Acs-Tens Treatment for Faecal Incontinence: a RCT With Sham-controls
Transcutaneous Electric Nerve Stimulation on Acupoints (Acu-TENS) for the Treatment of Faecal Incontinence: a Prospective, Randomised, Sham-controlled Trial.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Sha Tin, Hong Kong
- Chinese University of Hong Kong
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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)
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: AcuTENS
Patients treated with TENS over Acupuncture points for faecal incontinence
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Stimulation of acupuncture points with TENS machine
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Comparador falso: Sham
Sham treatment arm with no electrical stimulations over acupuncture points
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Stimulation of acupuncture points with TENS machine
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Effectiveness of AcuTENS as treatment for faecal incontinence compared with sham intervention
Periodo de tiempo: post treatment 8 weeks and 6 months compared with baseline
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Response to treatment is defined as 50% or greater change in Faecal incontinence Severity index score compared to sham
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post treatment 8 weeks and 6 months compared with baseline
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Changes in the severity of faecal incontience
Periodo de tiempo: post treatment 8 weeks and 6 months compared with baseline
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Wexner score will be used the assess the severity of faecal incontinence
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post treatment 8 weeks and 6 months compared with baseline
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Episodes of faecal urgency per week
Periodo de tiempo: post treatment 8 weeks and 6 months compared with baseline
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the number of episodes of faecal urgency experienced by the patient per week
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post treatment 8 weeks and 6 months compared with baseline
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Reduction in the number of incontinence episode per week
Periodo de tiempo: post treatment 8 weeks and 6 months compared with baseline
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the number of episodes of faecal incontience experienced by the patient per week
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post treatment 8 weeks and 6 months compared with baseline
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Differences in Quality of Life score between two groups
Periodo de tiempo: post treatment 8 weeks and 6 months compared with baseline
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using the tradition chinese version of the faecal incontinence quality of life questionnaire (FIQL)
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post treatment 8 weeks and 6 months compared with baseline
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Tony WC Mak, MD, FRCS, Chinese University of Hong Kong
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- HMRF13140421
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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Ensayos clínicos sobre AcuTENS
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Fundació Sant Joan de DéuDesconocidoEnfermedad Pulmonar Obstructiva CrónicaEspaña