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Acs-Tens Treatment for Faecal Incontinence: a RCT With Sham-controls

6. februar 2021 opdateret af: Tony Wing Chung Mak, Chinese University of Hong Kong

Transcutaneous Electric Nerve Stimulation on Acupoints (Acu-TENS) for the Treatment of Faecal Incontinence: a Prospective, Randomised, Sham-controlled Trial.

This study assess the effectiveness on AcuTENS on the treatment of faecal incontinence

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Faecal incontinence (FI) is the involuntary loss of flatus, liquid or solid stool per rectum. Owing to the emotional stress and the psychosocial stigma surrounding this problem, it is under-reported by patients.

Conservative management of FI involves lifestyle, medical adjustments and pelvic floor sphincter training. If conservative treatment fails, surgical options such as sphincter repair, sacral nerve stimulation (SNM) and percutaneous tibial nerve stimulation (PTNS) can be reformed. SNM and PTNS involve application of nervous electrical stimulation (neuromodulation) with significant improvement of symptoms. The positions of electrical stimuli are also very similar to acupuncture sites (acupoints) used in Traditional Chinese Medicine for the treatment of faecal incontinence. However, disadvantage of these methods are; 1) they are invasive and may cause complications such as pain, infection and bleeding and; 2) the devices for each SNM device can be costly.

Transcutaneous Electrical Nerve Stimulation (TENS) is non-invasive, which is commonly used for the management of pain. It works via the application of electrical stimuli using adhesive gel pads. They are cheap to run and are widely accepted by patients. Hence application of TENS over acupoints (Acu-TENS) may provide a novel non-invasive treatment.

A randomised controlled trial will be carried out on patients with FI. Demographic data, past medical history, in particular any structural or neurological causes of FI, will be recorded. Ano-rectal manometry and endoanal ultrasound will be performed before and after treatment. Acu-TENS machine will be applied to standardised acupuncture points. Assessment of FI via Cleveland Clinic Florida Faecal Incontinence Score and Quality of life measurements via the validated questionnaires Short Form 36 (SF-36) and the Fecal Incontinence Quality of Life Scale (FIQL) (Chinese version) questionnaires will be carried out at baseline, and followup intervals.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

53

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

  • Hong Kong
      • Sha Tin, Hong Kong
        • Chinese University of Hong Kong

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

18 år til 99 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Patients aged 18 years or above
  • Acupuncture naïve patients
  • Faecal incontinence with solid or liquid stool causing disruption of lifestyle
  • Psychological stability and suitability as determined by the investigator
  • Failed conservative or surgical treatment
  • Intact peripheral neurosensory nervous system as determined by clinical investigation
  • Able to read and write

Exclusion Criteria:

  • Major internal and/or external sphincter defect (>120 degrees of sphincter circumference)
  • Faecal impaction
  • Presence of full thickness rectal prolapse
  • Patients who have contact allergies to adhesive pads
  • Implanted pacemaker, defibrillator, cardiopathy
  • Pregnancy or intention to become pregnant
  • Neurogenic or congenital disorders resulting in faecal incontinence (e.g. Multiple Sclerosis, uncontrolled diabetes, Parkinson's disease, Spina Bifida)
  • Inflammatory bowel disease
  • Chronic diarrhoea uncontrolled by medication or diet
  • Previous rectal surgery (rectopexy or rectal resection)

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: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: AcuTENS
Patients treated with TENS over Acupuncture points for faecal incontinence
Procedure: AcuTENS
Stimulation of acupuncture points with TENS machine
Sham-komparator: Sham
Sham treatment arm with no electrical stimulations over acupuncture points
Procedure: AcuTENS
Stimulation of acupuncture points with TENS machine

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Effectiveness of AcuTENS as treatment for faecal incontinence compared with sham intervention
Tidsramme: post treatment 8 weeks and 6 months compared with baseline
Response to treatment is defined as 50% or greater change in Faecal incontinence Severity index score compared to sham
post treatment 8 weeks and 6 months compared with baseline

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Changes in the severity of faecal incontience
Tidsramme: post treatment 8 weeks and 6 months compared with baseline
Wexner score will be used the assess the severity of faecal incontinence
post treatment 8 weeks and 6 months compared with baseline
Episodes of faecal urgency per week
Tidsramme: post treatment 8 weeks and 6 months compared with baseline
the number of episodes of faecal urgency experienced by the patient per week
post treatment 8 weeks and 6 months compared with baseline
Reduction in the number of incontinence episode per week
Tidsramme: post treatment 8 weeks and 6 months compared with baseline
the number of episodes of faecal incontience experienced by the patient per week
post treatment 8 weeks and 6 months compared with baseline
Differences in Quality of Life score between two groups
Tidsramme: post treatment 8 weeks and 6 months compared with baseline
using the tradition chinese version of the faecal incontinence quality of life questionnaire (FIQL)
post treatment 8 weeks and 6 months compared with baseline

Samarbejdspartnere og efterforskere

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

Sponsor

Chinese University of Hong Kong

Samarbejdspartnere

Health and Medical Research Fund

Efterforskere

  • Ledende efterforsker: Tony WC Mak, MD, FRCS, Chinese University of Hong Kong

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)

1. august 2017

Primær færdiggørelse (Faktiske)

30. oktober 2020

Studieafslutning (Faktiske)

31. december 2020

Datoer for studieregistrering

Først indsendt

2. februar 2021

Først indsendt, der opfyldte QC-kriterier

6. februar 2021

Først opslået (Faktiske)

11. februar 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

11. februar 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

6. februar 2021

Sidst verificeret

1. februar 2021

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • HMRF13140421

Plan for individuelle deltagerdata (IPD)

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