Dose Response Curve - Sacral Nerve Stimulation for Faecal Incontinence
Descripción general del estudio
Estado
Condiciones
Descripción detallada
Faecal incontinence is a devastating condition with huge impact on quality of life. Sacral Nerve Stimulation (SNS) has since 1995 been a treatment option for patients not obtaining satisfactory continence result with standard non-surgical treatments. SNS is electrical stimulation of the sacral nerve root(s2,3 or 4). Stimulation of this nerve roots results in improved continence. The mechanism of action is at present not well described.
Standard the neuromodulator (pacemaker) stimulate with Frequency 14 Hz, pulse width 210 mic.sec. and amplitude set at sensory threshold. One study by SM. Koch et all confirms that subsensory stimulation can be effective. At present there is no doubled blinded study's to confirm this theory of effective sub sensory stimulation.
The aim of this study is to determine if subsensory stimulation will be as effective as stimulation with amplitude at sensory threshold. This will be investigated in 20 patients who have had at least a reduction in incontinence episodes or Wexner inc. score of 75 % between preimplantation and latest follow up. The patients will be randomized to three different amplitudes. 1: amplitude set at sensory threshold. 2: 75% of sensory threshold. 3: 50% of sensory threshold. The order of the three settings will be random and in a double blinded manner. The interval between these three pacemaker settings is four weeks. Patients serve as there own controls. Stimulation frequency (14 Hz) and pulse width (210 mic-sec) will remain fixed.
Evaluation will be by means of 4 week bowel habit diary and questionnaires (Wexner inc. score / St. Marks Score / Wexner constipation score / Altomares OD-score / IBS-score/ Rockwood FIQoL -score). All patients will be evaluated with anorectal measurements (sphincter strength and anorectal volume measurements) before any changes of stimulation amplitude.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Aarhus C
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Aarhus, Aarhus C, Dinamarca, 8000
- Anal Physiology Laboratory, Surgical Research Section 900, Aarhus University Hospital
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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:
- 18 years or older
- Informed consent
- Idiopathic fecal incontinence or Fecal incontinence due to small sphincter defect(≤60 o)
- fecal incontinence after primary/secondary sphincter repair
- Permanent neuromodulator (medtronic InterStim / Interstim II) implanted for at least 12 weeks before entering the study.
- Reduction in fecal incontinence episodes of at least 75% between baseline and latest follow up.(Bowel diary card) or 75% reduction of Wexner Inc. score.
- Willing and competent to fill out diary cards
Exclusion Criteria:
- Colorectal/proctological surgery since IPG-implant
- Pregnancy
- Anorectal Pain
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador activo: Sensory threshold - Amplitude
Stimulation amplitude set at sensory threshold.
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Sacral nerve stimulation with amplitude (sensory threshold), Frequency 14 Hz and pulse width 210 mic.sec.
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Experimental: 25% below sensory threshold - Amplitude
Stimulation amplitude 75% of sensory threshold.
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Sacral nerve stimulation with amplitude (75% of sensory threshold), Frequency 14 Hz and pulse width 210 mic.sec.
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Experimental: 50% below sensory threshold - Amplitude
Stimulation with amplitude set 50% below sensory threshold
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Sacral nerve stimulation with amplitude (50% of sensory threshold), Frequency 14 Hz and pulse width 210 mic.sec.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Number of incontinence episodes Assess number of incontinence episodes.
Periodo de tiempo: Will be assessed every four weeks during a twelve-week period
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Assess number of incontinence episodes, by means of bowel habit diary.
Four week bowel habit diary will be evaluated three times during the twelve-week protocol perioed.
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Will be assessed every four weeks during a twelve-week period
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Assess changes in anorectal volume and pressure with different amplitude.
Periodo de tiempo: Will be assessed every four weeks during a twelve-week period
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Resting and maximal anal sphincter pressure will be measured with different amplitude settings.
In total three evaluations will be made in the twelve week protocol perioed.
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Will be assessed every four weeks during a twelve-week period
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Assess Quality of life after decrease in stimulation amplitude.
Periodo de tiempo: Will be assessed every four weeks during a twelve-week period
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Quality of life will be recorded by means of Rockwood faecal incontinence quality of life score.
A total of three evaluations will be made every fourth week in the twelve week protocol perioed.
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Will be assessed every four weeks during a twelve-week period
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Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
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 (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
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
- 002 (University of CT Health Center)
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