group, open-label controlled trial. Participants will be randomized in a 1:1 ratio to either electrical stimulation with synchronized active sphincter contraction or electrical stimulation alone. The primary outcome is the change in Vaizey/St. Mark's Incontinence Score from baseline to week 12. Secondary outcomes include fecal incontinence episodes, quality of life, anorectal manometry parameters, adherence, safety, and sustained response during follow-up.

研究概览

地位

招聘中

条件

干预/治疗

详细说明

This prospective randomized controlled trial will compare two home-based rehabilitation approaches for fecal incontinence. Eligible adult patients with urge, passive, or mixed fecal incontinence will be enrolled at study site: University Hospital Martin, Slovakia. Possibility to incorporate another study centre with be allowed. Participants will be randomized in a 1:1 ratio to one of two treatment arms.

In the active treatment arm, participants will use anal electrical stimulation combined with active voluntary anal sphincter contraction. Electrical stimulation will be delivered using the commercially available NeuroTrac Continence device with a frequency of 40 Hz, pulse width of 250 µs, 5-second ON and 10-second OFF cycles, 1-second ramp-up, and a session duration of 25 minutes. Stimulation intensity will be adjusted by the patient up to the maximum tolerable level without pain. Participants will be instructed to perform a maximum voluntary anal sphincter contraction for 5 seconds at the start of each stimulation ON cycle and to relax during the rest phase.

In the control intervention arm, participants will use identical electrical stimulation parameters but will remain relaxed during stimulation and will not perform active voluntary sphincter contractions. Both groups will receive standardized patient education, including device training and written instructions.

The intervention period will last 12 weeks. Study assessments will include the Vaizey/St. Mark's Incontinence Score, Fecal Incontinence Quality of Life scale, 14-day bowel diary, adherence assessment, adverse event monitoring, and high-resolution anorectal manometry. Optionally patients will be also assessed by endoanal ultrasound to detect possible structural abnormalities where clinical suspicion of these will be present. Assessments will be performed at baseline, week 12, and week 36 (as a post treatment follow up), with interim phone or secure online follow-up for adherence and safety. The primary endpoint is the mean change in Vaizey/St. Mark's Incontinence Score from baseline to week 12. Secondary endpoints include changes in weekly fecal incontinence episodes, FIQL subscales, anorectal manometry parameters, treatment adherence, adverse events, and sustained clinical improvement during follow-up.

研究类型

介入性

注册 (估计的)

24

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

  • 斯洛伐克
      • Martin、斯洛伐克、03601
        • 招聘中
        • Clinic of Internal Medicine- Gastroenterology, University Hospital Martin
        • 接触：
        • 接触：

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  • Signed informed consent
  • Age ≥18 years
  • Diagnosis of fecal incontinence (urge, passive, or mixed type) with at least 1 episode of involuntary stool leakage requiring hygiene intervention or underwear change per month for ≥3 months
  • Vaizey (St. Mark's) Incontinence Score ≥8
  • Ability to understand study procedures and comply with the 12-week home intervention
  • Willingness to attend all study visits and assessments
  • Stable medical management for fecal incontinence for at least 4 weeks prior to enrollment

Exclusion Criteria:

  • Complete spinal cord injury above the conus medullaris
  • Active inflammatory bowel disease flare requiring systemic therapy or not in clinical remission
  • Rectal prolapse requiring surgical intervention
  • Severe symptomatic hemorrhoids interfering with anorectal assessments or device use
  • Active anal fissure or perianal fistula
  • Active colorectal cancer or history of colorectal cancer within 5 years
  • Colorectal surgery within the previous 6 months
  • Pregnancy or planned pregnancy during study participation
  • Implanted cardiac pacemaker or defibrillator
  • Other implanted electrical devices contraindicating electrical stimulation
  • Previous specialized pelvic floor physiotherapy, biofeedback therapy, EMG-guided rehabilitation, or anal electrical stimulation within 3 months prior to randomization
  • Cognitive impairment preventing understanding of study procedures or informed consent
  • Uncontrolled severe diarrhea (>5 liquid stools/day)
  • Anal stenosis preventing probe insertion
  • Severe anal sphincter defect (>120° on ultrasound) requiring surgical repair
  • Isolated severe rectal sensory dysfunction without significant sphincter dysfunction
  • Previous pelvic radiotherapy
  • Concurrent participation in another interventional clinical trial

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
有源比较器：Electrical Stimulation + Active Contraction
Home-based anal electrical stimulation combined with synchronized active voluntary anal sphincter contraction for 12 weeks
设备：Home-based anal electrical stimulator
Home-based anal electrical stimulation delivered using the NeuroTrac Continence device. Stimulation parameters include frequency 40 Hz, pulse width 250 µs, 5 seconds ON and 10 seconds OFF cycles, 1-second ramp-up, session duration 25 minutes, and patient-adjusted intensity up to the maximum tolerable level without pain.
有源比较器：Electrical Stimulation Alone
Home-based anal electrical stimulation alone without active voluntary sphincter contraction for 12 weeks.
设备：Home-based anal electrical stimulator
Home-based anal electrical stimulation delivered using the NeuroTrac Continence device. Stimulation parameters include frequency 40 Hz, pulse width 250 µs, 5 seconds ON and 10 seconds OFF cycles, 1-second ramp-up, session duration 25 minutes, and patient-adjusted intensity up to the maximum tolerable level without pain.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Change in Vaizey (St. Mark's) Incontinence Score From Baseline to Week 12
大体时间：Baseline to Week 12
Mean change in Vaizey (St. Mark's) Incontinence Score between baseline and week 12. The Vaizey score ranges from 0 to 24, with higher scores indicating more severe fecal incontinence symptoms.
Baseline to Week 12

次要结果测量

结果测量
措施说明
大体时间
Change in Weekly Fecal Incontinence Episodes From Baseline to Week 12
大体时间：Baseline to Week 12
Mean change in the number of weekly fecal incontinence episodes recorded in a 14-day bowel diary.
Baseline to Week 12
Proportion of Participants Achieving ≥30% Reduction in Vaizey Score at Week 12
大体时间：Week 12
Percentage of participants achieving at least a 30% reduction in Vaizey (St. Mark's) Incontinence Score compared with baseline.
Week 12
Sustained Improvement in Vaizey Score at Week 36
大体时间：Baseline to Week 36
Mean change in Vaizey (St. Mark's) Incontinence Score at long-term follow-up compared with baseline.
Baseline to Week 36
Change in Maximum Squeeze Pressure on High-Resolution Anorectal Manometry
大体时间：Baseline to Week 12
Mean change in maximum squeeze pressure measured by high-resolution anorectal manometry (HRAM).
Baseline to Week 12
Change in Resting Anal Pressure on High-Resolution Anorectal Manometry
大体时间：Baseline to Week 12
Mean change in resting anal pressure measured by high-resolution anorectal manometry (HRAM).
Baseline to Week 12
Change in Squeeze Endurance on High-Resolution Anorectal Manometry
大体时间：Baseline to Week 12
Mean change in squeeze endurance measured during HRAM assessment.
Baseline to Week 12
Treatment Adherence Rate
大体时间：During the 12-week intervention period
Percentage of prescribed home stimulation sessions completed during the 12-week intervention period
During the 12-week intervention period
Incidence of Adverse Events and Device-Related Complications
大体时间：Baseline to Week 36
Number and type of adverse events and device-related complications reported during the study period.
Baseline to Week 36
Change in Fecal Incontinence Quality of Life (FIQL) Scores
大体时间：Baseline to Week 12
Mean change in FIQL subscale scores (Lifestyle, Coping/Behavior, Depression/Self-Perception, and Embarrassment) from baseline. FIQL subscale scores range from 1 to 4, with higher scores indicating better quality of life.
Baseline to Week 12

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

University Hospital, Martin

合作者

Comenius University

调查人员

  • 研究主任：Peter Liptak, MD, PhD、Clinic of Internal Medicine- Gastroenterology, University Hospital Martin, Jessenous Faculty of Medicine in Martin, Comenius University, Slovakia

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年5月15日

初级完成 (估计的)

2029年5月1日

研究完成 (估计的)

2029年5月1日

研究注册日期

首次提交

2026年5月17日

首先提交符合 QC 标准的

2026年5月17日

首次发布 (实际的)

2026年5月22日

研究记录更新

最后更新发布 (实际的)

2026年5月28日

上次提交的符合 QC 标准的更新

2026年5月22日

最后验证

2026年5月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • EK38/2026

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

De-identified individual participant data underlying the reported study results may be shared upon reasonable request to the principal investigator following publication of the primary results. Data sharing will be considered for methodologically sound research proposals and in accordance with institutional policies, ethical approval requirements, and applicable data protection regulations (including GDPR).

IPD 共享时间框架

Beginning 6 months after publication of the primary study results and ending 5 years after publication

IPD 共享访问标准

Access will be provided to qualified researchers whose proposed use of the data has been approved by the study investigators and relevant institutional authorities. A data access agreement may be required.

IPD 共享支持信息类型

  • 研究方案
  • 树液

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

订阅