Active Versus Passive Anal Sphincter Training in Patients With Fecal Incontinence (ACTIPAST)
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.
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Peter Liptak, MD, PhD
- 電話番号：+421904820189
- メール：peter.liptak@gmail.com
研究連絡先のバックアップ
- 名前：Adam Lukac, MD
- メール：adamlukac99@gmail.com
研究場所
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-
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Martin、スロバキア、03601
- 募集
- Clinic of Internal Medicine- Gastroenterology, University Hospital Martin
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コンタクト：
- Peter Liptak, MD, PhD
- 電話番号：+421904820189
- メール：peter.liptak@gmail.com
-
コンタクト：
- Adam Lukac, MD
- メール：adamlukac99@gmail.com
-
-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
アクティブコンパレータ：Electrical Stimulation + Active Contraction
Home-based anal electrical stimulation combined with synchronized active voluntary anal sphincter contraction for 12 weeks
|
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.
|
|
アクティブコンパレータ：Electrical Stimulation Alone
Home-based anal electrical stimulation alone without active voluntary sphincter contraction for 12 weeks.
|
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.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Vaizey (St. Mark's) Incontinence Score From Baseline to Week 12
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Weekly Fecal Incontinence Episodes From Baseline to Week 12
時間枠：Baseline to Week 12
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Mean change in the number of weekly fecal incontinence episodes recorded in a 14-day bowel diary.
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Baseline to Week 12
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Proportion of Participants Achieving ≥30% Reduction in Vaizey Score at Week 12
時間枠：Week 12
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Percentage of participants achieving at least a 30% reduction in Vaizey (St.
Mark's) Incontinence Score compared with baseline.
|
Week 12
|
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Sustained Improvement in Vaizey Score at Week 36
時間枠：Baseline to Week 36
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Mean change in Vaizey (St.
Mark's) Incontinence Score at long-term follow-up compared with baseline.
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Baseline to Week 36
|
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Change in Maximum Squeeze Pressure on High-Resolution Anorectal Manometry
時間枠：Baseline to Week 12
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Mean change in maximum squeeze pressure measured by high-resolution anorectal manometry (HRAM).
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Baseline to Week 12
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Change in Resting Anal Pressure on High-Resolution Anorectal Manometry
時間枠：Baseline to Week 12
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Mean change in resting anal pressure measured by high-resolution anorectal manometry (HRAM).
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Baseline to Week 12
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Change in Squeeze Endurance on High-Resolution Anorectal Manometry
時間枠：Baseline to Week 12
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Mean change in squeeze endurance measured during HRAM assessment.
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Baseline to Week 12
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Treatment Adherence Rate
時間枠：During the 12-week intervention period
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Percentage of prescribed home stimulation sessions completed during the 12-week intervention period
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During the 12-week intervention period
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Incidence of Adverse Events and Device-Related Complications
時間枠：Baseline to Week 36
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Number and type of adverse events and device-related complications reported during the study period.
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Baseline to Week 36
|
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Change in Fecal Incontinence Quality of Life (FIQL) Scores
時間枠：Baseline to Week 12
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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.
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Baseline to Week 12
|
協力者と研究者
捜査官
- スタディディレクター：Peter Liptak, MD, PhD、Clinic of Internal Medicine- Gastroenterology, University Hospital Martin, Jessenous Faculty of Medicine in Martin, Comenius University, Slovakia
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
IPD 共有時間枠
IPD 共有アクセス基準
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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