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

22 maggio 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

24

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Luoghi di studio

  • Slovacchia
      • Martin, Slovacchia, 03601
        • Reclutamento
        • Clinic of Internal Medicine- Gastroenterology, University Hospital Martin
        • Contatto:
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: Electrical Stimulation + Active Contraction
Home-based anal electrical stimulation combined with synchronized active voluntary anal sphincter contraction for 12 weeks
Dispositivo: 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.
Comparatore attivo: Electrical Stimulation Alone
Home-based anal electrical stimulation alone without active voluntary sphincter contraction for 12 weeks.
Dispositivo: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in Vaizey (St. Mark's) Incontinence Score From Baseline to Week 12
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in Weekly Fecal Incontinence Episodes From Baseline to Week 12
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: Baseline to Week 12
Mean change in squeeze endurance measured during HRAM assessment.
Baseline to Week 12
Treatment Adherence Rate
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

University Hospital, Martin

Collaboratori

Comenius University

Investigatori

  • Direttore dello studio: Peter Liptak, MD, PhD, Clinic of Internal Medicine- Gastroenterology, University Hospital Martin, Jessenous Faculty of Medicine in Martin, Comenius University, Slovakia

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

15 maggio 2026

Completamento primario (Stimato)

1 maggio 2029

Completamento dello studio (Stimato)

1 maggio 2029

Date di iscrizione allo studio

Primo inviato

17 maggio 2026

Primo inviato che soddisfa i criteri di controllo qualità

17 maggio 2026

Primo Inserito (Effettivo)

22 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

28 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

22 maggio 2026

Ultimo verificato

1 maggio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • EK38/2026

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

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).

Periodo di condivisione IPD

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

Criteri di accesso alla condivisione IPD

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.

Tipo di informazioni di supporto alla condivisione IPD

  • STUDIO_PROTOCOLLO
  • LINFA

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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