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

22. maj 2026 opdateret af: 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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

24

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

  • Slovakiet
      • Martin, Slovakiet, 03601
        • Rekruttering
        • Clinic of Internal Medicine- Gastroenterology, University Hospital Martin
        • Kontakt:
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Electrical Stimulation + Active Contraction
Home-based anal electrical stimulation combined with synchronized active voluntary anal sphincter contraction for 12 weeks
Enhed: 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.
Aktiv komparator: Electrical Stimulation Alone
Home-based anal electrical stimulation alone without active voluntary sphincter contraction for 12 weeks.
Enhed: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Vaizey (St. Mark's) Incontinence Score From Baseline to Week 12
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Weekly Fecal Incontinence Episodes From Baseline to Week 12
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: Baseline to Week 12
Mean change in squeeze endurance measured during HRAM assessment.
Baseline to Week 12
Treatment Adherence Rate
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University Hospital, Martin

Samarbejdspartnere

Comenius University

Efterforskere

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

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

15. maj 2026

Primær færdiggørelse (Anslået)

1. maj 2029

Studieafslutning (Anslået)

1. maj 2029

Datoer for studieregistrering

Først indsendt

17. maj 2026

Først indsendt, der opfyldte QC-kriterier

17. maj 2026

Først opslået (Faktiske)

22. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

28. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

22. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • EK38/2026

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

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-delingstidsramme

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

IPD-delingsadgangskriterier

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-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Studerer et amerikansk FDA-reguleret enhedsprodukt

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